The Regulatory Environment for

February 1986

NTIS order #PB86-182003 Recommended Citation: U.S. Congress, Office of Technology Assessment, The Regulatory Environment for Science —A Technical Memorandum, OTA-TM-SET-34 (Washington, DC: U.S. Government Print- ing Office, February 1986).

Library of Congress Catalog Card Number 86-600503

For sale by the Superintendent of Documents U.S. Government Printing Office, Washington, DC 20402 Foreword

The vitality of American science is a principal component of our country’s eco- nomic and intellectual success. Congress, among other institutions, bears responsibil- ity for nurturing creativity and exploration in science while providing appropriate safe- guards. Various direct and indirect forces, however, are continually altering the agenda for scientific endeavor, its methods and practices, and the dissemination of results. It is therefore essential that Congress, in providing direction and funding for science at the Federal level, understands these forces and how they are changing. This technical memorandum, requested by the Task Force on Science Policy of the House Committee on Science and Technology, provides a “snapshot” of factors affect- ing science in the 1980s, and focuses on emerging issues that will require consideration by Congress.

- JOHN H. GIBBONS Director

iii Regulatory Environment for Science OTA Project Staff

John Andelin, Assistant Director, OTA Science, Information, and Natural Resources Division

Nancy Carson Naismith Science, Education, and Transportation Program Manager

Project Staff

Marcel C. LaFollette, Project Director, OTA Fellow Kathi Hanna Mesirow, Analyst Barbara Berman, Research Analyst Eugene Frankel, Senior Analyst

Administrative Staff

Marsha Fenn, Administrative Assistant Betty Jo Tatum, Secretary Christopher Clary, Secretary Gala Adams, Clerical Assistant

Contractors

Michael S. Baram Bracken and Baram Sheldon Krimsky Department of Urban and Environmental Policy Jon D. Miller Public Opinion Laboratory Northern Illinois University Dorothy Nelkin Program on Science, Technology, and Society Cornell University Regulatory Environment for Science Advisory Panel

Harvey Brooks, Chairman Benjamin Peirce Professor of Technology and Public Policy Harvard University

Diana Dutton Jonathan A. King School of Professor of Molecular Biology Stanford University Institute of Technology Harold P. Green Alan McGowan Associate Dean for Post J.D. Studies President The National Law Center Scientists’ Institute for Public Information George Washington University John Shattuck Clifford Grobstein Vice President of Government, Community, and Department of Biological Science and Public Affairs Public Policy Harvard University University of California, San Diego Irving S. Johnson Vice President of Research Lilly Research Laboratories

Contributors

Philip Alexander John Doble Massachusetts Institute of Technology The Public Agenda Foundation Nicholas A. Ashford George Dummer Massachusetts Institute of Technology Massachusetts Institute of Technology R.J. Augustine John T. Edsall National Institutes of Health Harvard University George Bush Howard Gobstein Council on Governmental Relations U.S. General Accounting Office Milton Goldberg Council on Governmental Relations Arthur Caplan Loren Graham The Hastings Center Massachusetts Institute of Technology Rosemary Chalk Susan P. Hadden American Association for the Advancement University of Texas, Austin of Science Judith C. Harris David Cheney Arthur D. Little, Inc. U.S. Congress, Library of Congress Gerald Holton Congressional Research Service Harvard University Daryl E. Chubin Eric Holtzman Georgia Institute of Technology Mary E. Curtis John Wiley & Sons, Inc. Deborah Marquis Kelly Robert Pearson American Psychological Association Social Science Research Council Melvin Kranzberg Carroll Pursell Georgia Institute of Technology University of California, Santa Barbara Sanford P. Lakoff Harold Relyea University of California, San Diego U.S. Congress, Library of Congress Congressional Research Service Rachel Levinson National Institutes of Health Sal Restivo Rensselaer Polytechnic Institute Charles MacKay National Institutes of Health Jurgen Schmandt University of Texas, Austin Louis Menand Massachusetts Institute of Technology Jeffrey K. Stine U.S. House of Representatives Alexander Morin Committee on Science and Technology National Science Foundation Judith Swazey Herbert Morton Acadia Institute American Council of Learned Societies Ed Tocus Thomas H. Moss U.S. Food and Drug Administration Case Western Reserve University Charles Weiner Thomas Murray Massachusetts Institute of Technology Medical Branch University of Texas, Galveston Dael Wolfle University of Washington, Seattle Mark V. Nadel U.S. General Accounting Office Leo Young U.S. Department of Defense Dorothy Nelkin Cornell University Robert Newton National Science Foundation

vi Contents Page CHAPTER l: Executive Summary ...... 3 Forces Shaping Science...... 5 Importance of This Issue for Congress ...... 7 CHAPTER 2: Historical and Political Context for Regulation of Research . . . . 11 Changing Political Concerns ...... 13 The 1960s: Public Criticism of Science ...... 19 The “Limits to Inquiry" Debate ...... 23 Recent Restrictions on Scientific Communication ...... 27 Political Influences on Regulation ...... 28 CHAPTER 3: Social and Political Rationales for Controls on Research ...... 33 Regulatory Forces on the Research Agenda ...... 33 To Fulfill Political Objectives or Avoid Political Effects ...... 34 To Avoid Environmental Damage ...... 36 To Promote or Avoid Predictable Economic Consequences ...... 37 To Preserve Moral Values ...... 37 Regulation of Research Procedures and Protocols ...... 38 To Protect Human Health and Safety ...... 38 To Protect Animals Used in Experimentation ...... 41 To Protect the Environment ...... 42 Regulation of the Dissemination of Scientific Knowledge ...... 42 To Uphold Scientific Standards ...... 43 To Protect a Professional or Economic Interest ...... 44 To Protect the Health, Privacy, or Safety of Individuals ...... 45 To Protect National Military and Economic Security ...... 45 Summary ...... 47 CHAPTER 4: The Mechanisms for Direct Control of Research ...... 51 Mechanisms for Individual or Research Group Control ...... 53 Agenda Controls ...... 53 Controls on Procedures ...... 54 Communication Controls ...... 55 Regulations Imposed by Institutions ...... 55 Controls by Professional Organizations in Science and Engineering ...... 57 Mechanisms for Government Regulation ...... 58 Agenda Controls ...... 59 Controls on Procedures ...... 62 Communication Controls ...... 64 The Role of the Courts in the Regulation of Research...... 67 Mechanisms for Social Control Outside of Government ...... 68 Summary ...... 69 CHAPTER 5: Mechanisms for Indirect Control of Research ...... 73 Administrative Requirements on Universities That Accept Federal Grants or Contracts. . . . . 73 Protective Legislation and Agency Rulemaking ...... 76 Antidiscrimination Statutes ...... 76 Small Business Innovation Research Programs and Use of Services Regulations . 76 Privacy Legislation ...... 77 Environmental Legislation ...... 77 Occupational and Public Health and Safety Regulations...... 78 Right-To-Know Legislation ...... 78 CHAPTER 6: Institutional Differences ...... 85 Profile of a Representative Industrial Laboratory ...... 85 Control of the Research Agenda ...... 85 Controls on the Research Process ...... 86 Management of Risks ...... 86 Restrictions on Communication of Information ...... 87

vii Page Profile of a Representative Nonprofit Independent Laboratory ...... 88 Control of the Research Agenda ...... 88 Control of the Research Process...... 90 Management of Risks ...... 91 Controls on Communication of Information ...... 91 Profile of a Representative University Laboratory ...... 92 Controls on the Research Agenda ...... 92 Controls on the Research Process ...... 93 Management of Risks ...... 93 Restrictions on Communication of Information ...... 95 CHAPTER 7: Community Control of Research: Two Case Studies ...... 99 Research Involving Recombinant DNA Molecules ...... 99 Testing Chemical Warfare Agents ...... 101 Comparison of the Cases ...... 103 Origins of Local Regulations...... 103 Types of Local Interventions, ...... 104 Stage of the Scientific Enterprise Affected ...... 105 Social Risk Assessment ...... 105 Parties Affected by the Proposed or Actual Regulations ...... 106 Legal Issues...... , . . . .107 Impacts of the City’s Interventions Beyond Its Borders, ...... 108 Arguments For and Against Regulations ...... 109 Recombinant DNA Controversy ...... 109 The Case of Chemical Weapons Research ...... 110 General Policy Implications...... 112 CHAPTER 8: Research Policy Issues That May Warrant Congressional Attention in the Future...... , . .117 Who Bears the Burden of Proof?...... 117 The Scientist’s Role in Assuring Safe Research ...... 118 Ex Post Facto Restrictions on Research Communication ...... 119 “Gray Areas” of Sensitive Information and Broader Classification ...... 120 Impact of New Communications Technologies ...... 120 Patents ...... 121 Public Education on the Basis and Procedure for Regulation...... 121 Shift in the Jurisdiction for Regulation ...... 122 General Issues ...... 122 APPENDIX A: The Regulatory Environment for Science ...... 127 APPENDIX B: Public Attitudes Toward Science ...... 130 APPENDIX C: Environmental Concerns and Laboratory Siting: The Morris Township-Bellcore Case ...... 136 REFERENCES ...... 143

List of Tables Table No. Page 2-1. Funding of Research and Development by Source in 1960 and 1985...... 12 3-1. Justifications for Control of Research ...... 33 B-1. European Attitudes Toward Science, 1978 ...... 131 B-2. Expectations for Future Scientific Achievements, 1979-83 ...... 132 B-3. Attitude Toward Contribution of Science, by Attentiveness, 1957-83 ...... 132 B-4. Expectation for Future Achievements, by Attentiveness, 1979-83 ...... 133 B-5. Public Concerns About Science, 1957-83 ...... 133 B-6. Concerns About Science, by Attentiveness, 1957-83 ...... 134 B-7. Public Assessment of the Risks and Benefits of Science, 1972-85 ...... 135 B-8. Public Confidence in Science and Selected Other Institutions, 1973-84 ...... 135 C-1. Comparison of Three Cases Involving Local Control of Research ...... 140

Vlll Chapter 1 Executive Summary

Photo credit: National Institutes of Health Chapter 1 Executive Summary

This OTA technical memorandum examines the over controls on scientific and technical informa- social and legal forces that act to restrict or regu- tion deemed vital to national military or economic late scientific and engineering research in the interests indicate further erosion of the trust in United States today. Recent controversies over the scientists’ governance which characterized the use of animals in experimentation, the risks asso- postwar arrangements. The increased regulation ciated with recombinant DNA research, and na- may also indicate that science is simply included tional security controls on scientific communica- as a target of society’s increasing willingness to tion have focused congressional attention on the regulate all types of institutions, professions, or policy issues raised when government intervenes activities. in the research process. As each issue has arisen, A wide spectrum of social and political ration- Congress has been called on to decide when and ales (ch. 3) ma justify controls linked to a spe- where intervention is appropriate, and how to y cific part of the research process: selection of structure intervention so as to protect public topic, experimentation or other procedures, and health and safety or national security without un- dissemination of results. The moral and ethical duly retarding scientific progress. At the request concerns expressed in attempts to restrict research of the Task Force on Science Policy of the House are not new. What is new, however, is the rais- Committee on Science and Technology, OTA ing of such concerns to the level of government looked at the entire “regulatory environment” for action or legally enforceable regulations. Some research, with the goals of analyzing the struc- governmental regulations manifest concerns about tures and mechanisms for regulation and of iden- the potential risks of a line of research; they dem- tifying significant policy issues that may require onstrate that society wants to protect the health congressional attention in the future. and safety of experimental subjects. Government Although scientists have always exercised re- restraints on the communication of scientific and straints on their work, the present system of gov- technical information seek to protect militarily ernment-based, legally enforceable regulations is sensitive information or to curtail economic losses relatively new (ch. 2). Until 1945, constraints were associated with international technological com- limited to social prohibitions on sensitive topics, petition. Public opinion data show that such reg- some controls on agricultural research, and na- ulation may reflect the American public’s willing- tional security controls on technical communica- ness to restrict research when the risk is perceived tion during wartime. Post-1945 arrangements for to be too great, despite the concurrent existence the support of science treated it as distinct from of widespread public support for science as a cul- other types of government programs in that it tural activity deserving Federal support. should be free from direct government control or Analysis of the mechanisms by which restraints economic self-interest and that scientists could be are imposed at the laboratory, institutional, or trusted to govern their own affairs. governmental levels (ch. 4) shows that controls The uncovering of a number of examples of in the modern research environment are wide- abuses of human subjects, growing fears that sci- spread, synergistic, and cumulative. They affect entific research was posing high risks to human every stage of the research process—what topics health, the identification of research with govern- may be pursued, how they may be pursued, and ment-sponsored activity, and the social and po- when and to whom the research may be dissemi- litical climate of the 1960s and 1970s (ch. 2), led nated. Institutional mechanisms include formal to a series of regulatory actions that began to con- administrative policies, institutional review com- strain not just what topics scientists should pur- mittees, or institutional cooperation with exter- sue, but also how they should be pursued and the nal requests for constraints. Professional socie- results disseminated. More recent controversies ties set up codes and guidelines and may cooperate

3 4

with government attempts to impose dissemina- force. Such regulations could have a long-term tion controls. Government control mechanisms adverse effect on innovation and progress in re- include: review commissions and ethics advisory search, There is clearly a need for better documen- boards, legislative review of proposals or projects, tation and monitoring of possible unintentional moratoria, regulations on the use or possession adverse effects on research and, in some cases, of substances used in research, interpretation of there may be a need to consider specific legisla- agency regulations, contract provisions, and dis- tive exemptions for research. semination or publication controls. The channels The local government interventions described through which government can affect research— in chapter 7, and in the case study in appendix legal regulations, formal administrative controls, C, point to a potential for increased confronta- judicial actions, priority-setting through budget tions between State and local authorities and the allocations—have increased in the last decade, Federal Government regarding the jurisdiction for largely because of increased Federal support of regulation. Should science be controlled through science (and, therefore, increased channels for im- a combination of self-regulation and broad Fed- plementation of regulations), but also because of eral oversight, insulated from local laws? The general demands for accountability and the wid- emergence of a number of cases in which research ening impact of science on society. The very mul- facilities have been the subject of local protests tiplicity of mechanisms for restraint increases the indicates that research no longer wears a mantle possibility that such regulations will be imple- of unquestionable civic respectability. Instead, it mented piecemeal, in isolation, and without co- is subject to the same political influences and atti- ordination, and that they therefore may produce tudes at the local level as are other institutions. an adverse synergistic effect on the progress of science and the research base for innovation. Given these circumstances, several changes may occur in the near future (ch. 8). One is a shift in As the case study in chapter.5 shows, the reg- who must bear the burden of proof for control ulatory effects, especially on the research proc- of research. That responsibility is increasingly ess, are not confined to basic research in univer- shifting to the regulated researcher, who must sities, even though most of the discussion of and prove that the research is safe or anticipate complaints about overregulation has been con- whether dissemination of the research results may centrated there. Many of the mechanisms de- have some adverse effect on the national inter- scribed in chapter 4—e.g., controls on research est. As this situation changes, the Federal Gov- materials, human subjects regulation, dissemina- ernment will increasingly have to consider the tion controls—apply with equal force to research appropriate role for scientists in the regulatory in industry and private laboratories. process itself. How much should be left to infor- In many cases, science may not have been so mal practice and how much required through leg- much singled out for control, however, as sim- ally enforceable regulation? Congress can also ex- ply sharing in society’s growing propensity for pect to confront a number of communications-re- regulating all types of specialized institutions or lated issues in the future. These issues relate to activities. Such regulations include administrative the need to protect both freedom of speech and reporting requirements for Federal grants and con- the freedom of scientific inquiry necessary to cul- tracts, social programs legislation (e.g., affirma- tivate progress and innovation. How should these tive action), Occupational Safety and Health freedoms be balanced with the very real need to Administration (OSHA) regulations and right- protect national military and economic interests? to-know laws, and laws and policies relating to Whether through ex post facto restrictions on international diplomatic relations. Although these hitherto unclassified research or through the actions are designed to serve a public objective broadening of “gray areas” of sensitive informa- and not to restrain research, they can add to an tion, the short-term goals of communication con- existing financial and administrative burden of in- trols must be balanced carefully against their long- tentional controls and their effects can be much term effects on the Nation’s science and technol- more difficult to avoid after they are legally in ogy base and on opportunities for U.S. scientists 5

to benefit from interactions with foreign col- Policy Task Force and for Congress. First, how leagues. can Congress assure balance among the protec- tion of public health and safety, the rights of Computerization of the scientific communica- citizens to govern their local communities, and tion system may also raise in the next decade the freedom of individual scientists, whether of equally difficult issues regarding not only the pro- speech or action? Second, how can the regulatory tection of intellectual property but also the ease process and the opportunities for public discus- and speed of classification of information. Issues sion of regulation be structured so that compet- of patent reform will continue to create the po- ing interests are negotiated before issues reach a tential for significant secondary effects on the re- stage of controversy and hostility? Third, which search system—both in what type of basic re- issues should receive congressional or State or lo- search is sponsored by industry and in interference cal attention and which are best left to the self- with intercollegial communication of ideas. Final- regulation of the research communities? And, ly, the apparent increase in regulatory activity at fourth, what can Congress do to assure that this the State and local level may be an indication of environment does not unduly erode innovation a jurisdictional shift in the initiative for regula- and creativity in U.S. industry or unreasonably tion, from Federal to State or local, with the ac- damage the Nation’s investment in university companying potential for “Balkanized” regula- research? tions and differential strictness of regulation. This new “regulatory environment for research” raises many important questions for the Science

FORCES SHAPING SCIENCE

Scientific research* —i.e., the organized, sys- training and education of its participants—that tematic search for knowledge about, insight to, are independent of specific project goals. Re- or understanding of a subject—is significantly in- straints on research may affect the choice of which fluenced by its social and political context. For subject to investigate or which to fund (controls example, the pressures of U. S, economic compe- on topic); the method by which that investiga- tition in world markets and the linking of research tion proceeds, including the tools of research and accomplishments to national stature affect which the objects or animals manipulated during the re- research is funded and which research results may search (controls on procedure); and the timing of be widely disseminated. Increased public aware- and audience for descriptions of the research and ness of the negative of the research its results (controls on communication). This re- results or processes have created pressure for gov- port analyzes the influences at each of these stages. ernment control. Thus, scientific research can be Different social or political mechanisms can in- constrained both for political and social purposes, fluence the research process in different ways. and when it is regarded as a negative force out Public approval or disapproval of research topics of control or a force that may become negative or procedures may be expressed in political dem- if allowed to continue. onstrations against laboratories, through refer- No matter what the field or institutional set- enda and local initiatives, as well as through moral ting (university, government, or industry), the re- condemnation and social pressure.1 search process has certain common characteris- More formal control is exercised through, for tics—e.g., in the use of a scientific knowledge example, laws passed specifically to direct some base, in the methods of investigation, and in the ‘Loren R. Graham, “Concerns About Science and Attempts to ● The report is not concerned with controls on the application of Regulate Inquiry, “ Limits of Scientific lnquir~, Gerald Holton and research knowledge in medical practice, commercial development Robert S. Morison (eds. ) (New York: W.W. Norton & Co., IQ7Q), of a product, or similar exploitation of research results. pp. 1-22. 6 aspect of the research process, through Federal mented for reasons associated with economic or interpretation of the language of such laws, or military protection. For both basic and applied through the provision or denial of research funding. research, such controls may take the form of a prior restraint on research publication or a denial Other economic or political forces can affect of access to laboratories. When controls are im- research through government actions intended to posed on basic research in universities, however, have some other effect. Economic considerations, the benefits of such controls may not be perceived the need to protect proprietary interests, Federal by the institution as outweighing the adverse ef- protections on public health and safety, and other fects on the education and training of students. Federal and State legislation may influence indus- Because such restrictions often appear to violate trial or other nonacademic research, For exam- traditions of academic freedom, universities may ple, the Food and Drug Administration’s (FDA) oppose their implementation. Critics of sweeping regulatory requirements, which govern the intro- controls argue that, in the long run, such restraints duction of new drugs, are reported to have slowed could harm the quality of the scientific work force, pharmaceutical industry research on new drugs, the traditional climates for creativity, and the particularly on “orphan drugs” (drugs for rare dis- progress in basic science which is necessary to eases), z where the cost of those regulations has technological advancement. not been outweighed by favorable economic and market conditions. In contrast, however, the even This OTA report takes a look at the entire range more stringent requirements of Nuclear Regula- of social, political, and economic forces that re- tory Commission and FDA regulations on radio- strain all stages of the research process, in all types pharmaceuticals appear not to have affected that of institutional settings, and that prompt changes research adversely. More favorable economic and in research projects or create sufficient political market forces allow these firms to overcome the pressure for the development of legislation or ad- effect of any regulatory burden. ministrative controls. In examining this “regula- tory environment, ” the OTA project attempts to The attitudes and professional values of the sci- locate the common ground, the similarities among entific community itself have played a prominent what on the surface may seem to involve dramat- role in influencing and sometimes constraining re- ically different issues and controversies. Restric- search activities. Self-imposed constraints were tions on communication, for example, are not used in the 1970s, for example, during the debate only confined to basic researchers in universities. over recombinant DNA. Molecular biologists ex- Controls and regulations—both internally and ex- ercised “restraint and caution” in their research ternally imposed—also affect scientists in indus- procedures and adhered to a voluntary morato- try and in government at all stages of research. rium on recombinant DNA research, even though The OTA study looks at research—regardless of they “had no certain proof that the need for limi- where or by whom it is conducted—as a univer- tation existed or that the consequences of it would 3 sal activity, searching for common factors in the be positive. ” mechanisms, justifications, and effects of the reg- Finally, control on the communication of scien- ulatory environment. A few restrictions apply tific and technical information may be imple- equally to all parts of the research system, to in- dustries as well as universities; others apply to spe- IBarry S. Roberts and David Z. Bodenheim, “The Drug Amend- ment of 1962: The Anatomy of Regulatory Failure, ” Arizona State cific parts of the process or only to one field. The [Jw Journal, vol. 1982, No. 3, 1982, p. 587, differences may be only in the extent to which re- ‘Clifford Grobstein, A Double Image of the Double Helix (San strictions are enforced or publicly discussed. Francisco, CA: W.H. Freeman & Co., 1979), p. 2. 7

IMPORTANCE OF THIS ISSUE FOR CONGRESS

Increased awareness of how science and tech- society. . . .“ The Task Force has focused on two nology affect both social structure and social aspects of this issue in particular: 1) how to shape values and vice versa has prompted increased the future regulatory environment for science pressure for political intervention in what hereto- while still responding to the necessity to avoid the 6 fore has been a decisionmaking activity domi- ill effects arising from regulating science; and 2) nated by scientists or science managers; but such how “the legislative and regulatory authorities interaction worries researchers who are accus- representing society as a whole can protect pub- tomed to substantive control over all aspects of lic health, safety, and values while avoiding the their own work. So there is a search underway imposition of unnecessary restraints on science.”7 for institutional forms that could permit more The topic of the regulatory environment for re- public involvement in critical policy decisions and search thus involves discussion of some of the yet still preserve “the flexibility y needed for the pur- most basic questions of American political phi- suit it of scientific research.”4 Congress may desire losophy: public control v. self-rule, Federal v. lo- or may be asked to play a role in developing these cal jurisdiction, the feasibility of regulation and new arrangements. the importance of consent by the regulated, gov- Agency regulations-and many of the second- ernment regulation v. individual liberty, and how ary controls on research —are also related directly to balance the conflicting rights and values of to the amount of Federal support available to sci- different social institutions. The events and the entific and engineering research and to priority debate will continue. Congress can expect to con- setting for allocation of that support. As the Task front these issues again and again. An Agenda for a Study of Gov- Force document, For many research areas, the question in the states: ernment Science Policy, 1980s is not whether there should be any limits . . . the immediate goals to which science can be but, instead, “what those limits should be. . . . expected to contribute, such as improved health, [A]nd, if we can define those boundaries, what a cleaner environment, and enhanced technologi- control options will maintain them most effec- cal innovation, cannot be considered in isolation. tively?” 8 The organized scientific community now Broader societal goals . . . should be taken into appears to acknowledge the need for “some po- consideration when formulating the goals for 5 litical and public input to the setting of the gen- science. eral directions and agenda of scientific research, ” Another aspect that relates directly to the work just as the political sphere appears to have ac- of Congress is the suggestion that some regula- cepted the importance of “some degree of self- tions instituted for legitimate and laudable social governance and internal agenda-setting” by the or political reasons may be having secondary, un- scientific community. The real issues have be- anticipated, and adverse effects on the quality of come, as Harvey Brooks notes, “where the lines science and may thereby diminish science’s use- should be drawn and the appropriate processes fulness to society. Regulation, according to the by which the scientific and political communities Task Force Agenda, “is one of the few areas in should negotiate the scientific agenda.”9 which the aims of science and the aims of society are not necessarily congruent. The manner in which these conflicting aims are accommodated is of significant importance to both science and

‘1’~ncl on .R-len(c and Te(hn(>logJ,: Science and IIangrrh (\\’a\h- ]ngt(~n, I)C I’re\]dent’s C (,mm]sti(,n for a N“ational Agenda for the Elxhtl[>> 1 Q80J, p 1 ~. [ I $ ( (~n~re~>, I {OLIW C(\mm]ttc,e on Sclt, nce and Technology, rc14. F(~rce (Jn Sclcnce I)OIIC~ .An Agenda t(lr J .Studjr of C;OL’ern- rnt’nt S[ It’nc e 1‘(1/IcIr Q8t h Con~ ~c~ ~c~ss ( \\rash I n~t (}n, I )( : [~ .$. ( ,(~lernmc’nt [’r]nt;ng (l ft]ce, 1 Q85 }, p 8 Chapter 2 Historical and Political Context for Regulation of Research Chapter 2 Historical and Political Context for Regulation of Research

In the context of the current extensive and often pened during wartime. During World War I, for generous support for scientific and engineering re- example, scientists had accepted military restric- search in the United States, it is easy to forget that, tions on their communications; they were subject although scientists have always exercised a vari- to censorship and were, in some cases, persuaded ety of restraints on their own work, the present to delay publication until the end of the war.4 The governmentally imposed, legally enforceable con- American Chemical Society had even opposed straints on research topics, procedures, and com- President Wilson’s order transferring gas warfare munication are relatively new. Most of the cur- research from Bureau of Mines control to War De- rent regulatory schemes were developed alongside partment control, not out of anti-war fervor but the post-World War II arrangements for Federal because it “feared the numbing effect of the . . . financing of research and were influenced by the ‘red tape’ of War Department methods upon the political attitudes and assumptions governing spirit of originality, daring and speed in follow- those arrangements and how they were instituted. ing new trails, so essential to the successful prose- cution of research. ”5 The chemists predicted a Before World War II, many scientists consid- “national disaster” if the “fast machine” of gas re- ered Federal research grants to private universi- search was slowed. Such attitudes of arms-length ties—where most basic research was conducted— cooperation with government were prevalent in to be improper if not unconstitutional. ’ In the the scientific community during the first part of 1930s, for example, the leaders of the National the century. Academy of “objected on principle to letting private universities accept government Before the 1940s, industry supported a substan- funds. ”2 In part, this attitude had to do with the tial proportion of the Nation’s research and de- scientists’ fears of losing autonomy. Some univer- velopment (R&D) effort; the Federal Government sity research was supported by the professors played a relatively minor part. Scientists in the themselves. They were not required to account 1930s felt confident in asserting that “most of our to the government for their time or for minor ex- great advances in the past have been through pri- penditures; “They simply did what research their vate initiative, “ including both industry and pri- other duties and their pocketbooks allowed them vate foundations.6 Even as late as 1940, the Fed- to do. ”3 But objections were also linked to con- eral Government paid only for about 19 percent cern that government funding might provide the of the Nation’s $345 million expenditures for scien- opportunity for restraints on research, as had hap- tific research and development.7 Since 1940, these funding patterns have changed ID(~n K. Price, “Enclless Frontier or Bureaucratic Morass?” The Lrnits ot .%entific inquiry, Gerald Holton and Robert S, Morison dramatically and, along with them, the regula- (eds. ) (New York: W,W. ,Norton & Co., 1979), pp. 75-92. tory environment for U.S. research in science and ‘Ibid, In 1445, Frank B. Jewett, President of the National Acad- Science in the Federal Government (Cam- emy of Sciences and also of Bell Labs, opposed the creation of the 4 A. Hunter Dupree, National Science Foundation on these grounds. In letters to Vanne- bridge, MA: Harvard University Press, 1957); also see Harold C, var Bush, ]ewett stated that private initiative should furnish the Relyea, “Increased National Security Controls on Scientific Com- means for fundamental research: munication, ” Government Information Quarter/j’, vol. 1, No. 2, Ever\ d]rect or ]ndlrect subvention by Government is not only coupled 1984, pp. 187-188. ]newltab[y w]th bureaucratic types of control, but []kewwe w]th polit]- ‘David Rhees, American Philosophical Society, personal commu- cal cent rol and w] th the urge to create pressure groups seek]ng to ad- nication, 1985, vance \peclal Interests ‘Robert H. Kargon (ed. ), The Maturing of American Science Merton J, England, A Patron for Pure Science (Washington, IX (Washington, DC: American Association for the Advancement of National Sc]ence Foundatlorr, 1Q82), p. 35, Science, 1974). ‘James I’enick, Jr., et al. (ecis. ), Politics of American Science, 1930 7John R. Steelman, ScJence and Public Policy, vol. 1 (New York: to the Present (Cambridge, MA: The MIT Press, 1972), p. 7, Arno Press, reprinted from 1947), p. 11,

11 engineering. As the Federal Government has as- Prior to the postwar infusion of Federal funds, sumed an ever larger share of all U.S. research government aid to science in the universities had funding, the institutional responsibility for also been managed with a philosophy of “loose nourishing the research system has begun to shift. control’’—sponsors of unclassified research left the In 1960, the government was funding about 57 researchers more or less free to conduct their re- percent of all basic and applied research in the search as they believed scientifically appropriate United States; industry, 37 percent; universities, and free to disseminate their results, subject to mi- 3 percent. By 1985, the government’s share was nor supervision and general accountability. The nearly 50 percent; industry’s, over 41 percent; and scientists perceived any threat to their autonomy universities’, 6 percent. The responsibility for as a questioning of their authority and expertise, basic research also appears to be shifting to the During World War II, of course, that autonomy Federal Government (from 60 percent in 1960 to had been curtailed, but after the wartime secu- almost 67 percent in 1985) while the responsibil- rity restrictions were lifted, government control ity for applied research has shifted to industry of research tended to return to the prewar man- (from 40 percent in 1960 to nearly 55 percent in agement model, expressing a basic political trust 1985). (See table 2-l. ) Who funds and sponsors in the productiveness and reliability of scientists. research can have considerable impact on the lo- George Pimentel, Professor of Chemistry at the cus for regulation and on the type of regulatory University of California at Berkeley, character- mechanism chosen. The shifts of funding source izes that post-1945 philosophy as one of “fund in the last 5 to 10 years, therefore, may be one creative people, but don’t tell them what to do.”8 explanation for the signs of strain described in this Especially over the last 40 years, however, the cli- report, as industry becomes subjected to regula- mate of unassailable autonomy has evolved into tions originally intended for basic research con- the current climate of strong economic support ducted in a university setting (e.g., recombinant coupled with attentive direction. Researchers now DNA regulation), and universities are asked to operate in a mixed environment of incentives and comply with regulations originally intended for restrictions, 9 which often replace scientists’ own industry. professional judgments about what subjects to work on and how to proceed. A quite different shift in emphasis has also oc- Table 2-1 .—Funding of Research and Development by Source in 1960 and 1985 curred in where the research is performed and therefore in who actually does the research. In 1960 1985 1940, 70 percent of government-funded basic re- Basic research: search took place in government facilities. By Federal Government...... 60.00/0 66.60/0 1944, only 30 percent was performed in govern- Industry ...... 28.5 18.7 Universities/colleges ...... 6.0 10.0 ment facilities; 50 percent was performed by pri- 10 Applied research: vate firms; and 20 percent in universities. After Federal Government...... 56.0 39.7 the war, the pattern of funding again changed, Industry ...... 40.0 54.6 Universities/colleges ...... 2.0 3.6 but the distribution among performers remained Basic and applied research: similar. Industrial spending for R&D began to in- Federal Government...... 57.0 49.5 crease. By 1982, industry was carrying out even Industry ...... 37.0 41.4 more of the Nation’s research (72 percent); univer- Universities/colleges ...... 3.0 6.0 sities, 9 percent; Federally Funded Research and Development: Federal Government...... 68.0 45.2 8U. S. Congress, House Committee on Science and Technology, Industry ...... 31.6 54.3 Science Policy Task Force, Hearing, Feb. 28, 1985. Universities/colleges ...... — — ‘Thane Gustafson, “Survey of the Structure and Policies of the Research and development: U.S. Federal Government for the Support of Fundamental Scien- Federal Government...... 64.6 46.7 tific Research, ” Systems [or Stimulating the Development of Basic Industry ...... 33.4 50.0 Research Washington, DC: National Academy of Sciences, 1978), Universities/colleges ...... 1.0 2.0 p. I-82. 1ODavid Noble, Th Forces J’roductjon (New SOURCE: Division of Science Resources Studies, National Science Foundation, e of York: Alfred A. 1985 Knopf, Inc., 1984). 13

Development Centers, 3 percent; nonprofit insti- to a fourth change in how science was funded and tutions, 3 percent; and government labs, 13 per- organized. Increased Department of Defense cent. ” The impact of this shift was to extend gov- spending led to an increased proportion of re- ernment control of research—through grant and search either totally classified—and hence per- contract provisions—into the private sector. formed away from traditional research networks— or else having the potential for classification (or Finally, the discovery during World War II– similar control) because of its potential military and in the subsequent U.S. nuclear program— applications. The course of the last 40 years has that basic research could have considerable value also seen significant shifts in the proportion of for maintaining the Nation’s military security led basic research sustained by the defense agencies and, as a consequence, shifts in the climate of 1 I William C. Boes man, Science Policy Research Division, “U.s. Civilian and Defense Research and Development Funding, ” Report more or less classification of new areas of basic No, 83-183, Congressional Research Service, Aug. 29, 1983. research.

CHANGING POLITICAL CONCERNS*

Before World War II, national politics had only ing. Although new and different, this relationship minimal influence on the research agenda for sci- with government proved to be successful for both ence and engineering. Because the Federal Gov- parties. ernment funded very little university research, for As the war was ending, the scientists who had example, it did not have the administrative mech- been administering the Federal research effort be- anisms for exerting influence. Only in a few se- gan to discuss how the science-government rela- lected fields, such as agriculture, did the agenda tionship might be sustained and structured after respond to political influence. 12 Moreover, even the war, The incentives were many. Not only had if scientists wanted society to benefit from their World War 11 fostered the creation of a formal activities, the traditions of science offered no pat- administrative relationship between government terns to guide them and few mechanisms through and science but the results of scientific projects which to provide advice to society. Scientists who such as radar and penicillin had also demonstrated were distrustful of government argued that finan- the power and potential of government-funded, cial dependence on government might damage the government-directed science. By and large, the “autonomy of their intellectual activities” in un- 13 community of scientists and friends of science predictable ways. agreed on the need for a government agency to This independence was put aside temporarily channel funding for basic research. They dis- during World War II, when thousands of scien- agreed, however, about the institutional structure tists and engineers worked, either as military or of such an organization and about who would ex- civilian personnel, in such government research ercise (and to what extent) political control over projects as the Committee on Medical Research the research agenda .14 (part of the Office of Scientific Research and De- There were two well-defined perspectives on velopment (OSRD)) and the Manhattan Project. how the postwar relationship should be struc- Most were required to shift to a different line of tured. The most prominent spokesman for a research. They conducted their inquiries under model of loose Federal control was Vannevar government control and with government fund- Bush, a Massachusetts Institute of Technology engineer who was Director of the wartime Office *This section benefits from work done at OTA by George Hoberg, of Scientific Research and Development, President Massachusetts Institute of Technology, in August 1984. IZAndr~ Mayer and Jean Mayer, “Agriculture: The Island Em- of the Carnegie Institution of Washington, and pire, ” Daedalus, vol. 103, summer 1974, pp. 83-96,

1 ~Lewis E, Auerb ach, “Scientists in the New Deal, ” fkfjnerva, vol. 3, summer 1965, pp. 457-482. IJNoble, op. cit., p. 192. 14 a principal science advisor to President Roosevelt. such funds should be composed of citizens selected Actively opposed to the Bush position was Sena- only on the basis of their interest in and capacity tor Harley Kilgore, (D-WV), who was supported to promote the work of the agency. They should by such scientists as Harold C. Urey, Edward U. be persons who understand the peculiarities of Condon, and Harlow Shapley. A group within scientific research and education, but need not be the executive branch, led by Presidential Assis- scientists. 3) The agency should promote research tant John R. Steelman, also opposed the Bush po- through contracts or grants to organizations out- sition and participated in the postwar debate on side the Federal Government, but should not oper- how the National Science Foundation would be ate any laboratories of its own. 4) Control of pol- structured. icy, personnel, and the method and scope of supported research should be left to the research Bush’s perspective on control of research was institutions themselves. 5) And finally, the agency most clearly articulated in the 1945 report Science should be responsible to the President in that pol- —The Endless Frontier. Written at President icies and procedures would be guided by the ex- Roosevelt’s request, the “Bush report” outlined a ecutive branch. The advocated policy was that plan for organizing science after the war. Bush “scientists should have control over how these wanted to create a secure funding base for Amer- funds were distributed, to ensure that the best ican scientific research while protecting science’s science was supported as it had been by OSRD traditional independence in matters of agenda, 17 during the war." Bush was not, however, “ask- procedure, and communication. Because there ing for free access to the Treasury; funds expended had been such clear separation between science in this way would represent only a small propor- and government before the war (and because the tion of those spent on research and development circumstances that had brought them together through the mission agencies of the Executive during the war were clearly unusual), the Bush 18 Branch . . . .“ report had to construct a basic argument for sup- port. It found the justification in a classic Amer- Although the report acknowledged the neces- ican metaphor: “Basic United States policy” had sity of wartime security restrictions, it advocated traditionally been to advance all types of front- that, when the war was over, scientists should iers, thus the Federal Government must take on once again enjoy freedom of inquiry. Controls new funding responsibilities to assure adequate should also be lifted on scientific information— cultivation of those “areas of science in which the especially that related to medicine—of potential public interest is acute” but where private sources use to civilian institutions. 19 Bush believed that may not supply sufficient resources.15 “Scientific removing the wartime controls would help to re- progress is essential, ” the Bush report stated, to cover “that healthy competitive scientific spirit so wage war on disease, to assure the future of Amer- necessary for expansion of the frontiers of scien- ican industry, and to prevent future military con- tific knowledge. ”20 Scientific progress, the report flicts. 16 continued, results from “the free play of free in- tellects, working on subjects of their own choice, In its plan for how such responsibilities would in the manner dictated by their curiosity for ex- be fulfilled, the Bush report provides a measure 21 ploration of the unknown. ” And open publica- for subsequent change in the regulation and con- tion of the research would be to the benefit of the trol of research. The report proposed five princi- Nation. ples to guide the government’s new role in science: 1) Whatever the extent of support may be, there must be stability of funds over a period of years so that scientists may undertake long-range re- search programs. 2) The agency to administer 1’Alex Roland, testimony before the U.S. Congress, House Com- mittee on Science and Technology, Science Policy Task Force, Mar. “Vannevar Bush, Science—The Endless Frontier, a report to the 7, 1985. President on a Program for Postwar Scientific Research (Washing- 1‘Ibid. ,~Eush, cit. r ton, DC: National Science Foundation, 1980 (reprinted from Of- op. P. 28’ fice of Scientific Research and Development, 1945)), p. 12. 201 bid., p. 12. ‘* Ibid., p. 5, * i Ibid, 15

One of the committees that assisted Bush, the to be left to the discretion of the new science agen- Committee on Science and the Public Welfare, * cy’s governing board .27 gave strong support to the idea that traditional These and many other of the Bush report’s rec- models of university research be preserved. Uni- ommendations were subsequently incorporated in versity research must not be “distorted” by the legislation (which Bush helped to draft) introduced government’s encouragement to examine short- by Senator Warren Magnuson (D-WA) in 1945. range problems at the expense of more fundamen- tal problems, for “. . . the freedom of the scien- The Bush report did not, however, represent tist may be decreased by the introduction of some a consensus in either the scientific or political com- degree of commercial control. ”22 Society must munities. During the war, Senator Harley Kilgore guard science against too much control by indus- held a series of hearings on post-war planning for try as well as by government. That committee science, before a subcommittee of the Senate urged the new agency “to devise ways and means Committee on Military Affairs. And in 1945, he of allocating funds in large measure without de- introduced a bill which expressed his ideas for a termining what particular problems are to be national science foundation. He favored a direc- worked on and who is to carry them out. ” “Va- tor who was appointed by and much more poli- riety” and “decentralization” foster novelty, they tically responsible to the President than had been wrote.23 advocated in the Bush report. Moreover, Kilgore’s position was that “organizations receiving funds The Medical Advisory Committee voiced sim- should be free to conduct their research and de- ilar concerns. If Federal aid was “misdirected, ” it velopment work in a manner which they think could do “serious harm” to the development of most productive, subject only to a routine super- medical science. Therefore, the new agency’s di- vision and review by the foundation. “28 rection and policies should be administered by people “who are experienced in research and who Soon after the publication of Science— The End- understand the problems of the investigator. “24 less Frontier, President Truman’s Scientific Re- The government should encourage “individual ini- search Board, objecting to what they considered tiative and freedom of research. ” Control that is to be an “underlying anti-democratic sentiment” too close (or, in the Committee’s words, “regimen- in the Bush report, issued their own report. The tation”) could lead to “mediocre work” and “dis- White House study, directed by John R. Steelman, astrous impairment . . . of research itself. ”25 placed the basic questions of science policy in a political context: “Public policy cannot be shaped Industry-based research, if it was to flourish in a vacuum and recommendations for a national after the war, also required some special arrange- policy on science must necessarily reflect many ments. Patent laws designed to “stimulate new considerations but remotely connected with the inventions” would “make it possible for new in- 29 laboratory. ” dustries to be built around new jobs and new processes” and would help small industries, the The “Steelman report” was just as effusive as Bush committees asserted. Although they were the Bush report in its praise of the social benefits concerned about the domination of markets by emanating from scientific advance and in the tone big industry, the committees did not support gov- of its underlying rationale for support of science: ernment ownership of patents;26 patent policy was “It is difficult to think of any other national activ- ity which more directly benefits all the people or which makes a larger contribution to the national 30 welfare and security. " But, despite agreement ‘Chairman of the Comrnlttee was Isaiah Bowman, I)resldent Ok on the need for a significant Federal role in fund- the J[>hns Hopk]ns University. ‘ 2 Bush, (>p. cit , p. Q] “lbld,, p Q4 ‘-blerton J. England, A Patron tor I’ure Science (Washington, DC ‘Ibid., p. 02 National Science Foundatl[)n, 1Q82 }, p. 14 ‘ Ibid p 03 2HI’en]ch, et al., op. c]t,, w>] 1, p. O ‘bl)anlel Ke\les, The [%~wclsts (New }’ork: Alfred A, Kn~]pf, Inc , “Steelman, op cit., vol. 1, p. b, 1Q78), pp. 342-344, “’Ib]d., v()] 1, p, Zb. 16 ing basic science and in training scientific person- tions of democratic government or from tested nel, the reports differed on the organization of principles of administrative organization, ”35 in- funding and on the control of the research proc- cluding the principles of close accountability and ess. The Steelman report did not object to fund- avoidance of the concentration of power. ing research in government laboratories; it rec- The conservative view represented by the Bush ommended maintaining the extant distribution of report regarded government intervention as a po- funds among universities, industry, and govern- 36 tential threat to scientific liberty, an attitude ment labs31 and it recommended that the new viewed by some as reflecting a lack of faith in the agency’s director be appointed by and responsi- competence of government administrators. But ble to the President. the Bush report supporters were also convinced The Steelman report also concluded that gov- that science was distinct from other types of gov- ernment security regulations should not be applied ernment programs, that it must be free from po- widely but instead should be applied “only when litical control, and that, to be successful, scien- strictly necessary and then limited to specific in- tists should be able to direct their own affairs. struments, machines or processes. They should Non-scientists might administer the foundation not attempt to cover basic principles or fundamen- but it would be the scientists who, through advi- tal knowledge. ”32 In the conclusion to Volume I, sory groups and a system of review by scientific “A Program for the Nation, ” the report states:33 peers, would decide how research should be con- ducted and would influence the research agenda, . . . it is sometimes argued that . . . the world This demand to have “support without control, ” is in its present state because the physical sciences have developed too rapidly and have unleashed according to one commentator, amounted to “be- forces too strong for us to control. It has even stowing upon science a unique and privileged been suggested that a moratorium should be place in the public process—in sum, for science called in science, while we catch our breaths. governed by scientists, and paid for by the pub- This is a doctrine of weaklings and of men of lie. ”37 little faith in the ultimate capacity of our peo- ple. There can never be too much knowledge, On July 22, 1947, Congress passed legislation though it can be discovered at uneven rates in (S.526, National Science Foundation Act of 1947, various fields. The cure is not to slow down the 80th Congress, 1st session) to establish a National runner who is ahead—but to extend a helping Science Foundation (NSF), This legislation con- hand to those who are behind. tained no patent provisions, no authority for sup- port for the social sciences, no mechanisms for The differences between the Bush and Steelman geographical distribution, and a large degree of reports represented more than the usual political autonomy from Presidential control .38 The gov- disagreements about the administration of a new erning structure was the most important point of agency. They reflected fundamentally different argument, however. When President Harry Tru- conceptions of the relationship between govern- man vetoed this first NSF legislation, he objected ment and science. The political perspective rep- primarily to the bill’s provisions for lack of politi- resented by the Kilgore hearings and the Steelman cal control. In his veto message, Truman stated:39 report regarded science as a special interest. Al- though large-scale government support for science . . . this bill contains provisions which represent was a new phenomenon, science was not consid- such a marked departure from sound principles ——- -—— ered to be sufficiently different from other pol- ‘ 5 Sleelman, op. cit., vol. 1, p, 31. icy areas to warrant any special political relation- ‘bEngland, op. cit., pp. 35-36, ships. 34 The characteristics of science were not “Daniel S. Greenberg, The Politics of Pure Science (New York: New ,4merican Library, 1967), p. 107, There was precedent for this believed to “justify a departure from our tradi- arrangement in the National Advisory Committee on Aeronautics (NA(’A), of which Bush was chairman in 1939. See James Killian, Sputrik, Scientists and Eisenhower (Cambridge, MA: The MIT Sllbid,, vO1. 1, p. 27. Press 1977). ~ZIbid, , vol. 3 p. 37. 3aEng]and, op. Cit., Pp. 78-80. Sslbid,, VO1. 1, p. 68. 3’Congressiona/ Record, vol. 93 (Washington, DC: U.S. Govern- JdNob]e, op. cit., P. 15 ment Printing office, Nov. 17, 1947), p. 10568. 17

for the administration of public affairs that I can- may be supported. . . without controlling or dis- not give it my approval. It would, in effect, vest turbing the aim of the investigator or the course the determination of vital national policies, the of the research. “42 The ONR contracting system expenditure of large public funds, and the admin- extended the traditional military R&D contract- istration of important governmental functions in ing with industry to research establishments, par- a group of individuals who would be essentially ticularly academic institutions, thereby enabling private citizens. The proposed National Science Foundation would be divorced from control by the government to utilize the most skilled scien- the people to an extent that implies a distinct lack tists and engineers available to do weapons re- of faith in democratic processes. search. Three years later, after extended debate and po- After several years of debate between the Budget litical maneuvering, another bill was passed by Bureau, NSF, and other agencies over NSF’s role Congress (National Science Foundation Act, May in Federal science policy, on March 19, 1954, 10, 1950, 64 Stat. 149) and signed by President President Eisenhower issued Executive Order 43 Truman. This bill represented a compromise be- 10521 that established the new agency’s role. tween the opposing political groups, but probably NSF’s role in policy development and evaluation reflected the preferences of a substantial portion was to be “cooperative rather than . . . regula- of the scientific community. The director of the tory. ” NSF was not made the principal Federal NSF would be appointed by the President, and sponsor of basic research; instead, the order sanc- the bill included a mandate for evaluating and co- tioned a pluralistic system of Federal support. It ordinating all Federal research efforts. It also pro- encouraged other agencies to sponsor basic re- vided that these responsibilities be shared with a search that was “closely related to their mis- 4 part-time National Science Board, organized along sions. “4 the lines suggested by Bush. The bill did not The Order declared that one of the purposes change patent granting procedures. for NSF’s establishment had been to develop and The Foundation’s first director, Alan Water- encourage pursuit of an appropriate and effective man, was previously the chief scientist at the Of- national policy for the promotion of basic research fice of Naval Research (ONR). He considered any and education in the sciences. From time to time, “centralized evaluation of Federal research impos- NSF would recommend to the President Federal sible and inappropriate. ”40 His experience at ONR policies that would strengthen the national scien- undoubtedly influenced the shape he gave to the tific effort and it would furnish guidance toward new foundation, for that agency had maintained defining the responsibilities of the Federal Gov- an unusual contract research program, especially ernment in the conduct and support of scientific in basic research. Established by an Act of Con- research. The Foundation, in concert with each gress in 1946, ONR was to “provide scientific liai- Federal agency concerned, would review the scien- son with the War Department and with that novel tific research programs and activities of the Fed- and highly effective civilian organization, the Of- eral Government in order to formulate methods fice of Scientific Research and Development. ”41 for strengthening the administration of such pro- The philosophy that guided ONR was best under- grams and activities by the responsible agencies; stood in its view of the basic researcher as one it would study areas of basic research where gaps “motivated by curiosity and interest in science or undesirable overlapping of support may exist; rather than applicability, ” and the administrator and it would make recommendations to the heads as influenced by the agency’s “practical mission. ” of agencies concerning the support given to basic The key was to keep these perspectives separate: research. “In this way selected mission-related basic research

dOKev]es, op. cit., p. 360; England, oP. cit., P. 149, ‘]Alan T. Waterman, “Pioneering in Federal Support of Basic Re- 5 search, ” Research in the Service of National Purpose: Proceedings dlwarren weaver, quoted in Weyl, oP. cit., P. of the Office of Naval Research Vicennial Convocation, F. Joachim ‘3 England, op. cit., ch, 10. 44 Weyl (cd. ) (Washington, DC: Office of Naval Researchr 1966), p. 3, 1 bid., ch, 15. 18

Sharp divisions over the political control of re- modeled their patent provisions on the Atomic search were not unique to the debate on the Na- Energy Act, would have enabled the government tional Science Foundation. In the late 1940s and to maintain ownership of patents generated by 1950s, intense debate preceded the creation of NASA-funded research. The final legislation gave both the Atomic Energy Commission (AEC) and patent ownership to the government, but also the National Aeronautics and Space Administra- gave the administrator of NASA the authority to tion (NASA), debates that also focused on pat- waive title. Similar discussions and debates over ent policies, communication restrictions, and the political control of research or of research mechanisms for political control of each agency. products took place during the development of other Federal agencies and programs. The legislation creating the Atomic Energy Commission–the Atomic Energy Act of 1946 Another critical outcome of the postwar sup- [Public Law 585] –gave the Federal Government port of science was the burgeoning of the National “an absolute monopoly over all aspects of atomic Institutes of Health (NIH), which before the war energy research, development, and production, ” had been a small “oldline” Federal health research including provisions to control the dissemination organization. The Public Health Service had been of data related to atomic weapons and the pro- created in 1912 to increase biomedical research duction, or use of fissionable material .45 This tight directly related to large public health problems. Federal structure essentially removed control of At the end of the 1920s, an effort to establish NIH even peacetime atomic energy research, or re- promoted a stronger Federal role in the encourage- search directed at civilian power applications, ment of research, and in 1930, the Ransdall Act from the scientific community that had developed expanded and redesigned the Hygenic Laboratory the research field in the first place. Moreover, it of the Public Health Service into NIH. Public and created a situation in which all atomic weapons congressional desire to find a cure for cancer re- or atomic energy information was “born classi- sulted in the creation of the National Cancer In- fied.” As political analyst Harold Relyea and stitute in 1937. others have pointed out, these provisions meant During World War II, advances in biomedical that no special governmental effort was necessary research had helped to demonstrate dramatically to bring such information under the statute’s “um- 46 the effects of Federal funding of biomedical re- brella of secrecy.” The Act also prohibited the search. This success reinforced intensive lobby- issuance of patents for inventions useful in the ing during the 1950s, by public interest groups and production or utilization of fissionable material. a number of powerful individuals, for aggressive Although these patent provisions were relaxed NIH-funded research focused on specific health somewhat in the subsequent Atomic Energy Act problems, Congress often responded to this pres- of 1954 and although that revision also author- sure by identifying and funding research areas that ized the controlled involvement of private indus- had broad public appeal, but that were scientifi- try in nonmilitary atomic technologies, many of cally misunderstood. The director during this the most stringent controls on research initiated period, James V. Shannon, was able to moder- by the original Act—including those on who may ate, however, between the call for targeted re- do such research or have access to technical in- search and the need for basic medical research; formation for such research—remained in force. he persuaded Congress that funding of both basic The initial legislation in 1958 to create the Na- and applied research was essential to reach the tional Aeronautics and Space Administration con- goals of diagnosing and curing disease. tained language that would have created a much Reflecting on the sweep of events during the for- looser policy on patents for that agency. But draft mation of the current bureaucratic arrangements bills in both the House and the Senate, which for science, Don K. Price has observed that the scientists engaged in constructing these arrange- ments adopted a three-part tactic to avoid, in par- 45 Harold C. Relyea, “Information, Secrecy, and Atomic Energy, ” ticular, the constraints in choice of topic which New York University Review of Law and Social Change, vol. 10, had characterized pre-war agricultural research .47 No. 2, 1980-1981. —— 401 bid., p. 269. ~7PriCe, op. cit., p. 77. 19

First, they sought to combine research with proposed by the scientists gave them a political university teaching. They regarded such an ar- authority not dependent on popular votes .50 In rangement as “the best way of strengthening basic many cases, they gained this control through a research in the one setting most free of commer- growing system “of policy planning by part-time cial self-interest or political pressure—the univer- advisers under government grants and contracts. ” sity, ”48 thereby obtaining a stable base from which But as Price notes carefully, the authority gained to defend science’s independence against “popu- by the scientists was not the type defensible as lar passions or economic self-interest. ” Second, a Constitutional right; rather, it was a delegated they focused on the mechanism of the project authority. “[I]t depended on the continued confi- grant, because it “offered a tactic to avoid detailed dence among elected politicians in the assumption congressional control of funds” and also allowed on which the tacit bargain was founded—that Federal support to universities “without adopt- basic research would lead automatically to fruit- ing a general program of aid to higher educa- ful developments. ”51 tion. ”49 And third, the pattern of organization —— “Ibi~ , p. 78 ‘“Ibid. “Ibid, “Ibid., p, 80.

