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The Regulatory Environment for Science (February 1986)

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The Regulatory Environment for Science (February 1986) The Regulatory Environment for Science 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 Tufts University 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 Medicine Professor of Molecular Biology Stanford University Massachusetts 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 Daniel Callahan Milton Goldberg The Hastings Center 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 Columbia University 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 . ..
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