2. Human Research Protection Program 101 March 20, 2007 Cincinnati, OH

3. Is this exempt? expedited? Presented by: Marisue Cody, PhD, RN Presented by: Marisue Cody, PhD, RN

4. Objectives Evaluate if a study is human subjects research Evaluate if a study meets exempt criteria Evaluate if a study meets expedited criteria

5. Definitions Exempt – Encarta Dictionary, “to allow or entitle one to not do what others are obliged to do”. The IRB Chair or designee must approve the exempt status. Expedited – Encarta Dictionary, “to deal with something swiftly and efficiently”. In reference to research, it is a review process by the IRB Chair or designee for a study that involves human subjects. FYI: The IRB & R&D Committees needs to be informed of what items have been exempted and expedited.

6. Is it “Research”?

7. … a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to “generalizable” knowledge. (45 CFR 46.102d) Widespread information… Research

8. Case #1: Social Work Intern project She is reviewing 3 groups of outpatients : (1)Day treatment group, (2)Never attended group, (3)Used to attend group but dropped out. She is asking standard questions regarding their feelings and opinions about the group. She will collect demographic and treatment information but it will be collected without identifiers. Her primary goal is to report the results to the Chief of Mental Health. Can it be exempt, expedited, or neither?

9. Are there “Human Subjects”?

10. Human subject …means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46.102f)

11. Case #2: An investigator proposes to do a study of genetic markers of colon cancer. He will purchase cells from a company that archives tissue for these purposes. The cells will have no identifiers.

12. Is it “Research with Human Subjects”?

13. Is it “Exempt”?

14. Exempt Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:  [Exemptions b(1-6)] 45 CFR 46.101(b)

15. Categories of Exempt Research 1.Research conducted in established educational settings, involving normal educational practices 2.Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior 3.Same as # 2, but covers elected officials 4.Research involving use of existing data 5.Research and demonstration projects by approval of agency heads 6.Taste and food quality

16. Exempt if it is “ONLY”… Research in one or more exempt categories, for example, an anonymous survey of adults. AND NOT research in any covered research category, for example, collecting private identifiable data from future records.

17. Is It a “Covered Activity”?

18. What are the Covered Research Categories? Identifiable private information? Vulnerable populations? Subjects vulnerable to coercion or undue influence? Treatments or procedures? Incomplete Information?

19. Case #4: The IRB chairperson receives a protocol requesting exemption from IRB review under 45 CFR 46.101(b) 4 (refer to chart 2 & 5). The protocol includes the use of adipose tissue being taken from patients during liposuction. The samples are being collected at another site, and the local investigator wants to obtain them for use in a study at the VA. When the VA investigator receives the samples they will be de-identified. The patients at the site collecting the samples were not consented for this use. What should the Chair do?

20. Points to consider… Does this study use existing specimens? “Existing” means existing before the research is proposed to the IRB to determine whether the research is exempt. Should the subjects be or have they been consented (from another study…use your data for future studies)? Are they asking for a waiver of consent? FDA may not recognize exemptions from a specimen collection that has not been authorized by an IRB.

21. IRB determinations for exemptions IRB Chair or an IRB member designated by the Chair R&D Committee must be notified Exemption documented in the IRB records (including category) Decision communicated in writing to investigator Subject to R&D Annual review

22. What research activities are eligible for expedited review? No more than Minimal Risk. Must fit one or more of the categories on the Expedited Review Categories List Minor changes in previously approved research during the period for which the approval is authorized

23. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests. (45 CFR 46.102(i))

24. Expedited Categories Clinical studies of drugs and medical devices only under specific conditions Collection of blood samples Biological specimens obtained by non-invasive means Collection of data through non-invasive procedures Materials collected solely for non-research purposes Collection of data from voice, video, etc. Research employing surveys, etc. (OMB Issue) Continuing review under specific conditions

25. Case #5: This study proposes to collect data on 5,000 VA patients with ICU admissions from 2003-2004 to compare statistical models of risk adjustment and mortality prediction. There is no direct patient contact and scrambled patient identifiers are used to link data from various sources (Austin, Pharmacy Benefits Management, CPRS).

26. Do you want more examples? From the Veterans Health Administration / Ann Arbor H.S.R. & D. http://vaww.va.gov/hsrdcomputersupport/IRB/

27. IRB Determinations IRB Chair or one or more experienced reviewers designated by the Chair from among members of the IRB Notification of IRB members & PI Minutes and/or protocol file must reflect eligibility category Subject to continuing review based on IRB approval date Requires R&D Approval (currently, there is no option for expedited/exempt review from the R&D Committee)

28. Thank you!