1. Conflict and Consent: Managing Disclosure in Human Subjects Research University of Miami Human Subjects Research Office Conflict of Interest Symposium May 11, 2007 Kenneth W. Goodman, Ph.D. University of Miami Ethics Programs kgoodman@miami.edu

2. Context  Ethics precedes regulation  Focus on compliance ignores reason and critical thinking IRBs must make educated judgments

3. “Checklist Ethics” 46.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

4. “Checklist Ethics” 2 §46.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. … (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

5. “Checklist Ethics” 2 §46.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116. (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

6. Valid Consent  Adequate information  Voluntariness  Capacity

8. Conflicts of Commitment  Publication and authorship  Social, policy advocacy  Career advancement

10. “Nonfinancial Conflicts” “Nonfinancial conflicts of interest are more subtle yet more pervasive and cannot be eliminated. They require continuous attention if they are to be managed successfully.” Levinsky NG. Nonfinancial conflicts of interest in research. NEJM 2002;347:759-761.

12. Disclosure Hypothesis: Prospective subjects tend to care more about nonfinancial conflicts than financial ones.

13. Disclosure 2 Some conflicts are unacceptable even when disclosed.

14. Managing CoC IRBs need to decide which ones, despite that:  45CFR46 is silent on the issue  There is no other guidance  There is no research

15. Challenges  IRBs are overwhelmed  Checklists produce the illusion of adequacy  Educational support is too often disdained, except …

16. Conflict and Consent: Managing Disclosure in Human Subjects Research University of Miami Human Subjects Research Office Conflict of Interest Symposium May 11, 2007 Kenneth W. Goodman, Ph.D. University of Miami Ethics Programs kgoodman@miami.edu