Recombinant DNA: A Case Study in Regulation of Scientific Research James C Chalfant* Michael E. Harmann** Alan Blakeboro*** INTRODUCTION The time when developments in science and technology were auto- matically welcomed as progressive and beneficial has passed. Public confidence in the scientific community has given way to skepticism, if not distrust.I This attitude is due in part to the recent development of highly complex and sophisticated technologies which, from their incep- tion, have been recognized as entailing substantial risks as well as bene- fits. The public now expects the government to evaluate independently the risks of new technologies before they are introduced and, moreover, demands input into the decisionmaking processes that sanction their use. Many of these new developments, however, cannot be adequately understood without a high level of scientific expertise. Indeed, these developments are so esoteric that only those working directly with the Copyright © 1979 by ECOLOGY LAW QUARTERLY. * 1978-79 Editor-in-Chief, ECOLOGY LAW QUARTERLY. B.A. 1974, Pomona College, J.D. 1979, University of California, Berkeley. ** 1978-79 Comments Editor, ECOLOGY LAW QUARTERLY. B.A. 1976, University of California, Los Angeles, J.D. 1979, University of California, Berkeley. *** Member Third Year Class, University of California, Berkeley. B.A. 1976, Univer- sity of California, Santa Barbara. 1. The last 20 years have marked a change in the public's view of science and its products. The environmental awareness of the 1960's, sparked by Rachel Carson's The Si- lent Spring (1962), has changed the public's mood from a trusting acceptance to a presump- tive distrust of technology and science. Note, Recombinant DNA and Technology Assessment, 11 GA. L. REV. 785, 786-87 (1977) [hereinafter cited as Note, Recombinant DNA]; Rowe, Governmental Regulation of Societal Risks, 45 GEO. WASH. L. REV. 944, 945- 47 (1977); PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH, U.S. DEP'T OF HEALTH, EDUCATION, AND WELFARE, PUB. No. 76-1138, 1 RECOMBINANT DNA RESEARCH 180, 341 (testimony of A. Ludwig) (1976) [hereinafter cited as 1976 HEW DOCUMENTS]. In addition, the increased power of "scientific progress" planted seeds of distrust. For example, Professor Laurence Tribe views recombinant DNA research as producing unease in "what it means to be a human being" because the research is an essential step in manipu- lating a person's genetic identity. Scientific advance of such impact will contribute to soci- ety's fear of technology generally. See Tribe, Technolog, Assessment and the Fourth Discontinui." The Limits of Instrumental Rationality, 46 S. CAL. L. REV. 617, 649 (1973). ECOLOGY LAW QUARTERLY [Vol. 8:55 technology are capable of understanding it; even scientists in related fields are unable to comprehend all of the complexities. Since applica- tion of knowledge from more than one field of scientific inquiry is nec- essary to evaluate properly all of the risks, benefits, and social consequences of the new technologies, a complete analysis can be made only through the cooperative efforts of many specialists from different fields. Yet the public not only expects the government to evaluate these complex technologies, but demands a voice in the assessment. This di- lemma is compounded because those who best understand the technol- ogies, the researchers in the field, cannot be entrusted with impartial evaluation due to the possibility of bias. Recombinant DNA experimentation presents a situation in which the public, the government, and the scientific community have at- tempted to resolve this dilemma. 2 The problems raised are unique, for this is the first instance in which the recognition and control of risk necessarily involves the regulation of pure scientific research.3 Further regulation of this kind is certain to follow as other similar technologies are developed.4 Recombinant DNA research is unique because the scientists who developed and used the technique were the first to appre- ciate its consequences. They took steps to regulate themselves, despite their role bias, until the issues came to the attention of the public. Such self-regulation is a highly fortuitous occurrence; it cannot be relied upon in the future as a method of risk control. Instead, society must develop the means to recognize the potential risks of scientific develop- ment, or, barring such foresight, the capability to deal quickly and ef- fectively with such risks as they become known. Imposition of any system of external controls on research meets with the argument that it is in the interest of society to maintain a sci- 2. For a description of recombinant DNA experimentation see text accompanying notes 37-41 infra. The term "gene-splicing" is used synonymously to recombinant DNA throughout this Article. Several books have been written about the recombinant DNA debate. Science Maga- zine's Nicolas Wade has written a straightforward history, The Ultimate Experiment (1977); Rolling Stone's science writer Michael Roger has written a more entertaining, yet scientifi- cally lucid account, Biohazard(1977); June Goodfield's Playing God (1977) and Ted How- ard's and Jeremy Rifkin's Who Should Play God? (1977) view the controversy from a perspective that examines the general ethical questions in scientific research and experimen- tation. For a shorter primer on the debate that does not oversimplify the science involved, see Grobstein, The Recombinant DNA Debate, SCIENTIFIC AM., July 1977, at 22. 