THE 1960s: PUBLIC CRITICISM OF SCIENCE

In the 1960s, questioning of several of these suggested that “every physical and chemical lab- basic assumptions began to shape a new political oratory be closed for about ten years to enable receptivity to science. More and more questions society at large to assimilate the staggering amounts were raised about the negative effects of scientific of new scientific knowledge. ” Although he report- knowledge, including both its informative value edly spoke partly in jest, the shock of such a sug- and its use as technology. News reports of cal- gestion produced considerable reaction in the loused abuse of human subjects in scientific ex- United States as well and the Bishop’s remark be- perimentation led to political calls for increased came the stimulus for debate over the “primacy social accountability. Vigorous criticism of science of ends over means” and the moral depth of came from a number of quarters: intellectual and science. 53 In the 1930s, many scientists expressed theological questioning of the philosophical foun- their apprehension about “anti-intellectuals who dations of science; the linking of science with war wish to impose ideological or theological con- (which came out of the protest against the Viet- straints on research, ”54 and humanists and the- nam war and nuclear escalation); concerns about ologians voiced their concern that science was like science’s “technological side effects” on the envi- an engine out of control. Many of these same con- ronment; and ethical questions about research cerns cropped up again in the 1960s in several procedures. As a 1971 Organisation for Economic widely-circulated intellectual criticisms of the Co-Operation and Development report, Science, scientific establishment and social values, such as Growth, and Society, observed, “Scientific re- Herbert Marcuse’s One-Dimensional Man (1964). search itself became associated in the minds of An early example of the 1960s questioning was many with war, and with environmental and so- 55 the controversy that arose over Project Camelot , cial deterioration resulting from the large-scale ap- 52 “Carroll Purse]], plication of technology.” “ ‘A Savage Struck by Lightning’: The Idea of A Research Moratoriumr 1927 -37,” Lex et Scierrtia, vol. 10, October- It is important to recognize, however, that the- December 1974, pp. 146-158. Siprice, Op. cit., P . 76. ological or political efforts to control or regulate 5’For more extensive discussion of Project Camelot, see TecAni- research are neither unique to the United States cal information for Congress, report to the U.S. Congress, House nor new. In 1927, for example, an English cleric Committee on Science and Technology, Subcommittee on Science, Research, and Technology, July 1979, pp. 145-179. Also see Irving

“Science, Growth and %ciet} (Parisr France: Organisation for L. Horowitz, “The Life and Death of Project Camelot, ” Trans- Economic Co-Operation and Development, 1971 ). action, November-December 1965, pp. 4-10. 20

In his 1961 message on the defense budget, Presi- science for military purposes .57 At some institu- dent John F. Kennedy, motivated by the first tions, the result of such activities was that clas- Cuban crisis and growing instability in some de- sified weapons research was transferred to lab- veloping countries, had proposed to increase the oratories that were off-campus and separately U.S. capability in dealing with “guerilla forces, administered. insurrections, and subversion, ” by strengthening Concerns about military domination of aca- military resources of anthropological, cultural, demic science were not confined to campus ac- and other social science data in relevant geo- tivists and scientists. Senator William J. Fulbright graphic regions. The result of this proposal was proclaimed in a 1967 Senate speech: 58 Project Camelot, a Department of Defense (DOD) project in applied research in the social sciences. The universities might have formed an effec- The project would have attempted to study the tive counterweight to the military-industrial political, economic, and social preconditions of complex by strengthening their emphasis on instability and potential Communist usurption of traditional values of our democracy, but many power in several developing countries. Political of our leading universities have instead joined reaction to the project, however, was strong and the monolith, adding greatly to its power and in- fluence. significantly negative. Congress opposed DOD in- trusion into foreign policy and the military take- Acting on these concerns, Congress passed an over of foreign policy research, and feared the po- amendment in August 1969 to the Defense Au- tential damage in foreign relations with Latin thorization Bill of 1970 which included language American countries. Social scientists were con- prohibiting DOD from funding basic research not cerned about military sponsorship of social science directly related to a specific military function or research and, more generally, about the relation- operation. Called the “Mansfield Amendment” af- ship between the Federal Government and the so- ter Senator Mike Mansfield (D-MT), who was a cial science community in the utilization of so- cosponsor and one of its most outspoken de- cial science research and data in serving national fenders, Section 203 of Public Law 91-121 sought purposes. As a result of the controversy, Project to realign the funding patterns for basic science :59 Camelot was eventually suspended. The intent of the provision is clear. It is a man- Later in the decade, as the universities became date to reduce the research community’s depen- the institutional arena for protest against the Viet- dence on the Defense Department when it ap- nam War, some of that activity was directed pears that the investigation under consideration against university involvement in scientific re- could be sponsored more reasonably by a civil- ian agency. After all, the National Science Foun- search supported by the Department of Defense. dation was created by Congress back in 1950 spe- Boycotts and petitions were spearheaded by Scien- cifically to channel federal funds into basic tists and Engineers for Social and Political Action, research. later renamed Science for the People. One of its founders, Charles Schwartz, described the animat- Mansfield proclaimed that the amendment was ing beliefs of this group as a reaction to the “spe- “neither anti-military nor anti-research”; rather, cific of science”: “Science as a whole its intention was to reinforce the role of the NSF is being abused by the powerful political, indus- as the “primary source” of basic research funds, trial and military interests, and we are all losers. ”56 because the role of DOD in sponsoring basic re- search was “intended to be incidental rather than This political movement was strengthened when 60 scientists at over 30 schools, following the lead predominant.“ of scientists at Harvard University and Massachu- 5’Jc~nathan Allen (cd.), A4arch 4: Scientists, Students, and Soci- setts Institute of Technology, held a work stop- ety (Cambridge, MA: The MIT Press, 1970). s8Davjd Dickson, The New Politics of Science (New York: pan- page for one day on March 4, 1969, interrupting theon, 1984). their research to protest the war and the use of 59U. S. Congress, House Committee on Science and Astronautics, Subcommittee on Science, Research, and Development, “National Science Policy, ” Hearings on H. Con. Res. 666, U.S. House of Rep- resentatives, 91st Cong., 2d sess., 1970. ~orenjck et a]., Op. cit., pp. 344-346. Also sw Rodney W. Nichols, s~penjck, et al,, op. cit., p. 430. “Miss~on-Onented R& D,” Science, vol. 172, Apr. 2, 1971, pp. 29-37. 21

The direct and immediate effect of the Mans- A legislative result of this concern was the pas- field Amendment was not very great. It was le- sage of the National Environmental Policy Act of gally in effect for only 1 year and was not re- 1969 (NEPA), which focused on the Federal Gov- newed. Only 220 of the 6,600 research projects ernment’s role in shaping and protecting the envi- that were reviewed were affected by the amend- ronment. The legislation gave a message that there ment, involving a total of $8.8 million, or only was a need to anticipate environmental impact 4 percent of Defense funds for academic research. and to do some of that through research. Lynton In the following year, the amendment’s language Caldwell has observed that: “The task set for its was changed from “direct and apparent relation- authors was to redirect national policy toward the ship” to military needs, to “in the opinion of the environment, ” but “the method was procedural Secretary of the Defense, a potential relation- reform, ” including the instigation of research.64 ship. “61 Nevertheless, the Mansfield Amendment In attempting to make Federal agencies account- did signify a change in policy toward the support able for “actions that significantly affected the of basic science, and in the words of former quality of the human environment,”65 NEPA re- Presidential science advisor, Edward E, David, Jr., quires Federal agencies to prepare environmental “its influence has continued to be felt throughout impact assessments for all major actions signifi- the Department of Defense . . . [and] it has drasti- cantly affecting the environment66 and it creates cally reduced the willingness of many other Fed- administrative requirements that agencies either eral agencies to fund basic scientific work that can- cite research knowledge as evidence for decisions not be clearly related to their current missions. “62 or, as necessary, commission and conduct re- The amendment appears to have created a climate search of their own. NEPA, Title 1, Section 102 of greater caution and uncertainty in making re- mandates agencies to “utilize a systematic, inter- search grants, not only in DOD but in other disciplinary approach which will insure [sic] the agencies. integrated use of the natural and social sciences and environmental design arts in planning and By the 1960s, the Federal agencies were also 67 decisionmaking. ” One of the responsibilities of playing an active role in shaping the Nation’s envi- the Council on Environmental Quality created by ronmental future, often without any clear state- NEPA was “to conduct investigations, studies, ment of national environmental policy. The U.S. surveys, research, and analyses relating to eco- Bureau of Reclamation, the U.S. Corps of Engi- 68 logical systems and environmental quality.” The neers, the U. S. Department of Agriculture, the Council on Environmental Quality later specified Federal Highway Administration, and similar 63 in new regulations that “if scientific uncertainty agencies had been reshaping the landscape. Their exists but can be cured by further research, the actions, however, were not always benign; some 69 agency must do or commission the research.” appeared to result in inadvertent, unanticipated In recent years, the courts have taken a more ac- degradation of the environment or destruction of tive role in requiring the agencies to fulfill this plant or animal species, or chemical contamina- mandate. tion of waterways. Although some of the envi- ronmental degradation may have actually been The increased environmental regulation of in- due more to deployment and expansion in the dustry—as well as other social legislation—had scale of old technologies, or due to actions taken a number of unplanned effects on the scientific to accomplish political goals, the negative effects research system. * In the late 1960s and early were often blamed on science and technology. b41bi~, p. 9, b51bid. ‘dMark Reeve, “Scientific Uncertainty and the National Environ- mental Policy Act—The Council on Environmental Quality’s Reg- “Dickson, op. cit., p. 122. ulation 40 CFR Section 1502 .22,” Washington Law Review VOI. 60, ~ZEdward E, David, Jr., “The Federal Support of Mathematics, ” No. 1, 1984-1985, p. 101. Scientific American, vol. 2.52, May 1985, p. 45. b’CaldwelI, op. cit., p. 12. b ~Lynton K, Cajdwe]l, Science and the ~ationa~ En vironmenta) b~Nationa] Environmental Policy Act, Title 11, Section 205(5). Policy Act; Redirecting Policy Through Procedural Reform (Univer- b~Reeve, Op. cit., p. 101. sity, AL: The University of Alabama Press, 1982), p. 8. *To be discussed in more detail in ch, 5. 22

1970s, Congress created the Environmental Pro- known, this, too, should be stated. In such a sit- tection Agency, the Occupational Safety and uation the subject at least knows that he is to be Health Administration, the National Highway a participant in an experiment. . . . Ordinary pa- Safety Commission, the Consumer Product Safety tients will not knowingly risk their health or their life for the sake of “science.” Commission, the Mining Safety and Enforcement Administration, and the Equal Employment Op- Prior to 1963, investigational or experimental portunity Commission. In addition, the jurisdic- new drugs, for example, could be used in research tion and enforcement powers of several existing involving human subjects if the drugs were labeled Federal agencies (such as the Federal Trade Com- and intended solely for investigational use.71 The mission) were expanded. This explosion in pro- Food and Drug Administration (FDA) had no di- tective regulation can be attributed to many rect control over the drugs, the investigators, or things, such as changes in the underlying technol- the research to be done; “there was no require- ogy of industry or changes in perception about ment that a patient be told that he or she was to what constitutes potential risk, combined with in- receive an investigational drug. ”72 That autonomy creasing awareness and growing intolerance of changed in 1963 when FDA, in response to the risks. Traditional protections, especially market 1962 Drug Amendments (known as the Kefauver- and liability laws, seemed inadequate to encour- Harris Amendments), issued Investigational New age socially responsible behavior. Moreover, the Drug regulations requiring that “any person or scientific research system—as it participated in the manufacturer seeking to study a new drug in hu- regulation—was becoming increasingly visible man subjects . . . prepare and present to the FDA and more federally dependent. In addition to its an acceptable plan for the investigation .”73 In use in forming regulatory policy, science was ex- 1966, the U.S. Public Health Service began to re- pected to comply with protective regulations and quire all institutions (e.g., universities, commer- social programs originally directed at industry or cial laboratories) to which it made grants to estab- the professions. lish boards to review investigations involving human beings: “. . . to safeguard the rights and Perhaps the most significant science policy de- welfare of research subjects, to ascertain whether bate of the 1960s-–in its long-term effects on pub- the methods used to gain their consent were ap- lic and political attitudes toward research and in propriate, and to evaluate the risks and benefits resulting regulation—surrounded the use of hu- of the experiment .“74 One analyst has character- man subjects in scientific experiments. The U.S. ized events of this time as the “legalization of ethi- mass media had in the 1960s carried a number of 75 cal choices. ” By the early 1970s, several legisla- reports about unsavory situations—here and tive and administrative actions had attempted to abroad—in which prisoners, children, the poor, implement such safeguards. Requirements for in- and the elderly were exposed to unwarranted risks stitutional review of research involving human in the name of “experimentation. ” The issue was subjects had gone from a matter of agency pol- politically volatile, and it touched on fundamen- icy to one of Federal law. The institutional review tal questions of who should set the standards for boards required for each institution receiving De- control of scientific research. In a 1966 article that partment of Health and Human Services (DHHS) captures the spirit of that debate, Henry K. Beecher wrote: 70 . . . it is absolutely essential to strive for [in- ‘] Alexander M. Schmidt, “The Politics of Drug Research and Devel- formed consent to experimentation] for moral, opment, ” The Social Context of Medical Research, Henry Wechsler (cd. ) [Cambridge, MA: Ballinger Publishing Co. r 1981), p. 243 sociologic and legal reasons. The statement that 7zIbid. consent has been obtained has little meaning un- ‘31bid., p. 253. less the subject or his guardian is capable of un- 74 Stanley Joel Reiser, “Human Experimentation and the Conver- derstanding what is to be undertaken and unless gence of Medical Research and Patient Care, ” Annals of the Ameri- all hazards are made clear. If these are not can Academy of Political and Social Science, vol. 437, May 1978, p. 18. psFrank p. Grad, “ and the Law, ” Annals of the 70 Henry K. Beecher, “Ethics and Clinical Research, ” The New Eng- American Academy of Political and Social Sciences, vol. 437, May land Journal of Medicine, vol. 274, June 16, 1966, p. 1360. 1978, pp. 19-36. 23 funds became the principal means for enforcing regulate so that detailed Federal Government reg- national political and social expectations. The ulations might not be necessary.76

7’Dael Wolfle, Emeritus Professor, Graduate School of Public Af- searchers and the grantee institutions to self- fairs, University of Washington, personal communication, 1985.

THE “LIMITS TO INQUIRY” DEBATE

These various controversies, protests, and po- ble side effects. As molecular biologists began to litical debates took their toll on both the com- develop exciting laboratory techniques for manip- placency and the autonomy of the scientific com- ulating and recombining DNA across species bar- munity. And in the 1970s, many researchers riers, more and more biologists began to discuss themselves became actively engaged in an intense the potential outcomes. These discussions led to debate revolving around social accountability and a dramatic example of self-regulation by the scien- the acceptability of limits on scientific inquiry. tific community. The 1960’s “human subjects” debate was by no In 1973, immediately following a major re- means resolved and had stimulated regulation of search conference, biologists Maxine Singer and research procedures at both the Federal and State 77 Dieter Soil wrote a letter to Science in which they levels. Advances in molecular biology raised new appealed to the National Academy of Sciences to questions about the risks of genetic manipulation. establish a committee to study various problems Social surveys of public opinion were showing of recombinant DNA research and to recommend that the American people did not have an unqual- specific actions or guidelines in the light of po- ified faith in science and were willing to support tential hazards .78 That committee recommended some controls on the research process. And, fi- the instigation of a voluntary moratorium on cer- nally, general political calls for increased fiscal ac- tain forms of rDNA research and the formation countability in government accounting led some of what later became a national committee to politicians to focus attention on shortcomings in review proposals for research using these tech- the research grants and contracts system. These niques, the NIH Recombinant DNA Molecule and many other issues and controversies became Program Advisory Committee, organized in 1974. the fodder for discussions throughout the scien- Molecular geneticists who voluntarily imposed the tific community—in journals and at meetings— moratorium asked others in the world to do like- about science’s social responsibility, about ethi- wise. Fears that flaws in these techniques might cal behavior of researchers, and about the appro- allow ecological disaster or create “new diseases” priateness of limitations on scientific inquiry. were also the impetus for proposals for regula- A central focus for one of the debates was how tion at State and local levels. 79 In February 1975, to balance the potential risks and benefits of the however, an international group of biologists, “new” biology. The controversy was heightened meeting at the Asilomar Conference Center in Pa- by two factors: the rapidity of advances in the cific Grove, California, agreed that the voluntary research, and the connections—often pointed out moratorium be lifted and that future research be by the researchers themselves—between the po- conducted under a set of rigid guidelines to be de- tential applications of the research and public veloped by the NIH Advisory Committee. policy. When, for example, a research team at Harvard Medical School successfully isolated a human gene in 1969, a scientific frontier with un- “’’Letters to the Editor, ” Science, vol. 181, Sept. 21, 1973. ‘“Daniel Callahan, “Recombinant DNA: Science and the Public, ” usual potential had been extended, but biologists Hastings Center Report, vol. 7, April 1977, p. 20. on that team also recognized that misuse of the “qJudith A. Johnson, “Regulation of Recombinant DNA Products, ” techniques of genetic manipulation would be un- Issue Brief 85090, Library of Congress, Congressional Research Serv- ice, Science Policy Research Division, Apr. 3, 1984; and Sheldon desirable. A member of the team, Jon Beckwith, Krimsky, Genetic A)chemy: The %cia) Histor}’ of the Recombinant in fact, publicly voiced his concern over undesira- DNA Contrivers.v (Cambridge, MA: The MIT Press, 1982). 24 .

The justification for that moratorium—and for 1957, only 70 percent of the public held the same subsequent regulation of the research—is dis- view in 1972.83 Similar results were obtained in cussed in chapter 3, but it is important to empha- the 1974 and 1976 studies.84 The percentage of size that, in this case, researchers were generally those willing to say that the world was worse off supportive of formal government commissions because of science did not increase significantly, and legislation; most accepted some regulation as but the percentage of persons who were uncer- inevitable and realized the importance of shap- tain, undecided, or felt that things were about ing the controls to fit their research needs. There equal did increase substantially over the 15-year was also relatively little public input to the early period spanned by the four studies. stages of the debate.80 The result of the national In a 1979 national study also sponsored by the scientific debate and congressional attention was National Science Board, several of the 1957 ques- the implementation in 1976 of a National Insti- tions were repeated, offering an opportunity for tutes of Health document Guidelines fez-Research comparison across two decades. In 1979, 81 per- Involving Recombinant DNA Molecules, which: cent of the public still agreed that scientific dis- 1) imposed restrictions on the types of experiments coveries were making their lives “healthier, easier, that might be performed at NIH grantee institu- and more comfortable” and 86 percent expressed tions, and 2) specified minimum levels of physi- the view that scientific discoveries were “largely cal and biological containment for permissible re- responsible” for the standard of living in the combinant DNA experiments. In 1977, in com- 85 United States. In a comparable national study pliance with the National Environmental Policy in 1983, Jon D. Miller found that 85 percent of Act, NIH adopted an environmental impact state- American adults continued to agree that science ment for the 1976 Guidelines. made their lives healthier, easier, and more com- At about this same time, a number of public fortable. 86 Contradictory evidence, however, was opinion surveys appeared to be indicating a de- provided by other surveys sponsored by NSB, cline in the public’s traditionally high support for which had asked respondents to assess the rela- and confidence in science .81 (See app. B for a gen- tive benefits and harms of science and to weigh eral discussion of public attitudes toward science. ) the two. Some survey data indicated that more and more The data from the 1970s thus indicated that al- non-scientists were inclined to question science’s though only about one in 20 Americans believed traditional autonomy or to express a lack of con- that science does more harm than good, about fidence in science’s ability to solve social prob- one-third were not sure where the balance fell. lems through research. People seemed to confuse Some of this uncertainty may have reflected a science with technology, and to see science “in a 82 wary attitude toward science; some may have very technological, instrumental light. ” As a part been due to a lack of interest or information. In of its new Science Indicators series, the National the 1970s “limits of inquiry” discussion, however, Science Board (NSB) decided to include a chap- the scientists found the potential “wariness” ter on public attitudes toward science. Using data frightening. from Opinion Research Corporation surveys in 1972, 1974, and 1976, the chapters of the NSB If there was a significant change in public opin- reports described a public that, although still hold- ion, why did it occur? Some argue that respect ing science and technology in high regard, was much less supportive than it had been in 1957, ~JScjence ~ndicators—~ 972 (Washington, DC: National Science the date of the last previous comprehensive sur- Board, 1973). EdScience zn~icators — z 974 (Washington, DC: National Science vey. While 90 percent of the public thought that Board, 1975); and Science Indicators–1976 (Washington, DC: Na- the world was “better off” because of science in tional Science Board, 1977). 8SJ(>n D. Miller, et al., The Attitudes of the U.S. Public Toward Soca]lahan, op. cit., p. 20. Science and Technology (Washington, DC: National Science Foun- “Amitai Etzioni and Clyde Nunn, “The Public Appearance of dation, 1980). SbJon D. Mil]er, “A National Surve of Adult Science in Contemporary America, ” Daedalus, vol. 103, summer y Attitudes TOWardS 1974, pp. 191-206. Science and Technology in the United States, ” Annenburg School ‘ZIbid., p. 203. of Communications, University of Pennsylvania, , 1983. 25 for scientists diminished because the scientific and suffered a loss of income and ability to earn establishment became “identified with the general income in the future. ” A Federal district court in power structure”; others believe that it was be- Madison, Wisconsin, granted a summary judg- cause of “an exchange of roles between science ment in Proxmire’s favor on the grounds that he and religion in relation to the stability of the enjoyed absolute immunity under the Speech and prevailing political system.”87 Some senior scien- Debate Clause of the Constitution; but in 1979 tists, unaccustomed to public criticism, sincerely the Supreme Court held that the researcher was believed at the time that scientific values and tra- not a public figure simply by virtue of receiving ditions were under serious attack. Federal funding, and that congressional immu- nity did not extend to statements made outside Many linked the change to science’s new sta- Congress. tus as a visible target in the Federal budget. Con- gressional attitudes—which were moving away Despite a lessening of political criticism follow- from relatively unquestioning support—may have ing the Supreme Court decision, the scientific been influenced by the social discussion. Some community reacted as if the integrity of all science criticism was undoubtedly prompted by the scien- in general had been questioned. Many research- tists’ own doubts about “the omnicompetence of ers seemed to be underestimating the demand for science in human affairs. ” But political scientist accountability inherent in acceptance of public Don K. Price speculated in 1972 that the politi- funding .89 “Those [scientists] who came of age cians’ questioning resulted most “from the nor- during the fifties and sixties, ” Robert S. Morison mal disposition of anyone who lends or grants observed in the 1970s, “may never quite under- money to want to know what use is being made stand why they have suddenly become ‘account- of it, and whether the terms of the bargain are able’ to a ‘participatory democracy’.“90 being kept."88 Insensitivity may not be the entire explanation, Such normal policy questions received wide- however, for public perceptions of science in gen- spread publicity when, in 1975, Senator William eral were also changing. Only a decade before, Proxmire (D-WI) launched an unprecedented at- science had had unquestioned social authority in tack against National Science Foundation fund- the culture and its research funding was ample, ing of social science research. Proxmire, then growing, and relatively easily acquired; by the Chairman of the Senate Appropriations Subcom- 1970s, research was being conducted in a social mittee that reviews the NSF budget, established climate that admitted scientific authority to ques- the “Golden Fleece of the Month” awards to il- tioning and in which other demands were biting lustrate what he regarded as examples of waste into science’s portion of the Federal budget. Scien- in the government—occasionally attacking proj- tists who had been trained before the war prob- ects that he asserted “at best, of nominal value ably also could not have imagined the extent of to the American taxpayer. ” Scientists, angered at regulation of the research process which had be- the attack, countered that projects with obscure gun to occur. titles and subjects may nevertheless deal with rele- Some scientists who took part in these discus- vant and important problems, They feared a dan- sions reacted negatively to the proposal of citi- gerous precedent if immediately applicable science zen participation in what were traditionally con- was perceived to be the only worthwhile science. 91 sidered to be “scientific” matters. “How, ” one The political momentum of the “Golden Fleece” commentator asked, “can public participation be awards was eventually slowed when a behavioral arranged without clashing with the very mean- scientist who had received such an award filed suit ing of science as a consensual activity among against Proxmire, arguing that, as a result of Prox- mire’s actions, he had suffered a loss of respect in his profession, was “held up to public scorn, “9Robert S. Morison, “Commentary on ‘The Boundaries of Scien- tific Freedom ’,” Newsletter on Science, Technology. & Human I’alues, June IQ77, pp. 22-24. ‘ ‘ Limits of Scientific [nquir}, ” Daedaius, spring 1~78, p. vli, ‘L’ Ibid., p. 2-I. ‘fiI>rice, op. cit., p. 80, ‘]’’ Limits of Scientific Inquiry, ” op. cit., p. viii trained specialists?”92 Scientists who had previ- dom of others?”97 Should low priority be given ously assumed total control over their research to those activities that have adverse consequences?98 now talked about being at the “mercy of citizens’ To Hellegers, the real topic of importance was groups” who were seeking input to the decision- “the ordering of priorities in things which affect making process .93 both science and human values.’’” Despite this reaction—or perhaps because of Don K. Price has observed that in the 1970s it—many leaders of the scientific community ap- scientists were often inclined to blame their prob- pear to have believed that public scrutiny inevi- lems on politicians. This tendency was exacer- tably implied restrictions. According to Dorothy bated by historic differences in the outlooks of Nelkin, by the 1970s, it was no longer a question the two groups. Scientists and politicians oper- of whether there would be public control, but of ate in different time frames—Congress in the short who would participate, how control would be or- term and scientists in the long term. Conflicts ganized, and how much they would influence re- often arise from the imposition of a political para- search decisions.94 The discussions then moved digm onto the agenda of the scientific community. to consideration of how the situation could be But Price believes that the problems themselves shaped to “protect” basic science, and to when evolved from three other factors. First, the polit- and how much the public representatives would ical strategy for the support of science was de- actually be involved.95 vised by scientists themselves and was based on the experience of private philanthropy before The scientists, philosophers, and policy analysts World War II. Second, the political authorities were not, however, always in agreement about had accepted science “as the dominant intellec- the question under debate. Some regarded it as tual approach to public issues, which scientists a debate over “limits to free scientific inquiry, ” and other liberal intellectuals agree must there- viewing proposed regulation as an attempt to in- fore be regulated in the public interest.” And third, hibit researchers’ freedom to pursue intellectual the U.S. constitutional structure is “too decentral- inquiry. Others began to frame the debate in terms ized to sustain the integrated and long-term view of funding priorities. Andre Hellegers once made of public policy which might justify the support this point forcefully, arguing that freedom of in- of science as an intellectual and educational en- quiry was not under assault because science was, 100 96 terprise. “ in fact, “royally” funded. Hellegers cited the two central issues for science as: 1) “Given finite re- The academic debate over “limits to scientific sources, how much should the public invest in an inquiry” can be seen as a response to social pres- enterprise such as science?; and 2) “How far (if sures, to events and progress within science, and at all) should any enterprises, in the name of free- to the scientists’ fear that public support for dom of inquiry, be allowed to infringe on the free- science was declining. The academic scientific community believed that it was necessary to de- ——. .——— fend the very core of science—which they per- “Ibid., p. 232. ‘31 bid., p, viii. ceived as under attack. They saw the humanists’ 94 Dorothy Nelkin, “Intellectual Property: The Control of Scien- criticism and the attempts to regulate as threats tific Infor,mation, ” Science, vol. 216, May 14, 1982, p. 207. to the legitimacy of modern science. “Andre Hellegers, “The Ethical Dilemmas of Medical Research” and Barry Casper “Value Conflicts in Restricting Scientific Inquiry, ” “Ibid., p. II. l?egu~ation of Scientific Znquiry, Keith M. Wulff (cd. ) (Boulder, CO: ‘sIbid., p. 22. Westview Press, 1979). 9gIbid., p. 29. “Ibid., p. 9. ]~oprice, Op, cit., p. 76. 27

RECENT RESTRICTIONS ON SCIENTIFIC COMMUNICATION

From the earliest days of the Nation, Federal cially its status as a valuable property or national policy has largely been supportive of open com- commodity, and from the growth in modes of dis- munication, free exchange of information, and semination of information. The decreasing distinc- wide publication in scientific research.101 From tion between basic and applied research added to time to time, however, recognition has been given the difficulty of assigning national security clas- in Federal law to “circumstances that constitute sification according to the information’s poten- what have been thought to be obvious and com- tial for application. And, especially in the last few pelling reasons for imposing official secrecy on years, there is an increased perception that the ex- research or restrictions on the dissemination of port of U.S. technology is weakening this coun- certain kinds of research findings .’’102 For exam- try politically and economically on a worldwide ple, the first War Powers Act, signed 11 days af- basis. 104 ter Pearl Harbor, gave the President the author- This series of disputes first arose in the late ity to censor all communications with foreign 1970s, when the National Security Agency (NSA) countries. But the scientific community has also and later the National Science Foundation at- made some attempts at voluntary control. In tempted to prevent university-based cryptology 1940, for example, editors of various professional researchers from publishing their unclassified journals cooperated with a special committee of work on encryption schemes. In these cases, the the National Research Council to review papers Federal Government invoked the Invention Se- for possible defense information. ’”’ This combi- crecy Act and the International Traffic in Arms nation of Federal support for open communica- Regulations, regulations intended to control the tion, defense-related restrictions imposed on a export of munitions and related technology. The case-by-case basis, and occasional voluntary co- result of discussions between the universities and operation by the scientific community continues the government was the adoption of a voluntary today. prepublication review process, under which co- pies of manuscripts on cryptology are sent to NSA Because of this history, it is noteworthy there- at the same time they are circulated to colleagues fore that the most controversial regulatory issue or submitted to journals.105 This system of volun- for science in the 1980s has been the imposition tary prior restraint was endorsed in 1980 by the of restrictions on the communication of basic sci- American Council on Education, and in 1981, ence. In part, the new restrictions have resulted NSF amended its policies on research grants to from the changing nature of information, espe- require similar prior restraint on “potentially clas- sifiable results .’’106 IL’i Harold C. Rel yea, “Shrouding the Endless Frontier—Scientific At about the same time, the Department of De- Communication and National Security: The Search for Balance, ” S&Aing a Balance: Nationa] Secufity and Scimtifjc Freedom, Harold fense—concerned especially about the leak of in- C Relyea (cd. ) (Washington, DC: American Association for the formation on Very High Speed Integrated Cir- Advancement of Science, 1985), p. 75. ‘L” Ibid, l~ilnterjm Report ~)f the Committee on the Chanb~inA~ Nature of L I ’’ Harold C. Relyea, “Increased National Security Controls on Information (Cambridge, MA: Massachusetts Institute (>t Techn<~l- Scientific Communication, ” Government information Quarterly, ogy, Mar. 9, 1983). vol. 1, No, 2, 1984, pp. 187-188, See also Michael M. Sokal, “Re- l~SJohn C, Cherniavsky, “Case Study: Openness and Secrecy in strictions on Scientific Publication, ” Science, vol. 215, Mar. 5, 1982, Computer Science Research, ” Science, Technology,, & Htlman p. 1182; and Michael M. Sokal and Janice F. Goldblum, “From the Values, vol. 10, spring 1985, pp. 99-104. Archives, ” Science, Technology, & Human Values, vol. 10, spring ‘“’ See sec. 794 on National Security in the NSF Grant Policy 1Q85, pp. 24-27. Manual. 28 cuits —began to use the Export Administration of Engineering-Institute of Medicine panel, under Regulations to restrict public communication of the direction of Dale Corson, which issued its results and to control the access of foreign scho- seminal report “Scientific Communication and lars to U.S. university research, ’07 The presidents National Security” in 1982.108 The Corson panel of five major universities objected to these restric- report has been a touchstone for subsequent re- tions and to the trend of increased control that action to government actions to restrict scientific they represented. That protest and the prior de- and technical communication. bate over restrictions on cryptology research were —— principal factors in the initiation of a special Na- ‘O”Scientific Communication and National Security, report by the tional Academy of Sciences-National Academy Panel on Scientific Communication and National Security Commit-

—. tee on Science, Engineeringr and Public Policy (Washington, DC: 1071 bid., p. 102. National Academy Press, 1982).

POLITICAL INFLUENCES ON REGULATION The science policy developed over the last 40 the question of who is the best judge of science, years reflects certain assumptions about the na- who is the expert, and who evaluates science. ture of science, the character of scientists, and the political management of science. There have been How are changes in these assumptions—and in important assumptions about the ability of scien- the social relations of science—affecting the in- tists to govern their own affairs; often, discussion tensity and extent of the regulatory environment of the peer review system will figure prominently for research? as evidence of whether or not this governance Without doubt, there is new pressure for a bal- “works.” Other assumptions are made about ance between the push for scientific and techni- whether, given the current structure of science, cal progress and the demand for regulation. Con- effective and equitable regulation is possible; and gressional management of science and technology related to that are a host of assumptions about today may require special legislative effort to the nature of expertise—especially the belief that, reconcile the complexity and sophistication of new on scientific matters (even those with heavy pol- technological challenges with society’s regulatory icy components), scientists alone can best iden- capabilities. tify promising projects and areas of research. Historian Alex Roland, in his March 7, 1985, tes- Another important force shaping enforcement timony to the Science Policy Task Force of the of Federal regulation on scientific research is a na- House Committee on Science and Technology, ar- tional fear of failure, especially in international ticulated this perspective well when he observed technological competitiveness. Science policy that “scientists understand nature’s laws better leaders argue for increased funding in order to than anyone else; they are in the best position to keep the United States from “falling behind” in see the potential applications of their under- certain scientific fields. But these same arguments taking. ” are used by the executive branch to justify in- creased restrictions on scientific communication. Some assumptions relate to the conduct of re- Such attitudes have repercussions on scientific re- search—such as where it is best performed—or search through the setting of national research pri- to the appropriate relationship between research orities and through pressures to achieve competi- and university education. Other assumptions re- tive status (or to “maintain the lead”) in all areas late to the process of regulation. There are, for of science. example, strong opinions about how far govern- ment “interference” should extend in all aspects One of the most visible changes—to be dis- of science policy and about who should partici- cussed in chapter 4—is in the creation of specific pate in the development of policy about controls. political or bureaucratic mechanisms for imple- Assumptions about who should control research mentation of social controls on research. As a and at what stage are also inextricably linked to handle for enforcing regulation, the requirement 29 —

for financial accountability inherent in the re- ulating research has not only shifted some con- search system has been successful. The post-war trol from the scientists but has introduced more contract between scientists and government had sensitivity to normative concerns, allowed the scientists, through the process of peer These and other influences on U.S. research review, to make decisions about the allocation of have helped to change the nature and character government funds to specific projects but required of the politics within which research is conducted, the universities to be accountable financially to When the Bush and Steelman reports outlined the government. Thus, regulatory requirements— their visions for how the Federal Government committees to review research for ethics, regula- should sponsor and finance a national structure tions on the disposal of hazardous materials— for scientific research, there was little reason to could be tied to the award and management of believe that those same arrangements could be- money. come the vehicles through which research might Changes have also occurred in the amount and be regulated according to prevailing social or po- type of public participation in decisionmaking on litical attitudes. Science was to be managed with issues related to science and technology. Changes loose reigns. It was not perceived as either requir- in public beliefs about the value of “expert” v. lay ing suspicious administration or warranting ex- opinions on political or social issues involving ternally-imposed controls. The specific links be- science or technology have reinforced the trend tween the events that stimulated much of the toward less autocratic control of science by scien- current regulation and the concurrent shifts in tists. Until the last decade or so, when policy- public attitudes are not well understood, but it makers turned to scientists for advice in making is clear that, in the 40 years since Bush, something decisions on technically-intensive public policy is- has changed. That shift is linked in some way to sues, the practice was to distinguish between the the original assumption that guided the design of technical and the political, or normative, aspects the system as well as to the assumptions that now of a problem. 109 Today, the involvement of more underpin priority-setting and funding today. laypersons in that decisionmaking process on reg- Science is now clearly conducted within a regu- latory environment that affects its agenda, its pro- cedures, and its communications. The next four ‘(’’ I.(lren R. Graham, ‘Comparing L’ S. anci Soi’]et Experiences: Science, Citizen>, and the Policy hlaklng Procms,” En\’ironrnent, chapters describe the existing situation—why reg- ~ro] ~b, %ptembvr 1 Q84, p 8, ulation occurs, how it occurs, and where it occurs. Chapter 3 Social and Political Rationales for Controls on Research

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Photo credit: National Institutes of Health Chapter 3 Social and Political Rationales for Controls on Research

Harold Green has observed that, all things be- This chapter describes the rationales or legal ing equal, there is no question that “a scientist has justifications for two types of regulation of scien- the freedom to think, to do calculations, to write, tific research. One type includes legal barriers, to speak and to publish’’—as long as these activ- incentives, or other actions that have some bind- ities remain within the area of abstractions.1 Re- ing or controlling effect. The other type of regu- search, of course, involves more than abstract lation includes forces or actions—ranging from thinking. Scientists experiment, observe subjects, changes in funding to negative public opinion— record data, and describe their work to others. that do not have the force of law but may have These activities can be affected by social mores some important effects because of the way in and customs and can in turn affect society, the which science is funded and is dependent on po- environment, or the people and objects involved litical and social support for the continuation of in the research. When research violates the social that funding. norms, or when society perceives risks or dangers in the research process, then restrictions may be implemented either by society or voluntarily by the research community. Table 3-1 .–Justifications for Control of Research This chapter develops a typology of the vari- Regulatory forces on the research agenda: ous reasons used to justify either legally enforce- Ž To fuIfiII political objectives ● To avoid environmental damage able regulations or social restraints on scientific . To promote or avoid specific economic consequences activity. In most cases, the rationale described is • To preserve moral values one that is used to explain why scientists should Regulation of research procedures and protocols: not do research on a certain topic or in a certain ● To protect human health and safety . To protect an i reals used in experimentation way, or should not describe their results to a par- . To protect the environment ticular group of people. In a few instances, the Regulation of the dissemination of scientific knowledge: justification may be used to discourage scientists . To uphold scientific standards from pursuing one research line or encourage . To protect a professional or economic interest . To protect the health, privacy, and safety of them to pursue another, or to protect government individuals or commercial rights in scientific information, * ● To protect the national miIitary or economic security

‘Harold I’. Green, “The Boundaries of Scientific Freedom, ” Reg- ulation of Scientific Inquirj’, Keith hf. Wulff (cd. ) (Boulder, CO: \\’e\tv]em I’res>, 1Q7QI, p. 140; reprinted from Newsletter on Science, Technc)lc)g~’ & Human I’alues, June 1977, pp. 17-21. ‘Is>ues or events are described in this chapter as examples of when a particular justlticatlon or rationale may have been employed. A sclent itic topic or project may have been regulated for more than one reason, but all these reasons are not necessarily listed for each example.

