CONTENTS 
Fat* 
Letter of transmittal III 
Summary of conclusions _ VII 
Issues and scope of the hearings 1 
1. General observations 1 
2. Conclusions 3 
A. DNA recombinant molecule research 3 
B. The NIH recombinant DNA research guidelines 5 
C. Risk-benefit assessments 6 
D. General implications for science policy 7 
E. Processes and procedures for setting policy 8 
F. International considerations 9 
Post-hearing developments - 11 
A. Changes in perception of risk 11 
B. Revisions of the guidelines 11 
C. International activities 12 
D. Procedural violations of the NIH guidelines 12 
E. Commercial developments 13 
F. Environmental impact statement on NIH guidelines for research 
involving recombinant DNA molecules 13 
Report of the hearings 15 
I. The biology of DNA recombinant molecule research 15 
A. Introduction 15 
B. Basic biology of the DNA recombinant molecule technique.. 16 
C. Alternative techniques 17 
D. Significance of the DNA recombinant molecule technique 18 
II. The objectives and status of the DNA recombinant molecule research 
guidelines 21 
A. Introduction 21 
B. Physical containment 21 
C. Biological containment 22 
D. The NIH guidelines for DNA recombinant molecule research. 23 
E. Industry views 26 
III. The place of risk-benefit analysis in scientific research — recombinant 
DNA research as a case history 29 
A. Introduction 29 
B. Risk-benefit debates in DNA recombinant molecule research. 29 
C. General perspectives on risk-benefit analysis in public policy 
decisions 37 
IV. Science policy implications of the DNA recombinant molecule issue.. 43 
A. Introduction 43 
B. International activities 43 
C. Public participation in science and technology decisionmaking- 46 
(1) Scientific societies 46 
(2) Public interest groups and universities 49 
V. Legal, moral, and ethical issues 55 
A. Introduction 55 
B. Patent policies and other legal perspectives of concern 55 
C. Constitutional issues of concern to basic research considera- 
tions 58 
D. Ethical issues of concern 61 
E. General views and perspectives 68 
APPENDIX 
Discoverer Would Lift Curbs on DNA 71 
Recombinant DNA: NIH Rules Broken in Insulin Gene Project 72 
U.S. Agency Bids Lab Halt Work on Genes 74 
Politics and People 76 
A Commercial Debut for DNA Technology 77 
(V) 
[Appendix B — 48] 
