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Formulation of the NIH Guidelines for Recombinant DNA Research as an Exercise in Due Process

Published online by Cambridge University Press:  28 February 2017

Joseph G. Perpich
Joseph G. Perpich*
Affiliation:
for Program Planning and Evaluation, National Institutes of Health
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Abstract

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Type
Biological Research and International Law
Information
Proceedings of the ASIL Annual Meeting , Volume 73 , 1979 , pp. 219 - 232
Copyright
Copyright © American Society of International Law 1979

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References

1 The Asilomar guidelines are reprinted in National Institutes of Health, Recombinant DNA Research; Documents Relating to “NIH Guidelines for Research Involving Recombinant DNA Molecules,” Vol. 1 (Aug. 1976). Vol. 1 is a ompendium of all documents relating to the NIH Guidelines during the period of Feb. 1975-June 1976; Vol. 2, June 1976-Nov. 1977; Vol. 3, Nov. 1977-Sept. 1978; Vol. 4, Aug.-Dee. 1978 [Herein after cited as “Recobinant DNA Research”]. For ad d itiona l ba ck g roun d history and debate, see National Academy of Sciences, Research with Recombinant DNA (1977).

2 Subcommittee on Science, Research , and Technology, House Commit tee on Science and Technology, 95th Cong. 2d Session, Science Policy Implications of Recombinant DNA Molecule Research at 62 (Comm. Prin t Mar. 1978).

3 Bazelon, , Coping with Technology Through the Legal Process, 62 Cornell L.R. 824 (June 1977)Google Scholar.

4 For thoughtful critiques o f the Science Court, see Casper, Technology, Policy, and Democracy: Is the Proposed Science Court What We Need? 194 S cience 29, and Bazelon, supra note 3, at 826-29. For a discussion on the concept of the commission, see Grobstein, The Recombinant DNA Debate, 237 S cientific A m. 22-33 (1977, and see Yezely, The Use o f an Advisory Commission 51 S. C a l . L.R. 1451-69. See also the Prologue to the Southern California Law Review Symposium, entitled Biotechnology and the Law: Recombinant DNA in the Control o f Scientific Research.

5 Green, The Boundaries o f Scientific Freedom, 20 N ewsletter on S cience, T echnology, and H uman V alues 17-20 (1977). A s Dorothy Melkin has pointed out, a major issue of the recombinant DN A controversy is the need to establish “a viable relationship between science and society that will allow continuing negotiation about the specific problems of research.” See Melkin, Threats and Promises: Negotiating the Control of Research, D aedalus, Spring 1978, 191-206

6 For detailed discussions on the nature of the technique and on potential risks and benefits, see N ational Institutes of H ealth, E nvironmental Impact Statement on NIH G uidelines for R esearch Involving R ecombinant DNA M olecules (1977). A draft Environmental Impact Statement on the Guidelines was published in 41 F ed. R eg. 38426 (Sept. 9, 1976), and the final Environmental Impact Statement was published in Oct. 1977.

7 National Institutes of Health, Environmental Impact Assessment of a Proposal to Release Revised NIH Guidelines for Research Involving Recombinant DNA Molecules, 43 F ed. R eg.33096-33178 (see 33104-5).

8 See 1 R ecombinant DNA R esearch 140-405 for a transcript o f the public hearing. See 41 F ed. R eg. 27902 (June 7,1976).

9 See Report o f the Working Party on the Practice o f Genetic Manipulation in Appendix IV of the R eport of the F ederal I nteragency C ommittee on R ecombinant DNA R esearch.- International A ctivities 2 R ecombinant DNA R esearch441-460 (Nov. 1977).

10 See id. 381-500

11 See Interim Report of the Federal Interagency Committee on Recombinant DNA Research: Suggested Elements for Legislation, 2 Recombinant DNA Research 279-345

12 See S.1217, 95th Cong. 1st Sess. 2 R ecombinant DNA R esearch 671-739. See H.R.6158, 95th Cong. 1st Sess. 2 R ecombinant DNA R esearch 559-76.

13 See H.R.7897, 95th Cong. 1st Sess. 2 R ecombinant DNA R esearch 618-70. (June 20, 1977).

14 See First Report to COGENE from the Working Group on Recombinant DNA Guidelines (Draft), Committee on Genetic Experimentation, (Mar. 1979).

15 Environmental Impact Statement on NIH Guidelines for Research Involving Recombinant DNA Molecules at 38-39 (Oct. 1977).

16 Supra note 15

17 3 R ecombinant DNA R esearch, Appendix C, at 13. See also supra note 1.

18 Id. at 33.

19 Id. at 117.

20 20 See 42 F ed. R eg. 4 9 5 9 6 (Sept. 2 7 ,1 9 7 7 ) , 3 Recombinant DNA Research 164. See also supra note 1.

21 21 See 42 F ed. R eg. 59918 (Nov. 22, 1977); 3 R ecombinant DNA R esearch, supra note 20, at 587. See also transcript, id. at 205.

22 See 43 F ed. R eg. 33042 (July 28, 1978).

23 23 See 43 F ed. R eg. 60080 in 4 R ecombinant DNA R esearch 3, 87 (Dec. 22, 1978).

24 For a contrary view see Singer, Spectacular Science and Ponderous Process (editorial) Science 203, (Jan. 5, 1979).

25 Supra note 3.