REGULATORY FORCES ON THE RESEARCH AGENDA

Attempts to control the research agenda of a are convinced that application of the research field or laboratory may take one of two forms. could bring harm. Others may be unwilling to Opponents of a research topic may wish to sup- grant legitimacy to a morally (or politically) ob- press a project or a line of research because they jectionable idea by implying that it is worthy of

33 34 scientific attention. Proponents of a research topic ing the 1970s controversy over research on the may seek to alter the research agenda to include laser separation of isotopes of uranium. That re- that topic. search topic became an active area of controversy in 1976, when experiments in both government For these reasons, justifications are likely to be and private industry labs showed a promising new affected by beliefs about the probability and type approach to laser isotope separation. A few of any eventual application. The regulator is con- months later, a private consortium, Jersey Nu- vinced that, should the research ever be done, clear-Avco Isotopes, Inc. (JNAI) applied to the some imaginable (or predictable) result or find- U.S. Nuclear Regulatory Commission for a license ing would be unacceptable or undesirable. The to build a $15 million facility for large-scale ex- potential of research for application—and the reg- periments using one of these approaches.’ Because ulator’s ability to envision such application—thus laser isotope separation was believed to promise can have considerable effect on the predisposition a cheaper, easier way to obtain enriched urani- to control. Harvey Brooks points out, “the regu- um—for both nuclear powerplants and weap- latory climate for research which is influenced by ons—these new developments provoked both its potential applications will depend on the considerable controversy and attempts to classify uniqueness of the relation of these applications the work. Many observers believed that existence to the substantive content of the research, since of a perfected process would increase the risk of the amount and richness of the applications vary 2 unintentional proliferation of nuclear weapons, considerably among types of research.” Some ob- would undermine existing international safe- servers, however, argue that all regulation occurs guards, and could aid terrorists. In proposing a because of the anticipation of some effect, al- moratorium on further research and development, though they may distinguish between attempts to physicist Barry Casper argued that “there is still limit inquiry because of: 1) “anticipated deleteri- time to stop and consider whether laser enrich- ous consequences of the inquiry itself” (e. g., ef- ment should be developed, in light of its broader fects of the research procedure on experimental consequences.”5 Proponents of the research ar- subjects); and 2) “anticipated deleterious conse- gued that laser isotope separation required sophis- quences of applications of knowledge obtained by ticated facilities and was not a “garage” technol- the inquiry.”3 ogy adaptable by terrorists, and that therefore The most common justifications for restraints those fears were groundless. * on research agenda are political, environmental, At the international level, the nuclear nations economic, and moral concerns. have tried to curb the proliferation of nuclear weapons by preventing additional countries—and To Fulfill Political Objectives or especially countries considered to be politically Avoid Political Effects unstable—from doing nuclear research that could produce weapons-grade plutonium. International Political reasons may underlie both the encour- political objectives have also justified government agement and the suppression of research, when actions that discouraged or denied permission to society perceives that research could achieve a spe- foreign students from certain countries who cific advantage or result in a negative effect. The wanted to study nuclear engineering in the United protection of national economic or military secu- States. By preventing access to advanced train- rity, for example, may justify either the redirec- ing in certain fields, the United States was effec- tion of research toward military goals or the tively attempting to control the other country’s inhibition, discouragement, or prohibition of research agenda. weapons development research outside of govern- ment control. Both justifications were used dur- 4Barry M, Casper, “Laser Enrichment: A New Path to Prolifera- tion?” Bufletin 01 the Atomic Scientists, January 1977, p. 29. IHarvey Brooks, Benjamin Peirce Professor of Technology and ‘Ibid. Public Policy, Harvard University, personal communication, 1985. *In fact a special panel of consultants appointed by JNAI con- 3Barry M. Casper, “Value Conflicts in Regulating Scientific In- cluded I hat the JNAI process was probably lms proliferation-prone Regulation of Scientific Inquiry, quiv, ” Keith M. Wulff (cd. ) (Boul- than th~ centrifuge process which was being commercialized, or than der, CO: Westview Press, 1979), p. 15. the process being developed at Los Alamos. 35

National economic priorities and international sities should accept Department of Defense standing may justify redirecting research toward funding.8 topics related to technological competition. When Special difficulties arise when the justifications a country decides to shore up its prestige in the for control are linked to a controversial social or international scientific community, it often con- political issue. Various forms of research to de- centrates on achieving or maintaining superiority tect XXY and XYY chromosomal aberrations, in some but not all scientific fields. Such justifi- such as the screening of male newborns to iden- cations may be discerned in, for example, the cur- tify and study prospectively the development of rent debate on funding high energy physics and those with a XYY karyotype, combine basic epi- the superconducting supercollider. Belief that the demiological research with longitudinal followup success of U.S. industry in competing in world of “experimental” (XYY) and “control” groups, markets is increasingly tied to research has 9 including potential therapeutic intervention. In prompted several regulatory actions in the field the mid-1970s, at Harvard Medical School, ob- of biotechnology. In 1984, for example, the Cab- jections by Harvard University faculty members inet Council on Natural Resources and Environ- and by geneticists elsewhere in the aca- ment asked 14 agencies to develop a framework demic community resulted in the voluntary ter- for the regulation of gene splicing. ’ George Key- mination of a research project on XXY and XYY worth, President Reagan’s Science Advisor, has 10 children. The project staff argued that research also suggested that the National Institutes of should proceed because of its potential therapeutic Health should broaden its mission by paying more value to the patients. They were sincerely attempt- attention to the needs of the biotechnology indus- ing to advance science and “to bring what they try through more funding of generic applied work perceived as the benefits of science to the resolu- in biotechnology, promotion of intellectual sup- 11 tion of a social problem.” Their opponents, with port for biotechnology companies, and training equal sincerity, sought to expose and stop what of bioprocess engineers and other needed person- 7 they perceived as a “misuse or abuse of scientific nel. International relations may also affect re- 12 hypotheses and techniques.” Scientists critical search when science and technology are used as of the research topic argued that there was no sci- tools for political diplomacy, as in scientific ex- entific evidence linking XYY and antisocial behav- change programs. 13 ior, and that the research should be stopped be- Government actions may also be directed at en- cause its goals directly contradicted American couraging or discouraging research related to spe- political beliefs about the rights of individuals. cific domestic political goals. During the Reagan Other critics believed that the research had the Administration, the regulatory system itself has potential of being just the first step in an attempt been used to influence the funding of research per- to determine a genetic basis for antisocial behav- taining to specific regulatory issues. Executive Or- ior. Infants tagged as having such a trait might der 12485 (Jan. 4, 1985) instituted an office of be treated differently all their lives and therefore Management and Budget (OMB) review of regu- identification might become a self-fulfilling pro- lation-related research proposed by executive branch agencies. Through its power to approve ‘Dorothy Nelhln, The llni~ersitj and hfilitar?’ Research: ,Jlc)ral I’oiitlcs at ,IIIT (Ithaca, ,~}’ Cornell Uni\’ersit}r I>ress, 1 ~72 ) the appearance of any research on the regulatory “Dorothy Nelkin and ludith A. Sw.ve}, ‘Science and St>c ial C(~n- calendar, OMB can control the agencies’ research trol: Controversies O\rer Research on L’io]ence, ” Report No 1970, before conference proceedings, Institute for Studie+ In Research and Higher agenda funding. In the late 1960s, both do- Education, Norwegian Research Council for Science and the Hu- mestic and international politics related to U.S. manities, p, 5. involvement in the Vietnam War shaped a num- 1OBarbara J, Cu]]iton, “XYY: Harvard Researcher Under Fire st(~ps ber of acrimonious debates over whether univer- Newborn Screening, ” Science, VO]. 188, ]une 27, lQ75, pp. 1284- 1285; Frederick Hecht, “Biomedical Research Ethics and Right\, ” Science, VC)I. 188, lC175r p, 502, and Loretta Kopelrnan, “Ethica[ Con- ‘An Acfmlnl>tration official was quoted as saying that the frame- troversies in hledica] Research: The Case of XYY Screen ing, ” Per- w.[)rk was aimed at avoiding “federal actions that could aitect the specti~’es In I?mlogjr and ,Iledicine, winter 1978, pp. 1 %204. lnd ust ry’s competitiveness. l?usiness J$’eek, May 21, 1984, p. 40, I ]Ne]kln and Stvazeyr [~p. clt., p. 211. ‘Barbara Cull]ton, “NIH Role in Biotechnology Debated, ” Science “Ibid. vo]. 22Q, July 12, 1~85, pp. 147-148. 1’Culliton, “XYY,” op. cit., p, 1,284. 36 phecy, ” And finally, some asserted that the re- over the presence of classified military research search should be stopped because the benefits to on university campuses, for example, the orga- society were dubious .15 Defenders of the research nization Scientists and Engineers for Social and called this latter argument “a misplaced ideolog- Political Action actively attempted to persuade ical approach. ”16 In this case, both proponents and researchers to forego participation in war research opponents had to weigh the importance of pro- or weapons production.19 tecting the rights of individuals against the im- Rejection of a research line by individuals or portance to society of predicting (and therefore groups can be a form of “conscientious objection possibly preventing) criminal behavior, the im- in science. “2° Individuals who “draw the line” in portance to future generations of developing chro- this way may simply decide to have nothing to mosome screening for the detection of genetically do with research linked to the military or, more linked illnesses, ’7 and the importance to current specifically, with nuclear weapons or chemical- patients should reliable therapy ever become biological warfare. Many physicists, whose line available. of interest and expertise would fit them notably Political concerns can also drive the research for the scientific task involved, justify their re- agenda when an individual or a group of research- fusal to work on nuclear weapons research on ers attempt to redirect the agenda of an institu- moral grounds. More recently, a few graduate stu- tion or a field away from one topic and toward dents in the field of artificial intelligence—where another considered to be more socially or politi- the proportion of Department of Defense fund- cally acceptable. Most often, such actions occur ing is increasing—are reported to have either at the individual or personal level; but on occa- switched their thesis topic to one unrelated to mil- sion there have been loosely coordinated actions itary applications or, in an extreme case, left by groups. In the 1950s, for example, the Soci- school or switched fields altogether. ety for Social Responsibility in Science and the In the 1980s, social anxiety about the nuclear Committee for Social Responsibility in Engineer- arms race has had a direct effect not in inhibiting ing “required their members to take a pledge upon but in stimulating research. Funding for—and re- joining the organization which stated that they searchers’ interest in—arms control research has would not engage in research for destructive pur- 18 increased. * Physicians, psychiatrists, and other poses.” In the 1960s and 1970s, many scientists medical professionals have encouraged and sup- switched fields rather than work on topics con- ported new research efforts on the medical con- nected to weapons or to the military. Some at- sequences of nuclear war or the psychological ef- tempted to choose research topics that they con- fect of the nuclear arms race on children. sidered to be more socially relevant or more expressive of their own moral or political philos- ophy. Some rejected certain topics out of protest To Avoid Environmental Damage (again, on moral or political grounds) to U.S. mil- Environmental concerns that provoke the im- itary action in Southeast Asia or because they es- position of regulation can trigger similar conflicts poused general pacifist objections to their coun- in values. At issue here is the narrowness of the try’s military research agenda. Decisions to reject relation of the potential application to the over- a line of research were, however, more often re- all substance and goals of the research. Does reg- lated to the proposed military sponsorship of the ulation undertaken because of the fear of one par- research than to any specific application of the ticular application serve to deny the potential particular investigation. In the late 1960s and early benefits to society of other possible applications 1970s (as discussed in ch. 2), during controversy perhaps not now clearly visible?21 This justifica- — liKope]man, op. cit,, notes 11 mcf 13. l+lbid p, B: See also Colin Norman, “Classification Dispute Stalls “Ibid., p. 200. NOAA” Program, ” Science, vol. 227, Feb. 8, 1985, p. 155. “Ibid. 20 Chalk, op. cit. ‘ 7 Culliton, “XYY,” op. cit.; and Hecht, op. cit., p. 502. *For example, the International Security Program of the John D. )~Rosemary chalk, “Drawing the Line: Science and Military Ile- and Catherine T. MacArthur Foundation. search, ” unpublished manuscript, May 1983, p. 8. “Brooks, op. cit. 37

tion underpins, for example, the legal action to To Preserve Moral Values halt deliberate release of genetically altered organ- isms, In a suit discussed in more detail in appen- In some instances, a society or a group within dix A, the Foundation on Economic Trends has the society may perceive the very exploration of charged that the National Institutes of Health a topic (or the legitimacy granted to the topic by failed to evaluate adequately the environmental a serious research effort) as a threat to moral or impact of experiments involving the release of ge- social beliefs. That is to say, the research hypothe- netically altered organisms into the environment. sis contradicts the social or political beliefs of the The plaintiffs are seeking to halt the work alto- opponents. Early 20th century attitudes to human gether because they are convinced that the poten- sexuality, for example, acted to inhibit all types of research relating to sexuality, contraception, tial long-range benefits of such research are sim- 24 ply not worth the potential risks to the environ- and reproduction. Research was discouraged be- ment. cause of fear that it might encourage or condone “immoral” behavior; religious and moral leaders To Promote or Avoid Predictable objected to laboratory consideration of what were considered to be private, personal matters. Economic Consequences Such objections continue to be raised today. In International competition in trade has been used public opinion polls run in 1983, approximately to justify suspending one line of research (or to one-quarter of the adult population of the United cut back on its funding) because another line ap- States were willing to endorse the statement that pears more promising. Such a situation currently one of the “bad effects of science” is that it breaks exists in the field of silicon electronics; work in down people’s ideas of “right and wrong.’’” that area has been so successful that research on alternative technologies has been cut back. On occasion, therefore, opponents of a research topic or hypothesis believe that any exploration In another recent case, predictions of adverse (however well-controlled) might endanger the so- economic effects alleged to result from the even- cial cohesion of the community. Such concerns tual application of research projects have stimu- fuel contemporary objections to research that lated protests that may yet lead to restraints. In would attempt to link human intelligence to ge- 1980, California Rural Legal Assistance filed a netic inheritance. American psychometrician Ar- lawsuit on behalf of 19 farm workers, which thur R. Jensen sparked a controversy in 1966 when charged the University of California “with unlaw- he argued that IQ is genetically fixed. ” Jensen pro- fully spending public funds on mechanization re- posed that social intervention aimed at boosting 2 search that displaced farm workers. “2 The plain- minority students’ IQ scores—e.g., Headstart and tiffs believe that the research—intended to develop other compensatory educational measures—were large, more efficient agricultural machines and a waste of time and money. Opponents of the Jen- new farm methods—would reduce the need for sen research are convinced that even to consider human labor in agriculture. They are convinced such research as scientifically legitimate and that such innovations would have an adverse eco- morally acceptable would be a racist act. The nomic effect on the workers displaced by machin- ery, on small farms, and on consumers, and there- fore that public funds should not be used to ‘“For a brief review of this history, see Emily H. Mudd, “The His- support such research. Defenders of this research torical Background of Ethical Considerations in Sex Research and argue that mechanization research should contin- Sex Therapy, ” Ethical Issues in Sex Therapy and Research, William H. Masters, Virginia E. Johnson, and Robert C. Kolodny (eds. ) (Bos- ue “in order to create more desirable jobs and to ton, MA: Little, Brown & Co., 1977), pp. 1-10. keep the American fruit and vegetable industry “ion D. h!iller, A Nationaj Survey of Adult Attitudes To\\rard competitive in the international economy.”23 (See Science anci Techno)oH’ in the United States (Philadelphia, I’A: An- nenberg School [Jf C[)mm un icat i ens, Uni\ersit}’ of Pennsylvania, app. A for further discussion. ) 1983). ‘pSee Richard l.e~vcmtin, “Race and Intelligence, ” l?u~letin of the ‘lI)h]l]p I Llartln and Alan L. Olmstead, ‘The Agricultural hfech- Atomic Scientist\, hlarch 1Q70. Also see Arthur R, lensen, “HOW an i7a t i (ln C<) n tr(~ver~}’, Science, vol. 227, Feb. 8, 1Q85, p. bOl N!uch Can \$re Boost IQ and Scholastic Achie\’ement?” Har~rard 1‘Ibid., p o(M. Educational l

REGULATION OF RESEARCH PROCEDURES AND PROTOCOLS

With the exception of protests over the use of To Protect Human Health and Safety animals, social criticism in the early 20th century By far the most visible and vocal science pol- was more likely to be directed at the topics than at the procedures of research. The moral and ethi- icy debates on regulation have been those sur- cal concerns expressed in attempts to control how rounding how to protect human health and safety. scientists conduct their research are not new, how- Although the preoccupation with safety is a re- ever. What is new is the raising of such concerns cent phenomenon, “it has taken hold so univer- to the level of government action or legally en- sally and absolutely that this operation hardly rec- 28 forceable regulation. ognizes the possibility of a different world.” Regulations set by local or Federal authorities to In these cases, the rationale for external con- protect the health and safety of workers (e.g., re- trol is most often that the scientific community’s quirements for certain types and amounts of safe- own safety procedures have been or are predicted ty equipment for persons working with hazard- to be inadequate or insufficient to prevent harm ous chemicals) apply with equal force to labora- to human beings, animals, or the environment. tories and, in some cases, may have been written The motivations for managing the risks inherent specifically to apply to laboratory workers. The in the research process are straightforward: to Occupational Health and Safety Act of 1970 (dis- comply with Federal, State and local laws and reg- cussed in more detail in ch. 5) includes protec- ulations and thereby to avoid enforcement actions tions for research workers who might be subjected or civil or criminal sanctions for noncompliance; to unnecessary hazards on the job. and to comply with common law duties (e. g., to act with due care) and thereby to avoid personal injuries or environmental degradation, as well as 28 Rc)[)ert L, Sproul], “Federal Regulatio and the Natural Sciences, ” any liability or duty to provide compensation n which could arise from claims brought by the in- Bureaucrats and Brainpower: Government Regulations of Univer- sities, Pau] Seaburg (ed. ) (San Francisco, CA: Institute of Contem- jured parties. porary Studies, 1979), p. 86. 39

Emotional controversy has surrounded efforts order to observe the complications arising dur- to extend special legal protections to the human ing terminal stages of the disease,31 served to subjects of experimentation (see box in ch. 4 for focus public and congressional attention on the the specific regulations). Human subjects are used need for more formal governmental surveillance in all parts of science. They are used to test new of research on human subjects. In these and other forms of diagnostic procedures, treatments, or cases, critics were able to show that human be- . Carefully controlled clinical trials in ings were subjected, usually without their know- drug research are necessary to prove effectiveness, ledgeable consent, to the risk of some potential to set dosage, and to uncover unknown side ef- harm: death, physical abuse or injury; psycho- fects before drugs may be licensed for general use. logical abuse or injury; damage to interpersonal Human subjects must be observed for research on relations (e. g., loss of trust in others); legal jeop- mental disorders. Private industry uses them to ardy (e.g., creating and revealing a record of crim- test new consumer goods, or in research on how inal behavior); career damage; economic harm; to make products more useful. or invasions of privacy.32 The types of experimental situations involving Of all aspects of the human subjects debate per- human subjects can be classified generally into haps the most sensitive has been the use of sub- four categories: jects with “limited civil freedom, ” a classification that includes prisoners, residents of institutions 1. experiments done to test physiological states for the mentally ill and retarded, and children/ and environmental manipulation, both in- minors .33 As research institutions are often located ternal and external, in “normal” subjects; in large urban areas, subjects are frequently drawn 2. studies of human performance and process— from the disadvantaged in those cities. Hospi- e.g., memory or vision; talized or incarcerated subjects also provide a con- 3. the trial of new methods, procedures, or venient, stable population that can be monitored drugs on persons who are ill; and 34 with ease. The large U.S. prison population, in 4. the use of terminally ill patients to test po- fact, makes it possible for a research project to tentially dangerous drugs or procedures .2’ choose subjects with any necessary characteris- In the latter case, research may be conducted tic. Proponents of the use of such subjects argue only as a “compassionate” procedure not requir- that, moreover, there are also considerable ad- ing the review of a local ethics board if it is an vantages to society: prisoners are provided with “emergency” treatment with potential therapeu- a break from monotony, a feeling of altruism, and tic value and involving a new or investigational some monetary reward; research on mental ill- drug or device. ness and retardation cannot proceed without ac- cess to such patients, Historically, the impetus for controls on the use of human subjects has been either the documen- Foremost in the discussion of whether minors tation of abuse of subjects or questions raised or institutionalized subjects should be used is the about potentially risky research. In the 1960s and question of coercion; for these subjects’ peculiar 1970s, studies such as the Milgram “psychology position renders their “consent” to participation of obedience” project (in which subjects were en- questionable and may also lead to subtle, and couraged to act with increasing severity against often unintended, abuse by experimenters.35 Op- other subjects),30 or the Public Health Service ] Tuskegee study experiments in which over 300 ‘ James H. Jones, Bad Blood: The TusAegee Sjpbi/is E~perinlent (New York: The Free Press, 1981 ). black prisoners with syphilis were examined and “Donald P. Warwick, ‘Types of Harm in Social Research, ‘ Ethical tested but not treated for more than 40 years in Issues in Social Science Research, Tom Beauchamp, et al. (eds. ) (Bal- timore, MD: The Johns Hopkins University Press, 1982 ), Pp, 105-110. “R{~bert E. Hodges and \V]lliam B. Bean, “The Use of Prisoners ‘} Robert ]. Ilvine, Ethics anci Regulations of Cljnical Research for hledlcal Research, ” The lournal of the American Afedical Assc)- (Baltimore, hlD: Urban & Schwarzenberg, 1Q81 ), cidt][)n, v()], 202, N’ov. 6, 1967, p, 177, “Ibid. ‘OStanley Nlllgram, Obedience to Authoritj (New York: Harper “Alexander Nl, Capron, “Nledical Research in Prisons, ” The Ffast- & Row, 1974). jngs Center Report, June 1~73, p. 4, 40 ponents argue that because such research may be would like to use new techniques or technologies carried out in prisons or mental hospitals, it does on patients before they have been fully tested. not receive the scrutiny and criticism by colleagues They believe that if a procedure could help a pa- which may be routine or required in normal re- tient, then they have a responsibility to try it, even search settings. if they are not sure it will work. Others believe that the physician’s responsibility is to be certain Concern that special populations might not be that a technique will result in some benefit. The adequately covered by existing regulations led in conflict between these two perspectives raises such the 1970s to the suggestion of a moratorium on questions as: Who is or is not an experimental sub- research involving prisoners. In some countries— ject? What are the justifications for delay in using e.g., England—prisoners may not be used as sub- a new technique? Ethicist Thomas Murray has jects of experiments. The World Medical Associ- pointed out, in discussion of the “Baby Fae” ba- ation’s Declaration of Helsinki (1964, revised in boon heart transplant, that even in a desperate 1975) states that the only appropriate subjects are therapeutic situation, certain rules should be fol- those “in such a mental, physical, and legal state lowed. He suggests that four questions should be as to be able to exercise fully [their] power[s] to asked before an experimental treatment is used: consent. ” Dissension over exactly how to treat Is the scientific background right? Is the next ex- prisoners has apparently stymied recent Food and perimental subject naturally a human being? Is Drug Administration efforts to finalize its regu- there no superior alternate therapy available? And lations on such research. can the researcher get truly informed consent— Additional questions may be raised about how or informed consent from a guardian or parent?38 human subjects are used in social science research. Similar questions are being raised for the use Quite a bit of controversy arose in the 1960s and 39 of human somatic-cell gene therapy when op- 1970s over deception that occurred in such re- ponents ask whether such research is playing with search. Because they used stooges or engaged in the very essence of humanness, or when animal covert observation of unsuspecting people, some rights groups object to the use of primates as a social scientists appeared to be using “dubious substitute for human experimental subjects .40 means to achieve questionable ends. ” The re- Those arguing for proceeding with the research searchers insisted that deception was only used cite the potential benefit to existing patients. The to advance human understanding and thus was “bottom line” for that debate—as with many beneficial to human welfare, that it helped in the others—has become, as Alexander Capron has study of “underdog” social groups such as homo- writ ten, “when may a society, actively or by ac- sexuals, and that deception in research—just as quiescence, expose some of its members to harm deception in muckraking journalism–could help in order to seek benefits for them, for others, or to expose the unethical conduct of the power elite. for society as a whole?”41 In some other contexts, Critics argued that any study that involved the society has already answered Capron’s question violation of moral norms could not advance the by putting some people in jeopardy to protect the human welfare, that “a chain of lies was not 36 whole population. We select firemen and mem- morally justified, “ and that no gain could off- bers of the military forces, sometimes by conscrip- set the magnitude of potential discomfort to the 37 tion, sometimes by lottery, sometimes by offer- subject . ing incentives. We have also used some of these The tremendous acceleration of medical re- search—e.g., in immunology, genetics, and bio- ‘8’’The MacNeil ‘Lehrer News Hour: The Baby Fae Case, ” tran- medical engineering-has created new controver- script 42385, Thirteen, Nov. 16, 1984, pp. 1-9. sies for those fields. Many medical researchers 3’See “Points to Consider in the Design and Submission of Hu- man Somatic-Cell Gene Therapy Protocols, ” prepared by the Work- ing Grc}up on Human Gene Therapy of the NIH, Ftderal Register, “Donald P. Warwick, “Social Scientists Ought to Stop Lying, ” vol. 50, No. 14, Jan. 22, 1985. Psychology Today, February 1975, pp. 38-40, 105-106. 40Jud[th A. Johnson, “Human Gene Therapy, Updated 10/30 /84,” ‘“See Tom L. Beauchamp, et al. (eds. ) Ethical Zssues in Social Library of Congress, Congressional Research Service, Science Pol- Scjence Research (Baltimore, MD: The Johns Hopkins University icy Research Division, Apr. 3, 1984. Press, 1982). i Ical)ron, op. cit. I P. 4‘ 41 —

means—incentives and lotteries—to select subjects animals—may be found in many countries for for experiments .42 hundreds of years.45 In the debates over experimentation on fetuses The controversy over the experimental use of (either still in the womb or newly aborted or mis- animals is characterized by certainty of moral po- carried), the emotionally charged issue of abor- sition on both sides. Thomas H. Moss of Case tion—as a potential “source” of fetuses or fetal Western Reserve University observes that: tissue—has often been the implicit or explicit jus- . . . those who are convinced that laboratory ani- tification for controls. (See ch. 4 for discussion mals are cruelly or unnecessarily used have often of specific regulations on use of fetuses. ) Similar characterized the scientific establishment as insen- debates are now raging in England. ’3 sitive to animal pain, and lacking in basic com- On occasion, objections to research have fo- passion toward living creatures. Those who are convinced that animal experiments are natural cused on accusations that a city or special popu- and appropriate tools to serve the advancement lation might be “experimented on. ” Concern that of science . . . have often characterized the ani- research might jeopardize the health and safety mal welfare movement as irrational and as blindly of the general public was, for example, expressed myopic in the sense of moral outrage at animal during the 1970s’ recombinant DNA controversy suffering but lack of recognition of human health in Cambridge, Massachusetts (see ch. 7).44 The needs .46 argument was not that such research was intrin- In its attempt to abolish totally the use of animals sically “bad” or that it might not result in posi- in experiments, the animal liberation movement tive gains for society, The argument was that the is saying: safety of the research procedures was untested and the consequences of an accident —even if only re- . . . that animals and humans have similar inter- motely possible—were potentially so negative that ests . . , those interests are to be counted equally, the community might be unwilling to risk any with no automatic discount just because one of mistake. In such cases, until the procedures can the beings is not human. be proved to be reliable, the public and the legis- This argument extends to such similarities as lative bodies have acted to suspend research tem- avoiding physical pain.47 porarily—until public study and debate can take place. The Catch-22 in this scenario is often that The justifications for the various positions are the procedures cannot be proven to be safe with- based on a number of philosophical arguments out trying them in some way. related to perceptions of the appropriate relation- ship between humans and animals. Members of To Protect Animals Used the animal rights community believe that animals possess a consciousness and certain attributes— in Experimentation e.g., symbolic communication, self-awareness, The first attempts at social regulation to pro- and anticipation of future events—which imbue tect the welfare of animals (to obtain legal pro- animals with rights as exercised by humans. They tection for members of nonhuman species) date see the animal rights movement as the progeny to 19th-century England, although social con- of the “humanitarian” movement, as the logical cern—in the form of cultural reverence for some successor to the civil rights movement and the feminist movement. In comparison, the animal animals, and/or repulsion at cruel treatment of welfare movement, which includes some animal

“Dael Wolile, Emeritus Professor, Graduate School of Public Af- “Harriet Ritvo, “PIus a Change: Anti-\ ’i\’isection Then and ~ fairs, University of \4rashington, personal communciation, 1985. Now, ” Science, Technology, & Human l~alues, VOI. ~, spring 1Q84, of life: The Warnock Report ~ 3See ~~ar~, ~j’arnoc~, A @estjon pp. 57-66. on Human F’ertilizat~on and Embr}~ologJ (New York: Basil Blach- “Thomas H, hloss, “The Nlodern Politics of Laboratory Animal well, Inc., 1~851. Use, ” Science, Technology?’, & Human \’a/ues, vo]. ~, spring 1~84, “Sheldon Krimsky, Genetic Alchemy: The Social History of the pp. 51-56. Recombinant D,\rA Controversy (Cambridge, MA: The MIT Press, “Peter Singer (cd. J, In Defense of Animals (New York: Basil Black- 19821. well, Inc., 1~8.5 }, p. ~. 42 researchers, believes that as humans, in the words cal balance, then regulation of the research proc- of Arthur Caplan, we hold a certain “moral ste- ess may be implemented with the specific inten- wardship” over animals, which requires that we tion of protecting the environment. treat them with respect even in the service of hu- The dangers in the introduction of new plant mans. The concept of moral stewardship infuses or animal species or new genetic forms have been a spectrum of regulatory activity, ranging from obvious for decades in the destruction caused by, outright bans on the use of certain animals (or for example, the introduction of such nonnative of any animal in certain types of research) to Na- species as kudzu vine and gypsy moths. Compar- tional Institutes of Health regulations governing ison of the effect of a current line of research to the treatment, handling, and use of animals in lab- the past adverse effects of nondeliberate altera- oratories. (See ch. 4). * tions of the balance between species or environ- ments forms the basis of many attempts to regu- To Protect the Environment late research on environmental grounds .48 Because it is virtually impossible to design tests to predict If research involves the use of toxic chemicals the ecological risk from a nonnative species, these or biological materials known or suspected of causing some adverse effect on the environment concerns have been raised again and again and have now reached the courts via legal action to by altering the natural composition of air, water, prevent agricultural research involving deliberate or soil, or by destroying or altering the ecologi- release of genetically engineered bacteria. ‘Concern about this issue has also lead to a National Academy of Sciences study of the numbers of animals used in the United States in research and testing and to an OTA report on Alternatives tO 48see fc)r examp]e, Winston J. Brill, “Safety Concerns and Genetic Animal Use in Research, Testing, and Education, OTA-BA-273, Jan- Engineering in Agriculture, ” Science, vol. 227, Jan. 25, 1985, pp. uary 1986, 381-384.

REGULATION OF THE DISSEMINATION OF SCIENTIFIC KNOWLEDGE

Open communication, through such things as and widespread verification and criticism of re- publications, symposia, and face-to-face meetings, sults and conclusions. 50 has always been an essential aspect of scientific Because openness in science also encourages un- endeavor. Unrestricted interaction sets forth a inhibited dissemination of results outside of the framework within which peer review, criticism, laboratory, the justifications for restraining such and data sharing can occur; it provides the arena communication center primarily around the po- for cross-fertilization of ideas, and helps avoid 49 tential effect of the information, the information’s duplication of effort . As the American Associa- “value” (economic or otherwise), and who is per- tion for the Advancement of Science, Commit- ceived to “own” the information (e. g., the scien- tee on Science in Promotion of Human Welfare, tist or the organization that supported the scien- stated in a 1965 report: tist’s work). Each separate study of nature yields an approx- Regulation of scientific communication is far imate result and inevitably contains some errors from simply a process of stamping a label on a and omissions. Science gets at the truth by a con- document, however; it involves restraints or con- tinuous process of self-examination which reme- dies omissions and corrects errors. The process trols on, for example: 1) who may know certain requires free disclosure of results, general dissem- ination of findings, interpretations, conclusions, ‘“Harold C. Relyea, “Shrouding the Endless Frontier—Scientific Communication and National Security: The Search for Balance, ” Striking a Balance: National Security and Scientific Freedom, Harold ~~NATO Science Committee, “open Communication in Science, C, Relyea (cd. ) (Washington, DC: American Association for the NATO Science & S

scientific data or information, 2) the dissemina- sharing of information with citizens of other coun- tion of printed documents, 3) who has access to tries and on the freedom of industrial scientists an electronic communication system, 4) descrip- or industry-supported university professors to tions of processes or computer programs, and 5) converse openly with their colleagues about their even who may share or receive certain cell lines work, 5 or biological strains. 1 Physicist Lee Grodzins has Four main rationales may underpin actions to pointed out that the appropriate point of classifi- restrict communication: cation often may not be a specific formula or in- struction but the knowledge that a result can be to uphold scientific standards; accomplished, for “once it is disclosed that some- to protect a professional or economic interest; thing can be done, then someone will be able to to protect the health, privacy, or safety of duplicate it. ”52 Joan Bromberg, a historian of individuals; and science, adds that “keeping secret that a research to protect national military and economic program exists is one way to hold the edge in a security. field, ” because such “revelations also give hints at the correct direction for research.”53 Because of the differing values of the groups Uphold Scientific Standards involved in the communication of science, the in- formation developed during research frequently Within science, both traditions and good lab- becomes the object of dispute or tension between oratory practice govern the flow of dissemination those who sponsor and those who conduct re- of research results—who can communicate, who search. In general, this tension derives from con- will receive communications, and when and where flicting desires to disseminate and to restrict communication takes place. A junior member of access to information, As each actor defines dif- a research team may be restricted from discuss- ferently the areas of restriction, then the tension ing his or her own original work until the team’s grows. publication is ready, or scientists in one labora- tory group may refrain from discussing their work This tension is particularly apparent in contem- with colleagues elsewhere in the organization or porary restraints on communications relating to with journalists until a writeup is submitted to a national security and commercial property rights scientific journal. The ultimate justification for in such things as biological materials. In these most such controls—whether reinforced by lab- cases, a lack of consensus on boundary definitions oratory “rules” or by the pressure of tradition— has resulted in increasingly large “gray areas” of is to uphold scientific standards, to assure that information perceived as possible candidates for only verifiable and replicable science is presented restriction in the future. The more that military as legitimate science. systems depend on advanced technology-includ- ing such things as large-scale integrated circuitry, The peer review system in scientific journals, space technology, and microbiology54—the more for example, seeks to filter out reports of scien- that basic research appears to have the potential tific work that do not meet the highest standards for military importance. For technology related of research in the field, Readers must be able to to international industrial competition, similar un- accept publication confidently as a seal of legiti- certainty about what may prove to be important macy and accuracy, thereby allowing them to in the future has stimulated restrictions on the trust the author’s conclusions without replicating the experiment or redoing the research. In theory, “1’atrick D, Kelley and Ernest G. Jaworski, “Agreements Cover- the norms of good scientific practice justify accept- ing Exchanges 0[ Biological Materials, ” American Association for the Advancement of Science, annual meeting, New York, May 1Q84. ance or rejection of communications; in practice, ““Openne\s and $ecrcc} in Scientific and Technical Communi- the current agenda and occasionally the of cation, Sernlnar, [Xc, ] 1, I Q84, hlassachusetts Institute (}[ Tech- the research field may determine which topics are nolo~}’, Cam bnd~c NIA ‘ ‘Ibid. favored as well as which determine the mode of “NATC) Science C(~mmittcw, op. cit. presentation. 44

The goal of preserving the quality and integrity tellectual property as a major determinant of of science, and the goal of protecting the public success: are both used to justify an unusual but effective There is a direct correlation between the secu- restriction on the timing and, in a few cases, the rity of patent rights and industry’s willingness to actual publication of articles in medicine. In 1969, commit large sums to the inherently risky efforts Franz J. Ingelfinger, editor of The New England needed to find and develop new technologies .58 Journal of Medicine, began to worry that prema- ture disclosure of unevaluated and unauthenti- In industrial research, the sponsor wants to pro- cated medical research results before they were tect the proprietary nature of the research and published in a peer-reviewed medical journal (and may not want competitors to have access to the hence presumed to be evaluated and authenti- information resulting from the sponsored re- cated) could be dangerous to the public. He ar- search. This justification for secrecy now extends gued that such reports might contribute to false widely as more and more universities enter into expectations of unevaluated drugs or treatments research agreements with industrial sponsors. The or, on occasion, might advocate treatments later institutions’ naturally opposing views about the found to be useless or potentially harmful.55 In- value of information are often a subject of nego- gelfinger therefore instituted an editorial policy tiation in university-industry relations, where the that denied publication to an article if its conclu- traditional openness of the university could act sions or major data had appeared in a medical against the commercial interests. Most frequently, news publication or similar unrefereed format. the resolution is a contract provision that allows This rule has been continued and reinforced by a prespecified delay of publication in order to per- the Joumal’s subsequent editor,56 and similar prac- mit the sponsor to file a patent application. Some tices are followed by editors at other journals. university research projects will submit to a de- lay to allow an industrial sponsor to review a doc- To Protect a Professional ument for proprietary data. or Economic Interest A desire to secure or protect certain legal rights of the generator or sponsor of the research may Scientists have always exercised a form of self- also motivate restrictions. With respect to new regulation in publication in order to achieve per- products or processes developed during research, sonal or professional rewards. Timing and place- three outcomes are possible: it may be kept secret; ment of publication, for example, can significantly it may enter the public domain; or it may be affect a scientist’s career success. granted a patent. The patent laws grant an ex- Protecting an economic advantage has also long clusive right, for a fixed period of time, to com- been accepted as a legitimate motive for commu- mercial exploitation of an innovative product or nications restraint in commercial circles; busi- process to the person who discloses the invention nesses control publication to protect their eco- to the U.S. Patent Office. Data or analyses col- nomic rights in the material, to make a profit, or lected during research may also receive protec- to avoid a loss. Examples of such motivations for tion via the copyright laws, which prevent pla- restrictions may be the protection of patent rights, giarism. The first U.S. regulation concerning the use of research results was, in fact, stated in the the maintenance of competitive advantage, or the 59 protection of rights in biological materials.57 In- patent and copyright clause of the Constitution. dustry, in fact, has cited the ability to protect in- Premature disclosure of patentable information could endanger the legal rights of the inventor and

55 Barbara J. Culliton, “Dual Publication: ‘Ingelfinger Rule’ De- bated by Scientists and Press, ” Scienm, VO]. 176, June 30, 1972, pp. Se Alexander MacLachlan, testimony before the U.S. Congress, 1403-1405, Science Policy Task Force, House Committee on Science and Tech- s~Arno]d S. Relman, “The Ingelfinger Rule, ” The New England nology, Apr. 25, 1985. journal of Medicine, vol. 305, 1981, pp. 824-826. S~Haro]d Relyea, Congressional Research service, personal com- SYKelley and Jaworski, oP. cit. municat~on, 1985. 45

therefore restriction is chosen. In other cases, dis- the panic or devaluation of property that might closure might be used to establish some such right. follow publication of an earthquake prediction for a specific area. The “Paigen” report, which ana- An organization may take action to impede dis- lyzed the alleged health effects of the chemicals semination (or to hasten dissemination) in order dumped at Love Canal, was later criticized by a to preserve a corporate image or administrative panel of scientists for improper epidemiologic power. Similar action might be taken to support methods that “fueled rather than resolved public the mission of a government agency. In a few re- 62 anxiety. “ One of the most important questions ported cases, businesses have acted to impede the raised in such situations is how, in the face of great dissemination of scientific data in order to pro- scientific uncertainty, adverse economic effects tect the company’s legal position or to avoid ad- should be weighed against possible health risks verse publicity. When studies of the toxic effects to individuals or the general public. of vinyl chloride on rats revealed cancer, one Ital- ian researcher, for example, found that his indus- Opponents of such restrictions argue that they trial sponsor refused to let the evidence be re- inhibit free discussion in a democracy. The Amer- leased. It was some time after that suppression ican public has a right to be told the technical in- occurred that cancers were found in workers in formation, even if the public policy decisions are the United States who had been exposed to vinyl ultimately based on normative rather than tech- chloride. 60 nical grounds. In the laser isotope separation case discussed earlier in this chapter, the argument was To Protect the Health, Privacy, made that severe classification of such research or Safety of Individuals might not, in the long run, prevent dissemination of the scientific “trick” or secret of the laser iso- Federal regulations as well as informal controls tope separation process to other countries, but on the publication of data from human subjects that it could discourage public discussion in the research often seek to control dissemination in or- United States on whether the work should con- der to protect the privacy or safety of individuals tinue. The “lid of secrecy” would “effectively pre- described in the reports, or to protect subjects who clude public scrutiny, ” one observer wrote.63 participate in research on controversial topics or illegal activity.”] To Protect National Military Some research information may have the po- and Economic Security tential of harm to the public welfare either because Protection of national security has been used of what is said or when it is said. In those cases, for centuries as a justification for government reg- dissemination is regulated (delayed or prohibited) 64 ulation of technical information. During World to protect the public health and safety. Announce- War II, American scientists and engineers accepted ments pertaining to some real or potential public two kinds of censorship or control of communi- health problems could cause panic, and so re- cations—voluntary (justified in the spirit of patri- straint is used in the dissemination or publicity otism) and mandatory. Scientific journal editors prior to publication—a justification that has been practiced extensive voluntary censorship during used for restricting communication of data on pos- the war—they believed that some type of censor- sible modes of transmittal of acquired immuno- ship was necessary to prevent the leakage of deficiency syndrome (AIDS). Dissemination of a 65 vital information to U.S. enemies. Scientific pub- result may also be delayed or controlled to pre- vent a potential adverse economic, social, or po- litical reaction. This justification is used to avoid *’Lewis Regenstein, America the Poisoned (Washin~t(~n, DC: Acropolis Books Ltd., 1982), p. 140. ‘“John T. Edsall, “Scientific Freedom and Responsibility: Report * ~Casper, “Lasa Enrichment, ” op. cit., p. 38. of the AAAS C<>mm ittee on Scient i tic Freedom and Responsibil- “Relyea, “Shrouding the Endless Frontier, ” op. cit., p. 80. ity, ” .%lence, vo], 188, .May 16, 1975, pp. 687-693, and \rol, 18Q, “hllchael Ivl, Sokal, “Restrictions on Scientific Publication, ” July 18, 1~75, pp. 174-175. Science, ~’o]. 215, hlar. 5, 1982, p. 1182; and Michael M. Sokal and “’Barr~’ Barnes, ;I’ho Shouid Knon’ ;l’h~t: Social Science, Pri\’ac> Janice F. Goldblum, ‘From the Archives, ” Science, Techno]og}, & and Ethics ( Cambridge, England: Cambridge University Press, 1979), Human I’a]ues. ~’o]. 10, spring 1~85, pp. 24-27, 46 lications of all types were also subject to manda- of restrictions believe that a steadily increasing tory review by the Office of Censorship. And share of these technologies is dual-use in nature, scientists engaged in weapons research were, of that is, that they can have both military and non- course, subject to the military’s restraints and con- military applications. ’a And fourth, such national trols on all their activities, including conversations policies as East-West detente and scientific ex- as well as written communications. In peacetime, changes with the Chinese are perceived to have however, the “conflicting imperatives of national increased the opportunities for leakage of tech- security and open scientific communication” have nical information of all types. Such rationales occasionally led to controversy and legal action were clearly stated in the draft “National Policy and are continually the subject of vigorous de- on the Transfer of Scientific and Technical Infor- bate.” The tension between these two objectives mation, “ issued by the executive branch on June arises primarily in a clash between the justifica- 15, 1984: tions for restraint and openness. The government The acquisition of advanced technology from wants to control all information that could be of the United States by Eastern Bloc nations for the possible value to potential enemy states; the scien- purpose of enhancing their military capabilities tists stress that such measures could damage scien- poses a significant threat to our national security. tific progress and creativity and abridge tradition- Intelligence studies indicate that a small but sig- al scientific freedom. ’7 nificant target of the Eastern Bloc intelligence gathering effort is science and engineering research The motives for restrictions justified by national performed at universities and federal laboratories. security can be both economic and military. At the same time, our leadership position in sci- Often, the restriction is indicative of whether the ence and technology is an essential element in our research has demonstrated application. * Although economic and physical security. The strength of “national security” is vaguely defined in the law American science requires a research environment and the uses of the term range from “defense of conducive to creativity, an environmentin which the United States” and “public peace and safety” the free exchange of ideas is a vital component .69 to “financial policies of the United States, ” there The government has recently justified the ap- is agreement among policy analysts that that pol- plication of export control regulations to basic re- icy concept does provide to the President a broad search as necessary to protect: 1) tangible goods, grant of administrative discretion to justify all including technical data, that relate to national sorts of policies. security; and 2) the domestic economy. The ap- Recently, the justifications for communications plication limits “information of any kind that can restraints based on national security considera- be used or adapted for use, in the design, produc- tions have tended to relate to quite specific per- tion, manufacture, utilization, or reconstruction 70 ceptions about the importance of science in an in- of articles or materials.” ternational context. First, those who believe that The ensuing controversy over the wide-scale the United States’ lead over the Soviet Union in application of these controls has led to a reaffir- some important areas of military technologies is mation by the Department of Defense/University diminishing attribute that situation to Soviet ab- Forum that: “No restriction may be placed upon sorption of U.S. technologies. Second, the mili- the conduct or reporting of fundamental research tary systems themselves have become more de- that has not received national security classifica- pendent on sophisticated new technologies and tion.“ However, how the various participants in on the science that feeds them. Third, proponents such restrictions define what is or is not fun-

“Richard D. DeLauer, “Scientific Communication and National bsPZ,nel ~jn Scientific Commmication and National Security ~’om- Security, ” science, vol. 226, Oct. 5, 1984, p. 9. mittec on Science, Engineering, and Public Po] icy, Scientific Com- “NATO Science Committee, op. cit. munication *,, andlVational Security (Washington, DC: National Acad- . . . know-how is a precious commodity leading to the com- emy Press, 1982), p, 11. mercial or military products that determine the fortunes of nations 69U S. Congress, “Scientific Communication and National Secu- in peace and in war. Yet sometimes it is hard to tell where scientific rity, ” hearings before the House Committee on Science and Tech- knowledge leaves off and engineering know-how begins. ” DeLauer, nology, May 25, 1984. op. cit. 7015 CFR 379. 1.a. 47

damental research can determine the extent of re- hand, if DOD abandons any attempt at regula-

striction. This window of uncertainty prompted tion in the university context, it could seriously the Department of Defense (DOD) to state its def- compromise and, in certain cases, totally under- inition of “fundamental research”: cut other efforts to control the out-flow of militar- ily critical technology. The middle ground is a dif- For DOD purposes the decision whether a par- ficult one to establish. ” ticular research activit is or is not fundamental y The Corson panel of the National Academy of will be determined primarily by considering the following easily identified characteristics: 1) per- Sciences, fearful that the government policy could former (for example, university, industry, in- begin to endorse a form of “blanket justification” house) 2) budget category (for example, 6.1, 6.2) for restricting some fields of basic research, at- 3) sponsoring DOD entity 4) special contract pro- tempted to clarify the limits of acceptable re- visions. . . Unclassified contract research sup- straints. The Corson panel’s report73 stated that ported by 6.1 funding shall be considered ‘fun- communication restrictions should not be applied damental. Similarly, unclassified research to any area of university research, be it basic or performed on campus at a university and sup- applied, unless they involve a technology meet- ported by 6.2 funding shall with rare exceptions 71 ing all the following criteria: be considered ‘fundamental.’ In the disputes over restrictions on scientific The technology is developing rapidly, and the time from basic science to application is short; communication, DOD sees itself as “caught in a The technology has identifiable direct military ap- dilemma. ” In the words of the Defense Science plications; or it is dual-use and involves process Board: or production-related techniques; Transfer of the technology would give the U.S.S.R a significant If it vigorously attempts to regulate the flow of scientific information in the scientific commu- near-term military benefit; and the U.S. is the nity, it could jeopardize the strength and vitality only source of information about the technology, or other friendly nations that could also be the of the very community it is seeking to revitalize 74 for the sake of national defense. On the other source have control systems as secure as ours. 71 Report (~t the Detense Science Board Task F(>rce In Universit\r “’I.e(l }’(lung, “( t~mrnentary The C(~ntr~>l of Government-Spon- Responsiveness t[> National Security I{equirements, )anuary 1982. w~rcd Tec hn ica 1 I nt or ma ti on, Scienm, Technology >,, & Human \’al- ‘~[>anel On Sclentlflc COmmunicatlon, (~p. c]t, ues, vol. 10, spr]n~ 1Q85, pp 82-80. ‘i[bid,

SUMMARY

In 1979, Miller, Prewitt, and Pearson conducted engineering declined some when the question spe- a public opinion poll for the National Science cified plants and animals rather than humans, but

Foundation in which they asked respondents there was still substantial disapproval of scientific about specific types of scientific studies and research in this area. In contrast, only one-quarter whether scientists should be “allowed” to conduct of the population expressed opposition to stud- those studies. Because the structure of the poll ies that would involve weather modification or questions implied regulation, the response can be the extension of the average human life span. interpreted as one measure of the public’s will- ingness to restrain certain types of scientific in- Such data tend to indicate that Americans, in quiry.75 The results indicate that a majority of the deciding whether research should be restricted or respondents would have liked to prohibit research prohibited, may make such decisions based on dealing with the creation of new life forms and whether they believe that the restriction would with the gender of children, Opposition to genetic respond to moral or social objections. The results

may also indicate that the public is more likely “ion 11 Nllller, et J]., The Attitudes of the 11, S, Public To;\ard Science and Ttt-hno)og},” ( ~f’ashln~ton, DC: Nat]ona] Science Fc~un- to approve regulation for reasons relating to the dation, 1 Q80 ), alw} J{~n D !vliller, The ,4nwrican People and Science immediate protection of human health or safety /’()/ic}, ( ~cw }’orh [)erg~m[,n I’ress, 1 Q83 ). or to preservation of the moral order than for rea- 48 sons relating to potential long-term damage of the on limiting or restraining certain areas of re- environment or depletion of economic resources. search .79 Although most Americans believe that the gov- Available public opinion data suggest that the ernment has some control over the work of scien- public is not unwilling, based on a number of ra- tists, the public does not appear to be willing to tionales, to restrict the scope of scientific inquiry, endorse more direct public control. A 1983 An- especially in the area of human health and safety nenberg study asked whether the government pre- such as genetic engineering. The data also sug- sently has any control over “what scientists do” gest that a larger portion of the public would be and 77 percent of the respondents indicated that comfortable with the genetic modification of they thought that the government did have that plants and animals, but that there is substantial kind of control. ” When asked if the government concern about work involving changes in the hu- “should” have control over what scientists do, 67 man genetic structure. Other evidence, such as in- percent of the public agreed that this kind of con- creased demonstrations, publicity, and legislative trol was appropriate. In a 1979 study, respond- initiatives, indicates that, in the eyes of the gen- ents were asked whether “most citizens are well eral public, some regulation of experimentation enough informed” to help set goals for scientific on animals is supported. research or to decide which new technologies It is possible that because the public appears should be developed .77 Approximately 85 percent to place such high value on science’s contribution of the public indicated that they did not feel that to human health and to quality of life, and be- most citizens had the knowledge needed either to 78 cause usefulness and application play such a sig- set research goals or to select technologies. Con- nificant role in the public’s evaluation of scien- tradictory evidence of such willingness to partici- tific priorities, a willingness to regulate may pate was found, however, in a pilot study con- indicate that, in such instances, the perceived risk ducted in 1979 by the Public Agenda Foundation, is believed to outweigh perceived benefit, even which concluded that public participation in deci- though there may be inadequate evidence to sup- sionmaking can extend to priority-setting based

Tqpllbllc Agenda Fo~&tion, Scienm Poiicy Pn”on’ties and the pu~- 7bMiller, The American People and Science Policy, op. cit. lic, a report to the National Science Foundation on a Pilot Project 7“Miller, et al., op. cit. to AS:CSS Public Attitudes About Priorities and Indicators of Qual- 781bid. ity for Scientific Research, New York, 1983. Chapter 4 The Mechanisms for Direct Control of Research Chapter 4 The Mechanisms for Direct Control of Research

At the laboratory bench level, each researcher Zoologist Alexander Faberge describes the “open controls his or her own activities, deciding which traditions” in one field:3 questions to answer and how to go about answer- Not only is it normal to discuss one’s ongoing ing them. Controls are also part of the normal research, but also to give away one’s research procedures of a research field or discipline—for material in the form of genetic stocks, with the example, the peer review system that governs the verbal understanding that the giver should be contents of disciplinary journals. Other, more for- given time to publish first. Such genetic stocks, mal control takes place at the laboratory or in- or cultures of organisms, sometimes take years stitutional level, through set policies or such mech- of work to prepare, and are placed in culture col- anisms as review committees. And finally, legal lections, freely available. and administrative regulation of research occurs “It would bean unheard of matter, ”Faberge con- at all levels of government, most likely in response tinues “to keep genetic stocks private . . .“ These to public opinion or public protest. This chapter and similar aspects of the sharing of research data looks at the administrative mechanisms for con- are discussed in a 1985 report from the National trol or influence at all stages of the research Academy of Sciences (NAS) which notes that, in process. general, access helps in reanalysis and verifica- In an idealized model of scientific freedom, a tion. 4 In fast-moving areas, the sharing of research scientist sets his or her own research agenda, per- data may jeopardize a researcher’s patent rights forms the research without fear of repercussion or the commercial return on a discovery, so there or criticism, and describes the work to anyone and are significant forces against openness. Neverthe- everyone. Sissela Bok characterizes such freedom less, the NAS committee concluded that without as “freedom of limitless thought and unfettered data sharing, scientific understanding and prog- speech. “I For scientists in some fields, that free- ress would be impeded. dom has traditionall been perceived to encom- y Even in early modern science, however, com- pass autonomy of action as well as responsibil- munication of ideas was not totally open. Inven- ity for how the work is conducted. Biologist tors delayed or repressed publication out of fear David Baltimore observes that contemporary re- of ecclesiastical or political displeasure. Because search in molecular biology, for example: the community of science rewards priority, re-

. . . has grown up in an era of almost complete searchers have also delayed sharing data until permissiveness. Its practitioners have been allowed credit is assured, usually through publication. His- to decide their own priorities and have met with torian David Hull attributes such secretiveness to virtually no restraints on the types of work they science’s “intrinsic competitive nature.”5 Techno- z can do. logical skills and knowledge regarded as applied In many research facilities and in many labora- have not always been tightly controlled by their tories, open communication has been routine, possessors; skills were assumed to be the prop-

