2. OHRP Electronic Access E-mail: ohrp@osophs.dhhs.gov Web Site: http://ohrp.osophs.dhhs.gov

3. IRB Review

4. Institutional Review Board (IRB) Membership: At least five members of varying backgrounds – Sufficiently qualified – Not solely of one profession – Gender diversity At least one non-scientist At least one non-affiliated member Expertise on “vulnerable populations” Outside consultants

5. IRB Responsibilities Review and approve, require modifications, or disapprove all covered research Require that informed consent is in accordance with regulations Require documentation of informed consent or may waive documentation in accordance with regulations Notify investigators in writing of decisions Conduct continuing review of research no less than once per year

6. IRB Decision Matrix BENEFICENCEJUSTICE RESPECT FOR PERSONS Privacy & Confidentiality Protection of subjects (especially vulnerable populations) Informed consent Surrogate consent Assent Risk/Benefit Analysis Experimental Design Qualifications of PI Subject selection Inclusion/exclusion Recruitment J. Cooper, Albany Medical Center

7. Expedited Review Expedited Review is not “review light”

8. Expedited Review 46.110(b) Expedited Review An IRB may use expedited review for – Research on list of eligible categories – Minor changes in previously approved research Carried out by IRB chair or one or more experienced IRB members Reviewers can exercise all of the authorities of the IRB except disapproval All IRB members must be informed of research approved under expedited review [46.110(c)]

9. Expedited Review Expedited Review Applicability No More Than Minimal Risk Categories Apply Regardless of Age Do Not Apply if Identification Place Subjects at Risk or Damage or Stigmatization Do Not Apply to Classified Research Standard Informed Consent Requirements Do Apply http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ expedited98.htm

10. Expedited Review Clinical Studies (No IDE/IND) Noninvasive Prospective Collection of Biological Specimens Noninvasive Data Collection Used in Clinical Practice Individual / Group Characteristics or Behavior Collection of Blood Samples Data, Documents, Records, Specimens Collected for Nonresearch Purposes Voice, Video, Digital, or Imaging Recordings for Research Continuing Review - No new subjects - Minimal risk approved under full review Expedited Review Categories

11. Full Review Convened meeting - no mail reviews (telephone participation OK) Quorum – Majority of IRB present – At least one non-scientist present – Approval by majority of those present Members with conflict of interest should be absent during discussion and vote Should the quorum fail during a meeting (e.g. those with conflicts being excused, early departures, loss of a non-scientist), no further votes can be taken unless the quorum can be restored

12. IRB Meeting Minutes Attendance at the meetings. Actions taken by the IRB. Vote on these actions including the number of members voting for, against, and abstaining. Basis for requiring changes in or disapproving research. Documentation of specific findings required by the regulations. Written summary of the discussion of controverted issues and their resolution.

13. Continuing Review Appropriate to the degree of risk and not less than once per year – Should be set for each protocol, not a routine annual review No grace period but may use original anniversary date Must be substantive and meaningful

14. Continuing Review Materials: protocol summary and a status report on the progress of the research – the number of subjects accrued; – a description of any adverse events or unanticipated problems involving risks to subjects or others and of any withdrawal of subjects from the research or complaints about the research; – a summary of new information relevant to human subjects, especially information about risks associated with the research; and – a copy of the current informed consent document One member should review entire protocol

15. Beyond the Consent Form Informed Consent

16. The Consent Process Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include: full disclosure of the nature of the research and the subject's participation, adequate comprehension on the part of the potential subjects, and the subject's voluntary choice to participate.

17. Tampa Tribune 3/11/00 TAMPA - A lawsuit accusing USF doctors of experimenting on pregnant women without their consent is settled for $3.8 million…. The experiment wasn't considered risky and no adverse effects were documented, plaintiffs in the suit agree. However, the failure to inform … as many as 3,000... pregnant women of various experiments conducted between 1986 and 1990 has cost Tampa General Hospital, USF and the state $3.8 million.

18. General Issues

19. An adversarial relationship between the IRB and investigators puts subjects at risk. The IRB should not become an IRS

20. The Myth of Dr. Frankenstein

21. Current Climate Reactive Hyper- Protectionism Not the appropriate response!