3. Another, earlier developed technology is nuclear power. To some extent the problems encountered in regulating nuclear power are relevant to the recombinant DNA debate and are considered in this Article. But an important difference is that nuclear power involves the application of atom splitting research; regulation does not reach directly the pure research itself. 4. For example, science is just beginning to develop the sophistication to experiment with humans and related species at a molecular level-an area fraught with potential bene- fits and risks. 19791 RECOMBINANT DNA entific community free from direct regulation.5 Those who make this argument see the value of an independent scientific community as of such overriding importance that research must be absolutely free from any direct restraint. Although the absence of control may result in some costs to society, the benefits of unhampered general inquiry far outweigh such costs. For example, control over scientific inquiry may discourage the "creative risk taking . and opportunities for seren- dipity on which original discovery depends."' 6 Also, direct regulation 7 may result in political encroachment upon legitimate research. It could provide government with a tool for exercising political influence over what should be a nonpolitical enterprise. The effect of such influ- ence could be to focus scientific expertise on practical short-term results rather than on long-term benefits associated with the accumulation of basic scientific knowledge." A related fear is that a regulatory system 5. See generally McGill, Science and the Law, 23 CATH. LAW. 85 (1978); Delgado & Millen, God, Galileo, and Government: Toward Constitutional Protection for Scientiic In- quiry, 53 WASH. L. REV. 349 (1978); Jonas, Freedom of Scientific Inquiry and the Public Interest, HASTINGS CENTER REPORT, Aug. 1976, at 15; Lederberg, The Freedom and the Control of Science:" Notes from the Ivory Tower, 45 S. CAL. L. REV. 596 (1972). Much has been written on the legal and policy issues of the recombinant DNA research controversy. See generally Comment, Considerations in the Regulation of Biological Re- search, 126 U. PA. L. REV. 1420 (1978); Note, Recombinant DNA, supra note 1;Berger, Government Regulation of the Pursuit of Knowledge. the Recombinant DNA Controversy, 3 VT. L. REV. 83 (1978); Comment, DNA and the Congressional Prerogatives. Proposals for a Deliberate Legislative Approach to Genetic Research, 53 IND. L. J. 571 (1978); Balmer, Re- combinant DNA: Legal Responses to a New Biohazard, 7 ENVT'L L. 293 (1977); Comment, Law vs. Science: Legal Control of Genetic Research, 65 Ky. L. J.880 (1977); and Symposium, Biotechnology and the Law- Recombinant DNA and the Control of Scientfic Reseasrch, 51 S. CAL. L. REV. 969 (1978) [hereinafter cited as Recombinant DNA Research Symposium]. For an examination of international implications, see Comment, Genetic Manipulation: Research Regulation and Legal Liability Under International Law, 7 CAL. W. INT'L L. J. 263 (1977); Comment, The Potentialfor Genetic Engineering. A Proposalfor International Legal Control, 16 VA. J. INT'L L. 403 (1976); and Kamely & Curtin, InternationalActivities in Recombinant DNA Research, RECOMBINANT DNA TECH. BULL., Fall 1977, at 28. For a focus on the National Environmental Policy Act, see Chalker & Catz, Case Analysis of NEPA Implementation: NIH and DNA Recombinant Research, 1978 DUKE L. J. 57. 6. 195 SCIENCE 939 (1977) (editorial by E. Shrieur, Pres., Biosystems Ass'n) [hereinaf- ter cited as SCIENCE EDITORIAL]. For the view that the rubric of "freedom of inquiry" should not automatically shield experimentation, see Lapp, The Non-Neutrality of Hypothe- sis Formation, in SCIENCE ETHICS AND MEDICINE 96 (H.T. Englehardt, Jr. & D. Callahan ed's 1976), reprinted in Science Policy Implications of DNA Recombinant Molecule Research: Hearings Before the Subcomm. on Science, Research, and Technology of the House Comm. on Science and Technology, 95th Cong., 1st Sess. 1022 (1977) [hereinafter cited as 1977 House Hearings]. 7. One example of this sort of influence is Senator -William Proxmire's well-known "Golden Fleece Award," given to federally funded experiments that appear to be devoid of merit. Publicizing individual experiments distorts their ultimate worth; they can only be properly evaluated in the context of a pattern of research in the field. Consequently this award may be more harmful than beneficial, especially in light of the much greater effect on reseach decisions of this type of indirect regulation than safety guidelines. See Berger, supra note 5, at 107. 8. For example, "result" emphasis could have led polio researchers of the 1940's and ECOLOGY L4W Q UARTERL Y [Vol.