‘A]exander C, Faberge~ “ Thoughts on the Clrlglns C}I Secrec } and Openness in Science, ” American As%lclat](~n t or the Adiranccmcnt ot Science, annual meeting, New York C i t}’, Nla}’ 1484. IS]\sela Bok, “Freedom and RIsL, ‘ l.{mifs of Scientltic lnqu)rj, ‘National Academ}r ot Sciences, Committee on Nat]ona] Stat]+ Gerald Ht)lt[)n and R[]bet-t 5 ~loris(~n leds ) INe\v }’c~rk. \$’ \lr N~~r- t]cs, .$h.]rinX l{ew~r~h Data (llrashlngtt~n, DC National Acaclem}r t(~n & Cc) 1~7~ ~, p 110 I)ress, 1Q851 ‘David Baltimore, “A Biologist’s Perspective, ” Limits of Scien- ‘Ila~’]d Hull, “Openness and Sccrec} in Sc]ence: Their Ori~ins tif~c inquiry, Gerald Holton and Robert S, Morlson (eds, ) (New and I.irnitat ions, ” Science Techno/og~,,” & Human \ ‘alues, v[~]. 10, York: W,W. Norton & Co., 1979), p. 37, ~pring 1Q85, pp. 8-0

51 52 — erty of those who exercised and developed them.6 puts the community at risk through hazardous, Although unqualified sharing (especially before dangerous procedures (e.g., experimenting with publication) has never been the norm, until sev- explosives in Times Square). Such “moral regu- eral decades ago, scientists exercised relatively few lations’’--enforced through social condemnation restraints on their communications to others. or disapproval—have been the predominant con- trols on research for centuries, other than those Contemporary attitudes to openness in univer- which arose in connection with military research. sity science are also influenced by the concept of Neither Federal nor local governments in the academic freedom in general. In the United States, United States had formal laws, rules, or policies “academic freedom” has stood for personal free- by which the subjects or procedures could be con- dom of the academic, rather than the collective trolled. freedom of the Nation. Because of this emphasis on the individual, some academics have regarded This environment changed for American scien- regulation more as a limit to which they are tists in the 1940s. When the United States entered obliged to submit. Limits have been, therefore, World War II, the scientific community joined in equated with “responsibilities.”7 But, Walter Metz- the war effort and, just like millions of other peo- ger points out, “academic freedom and scientific ple, scientists relinquished to the Government freedom are different species of freedom. . . .“8 their personal autonomy over how they did their The former is an ideology of a profession, across work. They accepted government control over the disciplines, with common duties; the latter is agenda, over process, and—in the case of infor- the ideology of various professions in a discipline mation considered to be of military importance— (e.g., science). And the latter need not be con- over dissemination even to their colleagues. When nected to a university. almost everyone in science was working behind the secrecy fence, the communications restrictions Historian Carroll Pursell takes a more prag- did not seem so onerous. There was a comraderie matic view. Science, he observes, is always “reg- and free exchange that participants recall as fre- ulated” in the sense that it is given shape, direc- quently greater than in the structure of univer- tion, and impetus by something. There is, he sity departments. Within the Manhattan Project, writes, “a tendency to take it simply as the work- for example, Robert Oppenheimer successfully ing of some invisible hand until the public (in the convinced General Leslie Groves not to implement form of government, mobs, or whatever) takes irrevocable application of “compartmentaliza- a more visible hand. This is, of course, non- tion. ” Groves wanted to keep scientists from shar- sense.”9 Communities have, for example, never ing information with their colleagues in other tolerated (for very long) any researcher who parts of the project; Oppenheimer argued that tackles topics outside the boundaries of accepted some decompartmentalization was necessary for moral behavior or social beliefs or who knowingly progress at both the laboratory and the individ- OErnan Nlchfullln, “Openness and Secrecy In Science: S(>me Notes ual level. The perspective argued by Oppenheimer on Early Hist(>ry, ” Science, TechniJ/(]~}’, & }fuman I’alues, ~r(~l. 10, spring 1985, pp. 14-23, was that the scientists were the best judge of how ‘Walter 1’, Metzger, “Academic Freedom and Scientific Freedom, ” to get to their goal. He also believed that the crea- Limits of Scientific inquiry, Gerald Holton and Robert S. Morison tive scientist required intellectual “elbow room” (eds. ) (New York: W.W. Norton & Co., 1979), p. 102. for the cross-fertilization that could be vital in a ‘Ibid , p. 107. ‘Carr[]ll I’ursell, [Department ~~t History, Universit} (lf Call[~~r- new field. Each individual had to feel free to pur- nia, Santa Barb,] ra, perw}nal c (~m mu nlcat i [>n, 1 Q85. sue research whatever way he or she wished. 53

MECHANISMS FOR INDIVIDUAL OR RESEARCH GROUP CONTROL

At the level of individual choice, then, research- Agenda Controls ers in a democratic system decide what line of re- search to pursue, how to test their hypotheses, In research groups, internal factors may not which data to gather and how to gather it, and only direct but also constrain research. At any when and to whom to tell about their results. The given point in the development of a scientific scientists simply seize on personal freedoms avail- speciality, for example, there exists some finite set able to all citizens. of research topics that are considered by the mem- bers of the speciality to be legitimate, interesting, The amateur astronomer provides an excellent and feasible.10 If peers do not consider an area example of how little externally imposed controls to contain “interesting” questions and hence to be can affect a researcher who is working outside intellectually stimulating or professionally reward- conventional institutional settings for research, ing, then researchers may suspend research out academic or otherwise. There are approximately of concern for their professional reputations. In- 10,000 amateur astronomers in the United States, fluence on the researchers to control or restrain many of them engaged in the search for new as- their own work may also come from the social tronomical bodies, or in recording astronomical environment, as when the public raises questions phenomena. Almost all work at their own ex- about the morality of a project. Other research pense, in return for the reward of discovery, the topics may receive little attention and no fund- joy of creative activity. Such an individual can ing because peers consider them to be outside the decide what to do, can build his or her own equip- boundaries of “legitimate” science; research on ment according to any schedule, and can elect to parapsychology often falls into this category, Re- tell everyone or no one* about the results. To searchers working on new chemicals for introduc- achieve recognition and acceptance by the com- tion into commerce or on new pesticide formula- munity of professional astronomers, however, a tions may tend to shape their investigations so that researcher must adhere to the standards and the chemical will withstand scrutiny and secure norms that govern conduct in the field and must approval under such Federal environmental reg- subject that work to review by colleagues, usu- ulations as the Toxic Substances Control Act or ally through the journal peer review system. the Federal pesticide laws. The cost of instrumentation and the internal al- location of resources can be devices for dramati- cally controlling the research agenda. The major experimental facilities for high energy particle physics research, for example, are few in number and because the demand for time on the acceler- ators far exceeds the time available, laboratories

‘ ‘Darvl E. Chubin and Terence C(lnn(}ll} Rcwarc h Trail\ and Science I’(~llcies: Local and ~xtr.~-l.(~ca] Nc~L~t iatl(~n (}i SC ltntlt IL \\’ork, Scientific ~Sfdb/l\hl?lf’rI~\ .Ind }firrar( hit’s .S[l( J()/()g~ ()/ th( Sciences I.TC)] b, Norbert Ella+, et al ~ vds } ( [ {Inxham \lA: I

tific merit, 2) technical feasibility, 3) capability Box A.-NIH Study Sectbns as a Mechankm of the experimental group, and 4) availability of for Control d A#?M48 , , the resources required. Thepeerreview system, whereby scientists ad- At the individual level, research may be re- vise the Federal Government on huw to akeate stricted not only by mechanisms driven by polit- research funds, is rqxesentative of a tw- ical, economic, or professional concerns but also pronged mechanism for control of the ms@arch -da: decisions an fundiq p&Wti4XdiW prop by personal values. Especially when alternatives are limited, individuals “feel forced to choose S& both S@ the current & kr~ WUI affect the direction of a field or discipline. The among projects they would normally not con- rnuki4?vel process used by NM provides a god sider, the moral questions . . . become more im- example of such controls. mediate and controversial.”11 The decision not to participate in military-supported or weapons- A research proposal submitted to NM is first scanned by an OffiUer in the Division of RM?arCh related research, therefore, may be also a deci- sion to alter one’s lifetime research agenda. This Grants, WhO refers the pro@wd to tk mostxeb Vant of 4S chartered Study -sl?!etkns arid to @w decision is a personal one, an individual rather most appropriate Institute of NM4. Each study than a collective control .12 section is composed of app+ximdy 1$ *n- In each of these instances, the regulatory force tis~s and a fulktime? nom- mwcwtk - tary who is an NIH scientitk W exaathm *- may actually be outside the research group, but retary nominates memti of *- study aeetigw the group or the individual chooses to suspend for selection by thehJIHDimctcw. s&ldy&q&m a line of research in response to either moral or members serve a 40year tgrm andme43 tbxkes economic pressure. a year to review mmr NM pFoposds pw Wmkm. Controls on Procedures The study SeCtiOt@ assi@’k to @ach + @ priority score ba8ed @n sCMNiEi4 merits R@ikw- Within each scientific field or research special- ers am not aware of the to@, bud@ary ratpwst on the prqxwal. The relevant Mtut@ theh re- ity, the social influence of tradition and “stand- ceives the falikedpmposak and pa$ses * Mx@” ard practice” also govern aspects of the research kg decision on to itit advisory coWwilrWhkk’i* process. Even though these practices are volun- composed of kth saientkt~ and publk &jgums. tary, they carry the authority of social norms. On BeC?#se h=titute$ with MJer bud@iets ,* abla occasion, they may later form the basis for insti- ta fired HM2* proje@#?, Solite CWq Ck@:thikt tutional or governmental regulation. -%- ~ high qualiky rAear&h ti’$o ~ where social and W- Many controls are linked to the formal princi- in i% lower priorfty-foi’ ples and rules that govern admission to a profes- h?sser quality m?aearcfl may be ftmdd @ IW08e sion. Since antiquity, the medical profession, for “glamorous” di#ase eat@&rie& The st##@MN& example, “has formalized principles and rules of tiolts ako CCMMkt workah@ps to*rSp@?t Qlx’tha conduct for its members in prayers, oaths, and status of the field, thereby prw!ding kqpterrn codes. ”13 Universal codes adopted by more than P- ~~● n to.tk one scientific field may relate basic ethical and and sen~ S@als to the!@/ntihlR Commimiiy moral principles to research practice. The Nurem- dxxlt areas of potential Merest to *h”@’ailtinff berg Code of 1947, for example, serves as the agency. model for many international and national codes pertaining to clinical research in general and to such topics as organ transplantation .14 Another adopt specific criteria for selecting experiments I IRc)~emary Chalk, “Drawing the Line: Science and hfilitary I~e- and assigning priorities to them. The International search, ” unpublished manuscript, May 1983, p. 24. Committee for Future Accelerators of the Inter- “Ibid,, p. 22, national Union of Pure and Applied Physics “Judith P, Swazey, “Protecting the ‘Animal of Necessity’: Limits to Inquiry in Clinical Investigation, ” Gerald Holton and Robert S. recommends four criteria be used for selecting ex- Morison (eds. ) (New York: W.W. Norton & Co., 1979), p. 136. periments and determining their priority: 1) scien- “Ibid., p. 132. 55

important code has been the World Medical Asso- results, either by withholding the information al- ciation’s Declaration of Helsinki (1964, revised together or by delaying dissemination for a short 1975). period of time. British mathematician John Na- pier, who had experimented with a new form of In some research areas, laboratory groups have artillery around 1600, “took great pains to con- not refrained from imposing voluntary clinical ceal the workings of his invention.”16 In 1947, moratoria—prohibiting researchers from, for ex- Massachusetts Institute of Technology professor ample, using on patients a procedure still consid- Norbert Weiner refused to supply a paper of his ered to be experimental. Such a moratorium can to an industry scientist engaged in military re- last weeks, even years .15 It is linked to percep- search. 17 In the 1980s, many biologists assert that tions of the risks associated with premature use researchers in certain areas are refraining from of a procedure and to the incomplete nature of sharing information and substances with col- the research process, however, not to the topic. leagues, ’a The most dramatic instance of a voluntary mor- The science community as a whole may sup- atorium on basic research was, of course, that im- port an investigator’s desire to avoid premature posed by molecular biologists in the 1970s. Re- disclosure, especially when data are incomplete combinant DNA regulation arose first in the form or not yet published in a refereed journal. Such of a moratorium called by researchers in the field. delay may also be linked to the researcher’s de- What began in private discussions was dramati- sire to maintain professional security through tem- cally brought to public attention when, as de- porary but exclusive control of knowledge. A dra- scribed in chapter 2, biologists proposed a vol- matic example of group self-censorship occurred untary suspension of certain types of genetic before World War II when a group of physicists research. This extraordinary step was followed tried to limit the publication of scientific research by the 1975 Asilomar meeting, when researchers relating to nuclear fission. By the middle of 1940, from the United States and elsewhere, discussed most physics journals had agreed informally “to the appropriateness of continuing the moratori- delay the publication of any article that might help um. After that meeting, action moved to the Fed- a knowledgeable scientist build an atomic eral Government level—to legislation and the for- 19 bomb.” mal development of National Institutes of Health (NIH) guidelines for the research.

‘“Cited in Chalk, c~p. cit , p Q. Communication Controls ‘“Norbert Weiner, The At)ant~c .Ilc)nthl}’, letter t(\ the edltot-, ]an- uary ICM7; reprinted in Science, Technolc)A~j, & Humdn I’alues, vol. Through the centuries, individuals have also ex- 8, No. 3, summer 1Q83. I H ~io](J~ist5 in[erJriem~e~ bv ercised self-restraint in dissemination of research Sandra Pan em ‘unltt]rnll! agreed t h~t there was more . free information exchange ]n the I Q~Os th~n currently .“ Sandra Panern, “The Interfer(}n D]lemma Swrec} \F ludlth I’ Sw~ze} and Rcnee C. Ft~x, “The Clinical \loratorium: Open Exchange, ” The Broohirrgs Re\iew’, winter 1 Q8?, p, ZO A (-ate clt hlltr~l L’alvc Surger}, E~perirnentat~on 1$’ith HunrarI ‘*Michael hl. Sokal and Janice F. Goldblurn, “Fr

REGULATIONS IMPOSED BY INSTITUTIONS

The attitudes and policies of research organi- perimental protocols and safety procedures and zations can regulate the agenda, procedures, and have policies on what subjects are not acceptable. communication of a project, through both infor- A research group may decide deliberately to take mal guidelines enforced by social pressure and for- up or drop a specific line of research for political mal rules enforced by threat of dismissal or pen- or moral as well as scientific considerations. Those alty. Although the extent and stringency of rules decisions—whether to pursue certain topics, or may vary, most organizations have specific ex- how to disseminate results—can reflect such fac- 56 tors as: 1) fear of social criticism or protest, 2) trust .“25 The Harvard report further points out accommodation to the pressures of the surround- that: ing social or political climate, or 3) a desire to pro- . . . the principal means by which the faculty ex- tect property rights (e.g., when a team delays pub- ercises control over the quality of the scholarly lication until assured of patent protection or keeps activities of its members is through its role in rec- a project secret in order to assure first publica- ommending the selection of its own members and 20 tion) . through the professional standards that it and the University apply in the selection process.26 As a result of discussions from the Vietnam era, some U.S. research laboratories or universities To administer such rules on a routine basis, decided not to allow classified research to be per- universities and private laboratories set up institu- formed on their campuses. ” Ohio State Univer- tional committees to review safety procedures, to sity, which accepted over $5 million in defense decide which topics to pursue, or to review the contracts research in 1982, now bans any campus quality or process of publication. Committees are research on offensive weapons .22 Other univer- dominated by members of the institution and are sities impose procedural restrictions—e.g., appointed and funded by the institution. Many whether classified work may be accepted with any exist as a direct result of Federal regulations tied entailing restrictions on publication23—or have to grant or contract funds. Institutional Animal placed such work off-campus and attempted to Care and Use Committees, Institutional Review insulate it from the research environment of un- Boards, and the Institutional Biosafety Commit- dergraduate or graduate students. tees, for example, are all required of institutions receiving funds from the Public Health Service, To enforce such administrative policies on NIH, or other compliant agencies. Institutional acceptable research topics or procedures, orga- review boards, which are (administratively and nizations employ a variety of mechanisms, rang- financially) local committees of the institution, ing from informal guidelines and review commit- nevertheless must include both scientists and non- tees, to formal administrative rules. In most cases, scientist members from the local community, all these controls are enforced through social pressure of whom “examine and pass judgment on the risks or reprimand. Many universities have adopted and benefits of a proposed study and on the ade- guidelines for the acceptance of externally spon- quacy of the consent proceeding as described in sored research which govern, for example, the 27 the research protocol.” terms of university-industry cooperative projects, the use of human subjects in experiments, or the Some institutional committees govern the handling of dangerous biological materials.” Such administration of a specific research program. For policy documents may govern with a velvet glove, example, in 1977, the Monsanto Co. and Harvard however. As the Harvard University guidelines University set up a special independent advisory note, “The pursuit of truth in the academic com- committee to oversee aspects of their $23 million munity is impossible without a measure of mutual research agreement. The five-person committee, trust between its members, and no set of detailed established out of concern for the public interest, principles and criteria can be a substitute for this assures that “both sides honor their contractual promises to protect academic freedom—namely, the right to publish—and to develop any prod- ucts that may emerge in a manner consistent with ‘“As described in, for example, lames D. Watson, The Double 28 The Health Effects Institute, Helix (New York: Atheneum, 1968). the public good. ” ‘ ‘Robert C. Cowan, “Degrees of Freedom, ” Technology Revie~\r, August September 1985, p. 6; also see Dorothy Nelkin, The Llnit’er- slt~r and ,$Iilitar}’ Resedrch: Lfc)rdl Politics at &flT f Ithaca, NY: Cor- “Report of the Committee on Criteria for Acceptance of Spon- nell University Press, 1972), sored Research in the Facult,v of Arts and Sciences (Cambridge, MA: “Kansas Cit.v Times, Jan. 13, 1983, p. A-7. Harvard University Press, October 1983), p, 3. “Chalk, op. cit., p. 13. “Ibid. “AS described in, for example, Nicholas H. Steneck, “The Univer- ‘ 7 Swazey, op. cit., p. 139. sit y and Research Ethics, ” Science, Technolog}r, & Human Values, “Barbara J. Culliton, “Harvard and Monsanto: The $23-Million VO]. q, fa]] 1984, pp. 6-15. Alliance, ” Science, vol. 195, Feb. 25, 1977, p. 759. 57

a private research firm, insulates scientists from Microfilms, Inc. (a general clearinghouse for U.S. pressure by using two independent committees, theses and dissertations) and that it was not un- one that creates the research agenda, another that usual for graduate schools to cooperate—as a mat- reviews finished work.29 In the national labora- ter of policy—by granting l-year delays .’” Typi- tories, visiting committees, composed of scientists cal reasons for such requests were: 1) to allow the from other institutions, are used to evaluate the student time to seek patent protection, 2) to al- quality of work in the lab. low time for first publication in a journal of rec- ord, 3) to provide a degree of protection for in- Institutional restraints on communication may dustrial sponsors of research, 4) to protect the result not just in suspension of publication but also safety and welfare of informants used in the re- deliberate, albeit temporary delays. At a 1984 search, or 5) to protect militarily-sensitive infor- seminar on secrecy in science, many university mation. deans of research remarked that it was not un- usual for them to receive requests to delay the sub-

mission of a Ph.D. dissertation to University ‘L’’’ Opennes~ and Secrecy in Scientific anci Tcchn]c.~1 Commun]- cation, “ seminar, Jranderbilt Universit}r, Nashville, Th’, Sept 24, “Sc~nce, Feb. i5, 1985, p, 72Q. 1Q84,

CONTROLS BY PROFESSIONAL ORGANIZATIONS IN SCIENCE AND ENGINEERING

Professional codes or industry association search Society has established professional stand- guidelines may act as a regulatory force on the ards for evaluation research. The American Chem- research conduct of members. These rules are ical Society developed the Chemists’ Creed and voluntary standards that reflect private consensus Professional Employment Guidelines, which set on public matters. They are enforceable primar- standards for practice in research settings. Most ily through the social pressure of membership in scientific societies have, at minimum, guiding the association and hence are effective only when principles for the conduct of research. Some have such membership is useful or necessary to acquir- extensive and detailed guidelines for agenda, pro- ing or maintaining employment in the field or in cedures, and communication of research results. acquiring a government grant or contract. Recent concern about the leakage of militarily In some scientific fields these rules may form sensitive information to the Soviet Union from the foundation for State licensing procedures— the U.S. western allies has led the Federal Gov- as in the case of physicians or engineers. In other ernment to request the specific cooperation of the fields, the codes may pertain to accepted proce- scientific and technical societies in regulating com- dures in the field or to testing. The American Psy- munication. The Government has asked societies chological Association, for example, has issued to restrict access to certain meeting sessions—that guidelines for research psychologists who use ani- is, the session would be neither classified nor open mals, as have such groups as the Society for Neu- to all meeting participants. The American Asso- roscience, the Society of Toxicology, and the In- ciation for the Advancement of Science Commit- ternational Society for the Study of Pain.31 The tee on Scientific Freedom and Responsibility has American Psychological Association has also de- identified examples of “self-imposed restrictions” veloped a set of Ethical Principles in the Conduct in a few professional societies that exclude non- of Research with Human Participants. The Amer- U.S. citizens from meeting sessions dealing with ican Anthropological Association and the Amer- militarily sensitive topics .32 The Society for the ican Sociological Association adopted new codes —- of ethics for research in 1971. The Evaluation Re- “Robert L. Park, “Intimidation Leads to Seli-Censorship in Science, ” Bulletin of the Atomic Scientists, IO]. 141, No. 3, spring “Science, vo]. 228, May 17, 1985, p, 830 1985, pp. 22-25, 58

Advancement of Material and Process Engineer- At least half a dozen professional societies are ei- ing and the Society of Manufacturing Engineers, ther reconsidering or reformulating their policies among others, have voluntarily censored them- eon restricted meetings. * selves, limiting attendance at their meetings (or at specific meeting sessions) to U.S. citizens only.33

“Janice R, Long, “Scientific Freedom: Focus of National Secu- rity Controls Shifting, r’ Chemical & Engineering News, July 1, 1985, ‘The AAAS is distributing a survey to determine the extent and p. 9. pervasiveness of this trend.

MECHANISMS FOR GOVERNMENT REGULATION

Federal, State, and local governments use leg- tional review of project applications.”36 Its prin- islation, executive (e.g., Presidential) directives, cipal regulatory effects are felt in the university agency rulemaking, and so forth, to exert con- research labs, although the regulations on molecu- trol on the conduct and dissemination of research. lar biology research or on the use of human sub- Such mechanisms differ from entity to entity. jects in experiments have also been applied to some industry research. A comparison of two Federal agencies that reg- ulate biomedical research demonstrates how dif- Because of the variety of mechanisms and en- ferent mechanisms can constrain research. The forcement in the executive branch agencies, new Food and Drug Administration (FDA) closely fields often face a thicket of duplicative or even monitors drug research and applies its program conflicting requirements. The December 31, 1984, of control—e.g., in requiring the assurance of con- Proposal for a Coordinated Framework for Reg- sent by subjects involved in clinical trials— ulation of Biotechnology37 issued by the Office uniformly throughout the United States. Tighter of Management and Budget is evidence of increas- requirements for the use of human subjects were ing concern about this problem. In May 1984, the instituted in 1962. This organizational approach White House Cabinet Council established a work- is tied to FDA’s principal mission of regulation ing group on biotechnology to review Federal reg- aimed at protecting the consuming public; its en- ulatory rules and procedures relating to the bio- forcement power to regulate research comes from technology industry. All three affected agencies the fact that it must approve the marketing, ad- (FDA, Environmental Protection Agency, and vertising, and distribution of all drugs sold in the U.S. Department of Agriculture) would review United States. The principal regulatory efforts of biotechnology products and processes. Under the this agency are thus directed at research in the Framework, review would proceed on a case-by- pharmaceutical industry .34 In contrast, NIH, as case basis, each with its own staff, consultants, an organization that supports and conducts basic and expert scientific advisory committees. The Re- research, applies a philosophy of encouraging aca- combinant DNA Advisory Committee (RAC) demic freedom and imagination in the research would continue to oversee rDNA experiments re- it supports through its extramural projects grants lated to biomedical research and the National 35 program. The NIH approach uses a system of Science Foundation (NSF) would form a review decentralized, institutional review committees that committee to examine the potential environmental operate under generalized ethical guidelines. NIH effects of basic research experiments employing also “takes direct responsibility for the protection rDNA. All five advisory committees would re- of research subjects under its own system of na- port to a parent committee, the Biotechnology Science Board, which would receive summaries “Alexander M. Schmidt, “The Politics of Drug Research and De- velopment, ” The Social Context of Mecficaf Research, Henry Wechs- of all recombinant DNA, recombinant RNA, or ler (cd. ) (Cambridge, MA: Ballinger Publishing Co., 1981), pp. cell fusion applications and may undertake itself, 233-262. 35 William J. Curran, “The Approach of Two Federal Agencies, ” Experimentation With Human Subjects, Paul A. Freund (cd. ) (New “Ibid, York: George Braziller, 1969), p. 449. 3749 Federal Register 50856-50907, 59

or request that the agency committee review, a Tax Credits specific proposal. In addition, the Board would Legislation offering tax credit or similar finan- evaluate review procedures and committee re- cial incentive to encourage and discourage re- ports, conduct evaluations of broad scientific is- search is passed usually to provide incentives for sues relating to this research, develop guidelines, private funding on designated topics (e. g., re- and provide “a forum for public concern. ” As of search on alternative energy sources). In 1980, this writing, NIH is in the process of reviewing Congress gave small businesses and universities comments on the proposed regulations, and no the opportunity to obtain patent rights on inven- final rule has been issued. 38 tions developed with Federal funds. In response Such coordination, is unusual, however. Nor- to the energy crisis of the 1970s, over 30 States mally, government regulation of research is ad- passed laws to promote solar energy. Most of ministered through a number of uncoordinated these laws provide tax incentives (income or prop- and therefore potentially conflicting mechanisms. erty tax reductions) to stimulate private sector re- These include: national or local commissions to search, development, and commercialization of review general procedures and policies; tax credits; solar systems .3” Congress has been similarly ac- legislative review and veto; moratoria; controls tive in passing legislation that promotes research of acquisition or possession of materials needed on alternative energy systems. And the 98th Con- for research; interpretation of regulations; con- gress enacted the Orphan Drug Amendments to 40 tract provisions; and publication or communica- the Food, Drug, and Cosmetic Act in order to tion review or classification. stimulate private research and development (R&D) of drugs for rare diseases. Agenda Controls The Internal Revenue Code also currently al- Governmental Review Commissions lows businesses the option of deducting or amor- tizing expenditures for research and experimen- The Government may set up a commission or tation over a period of 60 or more months. The board to review research, either with an eye to Economic Recovery Tax Act of 1981 (Public Law improving research procedures or to resolve some 97-34) provides a 25 percent tax credit for incre- dispute. An example at the local level is the Cam- mental research expenditures made after 1981. bridge Experimentation Review Board, which That legislation reflects a deliberate attempt by ruled on the safety of rDNA research in the 1970s Congress to reduce tax burdens in order to stim- at the request of the Cambridge City Council. At ulate research. It includes tax credits for labora- a national level, the NIH RAC approves experi- tory equipment leases, and for portions of pay- mental procedures and must consider any pro- ments to universities to perform basic research.41 posed changes in the NIH Guidelines for Research These provisions are set to expire at the end of Involving recombinant DNA Molecules. The NIH 1985. To stimulate research by private industry, committee, composed of both scientists and non- Congress has tried to lower the cost of private scientists, meets several times a year to examine R&D through a combination of tax policy, direct special cases of recombinant DNA research, pe- spending, and patent legislation. titions for examption, and proposals for chang- ing the Guidelines. The Committee must also rec- Social science research was specifically excluded ommend to the Director of NIH any proposed from the areas of research spending for which a change in the guidelines. tax credit is allowed. Bills introduced in the 98th National commissions have been used to for- mulate guidelines for research, but most have not had any power to restrict or delay actual re- search —e.g., the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established by Congress in 1974 to develop guidelines for such research. 60

Congress, which would have created additional ing of the award decisionmaking process, and the incentives for corporate investment in research possibility of making NSF more conservative (and and development, also excluded social science re- possibly less innovative) in its effort to please search from their definition of “qualified research” Congress. In 1983, the Supreme Court effectively for which a corporation may take a tax credit. ruled in INS v. Chadha (103 S. Ct. 2764) that legislative vetoes, such as proposed in the Bau- The Congressional Budget Office estimates that man amendment, were unconstitutional. the Federal Government gives the high-technology research system approximately $1.5 billion in the In the 99th Congress, Representative Robert G. form of tax credits.42 There are currently three ma- Torricelli of New Jersey introduced a bill entitled jor tax-related mechanisms that high-tech research the “Information Dissemination and Research Ac- industries may employ: 1) straight deductions, countability Act” (H. R. 1145), which has similar year by year, of research expenses such as sala- evaluative intent. The purpose of the bill is to ries and equipment [Internal Revenue Code, Sec- “promote the dissemination of biomedical infor- tion 174]; 2) the R&D tax credit, which expires mation through modern methods of science and in 1985 and allows a company to deduct from its technology and to prevent the duplication of ex- taxes 25 percent of amounts that exceed the pre- periments on live animals. ” It calls for a National vious 3-year average of amounts the company Center for Research Accountability, located spent on research [Public Law 97-34]; and 3) the within the Library of Medicine, which would pro- funding of research through R&D limited part- vide for a comprehensive, full-text literature nerships, possible through several provisions of search before any research proposal involving the the tax code. use of live animals could be approved. Thus, all animal research proposals would be funneled by Legislative Review the potential granting agency through the Cen- ter prior to approval. The President would ap- Congress has several times attempted to con- point 20 persons to serve as members of the Cen- trol specific research projects or types of projects ter. Critics of the bill claim that the process would through legislative review of proposals or proj- unnecessarily prolong the already extensive grants ects. In 1975, Representative Robert E. Bauman review process and would duplicate the peer re- of Maryland introduced an amendment to the view process. In addition, the duplication of re- NSF authorization bill (H.R. 4723) which would search that the bill intends to eliminate is often have allowed Congress to review all NSF pro- an important and required aspect of research in posals prior to the final awarding of the grants. that it enhances validity and reliability, Propo- The Bauman amendment passed the House, but nents of the bill feel that it will prevent the un- was deleted in Senate Subcommittee and there- necessary use of animals in research. fore not included in the final bill. The strongest argument against the amendment was the burden Moratoria that would be placed on Congress to review thou- sands of grants. A second argument was that The most dramatic device used by government Members of Congress are not scientists and there- to control research is the legally enforceable ban fore are not necessarily competent to judge spe- or moratorium. Moratoria on science—or the pro- cific research proposals. What might sound friv- posal of same—are effective ways to focus atten- olous and inconsequential to a layperson can be tion on a serious issue or to express a political per- of major importance to scientific development. spective that the researchers appear to have been A third argument was that consistency would re- ignoring. The 1974 act prohibiting experimenta- quire Congress to oversee the grants made by all tion on human fetuses (see box B) is an example other agencies, including the Department of De- of such a ban. In 1975, the Department of Health, fense (DOD). Other arguments included the ad- Education, and Welfare prohibited the funding of ded length of time to receive a grant, the politiciz- research on in vitro fertilization without review

‘2C;n~rewiclnal Budgyt Office, k(~eral Supptlrt for I{&[) 2nd ln - “h’[lchael Cold, “Research olt-limits, ” Sc)ence 8.5, vol. b, April no~r.]tion,” ilpri] 1Q84, pp. 7b-83. 1985, p. 36. 61

Box B.—Fetal Research The controversy over research on fetuses or fetal tissue illustrates the implementation and effect of various mechanisms for government control of research. Between 1970 and 1972, advisory groups within the National Institute of Child Health and Devel- opment debated NIH policies on the review and funding of human fetal research. Reports of abuses by researchers in other countries had led to pressure on NIH to declare a moratorium on any research with the living fetus before or after abortion, lest such abuses be repeated in the United States, Congressional debate and legislation (National Research Act, Public Law 93-348, Section 2130) created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced recommendations that became the core of the Federal regulations. The Commission intended the exist- ing independent, local institutional review boards (IRBs), with the addition of a national Ethics Advi- sory Board, as the means for control and consideration of fetal research. The fetal research guidelines were adopted as Federal regulations on July 29, 1975, but an Ethics Advisory Board was not chartered until 1977 or convened until 1978, so a de facto moratorium existed during this time on both fetal re- search and in vitro fertilization. The Ethics Advisory Board was allowed to die in 1980 and its absence means that the privately supported IRBs are still the only locus of practical control. Supplementing the Federal regulations are 25 State statutes and the Uniform Anatomical Gift Act (passed in all 50 States by 1973). That act governs research on dead fetuses generally by including explicit language to that effect. Department of Health and Human Services (DHHS) regulations cover only DHHS funded research or research institutions; other research is governed by State statutes, when they exist. They range from strict (no research except that of therapeutic value to mother or fetus) to those more liberal than the Federal regulations.l In summer 1974, the National Commission for the Protection of Human Subjects declared a na- tional moratorium on all fetal research, which remained in effect until the Commission issued interim regulations in 1975. In several cases in Boston in the 1970s, State-level protest also attempted to halt fetal research. Be- cause the research in question used dead fetal tissue obtained from abortion procedures, antiabortion groups charged that publication of findings based on research using such tissue was unethical. In re- sponse to the public protest, the 1974 session of the Massachusetts legislature passed “An Act Prohibit- ing Experimentation on Human Fetuses, ” which treated such research as a felony offense punishable by up to 5 years in prison. The law (amended in 1976) applies only to fetal tissue and does not prohibit experimentation on live fetuses in efforts that might be considered “beneficial” to the fetus. Many legal scholars consider the law to be imprecise and, because of that imprecision, to have the potential for producing a “chilling effect” on researchers. On the other hand, opponents of the research have pushed for stronger legislation that would make violation a criminal offense. Controversy has continued with the introduction of legislation in Congress proposing a national moratorium on research on live fetuses. Rules restricting federally funded research on human fetuses, set in place in 1974, specify that indi- vidual research proposals must be reviewed by a federally appointed Ethics Advisory Board. When the Ethics Advisory Board was allowed to lapse in 1980, the effect was a de facto ban. No research in this area can be done until it is reinstated. Four succeeding Secretaries of DHHS have failed to limit the morato- rium. In January 1984, the NIH sent a request to DHHS for reestablishment of the board, but as of this writing, the Secretary has not acted on the request.

‘John C. Fletcher and Joseph D. Schulman, “Fetal Research: The State of the Question,” Hastings Center Report, vol. 15, April 1985, pp. 6-11. 62

A moratorium was proposed in 1976 on all tion control agency. If the institution is within a R&D surrounding laser isotope separation of ura- “nonagreement” State, it must apply to NRC for nium. The proposal was to suspend all projects a license. All research must comply with Federal in the United States, “pending the results of ef- and State OSHA regulations, which regulate ex- forts to achieve agreement with other industrial- posure to toxic substances in laboratories. ized nations to halt their work in this area. “44 The proposers acknowledged the complexity of imple- For research using radioactive substances, then, mentation (and improbability of success) of such there are various degrees of licensing and permits, a moratorium, but used the proposal itself as a depending upon what is done and the substance way to further public discussion of the policy on in question. Regulatory jurisdiction varies from proceeding with the research. The Lilienthal- State to State and between the Federal Govern- Acheson proposals in 1946 for regulation of ment and the State. In addition, there is a tiered atomic energy would have entailed a similar ban system of control based on the quantity of mate- on research in certain sensitive fields .45 rial in question. (NRC has established categori- cal exemptions from certain regulatory require- Controls on Procedures ments for certain low-level radioactive materials. ) The requirements for a license pertain to the per- Acquisition or Possession of sonnel and their qualifications, the facility, uses Materials Used in Research of the material, estimated human exposures, rec- Research may be regulated through controls on ordkeeping and reporting systems, and disposal the acquisition or possession of the chemicals or practice .4’ Large institutions conducting a lot of other substances necessary to do the research. For research may apply for a broad license, which example, the Environmental Protection Agency delegates considerable decisionmaking power to (EPA) is authorized by the Toxic Substances the institution’s Radiation Safety Committee. In Control Act (TSCA) to regulate the approxi- all cases, radiation safety officers must be ap- mately 60,000 chemicals subject to the act, at all proved by the licensing agency and NRC must stages of their development.46 TSCA recordkeep- know and approve the qualifications of such in- ing and reporting requirements apply to research dividuals. Most research institutions have a ra- on chemicals and additional regulatory require- diation safety officer, even if they do not have ments apply when the chemicals are introduced a radiation safety committee. Licenses can be very into commerce .47 precise, authorizing one investigator to use a spe- cific material for a specific period of time. Federal regulations control the possession, use, and disposal of radioactive substances, including There are also regulations for disposal of radio- their use in research. Handling of nuclear and active waste. All Federal institutions must com- radioactive materials is governed primarily by the ply with the Clean Air and Clean Water Act, if Nuclear Regulatory Commission (NRC), under applicable. In addition, the institution must ap- the Atomic Energy Act of 1954.4a The NRC has ply for a discharge and disposal permit from the regulatory power over any materials made in a State air pollution agency and/or the State water reactor. It does not have any jurisdiction over ac- pollution agency. Both Federal and local regula- celerator materials or over naturally occurring tions may apply to disposal as well. radioactive materials, although some States do If an institution is found to be in violation of regulate these substances. If the research institu- the laws governing radioactive materials, civil tion is located within an “agreement” State, the monetary penalties can be imposed, and its license investigator must be licensed by the State radia- suspended or revoked; in addition, the organiza- “’Barry hf. Casper, “Laser Enrichment A New [’ath tt~ I’r[~lifera- tion would probably receive damaging press cov- tic)n?” Bulletin (Jl the Atomic Scientists, lanuar} 1477, pp. 28-41. erage. At large institutions, safety precautions “The c(>mplete text of the plan was contained in a State Depart- ment dc~cument, I)uh[icatlc}n 2498 (1946), may ‘be emphasized, therefore, because of the con- ‘“15 U.S, ~. Section 2(301 sequences of a single mistake, primarily the sus- ‘“15 U. SC. Section 2007 ‘“!k’ especially Title 10 (~t the Act ’910 CFR Parts 30-32. 63 —.

pension of all of the institution’s research using Regulation may also occur at the very end of radioactive materials. the research process, as in EPA regulation of field testing of new insecticides or for agricultural re- Department of Transportation regulations enacted search involving rDNA. In a recent case involv- under the Hazardous Materials Transportation ing insecticide-producing soil bacteria, the EPA Act govern shipments of certain research materi- has required the company to apply for an exper- als (e. g., radioactive materials, etiologic agents, imental use permit and to submit more research poisons, corrosives, flammables) by requiring spe- data on various aspects of the bacteria (e.g., its cific carriers, containers, or handling practices .50 longevity in soil and its effect on nontarget spe- Federal laws prohibiting the possession of nar- cies), an action that has the effect of restricting cotics act to restrict research in a number of fields, or delaying the use and dissemination of results Researchers who wish to use controlled or illegal from the project. substances as a legitimate part of their research The Federal Government may also require that must first register with the Department of Justice; an institution set up review committees to moni- they are then investigated by the Drug Enforce- tor, approve, and shut down projects. The three ment Administration and their research is vali- principal types are Institutional Biosafety Com- dated by FDA. If approval is granted, the re- mittees (IBC), Institutional Review Boards (IRB), searcher must request the drug from the National and Institutional Animal Care and Use Com- Institute of Drug Abuse. If the research also in- mittees. volves human subjects, additional reporting re- quirements must be fulfilled. According to the IBCs are mandated by the NIH Guidelines for Drug Abuse staff of FDA, the administration of Recombinant DNA Research and have served as these regulations used to be very time-consuming, the major locus of responsibility for oversight of but recent streamlining of the approval process that research since 1978. The latest NIH and an apparently diminished interest in research regulations 52 stipulate that an IBC must have “no involving controlled substances have reduced the fewer than five members so selected that they col- number of requests and the time required to proc- lectively have experience and expertise in recom- ess them. binant DNA technology and the capability to as- sess the safety of recombinant DNA research Requirements for Procedural experiments and any potential risk to public health Review Committees or the environment. ” At least two members must have no affiliation with the institution apart from Various Federal and State commissions have their membership on the IBC and should be cho- been given principal responsibility to implement sen to represent the interest of the surrounding legal regulations that apply to research proce- community with respect to health and protection dures—in the case of the rDNA commissions, re- of the environment. Unless exempt from review quirements for physical containment of the bio- under the Guidelines, all rDNA research must re- logical materials used in the research. By focusing ceive IBC approval. Certain categories of research on a very specific step in the research process, the considered to be of questionable or high risk must Federal Government was able to establish stand- be referred to the NIH Recombinant DNA Advi- ards of protection for workers and the commu- sory Committee for approval before work can be nity and as well as to set criteria for researcher 51 initiated. There are currently 301 IBCs registered (and institutional) accountability. Once the with the Office of Recombinant DNA Activity of rDNA guidelines were set (with the aid of the NIH. Approximately 250 are academic IBCs; the scientists), the discussion moved back to the rest are industrial. Compliance by industry is sphere of the policy makers and administration voluntary. officials, who were under political pressure from environmental and public interest groups. “Basic DHHS Policy for Protection of Human Research Subjects”53 requires that all research in- ’049 U.S. C. Sections 1803 et seq. and 49 C.F. R. Parts 100-179, “Dorothy N’elkin, “Threats and Promises: Negotiating the Con- “49 Federal Register 227, Nov. 23, 1984. trol of Research, ” Holton and Morison, op. cit., p, 199. 5’CFR 46, 64 volving human subjects conducted by the Depart- ing animals. By January 1, 1986, each institution ment of Health and Human Services (DHHS) or receiving PHS funds must submit an “assurance funded in whole or part by a Department grant, of compliance” (containing such documents as contract, cooperative agreement or fellowship, descriptions of the facilities and membership and undergo review by an IRB. (See box C.) As with procedure of the local IUCAC) to the NIH Of- an IBC, IRB membership is specified in the Fed- fice for Protection from Research Risks. eral regulations. The IRB must have five mem- bers and, per the Guidelines, “be sufficiently qual- Contract Provisions ified through experience and expertise of its The provisions of research grants and contracts members, and the diversity of the members’ back- are used to enforce such things as limitations on grounds including consideration of the racial and spending, allocations of funds among budget cat- cultural backgrounds of members and sensitivity egories, requirements that organizations be ac- to such issues as community attitudes, to promote credited or meet certain accreditation standards, respect for its advice and counsel in safeguard- and requirements that research designs or proce- ing the rights and welfare of human subjects. ” dures be approved by the monitoring committees According to the Office for Protection from Re- described in the previous section. search Risks, the office responsible for the imple- mentation of the IRB regulations, there are cur- In the case of recombinant DNA research, the rently over 5,000 operating IRBs in the United Asilomar recommendations were adopted by States. A 1979 study by Jeffrey M. Cohen and NIH, which then issued a set of guidelines cover- William B. Hedberg determined that, in 1 year, ing research in designated categories. It applied a typical IRB was in session 41 times and reviewed to all recombinant DNA research funded by NIH. 278 proposals, involving approximately 80,000 Today, the amended NIH Guidelines for Recom- potential research subjects.54 That IRB cost the binant DNA Research set forth the generic re- university $36,000 during the year, or about $130 quirements for safety in recombinant DNA re- per proposal. search. These safety requirements apply through contract provisions to all recombinant DNA re- Institutional Animal Care and Use Committees search in the United States which is conducted at (IUCAC) are required of all institutions that re- or sponsored by an institution that receives any ceive Public Health Service (PHS) funds for re- support for rDNA research from NIH.55 Failure search involving animals. Under revised PHS pol- to comply can lead to termination of NIH fund- icies released May 1, 1985, those committees, ing or other NIH sanctions. Although limited to which must have lay members, will have the re- institutions funded by NIH, the Guidelines have sponsibility for reviewing research plans and mon- been adopted or followed by virtually all Federal itoring compliance. Prior to the establishment of agencies, State and local agencies, and private these guidelines, nearly 1,000 institutions already organizations. had animal assurances through PHS. It is not known how many new committees will have to Communication Controls be established once the guidelines take effect. The new guidelines also require that all animal facil- Reporting requirements in contracts can include ities must also be accredited by the American regulations on the “deliverables” of a project, usu- Association for the Accreditation of Laboratory ally through prepublication review. Such contrac- Animal Care, a voluntary association that certi- tual provisions are currently being invoked in or- fies animal handling facilities, or must conduct der to restrict the flow of information believed an assessment based on the NIH Guidelines for to be linked to national military security or re- the Care and Use of Laboratory Animals. Accred- lated to the Nation’s ability to compete in world itation is a necessary condition if an institution markets. Contract provisions have been used, for wants to receive PHS funds for research involv- example, to prohibit foreign nationals from be-

siJ~ffr~Y M, Cohen and William B. Hedberg, “The Annual Activity of a University IRB, ” ZRB, May 1980, pp. 5-6. ~~er~l Register 77384, Nov. 21, 1980, and 77409. 65

Box C.—Research on Human Subjects Until the 1960s—with the exception of the Nuremburg Code (1947)—there were no legal decisions from the courts and no Federal or State laws concerned directly with how humans were used in experi- ments (again, with the exception of violations of criminal law). NIH and PHS first began in 1953 to develop formal standards for human experimentation, but these efforts were not productive. The turn- ing point was the increased volume of clinical investigations funded by the Federal Government (the shift in research performer) and government regulation of experimental drugs (manufacturing, distribu- tion, and safety) in interstate commerce through FDA. Another factor was the thalidomide tragedy abroad, which triggered the 1962 Kefauver-Harris Amendments to the U.S. Food and Drug Act. Congress, in debate and not in the original bill, added the requirement to the law that subjects or patients be informed that they were to receive an experimental drug not fully licensed by the Federal Government and that their consent be obtained prior to receiving it. In 1966, the U.S. Surgeon General issued the first PHS Policy and Procedure Order for extramural research on human subjects.1 This Order required all institu- tions receiving PHS funds to review projects for the potential of abuse and it led to the formalization of the current system of IRBs.2 At present, most categories of human subjects research funded by Federal money or conducted at institutions that receive Federal subsidies are subject to some form of review or regulation. Federalagen- cies with oversight in this area specifically list those categories that are exempt or not subject to regula- tion; but, research conducted without direct or indirect Federal funding is not subject to human subjects regulations. In addition, some populations may not be adequately protected by existing regulations. All research funded in whole or in part through DHHS by direct award, cooperative agreement, or fellowship, then, is subject to human subjects regulations [45 C.F.R. 46, Section 46.101]. Indirectly, all research conducted at or sponsored by institutions which do not receive DHHS funds are not legally required to comply, but according to Charles McKay, of the NIH Office for Protection from Research Risks, 96 percent of the 500 major institutions conducting research apply DHHS regulations to research not funded by DHHS. Compliance is indicated through a statement of assurance. Regulations of FDA cover clinical investigations with regard to products specified in the Food, Drug, and Cosmetic Act for marketing. These include drugs, biological, blood and blood products, devices, and food additives. In addition, the U.S. Department of Agriculture (USDA) regulates clinical investigations of food addi- tives. For the Department of Defense, the Veterans Administration, and 20 other agencies, varying degrees of regulations are tied to direct or indirect use of their funds. All use IRBs and informed consent prac- tices. There is an effort underway by the Office of Science and Technology Policy-and near completion— to have cross-agency uniform regulations very similar to the existing DHHS regulations. Despite these efforts, research on human subjects does take place under conditions or in institutions exempt from DHHS regulation. DHHS itself exempts educational research, test development, interview and observation research, and research involving specimens and/or medical records, as long as the in- formation taken from these sources is recorded in such a manner that subjects cannot be identified or that the information revealed would place the subject at risk. The Department of Justice has exemptions in their coverage of prison research, and has legal prohibitions against regulation of research on recidi- vism and probation. The Department of Defense exempts epidemiological research from regulation. In- dustrially related research (e.g., academics doing consultative work designing systems to improve worker efficiency) is not subject to regulation. All product marketing research (testing of products not FDA or USDA regulated) is exempt from DHHS regulations; some of it is covered by consumer safety laws, but those only apply after the product is on the market. Moreover, the regulatory intent is to protect the public rather than the subjects.

