Protection of Human Subjects in Research

1. Protection of Human Subjects in Research February 10, 2012 Gerberding Hall 142, University of Washington

2. Speaker Karen Moe, PhD Director and Assistant Vice Provost for Research Human Subjects Division kemoe@uw.edu 543-0098 Associate Research Professor, Psychiatry & Behavioral Sciences

3. Help, policies, guidance, forms HSD Email hsdinfo@uw.edu HSD Phone 206-543-0098 HSD website www.washington.edu/research/hsd/

4. What is the Human Subjects Division (HSD)? • Human subjects compliance • Supports UW Institutional Review Boards (IRBs) • About 40 people

5. The UW IRBs: n=7 Committee A: biomedical Committee B: biomedical Committee C: social/behavioral/humanities Committee D: biomedical Committee G: social/behavioral/humanities Committee J: social/behavioral/humanities Committee K: hybrid (mostly biomedical)

6. The UW IRBs Structure • IRB members & HSD support team • “Minimal Risk” = IRB subcommittees of HSD staff Timing • Bi-weekly meetings • Materials sent to IRB 5-7 days in advance

7. Other IRBs used for UW research Western IRB (WIRB) for industry-initiated-and-funded clinical trials Cancer Consortium IRB (CC-IRB, or “Hutch” IRB) for cancer-related research Cooperative agreements: avoid “dual review”

8. How do I start?

9. Time, money, frustration, non-compliance

10. Your activity • Is it research? • Does it involve human subjects? • Does it qualify for exempt status? • Which IRB does the review? • What type of review is required? • Any related compliance requirements?

11. Is it research? Definition: A systematicinvestigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge. • Includes research development, testing, and evaluation.

12. Activities that may not be “research” • Case report or case study • Program evaluation • Oral history • Quality assurance/quality improvement

13. How do I know? Ask HSD • Email hsdinfo@uw.edu • Phone Look at HSD’s form: “Case Report Research Self-Determination” for analysis of the definition of research. No need to submit the form.

14. HSD home page: Go to “Forms”

15. HSD Forms List: Case Report

16. Case Report Self-Determination Form Has definitions of: • Systematic investigation • Designed • Generalizable

17. Why does this matter? If it is not “research”, IRB review is not required, even if you are studying humans.

18. Does it involve human subjects? Definition: An individual about whom a researcher obtains • Data through intervention or interaction with the individual, or • Identifiable private information Not sure? Ask HSD, or see the Policy & Procedure document “Human Subject Definition”

19. HSD home page

20. HSD List: Policies & Procedures

21. Remember…. Records and specimens can be “human subjects”, even if you are not obtaining them directly from the individuals

22. When your research does not involve direct contact with humans Use this HSD form to self-determine whether “human subjects” are involved: Use of Non-identifiable Specimens/Data

23. When your research does not involve direct contact with humans

24. Public data sets: Not “human subjects”

25. Exempt Status Certain types of human subjects research are “exempt” from the regulations • Requires HSD administrative review • Median turnaround time: 6 business days Forms List on the HSD website Initial application form: Exempt Status Request

26. Human Subjects Research: Which IRB?

27. “Minimal Risk” review • Some types of research do not require review by the full IRB committee. • Advantage: faster (median=24 business days) • All requirements for approval are the same as for full IRB review.

28. Minimal Risk review How do I know if I qualify? • Instructions and guidance on the front of the standard Human Subjects application form: Human Subjects Review Application UW 13-11 How do I apply? • Human Subjects Review Application UW 13-11, or • Medical Records Review form

30. Full IRB Review What form do I use? • Human Subjects Review Application UW 13-11 • Repository Application How long does it take? Median = 56 business days

31. Most frequent reasons for delay • Incomplete applications (e.g., did not attach a complete copy of the grant) • Requested inappropriate type of review (e.g., exempt application) • Insufficient information about procedures • Unanswered questions • Lack of differentiation between what is the research and what is not

32. Funding and IRB approval • “Just in Time” Plan ahead! • NIH compared with NSF • Industry clinical trials • “LAD” status: Limited Activities Determination

33. IRB Metrics: Link on HSD home page

34. Detailed Quarterly Report

35. Working with Other Institutions • Every institution that is “engaged” in a human subjects project must do an IRB review, unless arrangements are made for one IRB to rely upon the other IRB: Institution-specific Cooperative Agreement or Study-specific IRB Authorization Agreement

36. Other HSD/IRB responsibilities • HIPAA and research • Registration of clinical trials (clinicaltrials.gov) • Comparing contract, consent, and budget for industry clinical trials • Confidentiality agreements • UW Injury Compensation Plan

37. Confidentiality Agreement • WA State Law: the use of state-owned records for research, without the consent of the individual, requires a formal Confidentiality Agreement between the state agency and the researcher. • UW records: medical, student, personnel, etc. Required even when UW physician-researcher is using own patient records.

38. HSD Forms: Confidentiality Agreement

39. UW Injury Compensation Plan • For medical problems caused by UW research: • Up to $10K reimbursement for expenses • Free medical care at UW Medicine • A “no fault” program • Research location is irrelevant • HSD administers the program

40. Requests for your research data Examples • From a research subject • An attorney, or a subpoena • Public records request Immediately forward the request to HSD, the UW Public Records office, or the UW Attorney General’s office. Do not respond on your own.

41. HSD Strategic Goals • Encourage research by facilitating fulfillment of ethical and compliance responsibilities • Achieve operational excellence • Create a wonderful place to work • Add value to the UW