Attachment I Draft List of Questions for Oral History Interviews 1. Please discuss your educational background and training. Do you have any memories of research ethics standards being taught or discussed while you were in medical or graduate school? If so, please tell me about them. 2. When did you begin to work with human subjects generally, or related to radiation work specifically? How did you make the decision to go from animal testing (if there was any) to human testing? Who did you talk to about your research? How were research subjects recruited? What were prospective subjects told, if anything? Were there explicit standards of consent? Were these standards adhered to? Were these enforced? In what manner was consent obtained? Was consent taken seriously in the profession, or was it done in a pro forma fashion? Do you recall any discussions among colleague- researchers about how to approach human subjects to obtain consent? Was there any attempt on your part or others to draw up a written document for research subjects? 3. Did any examples of human research impress you as models of particularly ethical or unethical practice with respect to consent? What constituted "normal" or more typical human research practices in your early days as a researcher? 4. How did you conceive of your responsibility, for the well- being of the persons who would be subjects in your research? Do you recall any discussions among colleague-researchers about the risks and benefits associated with your research or the research of others? 5. Are the practices and policies regarding human subjects different now than they were at the beginning of your career? When do you recall things started to change? Are you aware of the Surgeon General's 1966 rule requiring review of PHS-supported clinical research? When was any type of "IRB" review initiated at institutions with which you were associated? How important do you think "IRB" review is in ensuring the ethical conduct of human experimentation? Did "IRB" review change significantly in the early 1970s when IRB's began to include non-medical members? Have you ever served on an IRB? How would you characterize that experience? 6. How have consent standards changed over the course of your career? Do you know whether different parts of the country have had different standards? How about different institutions? Did it matter which kind of grant you were on? (i.e. Did a Rockefeller grant require more detailed explication of consent in the experiment than an NIH grant?) Did you see consent standards evolve steadily over time, or were standards erratically discussed and enforced? What was the impact on your research practices of the vastly increased regulation of human experimentation that has occurred beginning in the early 1970s? How have you responded to the various changes that have been made in the regulations since the early 1970s? 1 7. Did national security considerations ever influence the way in which you approached scientific and ethical considerations or in how risks and benefits were presented to research subjects? Do you know of others who were influenced by national security considerations? 8. Did the Cold War ethocs influence your work? How? Describe the atmosphere. 9. Were you aware of [radiation] experiments in the course of your career that you considered to be morally wrong? Were you aware of research that now, upon reflection, you consider to be morally problematic? Did you ever participate in such research? 10. Was there a closed circle of institutions (Chicago, California, Rochester, etc.) that had the market cornered on [radiation] research? Did this hamper research efforts? 11. What kind of oversight did government agencies provide for the individuals and institutions carrying out the research they sponsored? 12. Did you and your colleagues approach research conducted in a therapeutic context (on medical patients relative to their illness) and non-therapeutic context differently? Was there a difference between research done on those expected to die and other subjects? What were such differences, if any? Why did you make these distinctions? 13. How did you select or recruit the subject populations for your research? Do you think there is any validity to the claim that "vulnerable" populations have been disproportionately represented in the history of human experimentation? What are appropriate criteria to use in the selection of research subjects? Are non-medical characteristics ever relevant? 14. Have you ever performed experiments upon yourself or been involved in someone else's protocol? How did self- experimentation or the willingness to undergo a procedure influence your approach to human research? 15. Were or are you aware of the literature concerning human experimentation? Have you ever heard of Nuremberg? Helsinki? Ivy? Beecher? Did the pronouncements of the judges at Nuremberg regarding research ethics break new ground, or were they reinforcing ideas that already existed? Do you recall any discussion or reflection on the Nuremberg code or the Helsinki or the AMA codes that had been devised to govern research ethics? [Use this question to prompt people if necessary, but not until late in the interview.] 2 16. Do you know of the existence of any seminars or workshops at conventions which focuses on these questions. Were there any such seminars or workshops in the past? 17. Do you believe that public support of, and trust in, medical researchers and medical science has changed over the course of your career? Do you perceive a difference in the perceptions of research subjects and/ or patients? Describe the changes, if any. How do you explain the changes? 18. What influence did legal considerations or fears of a bad outcome have on the conduct of your research? Did you ever consult or feel that you would have liked legal advice about a research project or obtaining consent? 19. What problems do you see today regarding current regulations and practices in human experimentation? 3