‘Judith P. Swazey, “Protecting the ‘Animal of Necessity’: Limits to Injury in ClinicaJ Investigation, ” Limits of scientific Inquiry, Gerald Holton and Robert S. Morison (eds. ) (New York: W.W. Norton & Co., 1979), p. 138. William J. Curran, “The Approach of TWO Federal Agencies, ” Experimentation With Human Subjects, Paul A. Freund (cd. ) (New York: George Braziller, 1969). 66

One of the solutions to criticism has been to sharpen the procedures for ensuring that subjects have knowingly and willingly consented to participate in an experiment. There is now an extensive body of law and regulatory controls, and literature, debating the social and moral aspects surrounding the ques- tion of informed consent to human experimentation. Today, the United States regulates research to pro- tect the physical or psychological health or the privacy of the human subjects used in research under guidelines established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Research Act of 1974 instructs the Commission to: I) “identify the basic ethical principles which should govern research involving human subjects and to recommend guidelines and mechanisms for assuring that such principles are observed; 2) “to clarify the requirements of informed consent to research in the cases of children, prisoners, and the institutionalized mentally infirm;” and 3) “to investigate the use of psychosurgery and recommend policies for its regulation.”

ing employed on a research project.56 More re- The mechanism of classification (or the threat cently, the Federal Government has used grant of the possibility of classification) can also be used and contract terms as a means of directly control- to delay publication. This tactic has been used by ling dissemination of research results, 57 by requir- the National Security Agency to delay journal ing that the researcher or institution allow prepub- publication of a number of scientific articles on lication review by the sponsoring or interested cryptography. 58 From 1982 to 1985, Federal reg- Federal agency. Contracts for classified work, of ulations on the export of technical information course, routinely include such provisions but some have been used to bar certain foreign nationals agencies have begun to invoke prior approval pro- from attending otherwise open society meetings visions previously considered to be pro forma (or and have been used to require researchers to with- have considered revising their standard contracts draw unclassified technical papers scheduled for to include such provisions). The purpose of re- presentation at professional society meetings be- quested delays or review is to allow the opportu- cause foreign nationals might attend those meet- nity for either classification or alteration (editing ings. 59 and censorship). In addition to contract provisions, there are In one such case in 1980, NSF refused to fund nine major legal mechanisms by which the U.S. parts of a cryptology proposal submitted by a Government can restrict formal and certain in- computer scientist because of the national secu- formal communication of scientific and technical rity implications of his work. A later decision information. awarded the funds to the researcher with the stipu- 1. The Arms Export Control Act of 1976 and lation that he take responsibility for seeking prior the resulting International Traffic in Arms Regu- constraint as required by the content of his work. lations and U.S. Munitions List, administered by NSF eventually drafted new language for all its the Department of State, authorize control of the contracts to require that a grantee take responsi- export and import of defense articles and defense bility for notifying the cognizant NSF Program services, including export of technical data related Director if data, information, or materials devel- to defense articles. oped in the course of research appear to require classification. NSF retains the option—after re- 2. The Export Administration Act of 1979, im- view of the information—to defer dissemination, plemented through the Export Administration distribution, or publication. Regulations, Commodity Control List (CCL), and Militarily Critical Technologies List (MCTL), and

“Scientific Freedom and National Securjty, Issue 5 (Washington, administered by the Department of Commerce, DC: American Association for the Advancement of Science, March 1985), p. 7, 581bid.

“interim Report of the Committee on the Changing Nature O; “Free Trade in Ideas: A Constitutional Imperative (Washingtonr Inlorrnation (Cambridge, MA: Massachusetts Institute of Technol- DC: American Civil Liberties Union, May 1984); Long, op. cit., see ogy, Mar. Q, 1983), Section 4.5, especially the table of meetings that have been restricted. — -— 67 authorizes control of the export of tangible goods, and, if publication of the patent is deemed harm- including technical data, in the interest of national ful to national security, to declare the invention security and foreign policy and, to a lesser extent, secret for a period of 1 year (with restriction an- to protect the domestic economy. MCTL desig- nually renewable). The justifications for the In- nates arrays of technical information, expertise, vention Secrecy Act (1951) are to allow defense or equipment that DOD believes would make a agencies to review applications for patents sub- significant contribution to the military potential mitted to the Patent and Trademark Office, with of another country if exported. The unclassified the goal of catching inadvertent violations. If pub- version of this list is over 200 pages long; the clas- lication of a patent is judged to be potentially sified is reported to be over 700.60 Both the CCL harmful to national security, then a 1-year, renew- and the MCTL were not intended to be control able secrecy order is issued .02 documents, but rather to be reference lists of the 6. The Freedom of Information Act contains sensitive technologies, provisions allowing but not requiring agencies to 3. Executive Order 12356 of 1982 authorizes exempt certain types of information from man- classification of information, including that per- datory disclosure. taining to “scientific, technological, or economic 7. Executive Order 12333 on Intelligence, issued matters, ” that is “owned by, produced by or for, December 4, 1981, allows for the covert collec- or is under control of U.S. government” for na- tion of information by agents posing as aca- tional security purposes. The order contains a spe- demics. cific exemption for “basic scientific research in- formation not clearly related to national security,” 8. A number of DOD directives on national security and classification based on 10 U.S. C. 140c 4. The Atomic Energy Act of 1954, as amended, allow that agency to restrict information devel- places explicit controls on scientific information oped by scientists under DOD contract. Directive and defines restricted data. The act is not limited 5230.25 outlines the conditions under which DOD to nuclear physics nor even to activities of the Fed- can withhold classified data from general public eral Government; its language is sufficiently broad dissemination in accord with export control laws. to allow the extension to “privately generated” An October 1984 memorandum on “Publication knowledge as well. A 1981 amendment allows the of the Results of DOD sponsored Fundamental Secretary of Energy to adopt regulations on the Research” sets forth policies on publications. And dissemination of unclassified information regard- Directive 5230.24 (November 1984) requires all ing either the design of facilities or their security 61 newly created technical documents in DOD to measures. carry statements defining distribution and indicat- 5. The Invention Secrecy Act of 1951 author- ing how requests for the document should be izes the defense agencies to review applications handled. submitted to the Patent and Trademark Office 9. The Immigration and Nationality Act may ‘c’ Long, op. cit. be used to refuse admission to or deport foreign ] * Harold C. Relyea, “Shrouding the Endless Frontier—Scientific scholars from U.S. research activities. Communication and Natlona] Security: The Search for Balance, ” Striking a Balance: NatIonaI Secunt-t and Scientific Freedom, Harold C. Relyea (ed I (Washington, DC: American Association for the Advancement of Science, 1985), p. 85 b21bid.

THE ROLE OF THE COURTS IN THE REGULATION OF RESEARCH

Statutory law governs the role that the judicial Congress or regulatory actions taken under Fed- branch may play in the regulation of research: the eral, State, or local statutes. courts respond to and interpret existing govern- ment action. The Federal courts have no jurisdic- The courts have frequently been used, however, tion other than to interpret the laws enacted by in environmental disputes to require Federal agen- 68 cies to perform, commission, or use research to ronmental impact statement. NIH claimed that its support environmental policy decisions. The approval process more than satisfied the NEPA intent—through lawsuit—has been to force the requirements. 65 On April 12, 1984, Rifkin filed a agencies to increase or, in some cases, to improve motion for injunction to prevent the researchers their use of research. The effect, at least in the from proceeding with a field test experiment 1970s, was to strengthen the quality and increase scheduled for May. On May 16, Judge Sirica the amount of environmental science research. granted the motion for a preliminary injunction Environmental lawsuits are, however, just part and ordered that: 1) NIH be enjoined from ap- of a general shift in the use of the judicial system proving experiments involving the intentional re- to affect social policy.63 More dramatic use of the lease of recombinant DNA, and 2) that the Uni- courts occurs when, after a plaintiff has filed suit, versity of California be enjoined from proceeding the court issues an injunction that prohibits the with the experiment until final resolution on the research from going forward at all. In the case case. In subsequent court action, the U.S. Court study presented in chapter 7, the Supreme Judi- of Appeals for the District of Columbia ruled (Feb- cial Court of the Commonwealth of Massachu- ruary 27, 1985) that experiments could proceed setts at first issued a temporary restraining order if their potential environmental effects were prop- against a municipal public health order that had erly evaluated. NIH must now prepare environ- attempted to stop research at a local laboratory; mental assessments. that court later ruled to uphold the city’s right to Recently, an additional legal action has intro- impose such a ban. duced controversy into what has usually been a In May 1984, Federal District Judge John Sirica, quiet region of the scientific community, agricul- in effect, put a moratorium on all field tests of tural research. In 1979, attorneys filed a lawsuit, genetically modified microbes being conducted by on behalf of 17 farm workers and the California the University of California.64 The experiments Agrarian Action Project, that charged the Univer- in question involved tests of genetically engineered sity of California with unlawfully spending pub- bacteria (Pseudomonas syringae) designed to pre- lic funds on mechanization research that displaced vent frost formation on plants. In September farm workers.66 (For a full description of the case, 1983, a group of plaintiffs led by Jeremy Rifkin see app. A,) and the Foundation on Economic Trends claimed that NIH was violating National Environmental ‘5Judith A. Johnson, “Recombinant DNA: Legal Challenges to De- Protection Act (NEPA) requirements for an envi- liberate Release Experiments, ” U.S. Congress, Library of Congress, Congressional Research Service, Science Policy Research Division, “Donald L. Horowitz, The Courts and Social Policy (Washing- report No. 85-502, Jan. 7, 1985. ton, DC: The Brookings Institution, 1977), ~bphi]ip L, Martin and Alan L. Olmstead, “The Agricultural b’Marjorie Sun, “Rifkin and NIH Win in Court Ruling, ” science, Mechanization Controversy, ” Science, vol. 227, Feb. 8, 1985, pp. vo]. 227, Mar. 15, 1985, p. 1,321. 601-606.

MECHANISMS FOR SOCIAL CONTROL OUTSIDE OF GOVERNMENT

Public opinion can be a potent force for pres- been made to the lives and safety of investigators suring government to enact regulation or enforce and their staff. More moderate groups have used more stringently existing rules. It is most often the traditional policy arena to seek change, lob- expressed through the mechanisms of public meet- bying Congress and State legislators for stricter ings, picketing, protest, violence, or political ac- laws. In summer 1985, DHHS Secretary Margaret tion organizations. For example, recent activities Heckler suspended funding for a head trauma by animal rights organizations have included study utilizing anesthetized baboons at the Univer- break-ins, vandalism, and theft of animals, data sity of Pennsylvania after members of the Ani- and equipment from laboratories using animals mal Liberation Front (ALF) illegally raided the in their research; in some cases, direct threats have University lab, stealing videotapes and destroy- 69 ing equipment. DHHS officials contend that while ogy Study Group to develop a study guide for the research protocol was considered to be scien- use in churches. The guide addresses the impli- tifically justifiable, the laboratory had violated cations of new developments in gene therapy, its animal welfare assurance to NIH, and that the genetic engineering, and fetal research, Theolo- decision to suspend funds was unconnected to the gians have also taken more direct approaches in sit-in conducted by ALF at the NIH Bethesda registering their concern, such as the 1983 “The- Campus. ological Letter Concerning the Moral Arguments Against the Genetic Engineering of the Human A number of church groups, in the United Germline Cells, ” a letter signed by representatives States and abroad, have recently provided an ad- of virtually every major church organization in ditional mechanism for expression of social con- the United States. Most recently, the House of trol on research. Through conferences, newslet- Bishops of the Episcopal Church adoped an offi- ters, and “pastoral letters, ” religious organizations cial position on genetic engineering that “encour- have attempted to educate their members, raise ages . . . research directed to an increase in hu- public awareness about the theological and ethi- man understanding of vital processes, recognizing cal dilemmas posed by research, or to sway pub- 67 that human DNA is a great gift of God . . .” In lic action concerning regulation of specific areas addition, the Bishops asked that Congress ensure of research. In 1979, for example, the World that FDA or an appropriate agency seek advice Council of Churches sponsored a World Confer- from ethicists and the lay public to assure that ence on Science, Faith, and the Future at which 68 use of genetic engineering is ethically acceptable. scientists, theologians, trade unionists, business- men, and politicians met to discuss the nature of science and of faith. More recently, the Episcopal ‘-cited in Science, vol. 230, No. 4724, oct. 25, 1985, p. 423. Diocese of Massachusetts convened a Biotechnol- ‘*Ibid.

SUMMARY

There have always been measures of control can be exerted informally, through professional imposed on the scientific community. Most often and peer pressure; formally, through institutional the controls have been in the form of self-restraint, mechanisms; or legally, through Executive orders, imposed by the scientific community through peer legislation, and agency rulemaking. Finally, the review and peer pressure. These controls have courts can be used as a mechanism for interpre- been shaped by scientific and technological cri- tation of legal controls. teria as well as by the social values and norms The value of this “cobweb” of direct control lies apparent in the ethical codes and standards in its democratic and pluralistic nature. The dan- adopted by most scientific societies. It is only re- ger of this system, however, lies in the potential cently in the history of science that so many in- for uncoordinated and potentially conflicting stitutions and social forces have influenced in so mechanisms for direct control. The potential com- many ways the conduct of science. plexity of this approach to regulation may be ex- As described in this chapter, research can be acerbated when compounded by the many levels directly controlled at all stages of the scientific and forms of indirect control of research, to be process. Forces can affect the agenda, the proc- examined in chapter 5. ess, and the dissemination of results. These forces Chapter 5 Mechanisms for Indirect Control of Research

Photo credit: National Institutes of Health Chapter 5 Mechanisms for Indirect Control of Research

Research can often be as effectively restrained ness to regulate all kinds of specialized institutions by the secondary or tertiary impacts of laws or and activities.4 policies intended to do something else as by de- The most pervasive control on the scientific liberate imposition of regulatory law or policy. agenda is, of course, the supply of money, but Governmental activity can control the nature and that control is uncoordinated. Such influences are direction of science even when regulations would more likely to result in what historian Melvin seem to have very little to do with regulating the 1 Kranzberg terms a “shotgun approach” to regu- scientific enterprise. In fact, many of the con- lation via funding. This situation occurs when, straints that have been most burdensome to re- in response to a new government program di- search institutions—both financially and ad- rected at a narrow topic (e. g., some form of can- ministratively—were not intended to affect the cer), researchers alter their research descriptions substance of scientific work. Such constraints as in order to obtain funding for basic or arcane re- the clerical and managerial burdens of social secu- search they are already pursuing. rity taxes, equal opportunity and affirmative ac- tion requirements, environmental protection, or This chapter looks at some examples of gov- occupational health and safety “limit the auton- ernment laws or actions that, without so intend- omy of administrators and the freedom of re- ing, appear to be exerting some regulatory influ- search workers.”2 Research institutions that do not ence on research. They can be distinguished from question the importance of such general domes- the forces discussed in chapter 4 by the fact that tic policy actions may nevertheless question the they are not intended to restrain or inhibit the use of research grants or contracts and in particu- process of scientific research. This chapter ad- lar the withholding of Federal funds in order to dresses first those forces that act both at the force an institution to comply. They argue that project and the institutional level through the constraints are imposed not to sustain or ensure grant and contract funding mechanisms of the the quality of research but in an effort to secure Federal Government. Such restraints were among “short-term practical results, regional distribution those most frequently mentioned in OTA’s sur- of funds, and other criteria more or less irrele- vey of university administrators and laboratory vant to scientific excellence.”3 In these cases, directors. A second type of restraint results from science has not been so much singled out for reg- the implementation of legislation or rulemaking ulation as caught up in society’s growing willing- related to social programs, such as antidiscrimi- nation statutes or privacy legislation, and from ‘Melvln Kranzberg, Georgia Institute of Technology, personal comrnunlcation, 1985. occupational and public health and safety legis- ‘Don K. Price, “Endless Frontier or Bureaucratic Morass?” The lation. Limits of Scientific Inquir>,, Gerald Holton and Robert S. Morison (eds. 1 ~New York: W. M’. N’orton & Co., 1979), pp. 75-92. 4Harvey Brooks, Benjamin Peirce Professor of Technology and ‘Ibid,, pp. 75 and 81. Public Policy, Harvard University, personal communication, 1Q85.

ADMINISTRATIVE REQUIREMENTS ON UNIVERSITIES THAT ACCEPT FEDERAL GRANTS OR CONTRACTS

In the last 40 years, rules governing the research and legal requirements on the universities.5 These grant system, the procedures for assuring account- requirements have stimulated considerable an- ability in the administration of such grants, and tagonism and hostility because many university the system of Federal support to higher education 5David Dickson provides some discussion of the larger issues in in general have placed ever more administrative The New Politics of Science (New York: Pantheon Press, 1984). 73 74

administrators have seen it as an intrusion into Indirect costs. Donald Kennedy, President of their autonomy. In the 1970s, Steven Muller ex- Stanford University, has referred to the univer- pressed these feelings during congressional testi- sity-government indirect cost reimbursement sys- mony when he called for universities to: tem as “the basic fabric of understanding and trust that has supported science for 30 years.”8 Dur- . . . resist the tendency of the federal government ing those decades, “government policy has held to attach a growing body of regulations and con- ditions to its measures of support for higher edu- indirect costs to be an entirely legitimate part of cation. . . . At stake is the essential need of the total research costs, ” but as these cost rates have university to maintain the unfettered freedom of increased, and the resources for research at the the human mind to apply its powers and meth- Federal level have become more constrained, the ods of reason. b rates-–and the accounting necessary to calculate them-–have become an increasing source of ten- To many observers, relations between the gov- sion, Many university administrators and scien- ernment and the universities appear to have de- tists argue that the process of including an indirect teriorated over the last decade; they attribute this cost rate in a research proposal significantly af- change to policies and practices inherent in Fed- fects research because it can act to array a prin- eral support of research. These policies act as a cipal investigator and his/her sponsor or grant- form of indirect regulation on research. Under ing agency against the institution—a polarization most conditions, Robert Sproull observes: that is “damaging to morale and, ultimately, to . . . the principal investigator does not feel the research.”9 weight of this pyramid on his back. Although no one has ever calculated how much more research Indirect costs are paid as grant overhead to in- could be supported if this towering apparatus was stitutions to cover maintenance, administrators’ made leaner, the investigator can frequently ig- salaries, and other operating expenses. A 1984 nore it all. There is a growing intrusion, however, General Accounting Office (GAO) Report calcu- into the control of an investigator’s research.7 lated that, in the last decade, indirect costs have A major change in public control of science— increased so much that they now account for and a handle for enforcing regulation—has been about 30 percent of all National Institutes of Health (NIH) extramural grant expenditures (up the increased requirement for financial account- 10 ability imposed by the Federal Government. The from 21 percent in 1972) . Each institution receiv- post-war “contract” between government and ing a grant negotiates its rate. The Department science allowed scientists, through the process of of Health and Human Services (DHHS) may au- peer review, to make decisions about the alloca- dit an institution to determine whether indirect tion of government funds to specific projects, but cost claims are valid. OMB’s Circular A-21 “Cost required that universities be accountable fiscally Principles for Educational Institutions” lists allow- to the government. The universities do not argue able categories of indirect costs. Government rules over the need for accountability, rather about allow for the varying circumstances of institu- how it can be accomplished. This indirect regu- tions, but they do require that methods used for lation derives in part from the retroactive appli- calculations be consistent with sound accounting cation of increased standards and from the inter- principles. The disagreement over the reality of pretations applied to key principles contained in indirect costs, and what the costs of research indirect cost calculation, and Office of Manage- should include, form a major part of the prob- ment and Budget (OMB) Circulars A-21 and lems surrounding this topic. A-110. Indirect cost rates are based on the most recent actual expenditures for indirect costs. The costs %teven Muller, “A New American University, ” testimony before the U.S. Congress, House Committee on Science and Technology, ‘Donald Kennedy, “Government Policies and the Cost of Doing published as National Science and Technology Policy Issues, 1979. Research, ” Science, vol. 227, Feb. 1, 1985, p. 482. 7Robert L. Sproull, “Federal Regulation and the Natural Sciences, ” ‘Sproull, op. cit. Bureaucrats and Brainpower: Government Regulations of Univer- 10National Academy of Sciences, Strengthening the GOvernment- sities, Paul Seaburg (ed, ) (San Francisco, CA: Institute of Contem- Universjty Partnership in Science (Washington, DC: NAS, 1983), porary Studies, 1979), p. 72. p. 129. 75 rates are recomputed annually and submitted to “Never have I seen the lash of federal regulations a granting agency for evaluation, which uses one applied to a crucial area of the nation’s intellec- of two main systems for determining and reim- tual life with such seeming indifference to finan- bursing indirect costs. The NIH requires that prin- cial and human consequences.“12 The stringency cipal investigators submit proposals that specify of these OMB requirements has since been relaxed only the direct costs of the research proposed, Peer somewhat. In fall 1982, for example, DHHS reviewers see only the direct cost budget. A sep- awarded 22 contracts to large universities to test arate award is made to the institution for indirect a procedure whereby coordination audits would costs. Other agencies, such as the National Science be carried out by public accounting firms and Foundation (NSF), the Department of Defense university auditing staff. For research administra- (DOD), and the National Aeronautics and Space tors, this change meant added responsibility and Administration (NASA), require that proposals the imposition of a cost previously borne by the include both direct and indirect costs, and Federal granting agency, but it allowed the inde- reviewers see the complete budget. If an award pendent auditors to conduct an audit that better is made, the approved budget must be based on reflects the research environment in the institu- the last negotiated indirect costs rate for the in- tion under investigation. This single-audit con- stitution on the grant. If this rate is out of date cept, now allowable for all grantee institutions un- (as can occur), then rising indirect cost rates can der 1982 revisions to Circular A-21, provides for limit the funds available to a researcher on a proj- greater flexibility in university reporting of time ect-by-project basis. and effort, Some universities, Yale University and Stanford University, in particular, have negoti- As indirect cost rates rise, research budgets buy ated agreements with OMB that allow them to less. Some researchers “consider payment of in- eliminate time and effort reporting for the time direct costs a subsidy for higher education and 11 being. ’3 a diversion of support for research.” University administrators, however, see indirect cost recov- Concerns about the regulatory nature of the ery as essential to maintaining the research infra- Federal grant relationship date back to the 1960s. structure. A U.S. Commission on Government Procure- ment—set up in response to widespread concern Budget Circulars A-21 and A-110. Relations be- about grants and contracts administration rules— tween the universities and the Federal Govern- found that procurement-type Federal controls ment were strained considerably in 1979 as a re- were being inappropriately applied to grant-type sult of revisions to OMB Circular A-21 (Cost assistance relationships. The Commission’s rec- Principles for Educational Institutions). In order ommendations to deal with this problem were im- to allocate indirect costs, the universities were re- plemented eventually in the Federal Grant and Co- quired to institute “time and effort” reporting for operative Agreement Act of 1977 (Public Law employees whose salaries were charged in any 95-224), which distinguished Federal assistance part to the research grant. The rule required from Federal procurement and required that grant faculty to account for 100 percent of the time for relationships entail minimal government involve- which they were compensated, regardless of the ment in grantee affairs. However, OMB guidance fraction devoted to federally supported work. Al- issued to implement the act failed to require that though the OMB believed these procedures to be Federal agencies use the grant in the fashion en- necessary to determine if research funds were be- visioned by the act, thereby vitiating its regula- ing used for the purposes designated by Congress, tory-reducing effect .14 academic scientists considered them a violation of their autonomy. Emotions ran high. A. Bart- lett Giametti, President of Yale, proclaimed: “See discussion of these agreements in Report o} the Workshop on the Effort Reporting Requirements of OMB Circular A-21 (Wash- ington, DC: Nat ional Academy of Sciences, 1984). I I u ,.S Genera] Accounting office, Assuring Reasonableness @f “Quoted in Dickson, op. cit., p. ~8. Rising Indirect Costs on NIH Research Grants—A Difficult Prob- I JI Robert NeW~ton, Nationa] Science Foundation, persona] com- lem (Washington, DC: 1984). munication, 1~85. 76

In the late 1970s, the National Commission on search programs caused by multiple sources of Research concluded that the administrative and Federal support, might reduce overall research fiscal controls used by Federal agencies in the sup- costs, and might increase research productivity. port of academic research interfered with the con- Federal administrative and accounting rules might duct of research. During the same period, NSF begin to match the realities of how research is con- and the Association of American Universities con- ducted. One way would be to recognize the re- ducted an experiment in grant administration that searcher’s program of research as the administra- resulted in NSF delegating to grantees the respon- tive and accounting unit. Under the aegis of the sibility for administering most Federal controls. National Academy of Sciences Government-Uni- More recent discussions have focused on prob- versity-Industry Research Roundtable, a Federal lems caused by discrepancies between Federal effort is being undertaken to demonstrate such a rules, and so there are proposals now for a sim- simplified arrangement, including a demonstra- plified and standardized Federal approach to the tion project for the Federal support of academic support of academic research. Such an approach research in Florida. might reverse or remedy the fragmentation of re-

PROTECTIVE LEGISLATION AND AGENCY RULEMAKING Antidiscrimination Statutes ceiving Federal financial assistance. NSF interprets this to apply to grants under their Science Edu- Several statutes bar recipients of Federal finan- cation Programs but not to grants for scientific cial assistance from excluding persons, because research. Public Health Service (PHS) grantees, of their color, race, sex, or national origin, from however, are required to submit an assurance to participation in federally supported activities. the Office for Civil Rights, Office of the Secre- These antidiscrimination statutes apply to recip- tary, DHHS, before a grant, sub-grant, or con- ients of NSF and NIH grants and compliance must tract under a grant maybe made. In addition, all be assured prior to receipt of funds. PHS grantees are encouraged to “adopt practices that will eliminate sex discrimination and encour- Section 602 of the Civil Rights Act of 1964 re- age sex fairness, including but not limited to, using quires Federal agencies and programs to issue reg- ulations implementing Title VI of the Civil Rights language that represents both genders, avoiding Act. The act provides that no person shall, on the sex stereotyping, and representing women equi- grounds of color or national origin, be excluded tably in leadership and policymaking positions. ” from participation in, be denied the benefits of, or be otherwise subjected to discrimination un- Small Business Innovation Research der any program or activity receiving Federal fi- Programs and Use of Services nancial assistance. These regulations are also Regulations applicable to sub-grantees, contractors, and sub- contractors of a grantee. Grant applicants must Federal research funding and how the grantees issue an “Assurance of Compliance” to be filed use those funds are subject to laws and guidelines with the agency. * Similar assurances must be filed that are intended to promote opportunities for by the grantee to assure compliance with the Re- small businesses and minority-owned businesses, habilitation Act of 1973, and the Age Discrimi- and to favor American businesses over foreign in- nation Act of 1975. terests. Under Public Law 97-219 (the Small Busi- ness Innovation Development Act) each agency Title 1X of the Education Amendments of 1972 with a qualifying research and development (R&D) prohibits the exclusion of persons on the basis of budget in excess of $100 million must establish sex from any education program or activity re- a Small Business Innovation Research Program *See National Science Foundation and National Institutes of (SBIR). Each agency must set aside 1.25 percent Health Grant Policy Manuals. of its extramural R&D obligations for its SBIR 77 — —

program. The SBIR program is intended to pro- invasions of personal privacy. These include: 1) vide a mechanism for opening up Federal R&D the right of individuals to determine what infor- opportunities for small high-technology firms. mation about them is maintained in Federal agen- The Departments of Agriculture, Energy, Trans- cies’ files and to know how that information is portation, and Interior; the National Research used; and 2) the right of individuals to have ac- Council; the Environmental Protection Agency cess to such records and to correct, amend, or re- (EPA); DOD; DHHS; NASA; and NSF are all re- quest deletion of information in their records that quired to participate in this program. In addition, is inaccurate, irrelevant, or outdated .15 funds flow indirectly to small firms through the The act imposes requirements on Federal agen- subcontracting requirements of Public Law 95- cies with respect to the manner in which they 507, which requires that large prime contractors collect, use, disseminate, and maintain records must subcontract part of their Federal work to containing information pertaining to specific in- small firms. dividuals. Thus, information obtained for one Executive Order 12138 of 1979 establishes a na- purpose cannot be used for other purposes with- tional program to foster the role of women in busi- out the consent of the concerned individual. This ness, by encouraging preference in procurement regulation applies to records maintained by PHS and the deposit of Federal funds. Executive Or- with respect to grant applications, grant awards, der 11625 of 1971 strives for the same goals for and the administration of grants, as outlined in minority-owned businesses. Recipients of NSF DHHS regulations that implement the Privacy grants are also encouraged, but not required, to Act.16 Records maintained by grantees, however, use banks owned at least 50 percent by minority are not subject to these regulations. groups or women. In addition, according to the International Air Transportation Fair Competi- tive Act of 1974, grantees must use a certified U.S. flag carrier for foreign transportation of persons or property, for purposes of the research, unless not available.

Privacy Legislation “Public Health Service, “Grants Policy Statement, ” December The Privacy Act of 1974 (Public Law 93-579) 1982, p. 15. provides certain safeguards for individuals against ’045 CFR 5b,

ENVIRONMENTAL LEGISLATION

Until the end of 1984, EPA regulations for the and practice of waste stream reduction in proc- control of hazardous wastes under the Resource ess industries and laboratories. 19 In November Conservation and Recovery Act (RCRA)17 had 1984, amendments to RCRA severely limited these limited influence on some research activities, be- exemptions by requiring EPA to regulate genera- cause they established regulatory exemptions for tors of as little as 100 kilograms a month .20 It will “small quantity” generators18 but held all other be more difficult for research facilities to avoid generators subject to the full range of regulatory RCRA regulations in the future. requirements. To avoid regulatory costs and other burdens, many research institutions sought to stay Other laws administered by EPA have led to within EPA’s limit for small quantity generators. further unintentional regulations of research activ- ities. Research laboratories that emit air and water Chemical associations also promoted the concept 1 gsee L,ess IS L?etter: LabOrafOV Chemical Management for Waste 1-42 U.S, ~. Sections 6901 et seq Reduction (Washington, DC: American Chemical Society, 1985). ‘“40 cFR part 261, 2042 U, S.C. Sections 6931(D), added by Public Law 98-616 (1984). 78 pollutants are subject to EPA regulations under nificantly, especially when the research involves the Clean Air Act21 and the Clean Water Act,22 highly toxic substances. as well as corresponding State statutes. Research- Laboratory research in industry, universities, ers will have to secure permits and comply with and government may also be affected by such EPA and State permit restrictions on the discharge things as EPA regulations on disposal of hazard- of these pollutants. These “end-of-pipe” emission ous waste, health regulations set by the State or restrictions can influence the research process sig- city in which the laboratory is located, and regu- ~ 142 LJ .s. c. Sections 7401 et seq. lations on handling nuclear and other hazardous 2233 U.S. C. Sections 1251 et seq. substances.

OCCUPATIONAL AND PUBLIC HEALTH AND SAFETY REGULATIONS

As will be illustrated chapter 6, government reg- Health Act,25 by the Occupational Safety and ulations intended for business and industry can Health Administration (OSHA), and by other reg- have quite different effects when applied to ulations. 26 The act concerns the general duty of laboratory-based, university research activities. employers to provide safe working conditions for Richard W. Lyman has observed that “universi- their employees and for employer compliance ties are not quite the uniquely subtle and com- with OSHA regulations. The regulations limit plex organisms they like to consider themselves, worker exposure to various physical, chemical, but they do possess a good many characteristics and other agents and hazards to health and safety, that make regulations suitable to a steel mill not such as noise, radiation, or toxic chemicals. In always relevant or appropriate [to a university].“23 addition to requirements for recordkeeping, med- Most of these regulations are of two types: regu- ical surveillance, and monitoring, the regulations lations designed to apply to production, or pilot also set forth, on a generic basis, employee rights plant activities and regulations aimed at achiev- to request OSHA inspections and to obtain ac- ing some social goal. cess to medical records, exposure records, and labels on hazardous chemical containers. Some observers propose that, in principle, the cost imposed on various economic or research activities by regulation should be proportionate Right- To-Know Legislation to the potential environmental, health, or safety The need for people to obtain information on impact of these activities; but others disagree the risks they run by working with hazardous sharply with the argument that such regulation chemicals has recently prompted more specific leg- takes industrial financial resources away from re- islation, which could have a significant unin- search, and cite a lack of evidence for those ef- 24 tended regulatory impact on research laboratories, fects. especially those based in universities. Although The protection of worker health is required by current Federal regulations in this area do not ap- such legislation as the Occupational Safety and ply to such laboratories, the recent State and pro- posed Federal “right-to-know” legislation could have the secondary effect of creating new controls z ~Richard Lyman, quoted in Seaburg, op. cit. on university laboratories. These laboratories Z~Brooks, Op. cit.; for a general discussion of the effect of health work with hundreds of chemicals in an experi- and safety regulation on R&D, see, for example, Nicholas Ashford and George Heaton, “Regulation and Technological Innovation in mental situation or do research on hazardous the Chemical Industry, ” Law & Contemporary Problems, vol. 46, chemicals. No. 3, summer 1983, pp. 109-137; also see Nicholas Ashford, et al., “Using Regulations to Change the Market for Innovation, ” klar- 2529 IJ. S. C. Sections 651 et Seq. vard Environmental Law Review, vol. 9, No. 2, 1985. ZbL~ CFR part 1900. 79 — — —

In November 1983, OSHA issued a “hazard OSHA would not assert preemption over any 27 communication” rule, which establishes that State rules until the effective date of the Federal workers in the manufacturing industry have a standard (Nov. 25, 1985). Nevertheless, in the past right to know about the chemical and physical 3 years, numerous State and local governments hazards in their workplaces. Manufacturers and have enacted right-to-know laws and ordinances. importers of hazardous chemicals, and their cus- These enactments can be classified as follows: tomers who use the chemicals in subsequent man- ufacturing activities, thus have disclosure duties 1. Worker right-to-know laws are designed to under the rule. expand the rights created by OSHA by giv- ing workers in other sectors access to tech- The rule initially requires that manufacturers nical information concerning the hazardous and importers of chemicals provide their custom- substances to which they are exposed, and ers with labeled containers and a Material Safety by increasing the list of hazardous substances Data Sheet (MSDS) for each purchased chemical to which such access rights apply. that has been determined to be hazardous. It also 2. Comprehensive community right-to-know requires that all firms in the manufacturing sec- laws are designed to give local officials tor—both “downstream” customers and chemi- and/or residents access to technical informa- cal manufacturers themselves—institute hazard tion concerning hazardous substances at fa- communications programs to provide information cilities within a community, without regard to and train workers who could potentially be ex- to the use to be made of that information. posed to the chemicals. 3 Limited community right-to-know laws are The rights created by the OSHA rule do not designed to give specified local officials ac- currently extend to workers in research labora- cess to technical information concerning tories that are not within the manufacturing sec- hazardous substances at facilities within a tor. For research laboratories within the manu- community, for the purpose of facilitating facturing sector, however, employers must: appropriate responses in the event of emer- gency and/or protecting emergenc response ● ensure that labels on incoming containers of y hazardous chemicals are not removed or personnel. defaced; ● Such laws are likely to face a legal challenge maintain any MSDSs that are received with on the grounds that right-to-know requirements incoming shipments of hazardous chemicals, 28 have been preempted by the OSHA rule. Like and ensure that they are readily accessible to the OSHA rule, typical State right-to-know laws laboratory workers; and are limited in their application to a specific list ● provide laboratory workers with information of hazardous substances, rather than to hazard- and training on hazardous chemicals in their ous substances generally. For example, the Mas- work areas at the time of their initial assign- 29 sachusetts law directs its Commissioner of Public ment, and when a new hazard is introduced Health to compile a substance list. The initial list into their work area. included approximately 2,000 substances.

Chemical manufacturers must comply with its 30 New Jersey’s law has been challenged, and labeling and MSDS requirements by November found invalid by a U.S. District Court, in its ap- 25, 1985. Employers, thereafter, must meet the plication to the manufacturing sector, due to worker communication requirements by May 25, 31 OSHA preemption. It is still in effect for other 1986.

The rule provides that it is intended to preempt zsse~ for example, New Jersey Chamber of Commerce v. Hu~he~r. any state law pertaining to this subject, although 12 OSHC 1121 (t). N.1,, Jan, 3, 1Q85), which invalidates New Jer- the OSHA administrator has indicated that sey’s right-to-know law insofar as it applied to manufacturing in- dustries. ‘*Massachusetts General Laws c 11 IF. j~chapter 315 of the Acts of 1983, ‘“29 CFR SectIons IQ IO. 1200 1‘New lerse?’ Chamber of Commerce v. Hughe?, op. cit. 80 industries, however, and requires State agencies State or local action is necessary to protect the to compile three sets of lists: a short list of “Envi- health or safety. ronmental Hazardous Substances” (now approx- The New Jersey law is even less restrictive. It imately 154 substances); a more comprehensive requires employers to submit environmental sur- list of “Workplace Hazardous Substances” sub- veys to the Department of Environmental Protec- ject to less thorough reporting requirements tion (DEP) and the health department of the (about 800-1,000 substances); and a “Special county in which the facility is located, as well as Health Hazard” list of substances that pose spe- pertinent parts of the survey to local fire and po- cial hazards because of their known carcinogenic- lice departments. Any person making a written ity, mutagenicity, teratogenicity, flammability, request would obtain a copy of the survey from explosiveness, corrosivity, or reactivity. the DEP. In addition, a list of workplace hazard- The New Jersey law, as still valid, applies to ous substances at each installation and the MSDS research laboratories that are part of facilities en- for each one were to be maintained by the De- gaged in: partment of Health and made available on request to any person. ● pipelines, transportation, communications, electric, gas, and sanitary services; In the 99th Congress, a number of legislative ● wholesale trade, nondurable goods; proposals have sought to extend community right- ● automotive repair, services, and garages; to-know and accident control provisions. H.R. ● miscellaneous repair services; 963, introduced February 6, 1985, by Represent- ● health services; ative James Florio (D-NJ), would amend the Oc- ● educational services; and cupational Health and Safety Act of 1970 to per- ● museums, art galleries, botanical, and zoo- mit States to adopt more stringent right-to-know logical services. provisions for access to information. The “Chem- ical Manufacturing Safety Act of 1985, ” H.R. 965, The law also applies to State and local govern- also introduced on February 6, 1985, by Repre- mental laboratories. By exclusion, therefore, the sentative Florio, amends the Toxic Substance law does not apply to retail trades, the profes- Control Act to add provisions concerning a com- sions, most service industries, and R&D labora- munity’s right to know of the risks, emergency tories that are not part of a covered facility. planning, and liability for hazardous substances The Massachusetts law, as yet unchallenged releases. Research laboratories and hospitals are and now being implemented, exempts research exempt, if the substance is used under the direct laboratories not involved in the production or supervision of a technically qualified person. manufacture of goods for direct commercial sale. H. Con. Res. 53, introduced by Representative Comprehensive right-to-know laws, of course, Bob Edgar (D-PA), is a concurrent resolution ex- are far less restrictive. Massachusetts, for exam- pressing the sense of the Congress that all persons ple, requires that an MSDS for each substance at have a fundamental right to know when they are an installation be filed with the Department of exposed to hazardous substances that may be dan- Environmental Quality Engineering (DEQE) and, gerous to their health. In part it declares that the on request, with a designated municipal coordi- Assistant Secretary for Occupational Safety and nator from the community in which the installa- Health should immediately revise the hazard com- tion is located. Thereafter, any community resi- munication standards to extend right-to-know dent who has reason to believe that a hazardous protection to employees in any service or indus- substance may be endangering public health or try that employs hazardous substances and that safety may request an investigation by the mu- the Federal right-to-know standards should set nicipal coordinator. If an investigation is deemed only the minimum requirements that the States necessary, DEQE can provide relevant MSDSs to must follow. On March 6, 1985, Senator Alfonse the petitioning resident in appropriate cases. The D’Amato (R-NY) introduced S. 606, the “Com- investigation is intended to ascertain what, if any, munity Right to Know Act of 1985 .“ It provides 81

for the annual notification to a city or county of well as for chemical classification, packaging, and labeling. The Sixth the presence of hazardous substances in or near Amendment requires an importer or manufacturer proposing to place a new chemical on the market to submit a premarket notification such city or county (within a lo-mile radius) by to the appropriate regulatory body of the member nation where the the owner or operator of such a facility. substance is produced or imported. The notice must contain health, environmental, and physio-chemical test data on the substance, esti- On March 21, 1985, Representative Robert mated volume and uses, and recommended precautions. On the basis Wise (D-WV) introduced H.R. 1660, the “Haz- of the data submitted, packaging and labeling requirements may be imposed, Exempted are substances subject to other regulatory ardous Materials Manufacturing Safety Act of programs, such as medicinal and radioactive substances, waste sub- 1985.” Similar to H.R. 965, the bill would amend stances and pesticides, research substances for evaluation, and sub- the Toxic Substance Control Act to add provi- stances marketed in quantities less than 1 metric ton per year per manufacturer. sions concerning a community’s right to know of The most important European Community enactment on risk com- the risks, emergency planning, and liability for municant ion for the control of chemical accident hazards is the hazardous substances releases. And finally, H.J. “Seveso Directive. ” This Directive is named for the town in Italy where explosions at a Hoffman-LaRoche plant in 1976 spewed di- Res. 225, “The Hazardous Substances ‘Right-to- oxin into the community, necessitating removal and testing of its know’ Resolution, ” introduced by Representative inhabitants. Bruce Vento (D-MN) on April 4, 1985, mirrors Adopted in 1982, the Seveso Directive is to be fully implemented by the member nations in 1989. Under the directive, a manufac- the H. Con. Res. 53 expression of a person’s fun- turer who conducts activities which involve one or more of 178 des- damental right to know when they are handling ignated substances must provide to the competent national author- or are exposed to a hazardous substance that may ity: information on the substances and the processes used, information on the installation (facility), information on possible threaten their health and well-being. It also major accident situations, new information relevant to safety and declares that OSHA should immediately revise its hazard assessment on a periodic basis, and special information on Hazardous Communication Standard to extend multiple installations close to dangerous substances. Each member nation is required to designate a competent authority “right-to-know” protection to all workers in in- who will be responsible for receiving the information from the man- dustries and services and that the Federal stand- ufacturer, examining it, requesting additional information, devel- ards should only be minimum requirements that oping an off-site emergency plan, organizing inspections, and de- the States must follow. * termining that the manufacturer takes the most appropriate steps to prevent major accidents and limit accident consequences. The directive thus represents the most complete and integrated approach *These legislative initiatives contrast sharply with the political taken to date to prevent chemical accident hazards. The directive assumptions directing similar European efforts, where public dis- reflects European values in vesting full responsibility for public safety closure is limited, In 1979, the European Community adopted a in public officials, in restricting the flow of risk information to pro- Directive, commonly called the Sixth Amendment, containing pro- tect industrial secrecy, and in affording citizens and interest groups visions for the testing of chemicals to be placed on the market, and no access to the risk communication process or to the information for the notification to governments of the results of such tests, as outputs of the process. Chapter 6 Institutional Differences

: Photo credit: National Institutes of Health Chapter 6 Institutional Differences*

Research in the United States is performed in the mechanisms described in chapter 4 apply in a number of different institutional settings—in three different institutional settings. The profiles university laboratories, in industry, in nonprofit are based on interviews and data gathered in ac- institutions, and in government laboratories. The tual laboratories. following profiles give examples of how some of

PROFILE OF A REPRESENTATIVE INDUSTRIAL LABORATORY

After acquisition in 1981 by a major interna- be earned from new product sales, or the savings tional chemical firm, this laboratory was made to be anticipated from production efficiencies and part of a newly formed pharmaceutical products safety improvements. Funds for research are division. One of the largest U.S. producers of deemed an investment and, as such, are expected radioactive chemical compounds for life science to pay dividends. The laboratory’s research research and radiopharmaceuticals, the pharma- agenda therefore depends on corporate judgments ceutical products division’s research activities are concerning the potential of research to yield principally aimed at new product development, dividends. at improving production efficiencies, and at de- In this regard, U.S. tax policy has, in recent veloping radioisotope marking procedures for the years, promoted research investments by grant- fields of radiopharmacology, life science chemis- ing business deductions or credits for research try, and biotechnology. In addition, the division expenditures—for example through the Internal conducts research on industrial health and safety Revenue Code and the 1981 Economic Recovery improvement techniques. Tax Act (see ch. 4). The effect of these provisions Because the Laboratory’s primary function is to is to lower the effective cost of research to busi- develop and supply radioactive materials, a large nesses and thereby to make the research more portion of the research is conducted to accomplish likely to be profitable. To the extent that tax this corporate marketing or production objective. breaks are given without regard for the content Some research is aimed at developing a marketa- of research, all forms of research are stimulated. ble pharmaceutical that will receive U.S. Food and Virtually all of this laboratory’s research falls Drug Administration (FDA) approval. Other re- within the categories eligible for preferential tax search seeks to improve the efficiency or safety treatment under current law. of production processes. A small portion of the The most important regulatory impacts on the division’s research is conducted under contract to selection of research opportunities at this labora- other industrial firms, principall to develop y tory, however, are the result of policies or regu- product-specific radioisotope marking procedures lations of FDA. By specifying the evidence of usable in their own research. safety and efficacy it will require for new drug approval, the FDA sets forth much of the research Control of the Research Agenda agenda for product development. The FDA reg- Because the laboratory is a commercial facil- ulations also control the activities that may be un- ity, its research decisions are strongly influenced dertaken with investigational new drugs. By speci- by such considerations as the potential profit to fying the protocols to be followed for each step of such research, including toxicology and phar- *This chapter is based on the regulations in force in three differ- macology procedures for animal testing and use ent laboratories. Interviews and data collection were performed by Michael Baram and Raymond Miyares, Bracken & Baram, Boston, of human subjects, the FDA regulations chart the MA, under contract to the Office of Technology Assessment. course of new drug development research.

85 86

Outside of FDA requirements, the principal in- port a new drug but also the research procedures direct impacts on the selection of research oppor- to be utilized. Thus, to satisfy FDA, research must tunities are higher costs resulting from compliance meet regulatory requirements for a “scientifically with health, safety, and environmental regula- well controlled” study. Some of these steps are tions. Sometimes firms engage in research in or- undertaken for no other reason than FDA require- der to control and reduce these costs. For exam- ments; in the absence of FDA regulation, the re- ple, the high cost of hazardous and low-level search might be designed in a more streamlined radioactive waste disposal at licensed facilities fashion. stimulates interest in development, production, For other types of research, regulatory require- and recycling processes that produce less waste. ments play a far less pervasive role. Research is At this laboratory, decisions to undertake research designed so as to be most likely to yield the desired on ways to recover waste carbon isotopes and to information. Because regulatory agencies have lit- reduce the curies of tritium used to produce tle interest in production efficiencies, much of the tritium-marked products are attributable, in part, research conducted in this area, for example, is to waste disposal cost increases. designed to suit the objectives of the researcher. Regulations can also raise the cost of the re- search itself and thereby deter a firm from under- taking it. This firm, for example, has thus far Management of Risks declined to use P-3 level (high hazard) micro- Much of the division’s research is undertaken organisms in its biotechnology laboratory because by a permanent staff of scientists and technicians of the elaborate substance approval process re- who expect a long-term career with the company. quired by National Institutes of Health (NIH) The long-term consequences of radiation and toxic guidelines. In interviews, company officials sup- chemical exposure are as important to them as im- plied other examples of research that they aban- mediate health and safety effects. doned because of high regulatory compliance costs : Since its acquisition by an international corpo- ration, this laboratory has undertaken to conform ● The cost of establishing and maintaining a its occupational and environmental health and laboratory “closed box” acceptable under safety practices to those of its parent company, NIH guidelines and emission controls ade- which enjoys a national reputation for responsi- quate to meet State air pollution requirements bility in this area. The laboratory has a safety ex- was deemed so substantial that planned re- ecutive committee of senior managers, with sub- search utilizing aflatoxins was abandoned. committees on safety awareness, process hazards, ● Similarly, the cost of obtaining an antidote equipment safety, chemical safety, and radiation for the venom of an African poisonous safety. Every employee is required to attend a snake, in compliance with NIH guidelines, monthly safety seminar, and regular inspections was considered prohibitive and research uti- are made, not only of the obvious hazards of lizing the venom was dropped. chemical storage areas, radiation shielding, and ● The Occupational Safety and Health Admin- electrical wiring, but also of the more mundane, istration (OSHA) xylene and toluene ex- such as chair hazards. On-the-job injuries, lost posure standards (to protect workers) were work time, restricted work time, medical treat- considered too costly to comply with in re- ment, and off-the-job injuries are reported search on liquid scintillation cocktails, so that monthly to corporate headquarters. research was redirected to find scintillators with less toxic components. The laboratory workers are protected by several Federal and State regulatory programs. OSHA Controls on the Research Process regulations, the most comprehensive of these, set general safety standards as well as exposure stand-

The protocols specified in FDA regulations dic- ards for toxic chemicals. Nuclear Regulatory tate not only the type of research necessary to sup- Commission (NRC) regulations specifically gov- 87 ern the safety of laboratory work on radioactive customers with Material Safety Data Sheets materials and require dissemination of informa- (MSDSs) on–all hazardous products sold. Com- tion to workers on any materials used in the lab- pany practice is to compile a notebook of MSDSs oratory and reporting of any incident involving for all its products sold and to disseminate the radiation exposure. NIH guidelines govern the same notebook to all customers with a printout containment and security of micro-organisms used listing which products they purchased during the in biotechnology research. previous 18 months. The firm’s preoccupation with safety also ex- The laboratory was in virtual compliance with tends to environmental and community hazard the OSHA standard prior to its issuance and is concerns. The laboratory conducts annual emer- encountering no significant difficulty in adapting gency training programs for local fire officials, po- its prior community liaison activities to the State’s lice, and hospitals. In addition, it complies with right-to-know requirements. For laboratory work- a panoply of Federal and State requirements for ers, it is required, under the OSHA standard, to: construction and operation of industrial facilities. Ž ensure that labels on incoming containers of The State plumbing code, for example, requires hazardous chemicals are not removed or separate piping in the biotechnology lab for hu- defaced; man contact and contact with organisms. The Re- ● maintain any MSDSs that are received with source Conservation and Recovery Act and cor- incoming shipments of hazardous chemicals, responding State requirements, as well as NRC and ensure that they are readily accessible to regulations, govern the disposal of hazardous and laboratory workers; and radioactive waste. Federal and State air quality ● provide laboratory workers with information regulations limit emission of radionuclides into and training on hazardous chemicals in their the air. And, in addition, regulations under the work areas at the time of their initial assign- Clean Water Act restrict the disposal of waste into ments, and when a new hazard is introduced publicly owned treatment facilities as well as the into their work area. discharge of such waste into surface and ground- water. Under the Clean Water Act, even de The State has required further that the company minimis spills of hazardous substances must be supply a list of the hazardous substances that it reported. uses, and an MSDS for each one, to local offi- cials in both the State Capital and the town in Beyond these specific regulatory programs, the which the lab is located. Neither the OSHA nor potential for liability under the Federal Superfund the State list of hazardous substances, however, law, corresponding State laws, and the common includes radioactive materials. law influences the management of laboratory risks. Such potential for liability provides an in- Although the laboratory often seeks to dissem- centive for due care in the management and dis- inate a product developed in its research labora- posal of wastes and the emission of pollutants into tories, corporate policy necessarily restricts dis- the environment. However, the incentive oper- semination of information about its research or ates further to cause the company to reduce waste about research results. Such information may be generation so as to avoid strict liability even where legally patentable or protectable as a trade secret, due care has been exercised. and corporate policy is to control dissemination or publication of research data, especially on proc- ess refinements or improvements, unless there is Restrictions on Communication a valid business reason for dissemination. On the of Information other hand, the parent company’s policy is to dis- seminate fully any proven safety improvements As a manufacturer, the company is subject to developed by corporate research laboratories. both the OSHA hazard communication standard and the State’s right-to-know law, notwithstand- Again, the potential for liability affects the ing that law’s research laboratory component. Un- availability of information on research. The lab- der both provisions, it must label—and supply its oratory has a “document retention program” that 88

requires disposal of all documents not required gram can be seen as a prudent response to the to be retained for a business purpose or by regu- liberal discovery rights afforded litigants in the lation, the objective of which is to avoid a paper courts today, but it may also cause information trail that could be used in enforcement or liabil- on prior research to be lost to researchers within ity proceedings against the company. This pro- the company.

PROFILE OF A REPRESENTATIVE NONPROFIT INDEPENDENT LABORATORY

This cancer research center is one of several of the related risks before participating in a clini- teaching hospitals affiliated with a major medi- cal study in the hope of achieving therapeutic cal school, although its Board of Trustees is fully benefits. independent of the school. The center is involved The center’s research staff of 600 includes ap- in cancer research of virtually all types, from cell proximately 350 with doctoral degrees. Much lab- biology to clinical trials, with a special emphasis oratory research is conducted by technicians. Such on childhood cancers. Its research divisions in- technicians typically have a high turnover rate, clude specialities in: biostatistics and epidemiol- so that long-term exposure to laboratory chemi- ogy; cancer control, genetics, and pharmacology; cals and radiation is unusual. Nevertheless, some cell growth and regulation; immunogenetics; med- research personnel, both professional and non- ical and pediatric oncology; medicine; and tumor professional, perform research over a period of immunology and virology. several years. The center administers an annual budget which, in 1984, exceeded $55 million. Of this amount, approximately 45 percent was for patient care and Control of the Research Agenda services and the remainder was for research. The The center has a fairly formal administrative center maintains a 57-bed inpatient facility and hierarchy that sets the general theme of the re- provided care through nearly 24,000 outpatient search to be undertaken. Because the center is it- visits in 1984. Approximately 50 percent of the self mission-oriented (i. e., devoted to cancer re- center’s patients participate in some form of clin- search), and its principal funding sources share ical study, however, and the line between research nearly the identical research mission, the center’s and patient care is not always precise. broad outlines of research are not generally af- Approximately 80 to 85 percent of the center’s fected by considerations of funding availability. research is funded by Federal grants from NIH To be sure, the work of an individual researcher and the National Science Foundation (NSF). Of or laboratory might be terminated if funding were this amount, about 70 percent comes from the Na- withdrawn. Much of the research staff is depen- tional Cancer Institute (NCI). Of the remainder, dent on continuing funding for their employment. most comes from private granting organizations Further, if NCI were abolished or fundamentally such as the American Cancer Society and the Na- redirected, the center’s research agenda might be tional Leukemia Foundation (principally for stu- substantially affected. The importance of cancer dent fellowships). Approximatelys percent of re- research in American public health policy, how- search funds come from other private sources. ever, makes the possibility of a major redirection remote. The center’s therapeutic research often involves highly toxic chemical agents or radiation, and, of Indeed, it is this public policy commitment, course, the use of human subjects. The hazards rather than the mission of funding sources, that of the research may be concentrated on these sub- appears to affect the center’s selection of research jects in some circumstances, and human subjects opportunities. For example, the center has thus must be informed of, and consent to, acceptance far declined to undertake a large amount of epi- 89

Box A.—An Assessment of Regulatory Forces by Lab Directors and Research Administrators In March 1985, OTA sent questionnaires to 32 university research administrators (deans and vice presidents) and 112 laboratory directors around the United States. The two groups were selected be- cause of their varying roles in the university research process; administrators tend to be intimately involved in the research administration policies established and followed within the university and the lab directors are more involved with concerns linked to their particular field. The laboratory director group was selected from the Gale 1984-85 Research Centers Directory. Out of the 7,427 entries for the United States and Canada, at least two were chosen from every State and from the disciplinary divisions according to the following proportions: agricultural and nutrition sciences, s percent; astronomy, 5 per- cent; engineering (research), 20 percent; life sciences, 20 percent; mathematics and computer sciences, 20 percent; physics, 25 percent; and social sciences, 5 percent. Laboratories of all sizes were chosen ran- domly within the above parameters. The response rate for this group was 23 percent. The research administrators were chosen from the top 32 research universities in the country based on the level of Federal funding for research, according to the NSF Academic Science R&D Funds: Fiscal Year 1980, Surveys of Science Resources Series. Forty-four percent of the research administrators re- sponded to the survey. The aggregate response rate was 27.7 percent. Participants were asked to identify major regulatory forces in their research institutions, trends in regulation of research, and channels or forums for discussing solutions to potential problems. In gener- al, there were few differences in the forces listed between the responses of the two groups.

Major Regulatory Forces.—The regulatory forces listed by the respondents can be classified into four major areas: controls on substance, whereby nonscientific forces are setting or influencing the re- search agenda; controls on process, whereby the nature of the research is not under consideration, but the means and methods used to accomplish the research goals are regulated; administrative constraints (including the funding process); and restrictions on dissemination of research results. Clearly, the regulatory forces that are most keenly felt by both groups are the Federal guidelines for the protection of human participants and animals in research. But following closely in the ranking are many unintentional regulatory forces, such as environmental, health, and safety legislation intended to protect the general public; or radiation safety regulations, environmental and worker protection laws, and Good Laboratory Practice Standards intended to protect labor. Administrative constraints were listed as a major area of concern by 37.5 percent of all respond- ents. Perhaps predictably, university administrators saw the financial accounting requirements as most pernicious. When the responses are disaggregate, 64 percent of the administrators v. 23 percent of the lab directors, listed financial accounting requirements as a major force. Both groups found “social regulations” to play a major role, Social regulations include laws to en- courage small business and minority business subcontracting, Fair Labor Standards, and Equal Employ- ment Opportunity Commission and Affirmative Action requirements. Because respondents were not asked to rank their answers, it is not clear how much of a force they feel these regulations present. The fre- quency of responses, however, indicate that they are not as significant a force as the administrative and accounting requirements. There was not a strong indication that either group feels that there are major regulatory forces affecting the research agenda, although a few respondents from each group indicated that national priority set- ting is increasingly affecting the research agenda, particularly as a result of increased defense spending and concern about industrial competitiveness. Only 17.5 percent of the respondents listed controls on dissemination of research results as a major force. When asked whether they believed that the controls they had listed were any different from con- trols experienced by other universities, 86 percent of the administrators responded that they did not feel “singled out.” The major regulatory forces affecting them are most likely the same for other research institutions. 90

demiological research in the area of cancer pre- oratory research, and thus are followed even be- vention because of its doubts about the long-term yond the jurisdiction of NIH. NIH has published commitment of NCI to such research. A cancer guidelines for animal testing, for the use of hu- prevention epidemiological study would require man subjects, for recombinant DNA research, and a commitment to long-term funding without any for the use of investigational drugs. The latter important intermediate benefits to be derived from guidelines apply when NCI provides a pharma- the research. National policy, in contrast, focuses ceutical on which research is to be conducted; if on research with measurable output within a short an investigational drug were applied by a private time span, and the center has rot been satisfied firm, the firm would have to obtain FDA approval that funding for cancer prevention or epidemio- and meet FDA requirements established for such logical studies would not be terminated before us- drugs. In general, the center attempts to relieve able results could be achieved. its researchers from the nonsubstantive burdens of these guidelines and to assign to administra- With this exception, the principal factor govern- tive staff the responsibility for paperwork and ing the choice of research activities is the individ- managerial burdens. ual strategy of the principal investigator. Because staff investigators are selected on the basis of the A more fundamental effect on the conduct of congruence of their expertise and interests with research is perhaps caused by the structure of the the center’s research mission, the focus of its ef- usual grant agreement. Although NIH is author- fort is maintained without any formal structure ized to make research grants for up to 7 years, to review research proposals for consistency with the typical grant is generally for 3 to 5 years and the center’s objectives. never longer. On the average, an NIH grant pro- vides 3½ years of funding. This limit is set, not Virtually all of the research conducted at the so much by policy considerations, which argua- center is investigator-initiated, and very little is bly favor longer grants that are relatively easy to contract work. NIH and NSF proposals—as well administer and require burdensome administra- as others—are peer reviewed, and this review, in tive procedures less frequently, as by the demands some instances, may tend to discourage funding of peer review. Often reviewers recommend fund- of highly innovative research projects in favor of ing for less than the total period of time requested more conventional undertakings. However, the in order to allow for thorough review at frequent vagaries of peer review are regarded as less in- intervals. A possible impact of such temporal fluential on an organization such as this center limits, however, is to promote research protocols than they might be for another research facility that permit tangible work products in shorter time of lesser reputation. periods. The impact of all types of government regula- A principal limitation of NIH funding is that tion on the selection of research opportunities is it does not fully cover experimental patient care. also fairly minor. The cost of compliance with reg- This is not a reflection of any NIH judgment that ulatory requirements is incorporated into grant it is not responsible for experimental patient care, applications and is rarely so significant that fund- but rather a dictate of the limitations of available ing is jeopardized. Moreover, the very properties funds. Third-party procedures (e.g., Medicaid and that make a substance or procedure a candidate Blue Cross/Blue Shield), in contrast, do not as- for regulation often also make it attractive as a sume responsibility for experimental clinical pro- subject for research. cedures. Thus, a gap exists, at least in theory, be- tween NIH funding and third-party procedures. Control of the Research Process In practice, the gap is less significant than it ap- pears, in part because the line between clinical re- Because NIH funding is so important to the search (nonreimbursable) and “best patient care” center’s research, the protocols established by that (reimbursable) is not precisely drawn. However, agency strongly influence the conduct of that re- as pressure to control medical costs increases, search. Moreover, NIH guidelines have become, third-party providers are likely to draw a more in many instances, the industry custom for lab- restrictive line of distinction and more experi- 91 mental patient care may have to be funded by Controls on Communication of NIH. Information Management of Risks Because the center regards its staff to be both intelligent and well-educated, it relies on the pro- The center is subject to OSHA, the Environ- vision of chemical and radioactive hazard infor- mental Protection Agency, and NRC regulations mation as the principal instrument for managing governing work place safety, environmental pro- risk hazard. The center employs one half-time tection, and radiological health. The center’s Di- chemical safety information officer whose exclu- vision and Laboratory Chiefs are responsible for sive responsibility is to provide relevant informa- assuring compliance with such regulations by tion about substance hazards and appropriate those they supervise. In addition, the center is sub- precautions and responses, as well as to perform ject to the Joint Committee on Hospital Accredi- laboratory inspections. tation, a hospital self-regulating organization that The center, however, is not subject to either the approves radiation, chemical, and biological OSHA hazard communication standard or the safety programs. The State and city in which the State right-to-know law. The OSHA standard, as laboratory is located further regulate aspects of noted, applies only to workers within the manu- health, safety, and environmental hazards, includ- facturing sector. The State law exempts research ing fire and chemical hazards and the biohazards laboratories not involved in the production or of recombinant DNA. manufacture of goods for direct commercial sale. As noted, NIH guidelines govern the use of hu- The regulations issued under the law require an man subjects in research, and these guidelines gen- application for an exemption to be filed by each erally require the approval of the research pro- laboratory. The center has filed such an applica- tocol by an Institutional Review Board and the tion and, while that application is pending before informed consent of the human subject or legal the State department of public health, the center representative. Typically, the center has found, is exempt from right-to-know requirements. its patients are relatively sophisticated about the A principal objective of the research conducted nature of their disease, the hazards of research, at the center is the dissemination of user results. and the potential for harm. The center is a ter- Dissemination serves the interests of the center’s tiary care facility, and the majority of its patients mission by advancing the state of knowledge have substantial experience with medical proce- about cancer and also enhances the reputation and dures and treatments. Therefore, the content of standing of the center and its staff. Therefore, the its informed consent form can sometimes be rela- center will not accept research funding that re- tively more technical than corresponding docu- quires secrecy. Nevertheless, some limits on dis- ments at other facilities such as at a primary care semination are accepted. Grant agreements may hospital. specify, for example, that publication of research The informed consent form states the center has results might be delayed for up to 3 months in “no formal policy” with regard to compensation order to allow for review by the sponsor. Such of research subjects who are injured in the course limits do not generally appear in NIH or NSF of research. In practice, medical cost incurred as grant agreements. Indeed, the policy of Federal a result of such injury might be paid by the third- funding organizations is to stimulate the dissem- party provider. In particular circumstances, how- ination of research results, and failure to publish ever, the center might seek to assume or divide may be considered negatively in evaluation of new these costs. grant proposals. 92

A theoretical restriction may also derive from suits seemingly adverse to private clients. Such

the practice of some center staff to consult pri- an impact may be completely unconscious and im- vately for industry. In such circumstances, the possible to demonstrate, but the restriction may staff member could feel disinclined to publish re- nevertheless operate.

PROFILE OF A REPRESENTATIVE UNIVERSITY LABORATORY

The Department of Chemical Engineering at workers of the hazards of their research. This sit- this major research university engages in a range uation influences the amount and type of safety of research projects and activities in support of measures taken by the university. the academic development and advancement of its students and faculty. Although much of this Controls on the Research Agenda research is funded from outside sources, the de- partment does not principally engage in client Because the university lacks the formal hierar- services, but rather seeks grant support for re- chical administrative structure of a commercial search into chemical transformation and separa- enterprise, decisions to undertake research are tion processes, and energy intensive functions of relatively individual and idiosyncratic, rather than relevance to the interests of its members. The prin- directed by an overall institutional strategy. cipal areas of interest include coal conversion, Clearly, the availability of funding affects the re- synfuels developments, utilization of micro-orga- search agenda, but this financial incentive differs nisms in chemical processes, and polymer produc- from that of an industrial laboratory, which must tion. Approximately 30 to 40 percent of the de- make its research choices based, in part, on an partment’s research funds come from private estimate of the market impact of the anticipated sources (e. g., one international corporation con- results. Further, because of its stature in academic tributes $1 million annually); the remainder are circles, the department carries considerable weight Federal grants, principally from the departments in negotiations with potential sponsors over the of Energy and Defense (DOE and DOD) and NSF. content and conduct of its research activities. Much of the department’s research is conducted This is not to say that research sponsors have at a very small scale, utilizing small quantities no influence over the manner in which their funds (often less than a gram) of chemicals in any partic- are utilized. Many Federal sponsors and some ular step. However, a great variety of chemicals foundations, as well as virtually all commercial are involved in the department’s research pro- sponsors, are mission-oriented. Such sponsors grams so that the cumulative hazard of the re- make their grant awards based on whether they search is highly variable. An exception to this pat- perceive the research to promote their particular tern of low volume and high variety is in the area mission objectives. Approximately 75 to 80 per- of combustion engineering, in which substantial cent of the department’s research funds come from volumes of petroleum products are burned in the such mission-oriented sponsors, which include course of research. DOD and DOE, the petroleum and chemical man- ufacturing industries, integrated circuit manufac- In many instances, laboratory research is con- turers, and pharmaceutical companies. The re- ducted by students rather than by staff techni- mainder comes from sponsors seeking to support cians. Because the turnover rate for both students “basic” research–some DOE programs, NSF, and and technicians is fairly high, most of the people private foundations. who work in the department’s labs are not sub- ject to long-term exposure to laboratory chemi- The impact of regulation on the selection of re- cals. The students, however, may be more vul- search opportunities is, by contrast, fairly minor nerable to risks because they are relatively naive compared to the academic interests of the faculty and untrained in laboratory safety procedures and and the mission objectives of sponsors. Because may be somewhat less cognizant than career the department’s research seeks to be at the cut- 93

ting edge, regulation addressing the specific sub- Industrial sponsors may provide “foundation” stances or processes under investigation may not grants intended to support the department’s gen- yet have been developed. The cost of complying eral research activities, rather than any particu- with health, safety, and environmental regulations lar project. Such broad grants are less likely to is rarely so significant that research is foreclosed. constrain the specific conduct of research. When To the extent that such regulation raises the cost industrial sponsors underwrite a particular re- of certain lines of inquiry and thus may divert at- search project, however, the grant agreement may tention to other research activities, this effect is include specification of the research protocol. Sur- countered somewhat by intellectual interest in veillance of the department research, however, studying “problem” chemicals and process—those is somewhat more extensive in that reporting re- that may be the subject of extensive regulatory quirements are more often imposed and site visits attention. more frequent. Because combustion engineering research has Mission-oriented Federal agencies, such as different characteristics from other research con- DOD and DOE, tend to specify research protocols ducted in the department, the effect of regulation in the greatest detail. Such protocols are drafted, of this research is also somewhat different. In par- not only to assure the technical adequacy of the ticular, research into the emissions produced by research, but also to assure that research results combustion processes requires the use of substan- will be usable by the sponsor in achieving its ob- tial volumes of fuel. Often, from a purely research jectives. Commonly specified details include per- perspective the fuel of choice would be benzene, formance requirements, cost allocations, equip- but benzene is the subject of such intense regula- ment, milestones, and personnel. This greater tory scrutiny that researchers are reluctant to use specification is typically accompanied by greater it if a relatively less problematic alternative such supervision and monitoring of the research. The as toluene is available. This reluctance stems both Department of Defense is especially strict in its from current regulatory activities (principally by surveillance of the research it sponsors; however, OSHA) and from the concern that department re- this university does not automatically comply searchers share with regulators over the hazards with DOD’s (or any other sponsor’s) requests for of the substance. secrecy in the conduct of research. Because it is an academic institution principally devoted to A similar effect may be discerned with respect education, the university laboratories are widely to the use of radioisotopes in research. Because open to students and faculty. Classified or weap- of the regulatory burden of becoming licensed to ons-related research is deemed an inappropriate handle radioisotopes and the cost of their disposal activity for an academic institution, although it under NRC regulations, their use is discouraged may be conducted at university affiliated labora- if alternative research procedures are available. tories off campus. Again, the effect may be to skew the allocation of research resources. Management of Risks

Controls on the Research Process The university maintains a Safety Officer and an Office of Environmental Medical Services Most research grant agreements specify how re- which are intended as a resource to consult in the search activities are to be conducted; but the level design of laboratory risk management activities of specification varies considerably with the spon- and to facilitate compliance with environmental, sor. Sponsors of basic research typically require health, and safety regulations. In addition, the a proposal that sets forth the research protocol university faculty maintains nine standing com- in sufficient detail to allow reviewers to judge the mittees that develop risk management procedures technical adequac of the research. Such protocols y to be used in research: are often thereafter incorporated by reference into grant agreements, but most sponsors do little su- ● Council on Environmental Health and pervision or monitoring of performance under Safety, these agreements. • Committee on Assessment of Biohazards, 94

● Committee on Radiation Protection, (RCRA) for hazardous waste disposal. These reg- ● Committee on Safety, ulations essentially prohibit the disposal of sub- ● Committee on Animal Care, stances on the hazardous waste list by conven- ● Committee on the Use of Humans as Exper- tional means (emission standard =0) and instead imental Subjects, require that licensed hazardous waste transporters ● Committee on Toxic Chemicals, and disposal facilities be utilized. The regulations ● Committee on Radiation Exposure to Human further specify the packaging and paperwork re- Subjects, and quirements to be followed in the disposal of haz- ● Committee on Reactor Safeguards. ardous wastes. At this university, hazardous waste from chemical engineering laboratories is The university will not approve a grant agreement sent to the safety office where such waste is col- or research contract that has not been approved lected from all parts of the university. Much of by the committee having jurisdiction over such this waste is unique and packaged in tiny vials. research. Traditional practice has been to combine vials of In general, the safety practices established by compatible wastes in “laboratory packs’’—con- these offices and committees are equivalent to, or ventional drums lined with absorbent material— more stringent than, corresponding regulatory re- before shipping them off for disposal. The regu- quirements. Often, the faculty have been involved latory manifest, however, requires that the con- in the development of Federal regulatory require- tents of each vial in the lab pack be separately ments and their influence is reflected in the re- identified, and monthly and annual generator re- quirements adopted. Nevertheless, researchers are ports required under RCRA also must include in- always alert to proposals for regulatory require- formation on each vial. Because the waste in each ments that specify unachievable standards or un- vial may be unique, the information necessary to workable administrative burdens, For example, complete the manifest may not be routinely avail- a new State plumbing code originally would have able, and the safety officer may encounter some required that no micro-organisms be disposed of difficulty in preparing the waste for shipment. A in the wastewater of laboratories where biotech- barrel of industrial waste, in contrast, is likely to nological research was being conducted, even contain only one waste type that is routinely gen- though there are safe and acceptable levels of erated. The paperwork burden for this barrel is micro-organisms commonly allowable in waste- correspondingly light: Only one substance needs water generated by nonresearch facilities. to be identified on the manifest and the informa- tion to be provided is the same day after day. The department’s laboratories are subject to a range of environmental and occupational safety Similarly, the State’s Clean Air regulations re- and health requirements that typically include: 1) quire an individual permit for each vent through safety or health standards for emissions of, or ex- which air pollution emissions are made. The university has approximatel 20 such permits for posure to, a particular substance; and 2) y documentation of compliance with such stand- the Department of Chemical Engineering and each ards. Many of these regulations specify the chem- one is supposed to include a specification of the ical substance as the unit of regulatory attention, substances being emitted as well as the technol- and the paperwork burden of reporting require- ogy being employed to reduce those emissions. ments varies with the number of chemical sub- Because laboratory work varies over time, how- stances used in research. Because department re- ever, any specification of substances in the per- search typically utilizes tiny quantities of a mit is necessarily uncertain. Moreover, if an multitude of chemical substances, the paperwork honest effort is made to specify all of the sub- burden is substantial even though the exposure stances likely to be utilized in the laboratory, the and emission standards may be fairly easy to permit application must then demonstrate that the achieve. technology is in place to reduce emissions of the full list of substances. Nothing in this State law An example is provided by the regulations un- exempts from the permit requirement substances der the Resource Conservation and Recovery Act that are being emitted in de minimis quantities. 95

Essentially, these two environmental regulatory who also may be exposed. Faculty, administra- programs were devised with a different model of tion, and research supervisory personnel are re- facility in mind; it is increasingly apparent that sponsible for promoting safe practices and for in- regulations devised for industrial facilities may be forming individuals working in laboratories about poorly suited for application to research labora- safety in connection with the work being con- tories. RCRA regulations do include a partial ex- ducted. emption for small quantity generators, but this This policy derives from the university’s assess- is of no use to the university, which clearly does ment of its own responsibility under ethical and not qualify as a small generator because of its sub- general liability principles rather than from a par- stantial total volume of waste. If paperwork bur- ticular hazard disclosure regulation or statutory dens are to be more closely related to the hazards requirement. For example, the OSHA hazard of the regulated activity, new efforts are required communication standard applies only to work- to tailor regulatory requirements to the type of ers within the manufacturing sector. Therefore, enterprises being regulated. no university laboratory is subject to its re- One such effort is suggested by the statement quirements. of projected rulemaking issued by OSHA on April Similarly, the State right-to-know law exempts 29, 1985, concerning health hazards of chemicals research laboratories not involved in the produc- in laboratories. In that statement, OSHA ob- tion or manufacture of goods for direct commer- served: cial sale. The regulations issued under the law re- Existing OSHA standards are designed to pro- quire an application for exemption to be filed by tect employees who are engaged in work involv- each laboratory. The Department of Chemical ing exposure to only a few toxic chemicals dur- Engineering has filed such an application for its ing relatively standardized, continuous or laboratories, which is presently pending before repetitive processes. In contrast, laboratory the State Department of Public Health (DPH). Un- workers are exposed to a multitude of toxic sub- der the regulation, the department is exempt un- stances under frequently changing or unpredict- til DPH rules on the application. able conditions. OSHA will examine whether prudent work practices and protective equip- Nevertheless, the State law does affect univer- ment, chosen for the specific facility and task, sity operations in other ways. A number of ven- are more effective, feasible and economical for dors have terminated all business in the State in laboratory work than adhering to OSHA’s cur- response to the law, so that alternative vendors rent substance specific exposure standards. have had to be found in some instances. In addi- Such a proposal appears to be better suited to tion, MSDSs being supplied with chemical prod- achievement of the goals of environmental, health, ucts sometimes appear to have been prepared by and safety regulations than the traditional ap- lawyers to achieve minimal compliance with reg- proaches. The effect of traditional regulations, in ulatory standards and to provide the least in- many instances, is to consume the time of safety criminating information possible, rather than by personnel in the documentation of compliance persons desirous of promoting proper manage- rather than to stimulate such people to devote ment of substance hazards. For this reason, when their time to analyzing problems for which rou- the university is establishing safety procedures, tinized solutions are not readily achievable. it frequently uses MSDSs prepared by an inde- pendent service, rather than those supplied by manufacturers. Restrictions on Communication of Information Clearly, a principal objective of academic re- search is publication and dissemination of research It is the formal written policy of the university results both to advance the state of knowledge in that people who may be exposed to hazards the research field and to advance the reputation should be informed about the nature of these haz- and study of the department and its faculty. As ards and how to protect themselves and others noted, therefore, the university will not approve 96 funding arrangements that require secrecy in the The department’s agreement with the corpora- conduct of research and the dissemination of tion cited above, for example, illustrates how results. these provisions operate. Under that agreement, the university will hold the patent on any discov- Nevertheless, some limits on dissemination are ery made in the course of the research funded by common. Grant agreements may specify, for ex- the corporation, subject to the corporation’s ample, that publication of research results must royalty-free license. If the university does not de- await a release by the sponsor. In some circum- velop its patent, then the rights will revert to the stances—for example, where proprietary informa- corporation. The corporation is also given 10 days tion has been licensed to the department for the to review articles proposed for publication and conduct of research—the sponsor may require to make any objections. Of course, the principal that articles proposed for publication be submitted restraint on publication under this arrangement for review in advance to assure that inappropri- may not be the final restrictions of the grant agree- ate disclosures of patentable material or trade ment but the desire to maintain a harmonious rela- secrets are not made. tionship with a major source of research funding. Chapter 7 Community Control of Research: Two Case Studies

Photo credit: National Institutes of Health Chapter 7 Community Control of Research: Two Case Studies*

This chapter describes two cases involving case was kindled in October 1983 and has been precedent-setting interventions into scientific in- the subject of litigation since March 1984 when quiry by a local government in Massachusetts. the city promulgated its first regulation. The first describes the city’s two-phase regulation The case studies that follow describe the events of recombinant DNA molecule technology—in leading up to the respective regulations, discuss 1977, passage of the country’s first law regulat- the possible national impacts of these types of ing rDNA research, and in 1981, a revised law, cases, and survey the arguments presented in fa- enacted in response to research and development vor of and opposed to local regulation of research. (R&D) activities of newly established biotechnol- The report also examines the general policy im- ogy firms. The second case describes the city’s ef- plications of these cases on the issue of freedom forts to proscribe the handling and testing of cer- and accountability in the conduct of scientific re- tain chemical warfare agents by a consulting firm search. under contract with the Department of Defense (DOD). The public controversy over the second

RESEARCH INVOLVING RECOMBINANT DNA MOLECULES

The controversy in Cambridge, Massachusetts, of a P-3 facility, designed to provide a protective over research involving the use of recombinant barrier against the release of experimental organ- DNA molecules began in Spring 1976. At that isms. A laboratory of this type required several time, the administration of Harvard University hundred thousand dollars in equipment and spe- was considering a proposal for the renovation of cial construction techniques. one of its biological laboratories. The purpose of When plans for the $380,000 research labora- the renovation was to construct a facility that tory were being discussed by the university would conform to requirements of the National administration, several Harvard scientists ques- Institutes of Health (NIH) for performing certain tioned having an rDNA facility in a densely popu- classes of rDNA experiments, designated at the lated area close to other research and teaching time as “moderate risk.” NIH was also in the proc- activities. The issue was taken up by Harvard’s ess of issuing guidelines that defined six classes university-wide Committee on Research Policy. of gene-splicing experiments: research exempted The Committee responded by holding an open under the guidelines; P-1; P-2; P-3; P-4; and re- meeting for the Harvard community which was search prohibited under the guidelines. The planned also attended by a member of the Cambridge city Harvard laboratory was expected to meet the per- council and a reporter from a weekly newspaper, formance and physical containment specifications The Boston Phoenix. A news story on the meet- *This chapter was prepared by OTA staff, based largely on work ing, “Biohazards at Harvard’ ’-the first media re- performed under contract for OTA by Sheldon Krimsky and on port of the controversy surrounding the new reviewer comments thereon. Dr. Krimsky is Associate Professor in Urban and Environmental Policy, Tufts University, and in 1984 was laboratory—appeared in the Phoenix on June 8, appointed Chairman of the Cambridge Scientific Advisory Com- 1976.1 Troubled by the story, Cambridge Mayor mittee that played a major role in the Arthur D. Little controversy Alfred Vellucci decided to hold hearings on rDNA detailed in this chapter. Professor Krimsky’s contract report was reviewed by numerous experts, both within and outside of OTA, includlng Arthur D, Little, Inc. , and other participants in the con- ‘Charles Gottlieb and Ross Jerome, “Biohazards at Harvard, ” l?os- troversy. fo~ Phoenix, ]une 8, 1976,

99 100

research at Harvard. Mayor Vellucci was sup- postpone any work. However, Harvard pro- ported and advised by several scientists in the city, ceeded with the laboratory’s construction with- including some of Harvard’s own faculty. 2 When out assurances that an occupancy permit would the city council held hearings on June 23 and July be issued. 7, 1976, scientists and physicians affiliated with Members of CERB were appointed by the city Boston-area universities and hospitals were among manager in late August 1976. The manager con- those who testified. Academic and biomedical re- sciously avoided the appointment of any biologists search centers outside of Cambridge, contemplat- to the nine-member committee on the grounds ing rDNA research at the P-3 level, were con- that they were already divided on the question. cerned that the imposition of a city-wide ban on (Initially appointed as a full member, the Com- certain rDNA experiments would eventually af- missioner of Health and Hospitals subsequently fect their own institutions. became ex officio. ) Harvard’s Committee on Research Policy CERB met over a period of 4 months between agreed unanimously that the research should pro- September and December 1976. Harvard and MIT ceed despite its potential hazards. According to agreed to a 3-month extension to the good-faith the Committee, the new facility provided a suffi- moratorium on P-3 experiments otherwise sched- cient margin of safety. Harvard set up a parallel uled to elapse in September, The citizens’ com- review committee comprised exclusively of scien- mittee issued its report to the city manager and tists. Known by the name of its chairman, the the Commissioner of Health and Hospitals in Jan- Branton Committee also issued a favorable re- uary 1977. The report stated that P-3 rDNA re- sponse to the proposed rDNA facility. On June search may be permitted on the stipulation that 14, 1976, a week prior to the first Cambridge hear- additional safeguards be added to the require- ing, the Harvard Corporation authorized con- 3 ments of the NIH guidelines. CERB also recom- struction of the P-3 laboratory. mended passage of a new ordinance that included Subsequent to the public hearings, the city the creation of a Cambridge Biohazards Commit- council, frustrated by the technical complexity of tee (CBC) to oversee all rDNA research in the city. the issues and perplexed by the polarization of The committee’s recommendations were enacted viewpoints, voted on the recommendation of one into law on February 7, 1977. The law was not of its members to establish the Cambridge Ex- subjected to legal challenge by any of the affected perimentation Review Board (CERB). The city parties. Overall, public reaction to the outcome council order contained no specifications about was favorable and controversy subsided quickly. the composition of the citizen board, leaving the A second debate over rDNA activities erupted appointments to the discretion of the city man- in Cambridge during 1980. This time the issue was ager. The city council also requested that Harvard over R&D activities in genetics. Biogen, a newly and the Massachusetts Institute of Technology formed Swiss biotechnology firm, seeking its com- (MIT) accept a 3-month, good-faith moratorium mercial and management headquarters in the on any P-3 level rDNA research. Both universi- United States, chose a site in an area of Cambridge ties accepted the moratorium, thus giving the zoned for manufacturing and light industry. Un- newly established review board an opportunity daunted by the city’s reaction to rDNA experi- to evaluate the risks. Since the new laboratory ments 4 years earlier, Biogen officials notified the was expected to be completed by the spring of city manager and the health commissioner of the 1977, the city’s moratorium on research did not firm’s interest in selecting a site and its willing- ness to conform to all Federal and local regu-

‘For a detailed account of Cambridge, MA’s involvement in the lations. rDNA controversy, see ch. 22, Sheldon Krimsky, “Local Initiatives for Regulation, ” Genetic Alchemy: The Soa”al History of the Re- CBC called a public hearing on October 28, combinant DNA Controversy (Cambridge, MA: The MIT Press, 1980. Unlike the first rDNA debate, public op- 1982). position was mild. No biologists testified against ‘Marc M. Sadowsky, “Rosovsky Approves DNA Research Lab, ” Harvard Crimson, June 15, 1976. Also, Richard Knox, “Harvard siting the new biotechnology facility or spoke in and Genetics Controversy, ” Boston Globe, June 22, 1976. support of additional local controls. Furthermore, 101 —. beyond those employed by Biogen, Boston-area between small scale and large scale permits, the scientists were not present at the hearing. Public latter being required for cultures of genetically reaction centered around the release of genetically modified organisms in volumes greater than 10 modified biological agents into the air and water, liters. The deliberate release into the sewers, particularly when cultures of rDNA molecules drains, or the air of any organism containing were prepared in large scale. rDNA molecules is prohibited. For fermentation processes, the law also requires effective sterili- In response to public anxieties over commer- zation of spent organisms before they are released cial gene splicing, the city manager once again into the waste stream.4 called on the Cambridge Experimentation Review Board to respond. Since CBC was responsible for During the second rDNA debate, the city con- implementing the rDNA ordinance, CERB consid- vened a citizen review process while Biogen was ered it wise to involve this body in any decisions in the planning stages of siting and constructing on revising the law. Thus, CERB chose to hold its new facility. None of the firm’s research was its hearings in collaboration with CBC. The joint held up as a consequence of the city’s delibera- committee developed a consultative relationship tions. Similarly, Harvard’s P-3 laboratory was with representatives of Biogen, Harvard, and scheduled for completion in the spring of 1977, MIT. After several months of hearings and de- several months after the city’s moratorium on P- liberations, the CERB-CBC review panel issued 3 experiments was terminated. Neither of the two recommendations emphasizing safeguards against Cambridge rDNA laws was subjected to a legal the promiscuous release of genetically modified challenge. The universities considered that option organisms and, to a somewhat lesser degree, but favored a negotiated settlement that avoided against occupational hazards. The Cambridge city litigation. The 1981 Cambridge rDNA law is still council voted the recommendations into law on in effect and is administered by the Commissioner April 23, 1981. In contrast to the extensive pub- of Health and Hospitals, who currently heads the licity surrounding the passage of the first rDNA Cambridge Biohazards Committee. law, this new enactment was accompanied by lit- tle public discussion, and was only mildly ac- knowledged by the national media. The new law established a permit system for ‘A brief history of the passage of rIINA legislation in nine cities and towns (including Cambridge, LIA ) and two States is presented all institutions intending to use recombinant DNA in Sheldon Krimsky, et al., ,~lunicipal and State Rec[lmbinant DNA molecule technology. The ordinance distinguishes Lams (hledfor-d, LIA: Tufts University, lune 1Q82)

TESTING CHEMICAL WARFARE AGENTS

The second case centers around Arthur D. Lit- specifications of DOD for working with “chemi- tle, Inc. (ADL), a multi-faceted management and cal surety materials, ”—chemical warfare agents— technology consulting firm with its world head- consisting mainly of nerve and blister agents. quarters in Cambridge, Massachusetts. The firm, which has been operating in Cambridge since the The company’s investment in the laboratory ex- early part of the century, has offices in Europe, ceeded $750,000. The Philip L. Levins Laboratory was planned to occupy 1,300 square feet in ADL’s Canada, and South America, and a work force Acorn Park, a 40-acre complex located at the of 2,500. northern boundary of Cambridge, near the ad- Around June 1982, ADL decided to renovate joining towns of Arlington and Belmont. Because an existing chemical laboratory with state-of-the- of the extensive renovation required, ADL applied art safety features that would enable the firm to for and was issued a building permit on Decem- take on work with highly toxic chemicals. The ber 10, 1982. Approximately a month later, ADL renovated laboratory was designed to meet the personnel met with the Cambridge city manager, 102

the fire chief, and officials of the police depart- them. ” The news release omitted any mention of ment to inform them about the new testing facil- chemical nerve or blister agents. On October 20, ity. Notification of the police was in conformity 1983, the story of the laboratory was reported in with DOD stipulations; surface shipments of the the Arlington Advocate and the Boston Globe. chemical nerve and blister agents require a po- The Globe speculated that chemical warfare lice escort. ADL disclosed the general nature of agents may be among the agents handled at the the facility and indicated that, among its func- facility. On October 17 and 24, 1983, respectively, tions, it would be used for testing chemical agents the Arlington selectmen and the Cambridge city supplied by the army. According to an official of council held public meetings at which the ADL ADL, the company was not requested to provide matter was discussed. “specific names and toxicities of the materials it 5 At the October 24 Cambridge council meeting, was planning to test in the new laboratory.” the nature of the chemical warfare agents supplied ADL requested that city officials keep confiden- to ADL under DOD contract was disclosed by tial the location of the laboratory and the type company officials. By that time, the company had of work to be undertaken there. Public safety con- begun work on the DOD contract. The council siderations were given by the firm as the reason also heard residents of the North Cambridge com- it requested nondisclosure. The firm maintained munity voice a strong protest against ADL’s test- that its policy of confidentiality would reduce the ing of chemical nerve and blister agents adjacent chances that the laboratory would be a target for to a densely populated area. In response to pub- vandalism or terrorism. The city manager, police, lic concerns, at the same meeting the city council and fire chiefs complied with the request. ADL voted to establish a “citizens’ scientific advisory filed for an occupancy permit on May 18, 1983. board” to review the risks associated with the The certificate of occupancy was issued on May ADL laboratory. Individual councillors requested 25. The laboratory was approved for operation that ADL accept a moratorium on its tests of by DOD on September 19, 1983. chemical warfare agents until the city completed its risk assessment. ADL, having to contend with Responding to the cooperative arrangement its DOD contract requirements, did not accept a that existed between the fire departments of Cam- moratorium. bridge and its neighboring towns, ADL also con- tacted officials of Arlington and Belmont in Sep- By early winter, the Scientific Advisory Com- tember 1983 to inform them of the new facility. mittee (SAC) had still not been appointed, al- At a meeting with Arlington’s town manager, offi- though responsibility for implementing the orders cials of the police and fire department, and the passed by the city council had passed to the city town’s civil defense officer, ADL continued its pol- manager. Long delays between council orders and icy of requesting confidentiality about the nature their implementation are not unusual in Cam- of its facility. bridge. As the city’s principal fiscal agent, the manager must consider the financial impacts of Arlington’s town manager, however, informed council orders and the practical consequences of ADL that he planned to introduce the issue of the its policies. In this instance, however, the hiatus laboratory at the upcoming meeting of the town between the time the SAC was created by the selectmen. On that same day, October 14, 1983, council and the time its members were appointed ADL issued a press release announcing the estab- is indicative of the city manager’s hope that the lishment of a laboratory to be used for “advanced controversy could be resolved quickly. In late chemical analysis of toxic and hazardous chemi- winter, however, the conflict intensified when the cals so as to develop improved methods for de- Cambridge Commissioner of Health and Hospi- tecting, identifying, and detoxifying such mate- tals issued an emergency regulation (March 13, rials and new means of protecting people from 1984) that prohibited “testing, storage, transpor- tation and disposal of five specified nerve and blis- 5 Reid Weedon, Vice President of Arthur D. Little (ADL), com- ter agents within Cambridge, until SAC and an ments made on Mar. 7, 1985, during a community debate between ADL and the North Cambridge Toxic Alert. independent hazard assessment has been com- 103

pleted and these recommendations have been re- The majority of the SAC members judged the viewed by the Commissioner’s office.”6 risks associated with any such work to be unac- ceptable. 7 Three days later, ADL received a temporary re- straining order against enforcement of the regu- On receipt of the SAC report, the Commis- lation from a Massachusetts superior court judge. sioner of Health and Hospitals made his interim On March 27, 1984, the temporary restraining or- order—prohibiting any person from testing and der was converted into a preliminary injunction. handling three nerve agents and two blister The injunction against enforcement of the city reg- agents—into a permanent regulation on Septem- ulation remained in effect until February 27, 1985, ber 18, 1984. Hearings before the Massachusetts after a decision was issued by the Superior Court. Superior Court resumed, The judge severed the issues into the questions of Federal supremacy and The city manager appointed the membership the reasonableness of the Cambridge order. On to the Cambridge SAC on March 26, 1984. Fol- December 14, 1984, the Court ruled in favor of lowing established tradition, the manager ac- the city on the supremacy issue. The decision on cepted recommendations from the council. The whether the Cambridge regulation was reasonable committee was comprised of 16 members, includ- or not and whether it conformed to State law was ing scientists, individuals in the fields of public rendered on February 26, 1985. Once again the and occupational health, and residents from ruling favored the city. On the following day, the North Cambridge. Superior Court judge proclaimed the September SAC completed its inquiry and issued a report 1985 order of the city “valid and enforceable.” The in September 1984. The cornerstone of its deci- injunction, which had been in effect for 11 sion was a series of worst-case scenarios in which months, was removed by the court order. different volumes of nerve agent are hypotheti- ADL appealed the case to the Massachusetts cally released into the environment. The analyti- Appeals Court on March 12, 1984. The court gave cal calculations for the worst-case scenarios were ADL immediate relief by reinstating the injunc- developed by a risk assessment consultant hired tion against the order, pending the outcome of by the city. Building on those calculations, SAC the appeal. In response, the city petitioned the Su- concluded: preme Judical Court (SJC) of the State and asked . . . the benefits of research with these chemicals that it take the case over from the Appeals Court. do not justify lethal risks to the general public. The SJC agreed and heard the case on April 4, For this reason, the SAC believed that storage 1985. In a four to one decision issued on August and testing of these chemical warfare agents 1, 1985, the SJC upheld the Cambridge regula- within the densely populated city of Cambridge tion banning the testing, storage, transportation, in the quantities and concentrations used by ADL and disposal within the city of the five chemical is inappropriate. warfare agents.

‘Scientific Advisory Committee for the City of Cambridge, Re- ‘Melvin Chalfen, Commissioner of Health and Hospitals, City port to the Cib hfanager on the Use of Chemical If’arfare Agents of Cambridge, “Order on the Testing, Storage and Transportation at Arthur D, L“ttie Levins L.aborator}r (Cambridge, hlA: Septem- of Chemical Nerve and Blister Agents, ” Mar. 13, 1984. ber IQ84),

COMPARISON OF THE CASES Origins of Local Regulations tory, designed to conform to NIH specifications for working with rDNA molecules, was in its The city’s involvement in both rDNA research planning stages when the city council learned of and chemical weapons testing started with citi- its prospective use. In contrast, Arthur D. Little’s zen concerns over the research slated for a reno- testing laboratory for chemical toxins was com- vated Laboratory facility. Harvard’s P-3 labora- pleted and set for operation by the time its use 104 became known to the Cambridge citizens. In both In contrast, ADL was unwilling to accept a gen- instances, existing facilities owned by the respec- eral moratorium on its testing of chemical nerve tive institutions were significantly renovated. and blister agents pending investigation by a Building permits were obtained and several hun- citizens’ committee. However, on February 16, dred thousand dollars in renovation costs were 1984 ADL did agree to a 30-day moratorium on allocated. The planned P-3 laboratory was re- performing any work on new contracts involv- ported in the media after information was ob- ing chemical warfare agents. tained at a university hearing attended by several In neither of the two cases did the city attempt outsiders. Harvard neither attempted to keep the to withhold building permits or change the zon- laboratory’s presence confidential nor sought to ing regulations. ADL obtained its building per- inform city officials and the public of its inten- mit in December 1983, long before the city coun- tions to construct the facility. Funding for the cil became involved in the issue, Neither of the renovated moderate containment P-3 laboratory voluntary moratoria affected any ongoing re- and for the research for which it was designed search projects. The ADL voluntary moratorium came from science funding agencies of the Fed- was short-lived and probably not disruptive. The eral Government. rDNA moratorium was targeted to research that ADL’s Levins Laboratory was paid for entirely awaited completion of the new laboratory. There out of company funds. The laboratory was were several months between the end of the rDNA planned specifically for the testing of toxic sub- moratorium (January 1977) and the opening of stances. It was anticipated that one major source the P-3 facility at Harvard (spring 1977). of funding for recouping the investment in the lab- In response to ADL’s unwillingness to accept oratory was DOD. Other potential clients were a general testing moratorium, an action that might Federal and State environmental agencies and have threatened its contract with DOD, the city those segments of the private sector that, increas- council urged the Commissioner of Health and ingly, have become responsible for the control of Hospitals to act. After several months of discus- toxic substances. ADL sought to have the labora- sion and consultation, the commissioner issued tory’s purpose and function known only to a se- an interim public health order that prohibited the lect number of local officials in Cambridge, Ar- testing of five chemical warfare agents. A court lington, and Belmont, Massachusetts. Public injunction kept the order from being enforced dur- safety was the company’s reason for nondisclosure ing the entire period of litigation. As of the writ- of the laboratory’s purpose to the general pub- ing of this report, the commissioner’s order was lic. ADL’s efforts to preserve the confidentiality the sole nature of the city’s intervention into of the lab and the chemical warfare agents it was ADL’s testing program. SAC did recommend an testing was thwarted when a local official from ordinance that, if passed, potentially could affect the neighboring town of Arlington, informed research at universities and other R&D firms. To about the facility, filed a report with the town date, the proposed supertoxin ordinance has not selectmen. been acted on by the city. Types of Local Interventions One month after CERB issued its report on rDNA research, the city council passed an or- When the Cambridge city council learned of dinance incorporating the principal elements of Harvard’s plans for a new laboratory, it requested the recommendations. The rDNA law, amended both Harvard and MIT to accept a good-faith in 1981, requires that all individuals or institu- moratorium on rDNA experiments classified as tions undertaking experiments involving the pro- P-3 or greater under the 1976 NIH guidelines, until duction of recombinant DNA molecules must be CERB issued its recommendations. Harvard and licensed. Except for minor differences, the require- MIT complied. No other intervention was taken ments for research are ostensibly equivalent to the by the city until the release of CERB’s report. guidelines issued and periodically amended by 105

NIH. The law sets additional requirements for a ADL contracted with DOD to develop detec- large scale permit for which there is no counter- tion kits for nerve agents, to study the means by part in the NIH guidelines. which fabrics may be made impermeable to them, In conclusion, the Cambridge rDNA ordinance and to investigate methods of detoxification. The followed the general framework of the Federal firm’s R&D work incorporated the expertise of NIH guidelines. It permitted academic and com- analytical chemists, product development mercial research to continue while incorporating chemists, and electronics specialists. The order is- additional safeguards. The city’s intervention in sued by the city on chemical warfare agents was the testing of chemical warfare agents involved not targeted to a particular research technique or a specific, local prohibition against the use of five methodology, as in the rDNA case; instead, it pro- chemicals. This was the first stage in a long-term hibited the use of five substances cited in an ADL- plan supported by some city officials to regulate DOD contract. The regulation was, therefore, all highly toxic chemical agents in research and directed at the application of science and technol- commerce. In May 1984, Health Commissioner ogy for solving targeted problems. In distinction Murray Chalfen issued a report that included a to the rDNA case, ADL’s research was not de- proposed ordinance on toxic chemicals and haz- signed to generate new science. The purpose of ardous materials. The proposal, along with the the research was to supply the army with new in- SAC’s recommendations, is currently under re- formation on the handling, detection, and detoxi- view by the city. fication of chemical warfare agents.

Stage of the Scientific Enterprise Social Risk Assessment Affected The two cases illustrate different approaches to social risk assessment. This is particularly evident The first rDNA ordinance in Cambridge had in the composition, goals, and functions of the its direct impact on university research, particular- two citizens’ committees. CERB was a commit- ly the field of molecular genetics. The regulatory tee comprised of nonexperts in the subject mat- intervention was directed at a specific technique ter under consideration, namely molecular of scientific inquiry, namely, plasmid-mediated genetics. Out of eight members, the one who came gene transfer, which is of fundamental significance closest in expertise to the field was a physician, to genetics research. Any scientific discipline that board-certified in infectious diseases. The mem- planned to use the technique was ipso facto under bership of the committee was chosen to reflect ra- local regulation, however. cial, ethnic, and neighborhood diversity. It was The revised rDNA law of 1981 was a direct re- divided equally between men and women. In an sponse to the emergence of commercial biotech- internal memo, one member likened CERB’s func- nology. Its principal effect was on R&D applica- tion to that of a jury in a legal proceeding.8 This tions of gene splicing. Special attention was given memo clarified the role of nonexperts in a tech- to large volumes of genetically modified organ- nical controversy. CERB was asked to review the isms, The utilization of large cultures represents debate among scientists on the safety of rDNA a stage beyond basic science. Organisms geneti- research; but it was not asked nor was it equipped cally modified to produce a desired product are or prepared to undertake a risk assessment. Af- tested in pilot plant bioreactors with capacities of ter receiving testimony from experts, CERB mem- a hundred to several hundred liters, a stage in bers weighed the strengths of the arguments and product development prior to manufacturing and on that basis made their decisions. production. The Cambridge law sets environ- mental and occupational safety requirements spe- 6A detailed account of CERB’S decisionmaking process is contained in Sheldon Krimsky, “A Citizen Court in the Recombinant DNA cifically for large cultures of rDNA-generated Controversy, “ Bulletin of the Atomic Scientists, vol. 34, No. 8, Oc- organisms. tober 1978, pp. 37-43. 106

In contrast, the Cambridge Scientific Advisory agents prohibited for use were taken directly from Committee was comprised of experts and non- an ADL-DOD contract. For all practical purposes, experts with respect to the problems of highly therefore, the order was directed at ADL. The reg- toxic agents. Of the 16 members, 10 had advanced ulations covering the use of supertoxins recom- degrees in one or more of the relevant fields: mended by SAC were, however, much broader physics, chemistry/biochemistry, chemical engi- in scope and, if passed, probably would affect re- neering, biology, and public health. SAC was pre- search at other institutions. For example, SAC sented with three tasks: 1) to undertake a risk proposed that certain designated hazardous ma- assessment of ADL’s use of chemical warfare terials proposed for testing, use, storage, or dis- agents, 2) to make a determination about accept- posal within the city must be reported to the Com- able risks, and 3) to advise the city council on a missioner of Health and Hospitals at least 3 risk management plan. months prior to the date of planned entry into the city. The substances designated for reporting Although the structures and goals of the two inclucle: chemical warfare agents (as provided in social risk assessment processes differed, both a list), other nerve agents of different chemical SAC and CERB were given the charge of deter- structure to those listed when used in chemical mining whether the respective research activities weapons R&D, biological warfare agents, and should be prohibited, unconditionally permitted, other highly toxic agents as the Commissioner or conditionally permitted. Also, both processes may designate. SAC also proposed that each use resulted in a proposed framework of risk man- of the regulated agents be reviewed by the Com- agement involving the creation of a new institu- missioner and given a site evaluation in writing tional structure for the city. after appropriate information is provided. Should the Commissioner find that the use of the regu- Parties Affected by the Proposed or lated chemical presented an unacceptable hazard Actual Regulations to public health or safety, then a site assignment could not be given and the commissioner could The first Cambridge rDNA law had a direct im- prohibit the use of the materials. And, finally, pact on biomedical scientists, including biochem- SAC recommended that in addition to chemical ists and molecular geneticists who study gene warfare agents, the City of Cambridge develop structure and function. The revised law primar- policies to regulate other supertoxins. ily affected R&D firms that were investigating To date, the city has not acted on these recom- commercial and medical applications for geneti- mendations, which, if adopted, could significantly cally modified organisms. In the former case, affect university research. At the least, the pro- scientists responded as a community to the pros- posed regulations would apply to any experi- pect of being regulated and opposed differential mental uses of substances designated by DOD as standards of research between Cambridge and chemical warfare agents. Most broadly inter- other parts of the country. In the latter case, Har- preted, the rules might regulate research employ- vard and MIT joined with Biogen to ascertain the ing any highly toxic chemical such as dioxins, impacts of licensure on rDNA research in their chemotherapy agents, or potent mutagens. In the respective institutions. The revised law created former case, the impact to academic scientists new formal requirements for academic and com- would be minimal for chemical warfare agents are mercial institutions but the actual requirements not widely used in university laboratories (al- for individual investigators in academe remained though analogs and close derivatives of them may unchanged. be more readily found). In the latter case, many The Cambridge emergency order on nerve and chemical and biomedical facilities would be af- blister agents did not single out the names of any fected because it is not uncommon to find some institutions. However, no institution other than quantities of highly toxic agents in most well- ADL is known to have been directly affected. The equipped laboratories. 107

Legal Issues tion have placed undue burdens on scientific re- search, and scientists have adapted easily to the The authority of cities and towns to enact additional local requirements. health and safety regulations is firmly established under State laws. Both the rDNA law and the or- Cambridge’s public health regulation on chem- der on chemical warfare agents are examples of ical warfare agents took a different legal course. such powers exercised by the city of Cambridge. ADL challenged the order immediately after it was Three generic legal questions arise when the city issued. Counsel for ADL argued that the regula- regulates an activity under public health and tion was invalid on all three grounds cited above. safety statutes: 1) Are there any procedural er- The legal question with the widest implications rors in the process of issuing regulations? 2) Is the was whether DOD-sponsored research performed regulatory action arbitrary or capricious? 3) Is the at a private facility was protected against local regulation preempted by or does it conflict with regulations. Is this a case where Federal supremacy Federal and/or State laws or authority? over local authority applies? No legal challenges were directed to either of ADL offered the following arguments: the Cambridge rDNA laws. Similarly, laws of 1. Congress authorized DOD to establish a other cities and towns were also enacted and im- chemical warfare program and this includes 9 plemented without challenge. Because no Federal the authority to issue requirements for han- rDNA laws were passed and because Congress has dling and disposing of chemical warfare yet to express a policy on whether it occupies the agents. field of regulations for gene-splicing, the issue of 2. The framers of the U.S. Constitution as well preemption in either of the rDNA cases is gener- as Congress intended the Federal Govern- ally considered weak. NIH guidelines may have ment to have exclusive responsibility for na- the force of law to those who receive Federal tional defense. The city’s regulation prohibit- funds, but the agency lacks legislative authority ing ADL from conducting defense-related to preempt other political jurisdictions from pass- testing of chemical warfare agents is tanta- ing more stringent rules. mount to interference with government func- Harvard and MIT were prepared to challenge tions and represents a clear conflict with the the legality of the rDNA laws if they had pro- Federal interest. hibited or substantially inhibited scientific re- 3. If Cambridge is free to prohibit such work search. As it turned out, the universities avoided by a duly contracted agent of the Federal litigation and accepted rDNA standards some- Government, then so too is any other com- what stricter than those which were required of munity. If all jurisdictions followed Cam- other academic institutions in the country. The bridge, Federal programs in chemical war- “Balkanization” of standards for scientific research fare research would be frustrated. was a great concern to researchers during the 4. Because ADL is a contractor of the govern- Cambridge debate and for years thereafter as Con- ment, the firm is invested with “derivative gress considered Federal legislation; but the pre- sovereign immunity, ” which allows the dicted adverse consequences on scientific research supremacy clause of the Constitution to ap- from local rDNA laws never materialized. None ply to it with equal force to that of the Fed- of the 13 communities that passed rDNA legisla- eral Government. Counsel for the city argued that two conditions ‘Sheldon Krimsky, “Local Monitoring of Biotechnology: The Sec- ond Wave of rDNA Laws, ” Recombinant DNA Technical Bulletin< must be satisfied for Federal supremacy to hold. vol. 5, No. 2, June 1982, pp. 79-85. To date, the following cities Either the Federal Government has explicitly and towns have passed ordinances on recombinant DNA research. In Massachusetts: Amherst; Belmont; Boston; Cambridge; Canton; preempted the field of toxic substances regulation Lexington; Newton; Shrewsbury; Somerville; Waltham, In other or a fundamental conflict exists between the Fed- States: Berkeley, CA; Princeton, NJ; Emery vine, CA. eral and local governments on the regulation of 108

these substances. According to the city, Congress habitants under local police powers derived from never stipulated that testing of toxic substances State statutes. The court rejected arguments by would be exclusively regulated by the Federal ADL that the ruling violated the firm’s right to Government. Moreover, on the question of juris- due process or constituted an unjustified interfer- dictional conflict, the city maintained that the Fed- ence in its contract with DOD, The court also eral Government possesses other facilities at which ruled that the regulation is not invalid under the to carry out such tests. The facts do not demon- Supremacy Clause of the U.S. Constitution. The strate that prohibition of such tests in Cambridge SJC failed to find within Federal statutes congres- represents a fundamental conflict between local sional intent to preempt local communities from and Federal purpose. passing health and safety regulations for chemi- cal warfare agents. The court affirmed the right On December 14, 1984, a State Superior Court of local health authorities to prohibit activities as judge ruled that Federal supremacy was not in ef- long as the regulations are not “unreasonable, fect for this case. Subsequently, on February 26, arbitrary, whimsical, or capricious. ” 1985 after reviewing arguments on the reasonable- ness of the regulation and its legality with respect The context of legal similitude for the rDNA to State law, the same court found the regulation and the chemical weapons issues is very narrow. “valid and enforceable. ” The city’s arguments In both cases there are Federal guidelines or reg- prevailed on all the legal points. ulations for certain experimental activities. In both cases, the city chose to augment or supersede the The Massachusetts Supreme Judicial Court also role of a Federal agency. But from that point, the upheld the regulation, stating in its decision on legal issues evolved quite differently. August 1, 1985, that the regulation constituted a permissible attempt by the city to protect its in-

IMPACTS OF THE CITY’S INTERVENTIONS BEYOND ITS BORDERS

The 1976 rDNA debate was covered extensively tional seven communities in the greater Boston by the national and international media. Little re- area, including the City of Boston, passed simi- search has been done on the impact of the debate lar laws directed at commercial biotechnology but outside the United States, but within this country also applicable to scientific research. In an unusual there is documentation about direct and indirect case, a law passed in the City of Waltham, Mas- effects on other municipalities and on national sachusetts, prohibited the use of human experi- policies. Nearly two dozen city/town govern- mental subjects in recombinant DNA research. ments and State legislatures considered passing This is, perhaps, the first U.S. law prohibiting hu- laws that would have extended coverage of the man genetic engineering. NIH guidelines to privately funded institutions. The rDNA events in Cambridge also had rever- In response to the first Cambridge debate, two berations in Congress. The publicity surrounding States and four local governments enacted rDNA the Cambridge controversy was one of the key legislation. Several communities modeled their cit- factors influencing some Members of Congress to izen review process closely on that of Cambridge. file bills that would place gene-splicing under Fed- The City of Berkeley passed an rDNA law that eral regulation. Of the two leading bills, the Sen- incorporated verbatim sections of the Cambridge ate version, sponsored by Edward Kennedy (D- ordinance. By 1978, however, the ripple effect of MA), paid close attention to the events in Cam- the first Cambridge rDNA controversy had taken bridge, ’” The Kennedy bill contained weak its course and was affecting only a handful of preemption language, signifying a respect for the university communities. The national debate sub- rights of communities like Cambridge to estab- sided and so did the involvement of town and mu- lish standards of safety for rDNA research in ex- nicipal bodies. l~The lt~ding congressional bills were introduced by Representa- A second wave of community responses broke tive Paul Rogers (D-FL), H.R. 4759, on Mar. 9, 1977, and Senator after Cambridge passed its 1981 law. An addi- Edward Kennedy (D-MA), S. 1217, on Apr. 1, 1977. 109 cess of those required by the Federal Government. The ADL debate over the testing of chemical Despite considerable congressional activity, how- warfare agents is over a year old. It has been ac- ever, no legislation emerged during the years of companied by a limited amount of national pub- peak public interest between 1977 and 1980. licity. Lower court decisions were picked up by three national television news networks. The ABC The extensive publicity around the citizen par- TV news magazine program “20/20” produced a ticipation process in the Cambridge rDNA affair segment on the debate. National Public Radio also probably did have some influence in the reorgani- broadcast a program on “Morning Edition, ” Oc- zation of the Recombinant DNA Advisory Com- tober 3, 1984, describing the Cambridge-ADL mittee (RAC) in 1978. Department of Health, debate. Education, and Welfare (HEW) Secretary Joseph Califano expanded the size of the RAC from 16 Cambridge is one of at least 12 cities in the to 25 members to accommodate more public par- United States containing firms that have con- ticipation. Cambridge became a model for envi- tracted with DOD to conduct research with chem- ronmental groups like Friends of the Earth and ical warfare agents. This list became public as a the Sierra Club which lobbied Congress and HEW consequence of the “20/20” broadcast. There have for broadening public involvement in the decision- been no reported actions taken by any of these making process. One of the members of the Cam- communities in response to the Cambridge pro- bridge citizens’ committee was appointed to an hibition, but it is too early in the legal process to expanded RAC in 1979 when 30 percent of its speculate whether the case might serve as a prece- membership was drawn from the fields of public dent for local regulation of research involving health and public interest. highly toxic chemicals.

ARGUMENTS FOR AND AGAINST REGULATIONS

Recombinant DNA Controversy fectiveness as a containment strategy. Second, it was pointed out that the NIH guidelines had no For Regulation force over R&D activities that were not funded NIH released its first set of guidelines for rDNA by the Department of Health and Human Serv- research on the same day the city of Cambridge ices. At the time, biotechnology firms had not held public hearings to discuss Harvard’s planned sought entry into the city, but that was thought P-3 laboratory. The guidelines were issued in re- not to be far off. Third, opponents argued that sponse to concerns by molecular biologists that NIH had not enlisted sufficient participation from gene splicing might result in the unexpected cre- the general public and other segments of the scien- ation of a new epidemic pathogen, toxin-produc- tific community. Some scientists maintained that ing bacteria, or a coliform bacteria harboring a rDNA molecule technology was an unknown and human cancer virus. In Cambridge, the debate uncharted area of research with unpredictable centered on whether the research should be done risks. They felt it should not be done in proximity at all and whether the NIH guidelines provided to classrooms and other research activities. a sufficient margin of safety against an accident or unintended outcome. When the city was approached by the first of Scientists spoke forcefully on both sides of the several biotechnology firms planning to locate in issue. Those against the use of a P-3 facility at Cambridge, a new set of public anxieties arose. Harvard for rDNA experiments cited three defi- By that time the city’s rDNA law had been in ef- ciencies in NIH’s role as the overseer of the re- fect for 3 years. The principal rationale for pas- search. First, they argued that the guidelines were sage of the revised law was the concern over large constructed from untested a priori hypotheses and volumes (over 10 liters of culture) of genetically they placed little confidence in the regulation’s ef- modified organisms, and the potential hazards 110 associated with occupational exposure and envi- were established. Those critical of local regula- ronmental release. tion emphasized that the risks of rDNA research were at best hypothetical and quite likely non- The citizens’ committee was not aware of any existent, while the benefits were real. Not a sin- regulatory body at the Federal or State level which gle case of illness was linked to an agent of an set standards for large-scale work involving rDNA rDNA experiment. In their view, a significant molecules. After consultation with experts in fer- margin of safety was already provided by the NIH mentation engineering and the sterilization of guidelines. spent organisms in large vessels, the citizens’ com- mittee proposed revisions in the 1977 law. Among the restrictions cited in the revised law was: The Case of Chemical Weapons Research There shall be no deliberate release into the envi- ronment, that is the sewers, drains, or the air, of For Regulation any organism containing recombinant DNA and further that any accidental release shall be re- The arguments for regulating chemical warfare ported to the Commissioner of Health and Hos- agents centered around the potential adverse pub- pitals within five days. ” lic health consequences associated with their ac- cidental or intentional release. The Cambridge The new law created a system of accountability Scientific Advisory Committee examined several according to which biotechnology firms were re- worst-case scenarios in which quantities of 10, quired to have special licenses for large scale 100, and 500 ml. of nerve agent were hypotheti- work. The system included periodic inspections cally released from the testing facility. SAC con- to ensure that the environmental release provi- cluded that such an accident was unlikely but not sion was respected by the technology and prac- impossible; in the event of a 100 ml. release, mem- ticed by the institution. bers of the general public might be located within range of lethal doses of such agents .12 The com- Against Regulation mittee cited an independent consultant report that The principal opposition to local regulation of estimated between 10 to 30 members of the gen- rDNA research in 1976 came from scientists, grad- eral public might be located within range of lethal uate students, and university administrators. They levels of such agents in one of several worst-case emphasized the confidence that the vast majority scenarios. The case in question involved a sud- of scientists had in the NIH guidelines. RAC was den release of 100 ml. of sarin in the form of a cited as an exemplary system of oversight and one gaseous cloud. ’3 that a local community could not duplicate. The The SAC report stated that there were no satis- importance of uniform national guidelines was factory regulatory mechanisms for managing the stressed. Science, it was said, cannot flourish in use of supertoxic agents in the city. Having con- a patchwork of regulations. If Cambridge enacts cluded that even relatively small quantities of restrictive rDNA regulations, scientists will find chemical warfare agents used in R&D could pose it necessary to move away from the city to other a risk to the public, the committee proposed a mu- areas more conducive to their research. The nicipal ordinance for regulating such agents in par- universality of the scientific method requires uni- ticular and supertoxins in general. SAC made no formity in the social context within which research distinctions in its regulatory program between is carried out. This norm would be violated if each R&D or between university and nonuniversity community passed its own research guidelines. uses of supertoxins. Opponents of regulation also stressed the ben- efits of rDNA research. These benefits might be delayed significantly if restrictive local regulations lzscientific Advisory Committee for the City of Cambridge, oP. cit., p. 2. 13TR(: Environmental Consultants, Inc., Community Risks from 1 IKri~~kY, et ~1,, Munjcjpa] and State Recombinant DNA Laws. Experiments w“th Chemicaf Warfare Agents at ArthurD. Little (Hart- op. cit. ford, CT: 1984). 111

More than half the members of the committee worst-case accidents. It did not describe how favored a ban on any research involving chemi- chemicals stored in secure containers could be re- cal warfare agents on the grounds that the “risks leased into the environment from some accident. associated with any such work [are] unaccept- The SAC report did not take account of the many able. ” A smaller number of members expressed barriers there are to the kind of accident it postu- opposition to the research on ethical grounds— lated. In fact, if there were an accident, the com- that any work on chemical weapons is morally pany held, the effects would not be felt beyond reprehensible. They believed that no clear distinc- ADL. According to the company, the city’s at- tion can be drawn between offensive and defen- tempt to ban the five chemicals was unreasona- sive research. The city’s legal arguments for its ble and invalid because it was not shown that the regulation, however, focused exclusively on is- research posed any potential health hazard. sues of public health and safety. City council de- 3. The company also believed that the city’s ac- bates also centered on public health issues in con- tion was discriminatory. Selected city officials, trast to the rDNA episode when some councillors including the city manager, were first informed questioned the morality of genetic engineering. about ADL’s plans for the laboratory in January To some degree, the psychological impact of the 1983, but it was more than a year later, and after term “chemical warfare agents” was a relevant fac- an occupancy permit was issued, that ADL was tor, however, in the public’s sensibility to the ordered to cease its testing. In its letter to the pub- issue. lic, ADL wrote: “We worked closely with the Cambridge City Manager and the relevant pub- Against Regulation lic safety officials throughout the planning and construction of the facility, and they expressed Arthur D. Little’s case against the city’s ban can complete confidence in its safety and security. We be classified according to the following catego- hired outside consultants to check our findings ries: 1) safety of the facilities; 2) errors and defi- and designs. ” ciencies of the SAC report; 3) discriminatory na- ture of the action; 4) misunderstood goals of the ADL also faulted the city for not allowing the research; 5) compliance by ADL to all Federal, company to remedy any defects that may have State, and local laws and regulations; and 6) vio- been found in its safety program. As a result, the lation of Federal supremacy. city’s prohibition imposed upon ADL nearly a million-dollar loss in the cost of the laboratory 1. The company maintained that its laboratory in addition to substantial losses in present and fu- is among the safest that exists for the work in- ture DOD contracts. tended. The laboratory satisfied DOD specifica- tions for handling chemical warfare agents. ADL ADL also argued that it had been selected out was also in compliance with Federal and State for regulation. According to the company, there environmental regulations. The firm argued that are many risks to the people of the city that are its laboratory advances the state of the art for the far greater than its testing program, yet the city safe handling of hazardous substances. To further focused attention on a state-of-the-art testing lab- increase the margin of safety, ADL agreed not to oratory that uses small quantities of chemicals. store more than certain minimum volumes of the If the city wishes to regulate toxic substances, chemical agents. ADL proposed, it should treat all institutions and all substances on a comparable basis. The de- 2. ADL also argued that the committee’s tech- termination to regulate should not depend on nical analysis was flawed. According to company whether the research is done at a profit or non- spokespersons, the report drew conclusions from profit institution, involves basic or applied assumptions that do not reflect ADL’s operations. science, or is carried out under contract from One of the risk scenarios developed by SAC as- DOD or under a grant from NIH. sumed greater quantities of chemicals than ADL claimed it would ever have on hand. Furthermore, 4. ADL correctly surmised that some of the SAC did not determine the probability of its public concern over its research was motivated 112 — by concerns over the morality of chemical weap- 6. The supremacy arguments have been out- ons research. In a letter to the public, ADL clari- lined in detail in the section of this report com- fied the ethical basis of its contract with DOD: paring the rDNA research and chemical weapons testing. In summary, ADL contended that the city We believe something must be done to control has no authority to interfere with a contract of the threat of uncontrolled toxic chemicals in the environment. We have the professional capabil- the Federal Government when all Federal and ities and the resources to help solve some of the State safety standards are met. The city’s ban on inherent problems. That is why we went to the the testing and storage of the agents is argued to expense of constructing a safe, secure, facility for conflict with the Federal authority governing na- research designed to find better ways of protect- tional defense and is therefore unconstitutional. ing people from the effects of uncontrolled envi- If other municipalities passed similar prohibitions, ronmental hazards, ” there would be a direct conflict between the pol- The firm assured the citizenry that its research on icies of the U.S. Government and the actions of chemical and nerve agents is exclusively for “de- local communities. Under such conditions, the fensive and protective purposes.” policies of the Federal Government are preemp- tory, the company stated. We are using existing substances in analytic tests in order to develop better methods of de- Although the principal opposition to the city’s tecting minute quantities of these agents in the action banning the testing and storing of five environment and safer, more effective means of chemical warfare agents came from ADL, there destroying them on a large scale. We are also was some criticism expressed by university rep- working to develop better protection, including resentatives about the proposed regulations for clothing for people who might be exposed to supertoxins contained in the SAC report. MIT these substances .14 officials argued that SAC’s approach to chemi- 5. All Federal, State, and local regulations had cal regulation would have a “harsh and adverse been met before ADL’s lab went into operation. effect on the conduct of research in chemistry, bi- The facility had been inspected by DOD, State ology, nutrition and food science” at universities. agencies, and city officials. The company received Because SAC made no provisions for volume ex- an occupancy permit. The city’s ban thus was per- clusions in its proposed regulations of chemical ceived by the company as an afterthought to all warfare agents or closely related chemicals, many regulations that were in effect prior to and dur- substances used in the course of research would ing the time the laboratory was under con- fall under the proposed criteria. According to the struction. MIT officials, if enacted, these criteria would be an obstacle to scientific research without offer- 14John F. Magee, President of Arthur D. Little, Letter to the Pub- ing any additional protection to public health. lie, Jan. 28, 1985,

GENERAL POLICY IMPLICATIONS

The central issue underlying both case studies ernment, and a Federal funding agency. But a is the extent to which local communities are justi- well-defined scientific constituency is absent. fied in regulating research. Beyond this similarity, there is considerable variation in how these cases Three policy issues stand out in the rDNA epi- relate to issues of scientific freedom and social ac- sode. First, should science be self-regulated and countability. The rDNA case involves a well- therefore insulated from State and local laws? Sec- defined scientific population, a Federal funding ond, does NIH oversight of rDNA experiments agency, local universities, and a city government. provide a legal basis for Federal supremacy and, The case of chemical weapons testing is about pri- if not, should Congress establish legislation vate contract research. It too involves city gov- toward that purpose? Third, to what extent, if at 113

all, is scientific research a right granted under the rights to engage in research. Prompted by several First Amendment? inquiries, in 1977 the American Civil Liberties Union (ACLU) began a task of formulating a pol- NIH has been the de facto regulator of feder- icy on whether, or to what extent, scientific in- ally funded rDNA experiments. Scientists, how- quiry is a civil liberty protected under the first ever, have had an influential role in the establish- amendment. Special committees of the ACLU be- ment and implementation of guidelines. Through gan drafting policy statements that provided a the NIH structure, the molecular geneticists have civil liberties perspective on scientific research. had what has been ostensibly a self-governing Thus far, the Board of Directors of ACLU has not apparatus somewhat analogous to a peer review reached a consensus on the wording of such a process. The Cambridge debate threatened this policy. tradition of self-governance which began at Asilo- mar and evolved into the formation of the Re- ADL’s legal battle with Cambridge did not at- combinant DNA Advisory Committee. The city tract sympathetic support from other scientists. also challenged the idea of uniform safety stand- Most university-affiliated scientists did not view ards for experiments in molecular genetics. the possible restriction on specific contract re- search as a conflict between the local community Although Cambridge scientists were the only and freedom of scientific inquiry. The applied na- ones directly affected by the city’s intervention, ture of the testing work and the fact that the re- the possibility of multiple sets of guidelines for sults would probably be classified contributed to rDNA technology, based in part on local stand- this attitude. ards, troubled scientists throughout the country, Many biologists who opposed congressional inter- The policy dilemma is best interpreted as a con- vention, preferred it over a patchwork of regula- flict between the rights of a firm to accept Fed- tions. According to Rockefeller University biol- eral contract research under Federal guidelines and ogist Norton Zinder, the uniformity of scientific the rights of a city to set its own standards of pub- practice transcends local interests: lic health and safety including a prohibition of re- search it deems hazardous. The outcome of the The proliferation of local options with differ- ADL case has implications for any federally con- ent guidelines in different states and different cit- ies can only lead to a situation of chaos, confu- tracted research on nongovernmental property sion, and ultimately to hypocrisy amongst the that involves hazardous or potentially hazardous scientists involved. 15 procedures or materials. For example, a commu- nity might decide to establish prohibitions against Most legal scholars agreed that the NIH guide- certain animal experiments. As a consequence, lines did not provide a-basis for preempting the contract research and basic science would be af- Cambridge law. No judicial challenge was made fected adversely. Cases of this nature have not on the reasonableness of the Cambridge rDNA been widespread; but they are appearing. In law in the context of the Federal guidelines. Per- Washington Grove, Maryland, residents have ex- haps because the Cambridge rDNA laws (first and pressed opposition to the testing of chemical nerve second) added very little to the substance of the agents in the vicinity of a school. Morris Town- NIH guidelines, a legal challenge was avoided. ship, New Jersey, has been the site of a con- Had the city banned rDNA research, the ques- troversy involving Bell Communications Research tion of preemption most certainly would have (Bellcore), an AT&T spin-off company. At issue been addressed in litigation, if not through con- has been the use and storage of highly toxic gases, gressional action. such as arsine, commonly used in semiconductor Preemption was not the only legal question research (see discussion in app. C). Neither con- raised in the early rDNA debate. Facing the pros- gressional policies nor case law has settled the de- pect of Federal regulation, some scientists argued bate over Federal supremacy in these cases. If the that rDNA legislation would infringe on their ADL litigation continues beyond the Massachu- setts courts, Federal judicial interpretation may 1’National Academy of Sciences, Research 1}’ith Recombinant set some explicit parameters for local control of DNA: Academy Forum (Washington, DC: December 1977). private sector research. Chapter 8 Research Policy Issues That May Warrant Congressional Attention in the Future

Photo credit: National Institutes of Health Chapter 8 Research Policy Issues That May Warrant Congressional Attention in the Future

In OTA’s brief survey of laboratory directors ence between the climate of, say, 30 years ago and and research administrators, * the respondents today. were asked to reflect on how things have changed About one-third of the respondents stated that from when they were just starting out in science they were not aware of any research areas where and to list the major constraints then as opposed the trend is toward fewer rather than more con- to now, The trend most noted by both groups is trols. Of those laboratory directors who did cite understandably the increase in administrative and an area where controls have eased, 16 percent felt “bureaucratic” requirements of grant procurement that changes in the National Science Foundation and administration. Fifty percent of the univer- (NSF) procurement and granting procedures have sity administrators and 32 percent of the lab di- helped to ease the administrative controls result- rectors noted that administrative requirements for ing from grants arrangements with that agency. the investigator have increased substantially. Recombinant DNA research was also listed as an Time spent on detailed administrative work means area where the trend has been toward more re- less time and money spent on research. laxed regulations, Other areas mentioned were hu- Other changes in the regulatory environment man subjects research (where expedited review noted by the respondents were the greater chance processes and exemptions have made the approval of litigation and the appearance of more actors process less difficult) and a tendency toward de- involved in the scope and definition of research. creased controls at the Federal level with simul- Respondents see this latter trend as a result of in- taneous increase in controls at the State, local, creased Federal funding for research, which nec- and institutional levels. essarily involves more political actors, and in- If these research policy issues which have dom- creased media coverage, which attracts more inated the discussions for the last decade appear public attention to the research process. Many to be either resolving or, at least, not creating ma- also mentioned increased controls on dissemina- jor controversies among the research community, tion of research results as being a significant differ- then what issues do appear to be emerging for ‘~c~r ~c(;fi~, ~~~ ~c~x in ch. b. congressional attention?

WHO BEARS THE BURDEN OF PROOF?

The burden of proof for control of research ap- ample, cryptology researchers were asked to carry pears to be changing. Increasingly, the individ- the burden of deciding which papers to submit ual researcher or research facility must prove that to the National Security Agency for review.1 A the research is safe rather than the regulator prove similar shift in the burden of responsibility that it is unsafe. occurred in 1980 changes in NSF grant policy, which made the grantee responsible for notifying A shift in responsibility is clearly occurring in the case of restrictions on scientific and technical . I Massachusetts Institute of Technology, Interim Report of the communication. Under schemes proposed in 1980 Committee on the Changing Nature of Information (Cambridge, by the American Council on Education, for ex- MA: Mar. 9, 1983), Section 4.5.

117 118

NSF if, in the course of an NSF supported project, the burden of proof on the government to show “information or materials are developed which a compelling need to infringe. But some legal scho- may affect the defense and security of the United lars argue that the situation is now muddied be- States.”2 cause it is increasingly difficult to distinguish be- tween pure speech and “impure” special action. If a fundamental constitutional right is in- volved, then in the past the courts have placed

‘National Science Foundation, Grant Policy Manual, Section 794c.

THE SCIENTIST’S ROLE IN ASSURING SAFE RESEARCH

One of the principal unresolved issues is that Many agencies have reached out to the affected of who should be involved in the regulatory proc- research community, asking scientists to review ess. What is an appropriate role for the individ- proposed regulations, both formally and infor- ual scientist, for a professional science or engi- mally, and thereby hoping to assure that the reg- neering society, or for the public? ulations are written in such a way that they are enforceable and can and will be complied with To what degree should the scientific commu- (i.e., are not far-fetched). Such an approach tests nity itself take central responsibility for both polic- those scientists’ belief that the regulations are nec- ing its own safety procedures and participating essary to protect society. For example, some in the broadscale development of regulation? . . . social scientists argue that in the case of re- There are differing views on the extent to which combinant DNA the process was flawed, precisely scientists should be involved. Do scientists have because the political authorities put too much reli- some special right to be exempted from consid- ance in the judgement of the researchers them- eration of these issues? Or is it as John Edsall 3 selves” and that this situation led to “the capture wrote in 1975: of a regulatory agency by those it is supposed to The responsibilities are primary; scientists can regulate.” 5 Others argue that the recombinant claim no special rights, other than those pos- DNA case was “a model of responsible public pol- sessed by every citizen, except those necessary icy decisionmaking for science and technology.’” to fulfill the responsibilities that arise from the possession of special knowledge and of the in- How much should research be controlled by le- sight arising from that knowledge. gal regulation, how much by institutional rules, and how much left to informal practice or to the The conflict between these varying interests is codes or guidelines of professional societies? made clear in the specific provisions of the Ex- Strong arguments can be made that, when re- port Administration Act, for example, where straint is desirable, it should not involve the gov- scientists, whether employed by academic insti- ernment. Regulatory enforcement, court cases, or tutions or industry, are expected to comply with congressional legislation may be inappropriate set- the requirements of the Act and other “applica- tings in which to make social decisions about the ble provisions of law” when communicating re- dangers and risks of research. Neither the current search findings “by means of publication, teach- regulatory laws nor the agencies that enforce them ing, conferences, and other forms of scholarly 4 are geared to address social or ethical issues. For exchange.” many of the recent regulatory debates involving ‘John T. Edsall, Scientific Freedom and Responsibility, report of the American ksociation for the Advancement of Science, Com- ‘Susan Hadden, as quoted in Sanford A. Lakoff, “Moral Respon- mittee on Scientific Freedom and Responsibility (Washington, DC: sibility and the Galilean Imperative, “ Ethics, vol. 191, October 1980, American Association for the Advancement of Science, 1975), p. 5. pp. 110-116. 4Harold C. Relyea, “The Export Administration Act of 1985: Im- “Harold P. Green, “The Boundaries of Scientific Freedom, ” Reg- plications for Scientific Communication, ” memorandum to the Com- ulation of Scientific Inquiry, Keith M. Wulff (cd. ) (Boulder, CO: mittee on Scientific Freedom and Responsibility, American Asso- Westview Press, 1979); reprinted from Newsletter on Science, Tech- ciation for the Advancement of Science, June 8, 1985, p. 9. nolog~’, & Human Values, June 1977, p. 118. 119

science, Congress has legislated solutions to fit one system of consensual voluntary codes and stand- particular situation or crisis, While these proce- ards* is in this tradition, but this self-regulation dures or rules may work well to adjudicate among for certain forms of research appears to have been differing scientific or legal aspects of problems, questioned in many recent cases (e.g., animal ex- they are not always constructed in such a way perimentation). Should sanctions be imposed on as to resolve or negotiate compromise easily on professional communities or institutions that fail moral or ethical points. Critics of a new line of in their self-regulation? Or shall the disciplinary research may be left to feel that they have no real action continue to be directed at individuals? forum from which to effect change. One alternative to increased regulation might How extensive and complete should regulatory be better education of the young scientists in the legislation be? If the decision is to rely on self- rationale for and the ethical aspects of regulation. regulation, what criteria will be used? The phi- Today, such education occurs primarily through losophy behind both the Institutional Review apprenticeship, through informal learning. Con- Board (IRB) system and the Institutional Biosafety gress might be asked to consider encouraging— Committees is a form of “monitored self-regula- e.g., through fellowships—education in the ethics tion, ”7 in which the process of regulation is sub- or procedures of regulation. ject to review and monitoring by government au- thorities. The extensive use in the U.S. regulatory

‘Harvey Brooks, Ben]amin Peirce Professor of Technology and Public Policy, Harvard University, personal communication, 1985, *See discussion in ch. 4.

EX POST FACTO RESTRICTIONS ON RESEARCH COMMUNICATION

An individual researcher and the Federal Gov- These interests have been placed in especially ernment often can have overlapping but not iden- sharp contrast when the Government has at- tical interests in suppressing or disseminating tempted to restrict communication about research scientific and technical information. In this re- undertaken independently and without Federal spect, controls on research resemble government support, or when the Government classifies controls in all parts of society. “Most decisions retrospectively research that was not conducted about regulation involve decisions among com- under classification or even with military fund- peting societal ‘goods, ’ not decisions between ing. Similar issues are raised when there are at- ‘goods’ and ‘bads’.”8 To achieve greater benefits, tempts to control the dissemination of militarily society may be inclined to accept greater risks; or internationally “sensitive” but previously un- but in some situations the risks are experienced classified information or to control access to fa- differentially by particular groups or individuals. cilities. 10 In the decision to classify or control The Department of Commerce has, for example, scientific information, the risks to national secu- interpreted such normal scientific activities as pre- rity must be weighed against the long-term value senting papers and talking with colleagues as a of free flow of information among a nation’s scien- potential “export” of technology, which could be tists and against principles of scientific and aca- construed as requiring a scientist to obtain an ex- demic freedom. port license before participating in such activities. One consequence of U.S. restrictions may be In the opinion of some observers, this interpre- the inhibition of U.S. scientists’ access to infor- tation constitutes a prior restraint on speech, a mation abroad. Several European members of the “governmental intrusion on the scholarly ex- change of ideas.”9 l~Haro]d C, Re]yea, IVatjonaj Secun’tv Contro)s and sCkntifJ’C in- ‘Ibid. formation (updated 09 ’11 84), issue brief IB 82083, Library of Con- ‘American Civil Liberties Union, Free Trade in ideas: A Constitu- gress, Congressional Research Service, Government Division, Wash- tional Imperative (Washington, DC: May 1984), p. 18, ington, DC, 1984. 120

North Atlantic Treaty Organization (NATO) are The Committee expressed fear that the combina- reported to be considering the establishment of tion of an increasing amount of classification— a new technology transfer agency to coordinate for reasons relating both to national military and their political response to the controls placed by economic security—and increased international the United States on the flow of advanced tech- industrial competition could impede cooperation nology.” The NATO Science Committee recently between the scientific communities of friendly na- wrote that, around the world, “certain important tions, They also emphasized that restrictions will research institutions are . . . already being over- make it more difficult for small nations to obtain cautious” in communication of research results. 12 access to much-needed research results and that

“NATO Science Committee, “Open Communication in Science, ” more classification may lead to more costly dupli- NATO Science & Society, 1983. cation. ‘zIbid.

“GRAY AREAS” OF SENSITIVE INFORMATION AND BROADER CLASSIFICATION

“Significant attempts have been made to restrict with features that make them likely subjects for the flow of information in cases where it has been classification at a later date.”15 felt that, though unclassified, it was of such sen- As discussed in chapters 3 and 4, the use of Ex- sitive nature that our ‘enemies’ could use it to their 13 port Administration Regulations and International advantage.” For example, Executive Order Traffic in Arms Regulations to identif and con- 12356, a classification order issued by President y trol “gray areas” of research previousl unclassi- Reagan, “appears to allow classification to be im- y fied and usually not considered covered by those posed at any stage of a research project and to regulations has raised a number of questions be maintained for as long as government officials 14 about the potential of long-term adverse effects deem prudent.” John Shattuck, of Harvard on the U.S. scientific base. Increasing the areas University, observes that that order “could inhibit of unclassified but severely restricted information academic researchers from making long-term in- not only inhibits communication among col- tellectual investments in nonclassified projects leagues who could benefit from interaction but

“Alan McGowan, Scientists’ Institute for Public Information, New may also point out to opponents those scientific York, NY, personal communication, 1985, areas of potential fast progress. IdJohn w. Shattuck, Feder~ Restrictions on the Free F1OW of Aca- demic Information and Ideas (Cambridge, MA: Harvard Univer- sity, January 1985). ‘51bid.

IMPACT OF NEW COMMUNICATION TECHNOLOGIES

The information revolution creates new oppor- If recognized by the scientific community as a tunities or methods for delaying or classifying in- legitimate publication that signifies a claim to pri- formation as well as opportunities for more open ority, publication on electronic networks could dissemination. “As long as there were significant provide a new channel for scientific interaction. delays in publication of new scientific results, the It could also have the effect of increasing the review process for commercially sponsored re- amount of classification of scientific information search offered only modest impediments to scien- if, because of the speed of publication on such net- tific openness.”16 works, the Government feels compelled to act quickly to classify without adequate information ‘“Brooks, op. cit, to justify such classification. 121 —

New technologies also give rise to questions intellectual property. This issue is discussed in about how much control an originator/creator OTA’s forthcoming report on intellectual property. has over the research project’s results or data, its

PATENTS

Many observers propose the need for revision tion raises new questions about the interpretation of the patent system because they believe that the of current law when there is competition in a fast- existing policy inhibits the progress of science and moving field and where the language of the law stifles invention and innovation. Federal Govern- may be at variance with contemporary research ment policy has been to retain title and rights to practices. inventions resulting from federally funded re- An Organisation for Economic Co-Operation search and development (R&D) made either by and Development (OECD) task force has recently government contractors or grantees or by in- 17 recommended that OECD countries adopt the house government employees. However, only U.S. policy of making the date of conception, about 5 percent of the 25,000 to 26,000 patents rather than the date of filing, the legal date of a currently held by the government have been used. patent. If this were followed, then pressure to keep A related issue is whether there is a need for data confidential pending patent filing would be a uniform government-wide patent policy. Sev- much reduced because there would be a grace eral pharmaceutical firms have also begun to use period of 12 months after publication for filing the patent law to restrict research uses of patented of a patent application. The main reason for de- products and procedures, even for experimental lay of publication in most university-industry use (heretofore regarded as exempt).18 Such ac- agreements is to allow time for filing for foreign patents. Revisions in the patent laws could there- ‘-William C. Boesman, “Government Patent Policy: The Owner- ship of In\’cnt ions Resulting From Federally-Funded R& D,” issue fore result in significant long-term effects on re- briet ]B78057, Library ot Congress, Congressional Re\earch Set-w search. ice, Science Policy Research Division, 1985. ‘5 Jeffrey L. Fox, “Patents Encroaching on Research Freedom, ” Sc~ence, vol. 224, lune 3, 1Q84, p. 1080.

PUBLIC EDUCATION ON THE BASIS AND PROCEDURE FOR REGULATION

Understanding of and education in science play sumed to be acting on behalf of the public, but, a vital role in the public’s willingness to support for example, is there evidence of public support the regulation of research. If the public under- for the increased controls being placed on scien- stands the inadvertent and unintended effects of tific communication? government regulations, then it may be more As the case studies presented in chapter 7 and likely to support changes in policy which more appendix C show, how the public perceives or cal- accurately implement the intent of the law. Many culates the risks of research may greatly influence observers have described to OTA a growing dis- its willingness to control research and may simi- association between what the public believes larly influence public beliefs about when controls should be controlled and what the government or legal regulation should be imposed. actions are controlling. The government is pre- 122

SHIFT IN THE JURISDICTION FOR REGULATION

The discussions of such actions as the right-to- inconsistencies or variations in the strictness of know legislation, the Arthur D. Little and Bell- Federal and local regulations. As Allen G. Marr, core cases (chapter 7 and appendix C), and the Dean of the Graduate Division of the University animal experimentation controversy show that the of California, argued in a letter to OTA: public—through either community protest or ref- erendum—can act to control, direct, or influence Regulations promulgated uniformly on the ba- the topic choice, experimental procedures, or sis of federal law are far superior to patchwork regulation by state law or local ordinance. Codes communication of science. Although the evidence of ethical professional practice are art important is limited, such cases hint at the beginning of a complement but not a full substitute. jurisdictional shift in the regulatory arena for science, especially from the Federal to the State An issue raised by participants in the Arthur and local. This change may be a reaction to ei- D. Little case (see ch. 7), was that protests over ther real or perceived laxity in Federal regulations research involving hazardous chemicals might for health and safety protection, it may relate to have the unintended result of segregating such re- broader issues of the exertion of local control over search. States without the resources for develop- land use and community activity, or, in some ing comprehensive regulations (or for assuring cases, it does relate to the larger agenda of na- compliance) might become dumping grounds for tional political groups—e.g., protests linked to na- research no other States want. tionwide efforts to stop all nuclear power, abor- Is there a need for a new jurisdictional frame- tions, or the use of animals in research. work by which Congress can deal with these is- This jurisdictional shift raises the spectre of a sues, or are they best resolved at State and local number of negative effects on research caused by levels”!

GENERAL ISSUES

Underlying many of these issues are questions search also plays a role in regulation of biomedi- not resolvable through legislative activity but to cine. Experimental surgical procedures, for exam- which the Science Policy Task Force of the House ple, may be justified as therapeutic and not be Committee on Science and Technology, in its de- subjected to review by an ethics committee. A liberations, should attend. Once societal con- medical researcher who refers to a project as a straints may be imposed, a fundamental question “pilot study” or as “innovation” can keep it is that of what constitutes “research. ” For exam- outside such regulatory control mechanisms as ple, does there exist some constitutional protec- IRBs. 20 Better understanding of these and other tion for research, and if so what does the legal definitional questions will be essential to future definition of “research” include? Does it include attempts to resolve many of the issues mentioned not only thinking about a problem or talking to above. other scientists but also experimentation? The def- In setting an agenda for science, should policy- inition of what is or is not basic research currently makers look only to the potential benefits of the plays a role in the dissemination of Department research proposed or should equal consideration of Defense (DOD) -sponsored research results. De- be given, before funding, to the risk posed by the fining a project as falling within Federal budgetary research? If so, what parameters should be used category 6.1 (fundamental research), for exam- to make those determinations? Andre´ Hellegers ple, can determine whether or how it is classified once said that he, for example, would “assign a by DOD. ’9 The definition of what is or is not re- ——.—. 19 Janice R. Long, “Scientific Freedom: Focus of National Secu- rity Controls Shifting,” Chemical & Engineering News, July 1, 1985, ZOArthur Cap]an, T~ Hastings Center, Hastings-on-Hudson, NY, pp. 7-11. persona] communication, 1985. 123 -. very low priority” to any inquiry that “does not, what are the boundaries of control of science’s in the inquiry, harm nature, but which may be overall agenda. Such questions have been raised dangerous in its consequence. . .“.21 Ruth Macklin in connection with the current shift toward mili- made a similar point in her essay “On the Ethics tary dominance of basic research funding and with of Not Doing Scientific Research” when she wrote: the increased numbers of arrangements between universities and industry. Will such shifts result There is surely some disutility attached to an outcome that fails to benefit people who might in increased, long-term restrictions on communi- otherwise have been helped by research. But un- cation, and in controls on procedures as well as less we subscribe to a research imperative that on agenda-setting? How might such changes places freedom of scientific inquiry above all other affect—positively and negatively—the research values when potential danger lurks, we need to process and the openness of scientific communi- examine closely the value dimensions of each in- cation? stance of decisionmaking under certainty. ’z And, finally, as the case studies and many of To approach full understanding of this question, the examples show, the flow of public informa- one must also consider what consequences—e.g., tion plays a significant role in the regulatory envi- only the most probable or only the most nega- ronment for science. There is, of course, an ur- tive—are to be included in such a determination gent need for truly sensitive information to be and also what relative weights should be assigned protected by the classification system, whether for to various potential outcomes. Is there not just reasons of military security or economic protec- one but a spectrum of possible ways in which so- tionism, and such arguments are equally valid for ciety might use the results, and what relative industrial or academic protection of intellectual weights can be assigned to the better or worse con- property. Arbitrary and capricious use of secrecy 23 sequences? and classification, however, may inadvertently In setting funding priorities, Congress may in- damage the progress of science by inhibiting the creasingly have to confront determinations of free flow of information among researchers and the flow of information to the public. In the lat- ter case, inadequate or incomplete information ‘iAndre’HeIlegers, Regulation of Scientific Inqul~’, Keith hf. Wu]ff could, in fact, increase the probability of arbitrary (cd. J (Boulder, CO: Westview Press, 1979). regulation at the local level and, on matters re- “Ruth Macklin, “On the Ethics of Not Doing Scientific Research, ” lating to national policy debates, inhibit free po- Hastings Center Reportr vol. 7, December 1977, pp. 11-15. 2‘Brooksf op. cit. litical discourse. Appendixes Appendix A The Regulatory Environment for Science

Regulatory Forces on Specific and demonstrations. The four SAES geographical re- Fields—Two Case Studies gions are each headed by a deputy administrator and typically include a central station located often on the These case studies illustrate the regulatory forces at campus of a State’s land-grant university, and a num- work on two different research areas—agricultural re- ber of branch stations throughout the State. Major pri- search and research on acquired immunodeficiency vate performers in agricultural research include such syndrome (AIDS). The first area, agricultural research, companies as General Foods Corp., Ralston Purina is highly organized and highly controlled. Regional Co., and Campbell Soup Co.. needs largely determine the substance and agenda of In general, public sector agricultural research focuses research, even though the actors who set the agenda on biological technologies, while the private sector may be part of centralized government or in a mul- sponsors research on mechanical and chemical tech- tinational corporation. Recently, two well-publicized nologies. In 1978, total Federal expenditures for all re- legal actions have had a dramatic influence on the re- search and development (R&D) were $26.2 billion. search process in agriculture, attempting to prohibit USDA’s expenditures were $381 million, or only 1.5 research from progressing on certain topics or in a cer- percent of the total U.S. R&D budget. The total pri- tain manner. The second area, research on AIDS, vate sector agricultural R&D budget is about three- offers an interesting contrast in the types of forces reg- fourths of the total USDA contribution. ulating a “hot” research field. Here, the methodologi- A multiplicity of actors—consumers, producers, in- cal traditions of science and some significant liability vestors, in-house scientists, scientific societies, the reg- and privacy issues may be colliding with the push by ulatory agencies, the executive branch and Congress— advocacy groups for acceleration of the research. thus determine research priority setting in agricultural research. Within the SAES system, for example, line Regulatory Forces on item administrators and scientists set specific project 1 priorities according to their assumptions about what Agricultural Research is the greatest need in their field and what would be of greatest value to the State. Traditionally, federally In April 1863, the U.S. Department of Agriculture sponsored research has been managed through a clas- (USDA) was given authority to use about 40 acres of sification system based on geography, type of research land at the west end of the Capitol Mall in Washing- (i.e., basic or applied), the problem area, and program ton, DC, as an experimental farm. Since then, food structure. A less direct, but no less influential deter- and agricultural research in the United States has ex- minant of research direction has been Federal environ- panded and now includes three major performers: the mental and safety regulations, such as regulations on USDA; the State agricultural experimental stations chemical residues or additives in food. (SAES), and private industry, all of which do both Recently, two separate legal actions have introduced mission-oriented research and basic research. controversy into what has usually been a quiet region For its research activities, USDA maintains three of the scientific community. In 1979, attorneys filed separate operating agencies—Agricultural Research, a lawsuit, on behalf of 17 farm workers and the Cali- Cooperative Research, and Extension Service-and an fornia Agrarian Action Project, which charged the Office of Science and Education, which sets broad agri- University of California with unlawfully spending pub- cultural research policies. The Agricultural Research lic funds on mechanization research that displaced Agency is responsible for most of USDA’s in-house farm workers. That suit is still in litigation. agricultural research and is accountable and respon- Mechanization research includes the development sive to Congress and the executive branch for broad of machinery, crop varieties, chemical herbicides, regional, national, and international concerns. The growth regulators, and laborsaving methods of han- Cooperative Research Agency administers Federal dling, transporting, and processing crops. Lawyers for funds that go to States for agricultural research. The the farm workers allege that such research displaces Extension Service disseminates research results farm workers, eliminates small farms, harms con- through, for example, publications, public meetings, sumers, impairs the quality of rural life, and impedes collective bargaining, thereby failing to satisfy the gov- ‘This section summarizes material In U.S Congress, Off Ice of Technology Assessment, Lln~ted States Food and Agricultural Research System (Wash- ernment’s obligation to consider the needs of small and ington, DC U S Goverment Pr]ntlng OftIce, December 1981) family farmers, as specified in various Land-Grant

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Acts and the Hatch Act of 1877, which authorizes result of federally sponsored research activities; for ex- Agricultural Experiment Stations. ample, Public Health Service (PHS) grantees “discov- The plaintiffs are demanding that all mechanization ered” AIDS as a syndrome, PHS has conducted sur- research at the University of California be halted un- veillance of AIDS, and PHS investigators and others til a fund is created to be used to assist and retrain farm have made significant scientific advances, including the workers. z Their supporters feel that Federal funding discovery of the probable etiologic agent for AIDS. for research on laborsaving devices is an improper use Furthermore, PHS investigators-are extensively in- of Federal money; it is best supported by the market- volved in collaborations with non-Federal researchers, place because agribusiness is the primary group that both nationally and internationally. Thus, the envi- stands to gain most from the benefits of such research. ronment in which AIDS research is funded, conducted, Opponents see it as a battle between consumerism and and reported is influenced not only by the politics of good science at best, and the imposition of Federal con- the disease (i. e., the special populations which it ef- trols on research and a violation of academic freedom fects), but also by the traditional funding mechanisms, at worst. They cite many cases where mechanization the grants review process, and the way in which com- research has resulted in lower prices for the consumer mercial interest turns basic research results into vac- and more humane working conditions for the farm cines. In the case of AIDS, these forces appear to have worker. The case, as yet unresolved, raises issues both contributed to and impeded the research.

about: 1) the social costs of innovation through agri- Although AIDS funding increased substantially in cultural research, and 2) the legal and social responsi- fiscal years 1984 and 1985, the history of specific fund- bilities of those who conduct research that might ad- ing for AIDS has been marked by tension among the versely affect certain populations. In the legal sense, individual PHS agencies, Department of Health and the case raises questions about the propriety of Fed- Human Services (DHHS), and Congress. Through the eral expenditures for research activities that might pri- Assistant Secretary for Health, individual PHS agen- marily benefit private interests. cies have consistently asked DHHS to request specific The other legal action and public protest, launched sums from Congress; DHHS has submitted requests by activist Jeremy Rifkin and the Council on Economic for amounts smaller than those suggested by the agen- Trends, has attempted to halt the deliberate release of cies; and Congress typically has appropriated amounts genetically engineered products into the environment, greater than those requested by the Department, Ex- a technology of potential use to the agricultural indus- cept when prodded by Congress, DHHS has main- try as a means of increasing and improving crop pro- tained that PHS agencies should be able to conduct duction. A Federal appeals court has ruled that exper- AIDS research without extra funds. However, threat- iments involving the release of genetically altered ened cuts in overall funding and personnel levels have organisms into the environment can proceed, provided restricted the ability of affected agencies to redirect re- that their potential ecological effects have been prop- sources. erly evaluated. Rifkin’s group has also filed suit along An additional indirect influence on the research has with the Humane Societies of the United States and been the uncertainty of project staff levels. At critical the Minor Breeds Conservancy against the Department times in the planning stages”, the number of personnel of Agriculture on the issue of transferring genes be- needed to conduct and support the research-has actu- tween species, such as injecting genes for human ally been reduced in several of the PHS agencies. As growth hormone into livestock to promote more rapid a result, the PHS agencies have been unable to plan and exaggerated growth, As of September 1985, a their activities adequately because they have not hearing date had not been scheduled, known how much funding and staff will be available These actions demonstrate that even the most highly to them, Now that an etiologic agent for AIDS has controlled of research fields may be disrupted by new been discovered and the research could move into regulatory forces. areas where several agencies have overlapping exper- tise, the jurisdictional uncertainty—because of the un- Research on AIDS3 certain}’ in resource allocation—has intensified com- petition. Much of what we know about the biology of ac- The question of whether AIDS funds should come quired immunodeficiency syndrome (AIDS) is also a out of existing PHS agency budgets, or whether such funds should augment agency budgets, also reflects

‘Calitornja Agrarian Action Project (CAAP) et al v The Regents of the concern about the perceived appropriateness of PHS University of California, Case 516427-5, Superior Court of the State ot Call- funding of AIDS-related research and the perceived forn,a, Oakland (filed Sept. 4, 1979) magnitude and importance of the AIDS epidemic. ‘This section summarizes material m U.S. Congress, Ottlce d Technology Assessment, RevJew, of the Public Health .%vice’$ Re3ponse to AIDS (Wash- Some scientists have expressed concern that ‘research ington, DC U.S. Government Printing Ofhce, February 1985) on other diseases will suffer because funds are being 129 — transferred from these areas to AIDS-related research; Federal researchers who are not directly involved in other observers believe that AIDS-related research these activities. Yet the Federal researchers will gen- may be delayed because of wrangling over such erally share their research, including their research ma- transfers. terials; their primary concerns are the qualifications In AIDS research, some sharing of information has of the private researchers and the quality control proc- taken place through the informal networks that exist esses they have established. In the case of AIDS, the among PHS agencies and among their researchers, but sharing of information developed by commercial firms tensions also surround formal communication, Since was enhanced in small part because PHS selected the the National Cancer Institute’s work on HTLV-III was companies that would get the HTLV-III culture devel- announced in April 1984, formal information-sharing oped by the NCI laboratory. Other laboratories, how- on a management level has increased substantially, and ever, have now cultured the virus and sold or given centralized coordination of activities is also on the in- it to companies other than those selected by PHS, and crease. Members of the PHS Epidemiology and Pre- the status of those companies’ activities is formally un- vention Task Force have agreed to distribute articles known to any Federal researcher at FDA. prior to publication, and to discuss studies at the plan- Finally, AIDS has been described as a “legal emer- ning stage in order to avoid unnecessary redundan- gency” as well as a medical crisis. Much of the con- cies and to ensure that all the necessary areas are be- cern centers on social discrimination experienced by ing covered. Many of these sharing and coordinating members of the groups at risk to contract the disease, activities would have taken place regardless of any especially homosexual men and intravenous drug directive from PHS central management, but in other users. Two sections of the Public Health Service Act, instances, earlier PHS guidance might have led to bet- therefore, have been used to protect confidentiality in ter coordination —e.g., PHS might have directed the federally sponsored research. Section 242a authorizes National Cancer Institute (NCI) to share AIDS virus the Secretary of DHHS to protect the privacy of indi- culture with the Centers for Disease Control, an ac- viduals participating in research on mental health, in- tion which was not taken. cluding research on the use and effect of alcohol and Another factor that may have impeded the genera- other psychoactive drugs, by: 1) withholding from all tion and dissemination of information is the Federal persons not connected with the conduct of such re- grants application and approval process for extramural search the names or other identifying characteristics research. National Institutes of Health (NIH) research of such individuals; and 2) prohibiting persons author- grants take about 16 months from conceptualization ized to protect the privacy of such individuals from to awards; contracts, about 14 months. The first round being compelled to identify them in any Federal, State, of extramural grants awarded by NIH for AIDS re- or local civil, criminal, administrative, legislative, or search took 14 months to be processed, in part because other proceedings. Section 242m(d) provides that in- of negotiations with the Office of Management and formation may not be used for any purpose other than Budget over the specific language used in the agree- the purpose for which it was supplied unless consent ments. Since that time, some steps have been taken has been given. to speed up the process, such as mail balloting instead As more is known about the relationship between of face-to-face meetings by reviewers. Shortening the HTLV-III and AIDS, or as other diagnostic tests are process, however, may only increase concerns about developed, confidentiality safeguards will have to be the quality of the research activities funded. implemented without sacrificing the surveillance needs Federal regulations covering commercial develop- of public health officials or data sharing among re- ment of drugs, biologics, and devices have also searchers. Informed consent will be an especially dif- impeded open communication. In the United States, ficult issue, for example, because the first test to be Federal policy tends to leave commercial development applied will detect exposure to HTLV-III only through of technologies, including technologies derived from the presence or absence of antibodies and persons who Federal biomedical research, to the private sector. test positive may actually be carriers of HTLV-III, may Once under commercial sponsorship, R&D activities develop AIDS, or may remain well. Regulatory deci- are considered proprietary and will not be made pub- sions, therefore, will have to balance the public health lic unless voluntarily released. The Food and Drug concerns surrounding the transmissibility of AIDS Administration (FDA), therefore, cannot even divulge with the social stigma or employment discrimination the protocols being used by the five companies under that may accompany identification as a potential car- license from NCI to develop AIDS screening tests to rier or potential victim. Appendix B Public Attitudes Toward Science*

The attitudinal environment for science includes the spectacular results in the future. Even though most attitudes of the public toward science and technology Americans still see science as a magic black box, ’ the in general or institutional terms. These attitudes may evidence is clear that they also believe that their cur- be usefully grouped as hopes and expectations, reser- rent standard of living is in large part the result of mod- vations and concerns, and confidence in the leader- ern science and technology. The substantial gains in ship of the scientific community. This appendix will medical science, for example, symbolize the achieve- examine both the literature and the data relevant to ments of science for most Americans. 1 each of these three sets of attitudes. The first national study of public attitudes toward science in the post-war years was conducted in 1957 Hopes and Expectations by the Survey Research Center of the University of Michigan. Sponsored by the National Association of In broad strokes, the literature and the publication Science Writers (NASW) and the Rockefeller Founda- data from the 4 decades since 1945 portray a public tion, the study was designed to assess the public’s in- that has a high regard for the past achievements of terest in and knowledge about science and technology, science and technology and high hopes for even more the major sources of information on current science issues, and the appetite of the public for science news. *This appendix is based on an OTA contractor report written by Jon D. The study included personal interviews with a national Miller, Northern Illinois University. ‘The following data sources were utilized in secondary analyses. The 1957 probability sample of 1,919 adults and the field work National Association of Science Writers study was based on personal in-home was completed in early October 1957, just 2 weeks interviews with a national probability sample of 1,919 Americans. The in- prior to the launching of Sputnik I. Inadvertently, the terviews were conducted by the Survey Research Center at the University of Michigan. The field work for this survey was completed just prior (about 1957 NASW study became the only existing set of 2 weeks) to the launch of Sputnik 1 by the Soviet Union and is the last meas- measures of the attitudes of the American public urement of American attitudes toward science and technology prior to the toward science prior to the beginning of what is often Space Age For a full description of the study and results, see R.C. Davis, The Public Impact of Science in the Mass Media, Survey Research Center termed the Space Age. The study offers, therefore, a monograph No. 25 (Ann Arbor, MI: University of Michigan, 1958). unique opportunity to look back to the calm of the The 1979 survey of public attitudes toward science and technology was based on personal In-home interviews of a national probability sample of mid-1950s. 1,635 adults. Sponsored by the National Science Foundation (C-SRS78-16839), The 1957 NASW study found a public that believed the field work was conducted by the Institute for Survey Research at Temple that science and technology had won the war, created University. For a description of the design and results of the study, see Jon D Miller, et al , The Attitudes of the US. Public Toward Science and Tech- “miracle” drugs, and would continue to produce a cor- 3 nology (Washington, DC. The National Science Foundation, 1980) nucopia of benefits for American society. Almost 90 The 1981 survey of public attitudes toward science and technology was based on telephone interviews with a national probability sample of 3,195 percent of the American adults polled said that the adults The study was sponsored by a grant from the National Science Foun- world was “better off because of science. ” When asked dation (NSF 8105662) and was conducted by the Public Opinion Laboratory why they thought so, slightly more than half cited at Northern Illinois University. For a description of the sample and results, see Jon D Miller, A National Survey of Public Attitudes Toward Science medical advances and about 40 percent pointed to the and Technology (DeKalb, IL Northern Illinois University, 1982). American standard of living. When asked to name The 1983 survey of public attitudes toward science and scientists was based some potential “bad effects” of science, 90 percent of on telephone Interviews with a national probability sample of 1,630 adults, Sponsored by the Annenberg School of Communications at the University the adults in the study could not think of a single pos- of Pennsylvania, the survey was conducted by the Public Opinion Labora- sible negative effect. Ninety-four percent of the pop- tory at Northern Illinois University. For a description of the design and re- ulation were willing to agree that science was making sults of the study, see Jon D. Miller, A National Survey of Adult Attitudes Toward Science and Technology in the United States (Philadelphia, PA: their lives “healthier, easier, and more comfortable. ” University of Pennsylvania, Annenburg School of Communications, 1983), Ninety percent agreed that “most scientists want to The 1985 data on attentiveness to science policy were taken from a tele- phone survey of a national probability sample of 1,514 adults. The study work on things that will make life better for the aver- was sponsored by Family Circle magazine and conducted by the Public Opin- age person” and 88 percent felt that science was “the ion Laboratory at Northern Illinois University, A technical report on this study main reason for our rapid progress. ” It would be hard will be released by the Public Opinion Laboratory in the fall of 1985, The 1981-82 study of the attitudes of science policy leaders was based on to imagine a more supportive public, telephone interviews with a national sample of 282 individuals, Sponsored Despite the influence of the space race and the con- b a grant from the National Science Foundation (NSF 8105662), the survey y tinued growth of post-war science and technology, was conducted by the Public Opinion Laboratory at Northern Illinois Univer- sity. For a description of the study design and the methods used to identify and sample science policy leaders, see Jon D, Miller and Kenneth Prewitt, ‘Jon D. Miller, “Scientific Literacy: A Conceptual and Empirical Review, ” “National Survey of the Non-Governmental Leadership of American Science Daedalus vol. 112, No. 2, 1983, pp. 29-48, and Technology, ” a report to the National Science Foundation, 1982, ‘Davis, op. cit.

130 131

there were few efforts made in the 1960s to measure Table B-1 .—European Attitudes Toward Science, 1978 public attitudes toward science. The next systematic effort to assess the attitudes of the American people Country Percent agree toward science and technology was initiated by the Northern Ireland ...... 800/0 National Science Board (NSB) in 1972. As a part of United Kingdom ...... 79 Italy. ., ., ...... , 76 its new Science Indicators series, the NSB decided to France ., ...... 75 include a chapter on public attitudes toward science. Ireland ...... 75 The NSB staff prepared a set of questions and used West Germany ...... 71 the Opinion Research Corporation to collect national Luxembourg ...... , ... 70 Denmark...... 67 data sets in 1972, 1974, and 1976. Belgium ...... 66 These NSB surveys found a public that still held Netherlands . —...... 65 science and technology in high regard, although less “Science will continue in the future as it has so than in 1957. In contrast to the almost 90 percent done in the past to be one of the most impor- of the public that thought in 1957 that the world was tant factors in improving our lives. ” “better off” because of science, only 70 percent of the — public held the same view in 1972. ’ Similar results were mately threequarters of western Europeans were will- obtained in the 1974 and 1976 studies.5 While the abso- ing to agree with a statement that science had been and lute level was down somewhat, a substantial majority would continue to be a major factor in improving their of the total public held very positive views of the con- lives. There was a high degree of consensus among tributions of science to American society. countries, ranging from 80 percent in Northern Ireland In a 1979 national study of public attitudes toward to 65 percent in the Netherlands. science and technology, also sponsored by NSB, sev- Another facet of the attitudinal environment for eral of the 1957 questions were repeated, offering an science is reflected by the public’s expectations for fu- opportunity for comparison across 2 decades. In 1979, ture achievements. The belief that science has contrib- 81 percent of the public still agreed that scientific dis- uted to the health and comfort of the society is, of coveries were making their lives “healthier, easier, and course, inherentl retrospective; and so it is important more comfortable” and 86 percent expressed the view y to inquire whether the public expects similar achieve- that scientific discoveries were “largely responsible” ment from science in the future, or whether the pub- for the standard of living in the United States. ’ In a lic thinks that the frontiers of science have been ex- comparable national study in 1983, Miller found that plored thoroughly. Beginning with the 1979 study for 85 per cent of American adults continued to agree that NSB, one series of questions have asked respondents science made their lives healthier, easier, and more to assess how likely it is that science will achieve cer- comfortable. 7 tain results in the next 25 years. The results indicate Although the material gains attributable to science that a large segment of the public holds high expecta- have undoubtedly influenced public attitudes toward tions for future outcomes from science and technol- science, there is evidence that Americans also have a ogy. By 1983, a majority of the public thought that commitment to the value of science per se. In a 1983 it was “very likely” that within the next 25 years national survey, Louis Harris found that 82 percent science would find a cure for the common forms of of American adults agreed that scientific research cancer, have people working in a space station, and “which advanced the frontiers of knowledge” was find efficient sources of cheap energy (see table B-2). worth supporting “even if it brings no immediate ben- In contrast, a substantial portion of the public indi- efits.’” Only 14 percent of Americans rejected this idea. cated that they did not expect science to be able to cure Evidence from the European Barometer indicates mental retardation, communicate with alien beings, that western Europeans hold very similar views about or put whole communities of people into outer space. the positive contributions of science and technology These results indicate that the public does have some to their standard of living.9 (See table B-l. ) Approxi- ability to differentiate between likely and less likely ‘National Science Board, Science Indicators—lQ72 (h’ashington, DC 1973 ) outcomes and that the optimism found in several pre- ‘N’atlonal Science Board, .%-)errct= [ndicators—lvd (Washington, DC. vious responses is not a simple yea-saying reaction. 1975 ), and Nat]onal Science Board, .Sc]ence IrrdJcatom — 2976 (Washington, From these aggregate results, it would appear that DC IQ77) ‘Miller, et al , op c]t a significant portion of the American people hold some “Miller, A Nat]ona/ Surve}, of Adult AttJ/udes To~\ard Sc]ence and Tech- positive general attitudes toward science. It is also im- nology In the Lrrf/ted States op clt r portant to inquire whether the attentive public* for “Louis Harris ‘The Road After 1984. The Impact ot Technology on Soci- ety, a report prepared tor the SOu them New England Telephone Cornpan>’, ‘ln brle~, the basic dimensions of an ‘attentive public” tor science pollcy 1Q84 are h]gh level of Interest in the topic, comb]ned with the perception of be]ng 9Jacques-Rene Rabler Euro-baromefer I(?a .%-~entlf]c F’rlorjtie, in the Furo- adequately lntormed For a discussion of th]s concept In more depth, see l(~n pean Commurrlty octoher-,~f”~remher,” 1978 ( Ann Arbor MI. Inter- D Miller, I’ubl]c Attitudes Toward the Regulation of Research, c{~ntra~- Unlvers]ty Consort] urn for Pol]tlca] and Soc]al Research 1981) tor report prepared for the U S Congress, OttIce of Techno]og}, Assessment 132

Table B-2.—Expectations for Future Scientific Achievements, 1979-83

Percent saying that the following results will Possible, but Not likely Number of be achieved in the next 25 years: Year Very likely not too likely at all people surveyed A cure for the common forms of cancer. . . . 1979 46 44 - 8 1,635 1983 57 36 6 1,630 A cure for mental retardation ...... 1983 11 40 47 1,630 A way to put communities of people in outer space ...... 1979 17 38 42 1,635 People working in a space station ...... 1983 52 34 12 1,630 Humans communicating with alien beings . 1983 14 33 51 1,630 More efficient sources of cheap energy . . . . . 1979 57 34 7 1,635 A safe method of disposing of nuclear wastes ...... 1983 29 41 26 1,630

“NOW let me ask you to think about the long-term future. I am going to read you a list of possible scientific results and ask you how likely you think it is that each of these will be achieved in the next 25 years or so. ”

science policy shares these same positive views of the scientific research. Those who have a high level of in- past and future results of science. Fortunately, the na- terest in science and who feel reasonably well informed tional data sets collected in 1957, 1979, 1981, and 1983 about it tend to hold even more positive views about are available for retabulation for this purpose. the past and future benefits of science. The one question relevant to this section of the anal- ysis that has been asked repeatedly throughout the last Reservations and Concerns 3 decades has been the agree-disagree statement con- cerning the contribution of science to making our lives Throughout the post-war years, there has been some “healthier, easier, and more comfortable. ” A retabu- level of wariness about some of the possible negative lation of three previous studies indicates that there has effects of science among a substantial minority of the been some decline in the proportion of both the at- American people. On balance, these reservations have tentive public and other citizens willing to agree with not offset the high levels of positive affect and expec- the statement, but 9 of 10 members of the attentive tation described above, but it is necessary to review public for science policy and 8 of 10 other Americans and understand the magnitude and substance of these still hold that belief (see table B-3). At all three meas- attitudes. urement points, at least 10 percent more of the atten- The 1957 NASW study found some reservations tive public were willing to agree with this view than about the effects of science, but it was muted and most were other citizens. often accepted as the price of gaining good things from Some of the more recent data sets allow an exami- science. Slightly over 40 percent of the public were nation of the difference in expectations between those willing to agree that science “makes our way of life who follow science policy matters and those who do change too fast” and 23 percent agreed with the state- not. In general, people who were attentive to science ment that “one of the bad effects of science is that it policy issues were more optimistic about the future breaks down people’s ideas of right and wrong. ” Al- achievements of science and technology than were though 70 percent of the adults in the 1957 study those who were nonattentive (see table B-4). The gen- agreed that “the things that happen in this world are eral pattern of expectations by the attentive public and mostly controlled by God” and about half felt that by the others did not differ significantly. “one of our big troubles is that we depend too much In summary, both the existing literature and selected on science and not enough on faith, ” when asked to retabulation of available data indicate that most assess the net effect, 9 out of 10 concluded that the Americans have a positive image of science and/or world was better off because of science. There was

Table B.3.—Attitude Toward Contribution of Science, by Attentiveness, 1957.83

Attentive Not Number surveyed Year public attentive Attentive Not attentive Percent agreeing that science makes our 1957 980/o 930/0 183 1,736 lives healthier, easier, and more 1979 89 79 232 1,313 comfortable — 1983 92 82 398 1,232 133

Table B-4.–Expectation for Future Achievements, by Attentiveness, 1979-83

Percent saying it is “very Iikely’’ that the following results wiII be Attentive public achieved in the next 25 years: — Year Not attentive Ž A cure for the common forms of cancer, ...... 1979 55 “/0 44 1983 68 54 ● A cure for mental retardation ...... 1983 13 10 ● A way to put communities of people in outer space ...... 1979 13 10 ● People working in a space station ...... 1983 62 49 ● Humans communicating with alien beings...... 1983 17 13 ● More efficient sources of cheap energy ...... 1979 76 53 ● A safe method of disposing of nuclear wastes ...... 1983 35 27 N (1979) = 307 1,328 N (1983) = 398 1,232 “Now let me ask you to think about the long-term future. I am going to read you a list of possible scientific results and ask you how likely you think It is that each of these will be achieved in the next 25 years or so. some wariness, but not enough to offset the desire for Finally, these data indicated a persistent public con- increased health and comfort. cern about the potential for a few people to control Karen Oppenheim repeated some of the 1957 NASW the lives of the total society, using the power of science. items in a national survey conducted by the National In both years, about one-third of the adult population Opinion Research Center in 1964 and found that the was willing to agree with the statement that the level of public wariness or concern was increasing .’” “growth of science” meant that a few people could The NSB-sponsored studies in the early 1970s found “control our lives. ” the same trend. Recent studies indicate a renewed concern about the Four of the items originally used in the 1957 NASW tie between science and weapons. A 1983 national sur- study were replicated in a 1983 survey sponsored by vey by Harris found that 74 percent of adults in the the Annenberg School of Communication at the United States were willing to agree with the statement University of Pennsylvania. ” A comparison of the re- that “with the development of nuclear, chemical, and sults indicates that the reservations expressed by those biological weapons, science and technology may end citizens included in the 1957 study have remained up destroying the human race.“12 Another 1983 study largely unchanged over the last quarter century. found that one-quarter of the adult population thought The concern over the impact of science on the pace that it was very likely that “wars in space” would oc- of change in society has also continued at virtually the cur in the next 25 years and an additional 36 percent same level. In both years, about 4 in 10 Americans ex- of the American people thought that space wars were pressed some concern that science was causing our “possible.’’” lives to “change too fast” (see table B-5). Do people who pay more attention to science (the — “attentive public” ) have the same kinds of reservations ‘Karen [)ppenhelm Acceptance and [)lstrust Att]tudes C)I Amerlcdn Adults Toward Science, ma~ter s the~]s Llnlversi t}. ot C hlcagc), I WJO as those reviewed above? A retabulation of the 1957 I I hfllier .-i ,\’a IIorIa/ $ur~’e~ (): .A(fult .IftItUdCS T(JH ard SC 1~’nce .?n~j ~e~ h- and 1983 data indicated that the attentive public holds rr(llo~~’ /n the ( ‘n)tml .5tJ(es OF ( it many of the same reservations found in the previous data, but that the proportion of persons holding those Table B-5.— Public Concerns About Science, 1957.83 reservations is slightly lower among the attentive pub- lic than other people (see table B-6). Although 4 in 10 Year members of the attentive public were concerned that 1957 1983 society depends too much on science and not enough ● We depend too much on science on faith, only 2 in 10 felt that science tended to break and not enough on faith ...... 500/0 500/0 down people’s ideas of right and wrong. The propor- • One trouble with science IS that it makes our way of life change tion of the attentive public concerned about changes too fast ...... 43 44 in the pace of life and in the loss of the control of their • The growth of science means that a lives to science did not differ significantly from the few people could control our lives . 32 35 proportion for the nonattentive public. . One of the bad effects of science is that it breaks down people’s ideas of right and wrong ...... 23 29 “}iarrl~ op clt I ~Nll]]er ,,1 ,\.

Table B-6.—Concerns About Science, Beginning in the 1970s, the surveys sponsored by by Attentiveness, 1957-83 the NSB asked each respondent to make an assessment Year of the relative benefits and harms and to weigh the two. Similar questions have been asked since that time Not Attentive attentive by Cambridge Reports. ’s The data from the last 15 years indicate that a solid Percent agreeing that . . . . . 1957 1983 1957 1983 majority of Americans believe that science does more ● We depend too much on science and not enough good than harm (see table B-7). Only about 1 in 20 on faith ...... 440/0 430/0 50% 53 ”/0 Americans believe that science does more harm than ● One trouble with good, but about one-third of U.S. adults are unsure science is that it makes as to where the balance falls. Some of this uncertainty our way of life change too fast ...... 34 36 44 48 may reflect a lack of interest or information. About ● The growth of science 5 percent of current respondents are simply unable to means that a few people answer the question. could control our lives . . 31 31 32 38 Although the exact items discussed above have not ● One of the bad effects been used in a survey that would allow the separation of science is that it breaks down people’s of attentive and nonattentives for analysis purposes, ideas of right and the 1983 Annenberg study did include two items that wrong ...... 16 24 24 32 reflect the same attitude. Each respondent was asked Number ...... 183 321 1,736 1,309 to agree or disagree with the statement that “the ben- efits of science outweigh whatever harm it does. ” Two- thirds of the attentive public agreed with the statement In summary, from the literature and from selective in comparison to 55 percent of nonattentives.16 The retabulation of previous data, it appears that a sub- same sentiment was measured with a paired statement stantial portion of the American people hold some res- worded in the other direction. When asked to agree ervations about the impact of science on society. In or disagree with the statement that “science is likely the context of the very positive views found in the to cause more problems than to find solutions, ” only preceding section, it would appear that a significant 16 percent of the attentive public and 27 percent of portion of the American people recognize and under- the nonattentive public agreed. These results suggest stand that science involves both the potential for sub- that those who are interested in science issues and who stantial benefits and the possibility of damage or follow science policy matters believe that the benefits misuse. of science outweigh its potential harm. This same view is reflected in the larger public, but it is not likely to Confidence in Science be as solidly rooted in the larger population as it would be in the attentive public. Given the combination of positive hopes and expec- A second approach to reconciling the potential for tations and the simultaneous level of concern, how good and harm. from science is reflected in measures does the public reconcile these attitudes? Is there an of confidence in the leadership of organized science. overall view of science? In general terms, the attitude Most Americans have considerable pressure on their research data from the last three decades suggest that time and do not normally set aside a significant por- people have concluded that the benefits outweigh the tion of time to consider the flow of issues in areas like potential harms from organized science in the United science policy. If people (especially those attentive to States. science) have confidence in the leadership of major As noted earlier, 88 percent of the adults studied in scientific organizations and corporations, then the 1957 reported that they felt that the world was better leaders can be relied on to monitor the process and 14 The preceding analyses have off because of science, the public can wait until a real controversy emerges demonstrated that the level of concern was as high in before becoming concerned about the issue. 1957 and in the early 1980s. The conclusion that the The evidence from the General Social Survey17 in- world was still better off for the contributions of dicates that the leadership of the scientific community science could be interpreted, therefore, as an assess- ment that the benefits outweighed the past and pro- I sNatlon,~cience bard, Science Indicators— 1984 (Washington, IX. spective risks. 1985). lbM1]]er A Natjona] Survev of Adult Attitudes Toward Science and Tech- nology in (he United States, op. cit, “J. A D,IVIS and T. Smith, General Soc]al Surveys 1972-1984: Cumula- “Ibid, tit,e Code Book (Chicago, 11.: National Opinion Research Center, 1984). 135

has been and continues to be held in high esteem (see to indicate that the leadership of the scientific com- table B-8). The only major institution in American so- munity is held in high regard, implying a degree of ciety that has consistently claimed a high level of con- trust in their monitoring of the work of organized fidence from more Americans has been medicine, science. But it should be noted that no major survey which may be viewed as at least closely related to the to date has specifically addressed the philosophical and scientific community. political issue of direct regulation of scientific research. In summary, the literature and the reanalysis of pre- Episodes such as those discussed in chapter 7—and the vious data can be interpreted to indicate that most existence of considerable congressional legislative Americans see the benefits of science as greater than activity resulting in regulation—can be interpreted just any potential harms or risks. This view is apparently as strongly as indicators of, if not a lack of trust, at held even more firmly by the attentive public for least a wariness on the part of some communities and science policy. The evidence may also be interpreted constituencies.

Table B-7.— Public Assessment of the Risks and Benefits of Science, 1972-85

Science and technology . . . . . do about the do more good do more harm same amount dent know/ Year than harm than good of each not sure Number 1972 ...., ...... 54 4 31 11 2,209 1974 ..., ...... 57 2 31 10 2,074 1976 .., ...... 52 4 37 7 2,108 1983. , ...... 73 3 21 3 1,466 1984. , ...... 63 5 27 5 1,864 1985. , ...... 58 5 32 5 1,866 “Overall, would you say that science and technology do more good than harm, more harm than good, or about the same amount of each?”

SOURCES Opinion Research Corp. (1972 1974 1976), Cambridge Reports (1963, 1984, 1985)

Table B-8.– Public Confidence in Science and Selected Other Institutions, 1973-84

Have a “great deal of confidence” in: 1973 1974 1975 1976 1978 1980 1982 1984 Medicine ., ...... 54 60 50 56 46 52 46 52 Scientific community ...... 37 45 38 43 36 41 38 47 Education ...... 37 49 31 37 28 30 33 29 Organized religion ...... 35 44 24 30 31 35 32 32 Military ...... 32 40 35 39 29 28 31 37 Major companies ...... 29 31 19 22 22 27 23 32 Press ...... 23 26 24 28 20 22 18 17 Television ...... 19 23 18 19 14 16 14 13 Organized labor ...... 15 18 10 12 11 15 12 9 Executive branch ...... 29 14 13 13 12 12 19 19 Congress ...... 23 17 13 14 13 9 13 13 Supreme Court...... 31 33 31 35 28 25 30 35 N = 1,504 1,484 1,490 1,499 1,532 1,469 1,506 943 “I am going to name some institutions in this country. As far as the people running these institutions are concerned, would you say you have a great deal of confidence, only some confidence, or hardly any confidence at all in them ?“

SOURCE James A. Davis and Tom W Smith General Social Surveys Cumulative File, 1972-1984 (Ann Arbor Inter-University Consortium for Political and Social Research, 1984), p 152 Appendix C Environmental Concerns and Laboratory Siting: The Morris Township-Bellcore Case*

From February 1984 to May 1985, Morris Town- Three years later, during the summer of 1983, with ship, New Jersey, was embroiled in a controversy over three office buildings under partial completion, the the siting of a new research facility for Bell Commu- Southgate Corporation leased the site to Bell Commu- nications Research, Inc. (Bellcore). The site plan of the nications Research, Inc. (Bellcore), a research organiza- proposed telecommunications research complex was tion owned by seven regional telephone companies. debated extensively before the township planning Bellcore is a by-product of AT&T’s court-ordered board. At issue was the storage, use, and disposal of divestiture of the Bell System. The Bell System Plan highly toxic and flammable gases. A group of residents of Reorganization stipulated that the regional tele- formed the Concerned Citizens of Morris Township phone companies create a central services organiza- (CCMT)—an organization that spearheaded opposi- tion to provide them with research and technical tion to the research facility on the grounds that the services. work being planned there was potentially hazardous On behalf of its tenant, the Southgate Corporation to public health and environmental quality. The Mor- submitted an amended site plan on December 1983, ris Township-Bellcore case draws attention to the ef- which included the construction of an additional build- forts by citizens to set community standards of accept- ing devoted to research, and the use, as a laboratory, able risk for privately financed research that requires of two floors of a building previously approved as of- the use of toxic materials. This brief case study sum- fice space. Bellcore had planned to locate its Morris marizes the key events of the controversy, examines Research and Engineering Center at the Southgate loca- the legal basis of local regulation for the proposed tion. A. number of AT&T employees at Bell Labs fa- research, reviews the justifications for and against sit- cilities in Murray Hill, New Jersey, and Whippany, ing the research facility, and finally, casts some pre- New Jersey, were expected to be transferred to the new liminary comparisons to the two Cambridge, Massa- center. chusetts, cases discussed in chapter 7, in which The proposed facility was devoted to advanced re- recombinant DNA research and chemical warfare search in semi-conductors and fiber optics. This type agents were regulated. of research commonly employs toxic gases such as ar- sine, phosphine, and diborane as well as liquified Historical Background hydrogen. Residential abutters to the site had attended a plan- This case began like many land use decisions in com- ning board meeting in February 1984 to discuss traf- munities throughout the United States. In the late fic patterns when they learned that toxic and flamma- 1970s, residents of a suburban neighborhood in Morris ble gases would be used under the amended site plan. Township, New Jersey, raised concern over the devel- Within a month, a core group of residents organized opment of a parcel of land adjacent to single-family themselves into CCMT. subdivisions and a recreational area. The issues ex- The citizens framed their opposition to the research pressed during this period were predominantly those facility on two principal grounds: 1) the health effects of traffic, noise, density, and aesthetics. In February of an accidental release of toxic gases into their neigh- 1980, after 15 public hearings over a 12-month period, borhooods, and 2) a potential release of untreated or the Morris Township planning board approved a plan partial] y treated toxic effluent from the research facil- submitted by the Southgate Corporation, developer ity into Loantaka Brook—a major tributary of the of the site. The 58-acre parcel, called the Southgate Great Swamp National Wildlife Refuge. Office Park Complex (Southgate Complex), was des- CCMT’s main effort to prevent construction of the ignated exclusively for office use. research facility was directed at the Morris Township Planning Board, a body consisting of nine appointed members legally responsible for land use decisions. ‘This case study was prepared for OTA by Sheldon Krimsky, Tufts University. Over two dozen public hearings were held by the plan-

136 137

ning board on the Bellcore case between December nouncement that it was withdrawing several con- 1983 and May 1985. CCMT brought in paid consul- troversial elements of its site plan including the new tants, some from outside the State, to testify in its be- laboratory building, and the use of certain toxic and half on the potential hazards to the community of the flammable gases. The planning board hastily accepted proposed facility. Eventually, CCMT drew support the modified proposal by a vote of 9-O. Realizing that from a broad range of constituencies covering Morris even a vote in its favor would not end the controversy Township and neighboring communities. Included or the delay in construction, the company appears to among these were: Harding Township Environmental have capitulated to the concerns of the citizen protes- Commission; over 50 Harding residents; the Great tors. In response, the citizen’s group chose not to ap- Swamp Watershed Association; 14 civic associations peal the final decision of the planning board—despite with a putative representation of 2,000 households in some uneasiness among CCMT members that they had Morris Township and neighboring communities; and not seen a completed version of the adopted site plan. an official of the U.S. Fish and Wildlife Service. This decision brought to a close an 18-month con- A letter signed by 14 representatives of civic asso- troversy over potentially hazardous research in ciations expresses the intensity of public opposition: telecommunications. We question the need for Bellcore to impose the lab- oratory on a community that does not want it . . . The Legal Dimension We emphatically state that the Bellcore laboratory is Local planning boards derive their authority to ex- not welcome and that we will pursue every means avail- ercise land use controls from State statutes. In New able to expose and publicize the fact that, in this in- stance, Bellcore has failed to fulfill its role as a respon- Jersey, Chapter 57 of the State Land Development Or- sible corporate citizen . .1 dinance sets forth principles of municipal land use con- What started out as a controversy involving abut- trols that include the promotion of public health and ters to an industrial site, soon evolved into a regional safety and protection against man-made and natural disasters. In the written opinion of the Morris Town- conflict over a proposed research and engineering cen- ship counsel, “both municipal land use law as well as ter. As community pressure grew, so did Bellcore’s im- patience with the uncertainty of locating its new re- the Morris Township ordinances provide sufficient le- gal basis to deny the [Bellcore] application if the Board search home. The company made serious attempts to feels it would present an unacceptable risk. ” The ke communicate its position that “the small quantities of y chemicals that [the company] plans to use and the to the planning board’s authority to proscribe research ‘state-of-the-art’ safety systems and procedures that it is in the interpretation of “unacceptable risk” —a vague plans to employ will make the Southgate facility safe and elusive term that was the centerpoint of much of beyond any reasonable question whatsoever.’” the public debate. In May 1984, Bellcore submitted an environmental The Southgate Complex is on land zoned for office information document to the planning board, describ- and laboratory use, a point emphasized by Bellcore ing its prospective laboratory operations, providing in its repeated contention that the amended site plan a representative chemical inventory for the new com- was in conformity with zoning requirements for the plex, and outlining safety procedures for the storage parcel. CCMT claimed that it was within the purview and handling of toxic materials. The company also of the planning board to restrict research activities that hired risk assessment consultants to present its case be- pose a threat to human health, public safety, or envi- fore the planning board. Bellcore scientists provided ronmental quality, even though the parcel is zoned for an additional source of technical assistance to the com- laboratory use. It argued that the zoning classification pany during the protracted debate. “research” is only a guide. Each activity must be care- In the 18-month period during which the planning fully examined under this broad category (which in- board held public hearings on Bellcore’s proposed re- cludes everything from pencil and paper operations to search complex, proponents and opponents of the the storage and use of hazardous chemicals) to deter- mine whether it conforms to community standards of amended site plan were assigned scheduled sessions at which to present their respective arguments. On May acceptable risk. Acting in a quasi-legal manner but without strict 3, 1985, the planning board prepared for a final vote on the site plan. However, at the outset of the session rules of evidence, the planning board heard testimony and per- prior to the vote, Bellcore made an unexpected an- from both sides, cross-examined witnesses, mitted adversaries to question one another. A deci- IThc,ma\ Fuschett[> Ir , Bel]core [’r{)test Cont]nucs t{) Build ObserLrer- sion by the planning board is subject to an appeal in Tr/hunf, Nlar 28, 1Q8.5 the State courts if the petitioner files the appeal in h’ Nllchael (;rt)ve, LrICe President and General C<)unse], Ije[[cc)re, ]etter to lames $tenger Concerned Cltlzens ot Morris Township, Nlar 11, 1 Q85 accordance with accepted guidelines. 138

Citizen opposition to the facility was not directed Acute inhalation [of arsine gas] can cause rapid de- at a particular research program per se, but rather at struction of red blood cells, followed by severe kid- the chemical substances that were a critical part of the ney damage, and if the patient is not immediately research activities. treated-death. Given sufficient low-level exposure over time, arsine also may be carcinogenic. The ac- cidental release of the contents of a 20-pound cylin- Arguments For and Against a der of 100 percent phosphine would have to be spread Research Ban over 1,792 acres—or 276 city blocks—before being diluted to the permissible exposure level of 0.3 ppm. In its presentation before the planning board, Bell- A second argument, which evolved somewhat later core maintained that the site plan was in conformity in the controversy, centered around the environmental to the zoning requirements of the parcel, Moreover, protection of the Great Swamp National Wildlife Ref- the proposed laboratory facility was designed to meet uge. The proposed laboratory facility borders on Loan- or exceed all Federal, State, and local laws on handling taka Brook, which flows into the Great Swamp. In re- toxic materials. Company officials argued that “their sponse to the prospect of having pretreated emissions plans are a logical extension of work done safely since from the research facility flush into Loantaka Brook, 1941 at Bell Labs in Murray Hill where Bellcore scien- a spokesperson for the Great Swamp Watershed Asso- tists are working now until their company opens a ciation said: home for them.’” [A]ny accidental discharge of hazardous materials Bellcore cited results of its commissioned risk assess- from the Bellcore facility could impair the Woodland ment studies that examined the case of a worst-credible Treatment plant operation and seriously degrade water arsine leak. The conditions defining the worst-credible quality in the brook and further downstream in the case are a failure in the mechanical scrubber (a device Great Swamp. ’ that filters out unwanted gases) resulting in a slow leak Environmentalists also expressed concerns about of arsine, or an accidental release of arsine as a result seepage of toxic materials into the groundwater from of a tube fracture, According to those studies, the max- accidental spillage or a gas cylinder rupture. It was imum exposure of any citizen in the community would stressed that two streams running through Southgate be about one fortieth of the safe arsine levels permis- --feed a major drinking water source for 600,000 peo- sible for workers. ple. By dramatizing the potential environmental im- The risk assessment consultant to CCMT developed pacts, CCMT was able to build a broad coalition of a worst-case scenario that differed considerably from supporters, consisting of civic associations and envi- cases cited by Bellcore. The storage of 1,500 gallons ronmental protection groups, to oppose the Southgate of liquid hydrogen on the roof of the laboratory build- site of the research facility. ing was the basis of one potential worst-case accident. A key difference between Bellcore and CCMT on A CCMT consultant cited as a plausible event a large the conceptualization of risk is exemplified by the hydrogen leak that could cause an explosion that terms “worst-credible case” and “worst-possible case” would rupture the arsine tank and send toxic gases out as applied to an accidental release of hazardous sub- toward the neighborhood. stances, In emphasizing the former phrase, Bellcore CCMT was uncompromising on the matter of stor- urged the community, in evaluating the risks, to con- ing toxic gases on the roof of the proposed facility. sider plausible accidents and not extremely remote or The citizens group was not persuaded by company sta- unrealistic events. However, CCMT fixed on the worst tistics on the low probability of hydrogen explosions, event that was conceivable, without considerations of or the gas detection and monitoring systems planned probability. Neither side introduced a quantitative for the new facility. Opponents of the facility fixed assessment of the likelihood that any accident could their attention on the worst-case explosive release of take place. Each party argued its case within a pre- toxic gases. That became the standard against which ferred model of risk assessment, the choice of which they would judge acceptable risk. is more a question of culture than of science. This An article in Technology Review which was distrib- difference made a negotiated settlement between ad- uted widely among members of CCMT fueled the citi- versary groups extremely difficult. zens’ resolve against accepting a compromise on the The Morris Township case is thus not one of a com- storage of toxic gases. Passages of the article read:4 munity regulating a form of objectionable research. Barely any interest was expressed by citizens about the ‘Timothy Mullaney, “Neighbors, Firm Struggle Over Chemical Risk, ” Dail.v nature of the semi-conductor and fiber optic research Record, Apr. 22, 1985. ‘Joseph La Dou, “The Not-So-Clean Bus]ness of Mak]ng Chips, ” Technol- ogy Review, May June 1984, pp. 23-25, 32, 36 ‘Sally Dudley, letter to the ed]tor, Observer-Tribune, Mar. 21, 1985 139

planned for the site. The entire focus of the debate was Morris Township debate, but were of little significance on the types of chemicals on site and the possibilities in the issue of chemical warfare research. However, of their release into the environment. Had the plan- the morality of research was discussed, to some de- ning board ruled against Bellcore, the decision would gree, in both the debate over rDNA molecules and also not have established a legal precedent for similar chemical warfare agents. Moral discourse about the cases that might arise elsewhere in the township. Plan- nature of the research program did not arise among ning board decisions are rendered for specific circum- Morris Township citizens. stances and do not accumulate as in case law. How- Bellcore’s research program is a mixture of basic and ever, had such a decision been made, it is likely to have applied science/engineering. The character of its re- created for the township an informal regulatory prece- search is a blend of what we would find at a univer- dent against similar proposals involving research with sity and what might be carried out at ADL. In Morris highly toxic gases. Although the company withdrew Township, the restraints on research came prior to the the proposal before a planning board vote was taken, construction of a laboratory; that compares favora- a mood has been created in Morris Township that, bly with the rDNA case. In contrast, ADL had initi- while not codified into law, may be no less effective ated its research before local restraints were imposed. in proscribing such activities should they arise in a fu- The social instruments for regulating research are ture site plan. markedly different between the Cambridge and Morris Township cases. The Cambridge city council and the Comparisons With Two Cambridge, health commissioner played key roles in the control Massachusetts Cases of rDNA molecules and chemical nerve agents. In con- trast, the township planning board acted as the exclu- Table C-1 illustrates some comparisons and con- sive social instrument for regulating Bellcore’s research trasts between the Morris Township case and the two program. The public health officials of the township Cambridge controversies. Notably, both the Arthur did not have a visible role in the controversy. D. Little (ADL) and Bellcore cases involve private sec- Whereas codification of research restrictions tor research for which highly toxic chemicals are re- emerged in both the Cambridge cases, no formal re- quired. Citizens of both communities cast their oppo- strictions on research were imposed in the Morris sition to the respective research activities on public Township situation. In the latter case, withdrawal by health grounds emphasizing worst-case scenarios. Op- Bellcore of its proposed solid state laboratory revealed ponents of the research in both cases were not per- the importance of a local cultural barrier to specific suaded by comparative risk analysis and arguments types of research. The barrier, although informal and that they consider the probability of a worst-case ac- unmodified, may have the persistence and efficacy of cident. Environmental factors became important in the a law. 140 -.

Table C-1 .—Comparison of Three Cases Involving Local Control of Research

Arthur D. Little Category of comparison rDNA—Cambridge (ADL)–Cambridge Bellcore—Morris Township Type of research ...... Basic science Applied chemical and Basic and applied science engineering and engineering Nature of institutions ...... Academic/nonprofit Consultant/for profit Private sector/for profit Stage of the research at outset of local intervention ...... Not yet begun 7 months ongoing Not yet begun Source of research funding . . . . NIH and NSF primarily DOD Private sector: regional telephone companies Origins of controversy ...... National and within Local and centered on a Local and centered on a scientific community city and two towns township Stimulus of local involvement ...... Newspaper story on Newspaper story on ADL’s Planning board hearing on Harvard’s plan to build new lab for testing site plan for commercial P-3 genetics lab chemical warfare agents development Primary regulatory agent ...... City council Public health commissioner Township planning board Time period of controversy . . . . Stage 1: 7 months 20 months as of July 1985 18 months Stage 2: 5 months Codification of ruling ...... Municipal ordinance Public health order banning None; withdrawal of planned regulating rDNA uses of certain chemical research by firm activities warfare agents Institutional response to community reaction . . . . Universities accept ADL rejects moratorium; Followed process through temporary moratorium litigates public health planning board; finally order withdrew proposal, no Iitigation Actual interference with research...... No appreciable delay Not prevented or Research was delayed and appreciably delayed to finally prevented at site date Judicial action ...... No legal test of moratorium Litigation taken on research No litigation or rDNA ordinance ban Nature of community involvement...... Primarily from academic No organized opposition at Organized opposition at the sector; no grass roots the early stages; intense outset; coalition-building organizations community organizing with other townships and after release of SACa regional groups report Perceived community risk . . . . Unspecified speculative Explosive release of nerve Explosion of hydrogen tank scenario of creation and agents exposing residents and release of arsine gas; release of disease-carrying also release of toxic organisms chemicals into fragile preservation area and groundwater —. aSclentific Advisory Commfttee References References

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