1. Session C: What Deans Should Know About the IRB Process Presiding: Carmen R. Cid, Eastern Connecticut State University Panelists: – Roy Barnes, University of Michigan-Flint – Michelle Feige, Office for Human Research Protections – David Bozak, State University of New York at Oswego – Laura Argys, University of Colorado Denver

2. The “TOP 10” Things Deans Should Know About the IRB Roy C. Barnes Assistant Dean College of Arts and Sciences University of Michigan-Flint

3. 10.Human Subjects Protection is important and serious business 9.IRBs view RISK broadly – immediate risk from participation and risks to reputation

4. 8.Key Historical Document, the 1979 Belmont Report 7.Key Regulation: CFR 45-46 on Protection of Human Subjects

5. 6.Vulnerable populations require additional protections 5.IRBs do not evaluate the quality of the proposed research – per se

6. 4.IRBs oversee RESEARCH. If is not “research,” it is not subject to IRB approval 3.As a corollary, Assessment Data are not subject to IRB approval

7. 2.You cannot retroactively seek IRB approval for data you have already collected 1. IRBs do not deal only with biomedical research

8. CCAS Annual Conference: New Orleans, LA November 11, 2010 The Role of Deans: Regulatory & Administrative Responsibilities Michelle Feige, MSW Public Health Analyst Division of Education and Development (DED) Office for Human Research Protections (OHRP) Department of Health & Human Services (DHHS) Office for Human Research Protections

9. Presentation Overview What is OHRP? Regulatory Provisions What is Non-Exempt Human Subjects Research? Terms of the FWA & Role of Institutional Official Compliance Contact Information

10. What is OHRP?

11. 11 OHRP’s Organizational Structure OHRP, Office of the Director Jerry Menikoff, Director Melody Lin, Deputy Director Michael Carome, Associate Director for Regulatory Affairs Division of Compliance Oversight Kristina Borror Director Division of Policy and Assurances Irene Stith-Coleman Director Division of Education and Development Elyse I. Summers Director HHS Kathleen Sebelius, Secretary Other HHS Agencies (FDA, NIH, CDC, etc) International Activities Melody Lin, Deputy Director Office of the Assistant Secretary for Health Howard Koh, Assistant Secretary for Health

12. 12 Title 45 Code of Federal Regulations Part 46

13. Regulations for Protection of Human Subjects HHS regulations: Title 45 CFR part 46 Subpart A – basic HHS Policy - “The Common Rule” or Federal Policy - Basic IRB & informed consent requirements -Other federal departments & agencies have adopted – FDA has its own Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, HHS, & Homeland Security. NSF, NASA, EPA, AID, Social Security Administration*, CIA, and the Consumer Product Safety Commission *only in part

14. HHS Regulations: Title 45 CFR part 46, cont’d Subpart B - Pregnant Women, Human Fetuses, and Neonates Subpart C - Prisoners Subpart D - Children Subpart E – IRB Registration (effective 7/2009)

15. Other Regulatory Entities… FDA Regulations Other Dept/Agencies State and Local Laws Institutional Policies

16. The Regulations Apply When: Research involving human subjects conducted or supported by HHS that is not otherwise exempt -OR- Non-exempt human subject research covered by Assurance of Compliance

17. Do the Regulations Apply? 1.Does activity involve Research? 2.Does research involve Human Subjects? 3.Is human subjects research Exempt? ASK QUESTIONS IN THIS ORDER!

18. What is Research? Research - a systematic investigation designed to develop or contribute to generalizable knowledge – includes research development, testing, evaluation, e.g., pilot studies §46.102(c)

19. Where Can You Find Help? Human Subject Regulations Decision Charts hhs.gov/ohrp/humansubjects/guidance/decisionch arts.htm FAQs on Quality Improvement Activities hhs.gov/ohrp/qualityfaq.html Guidance on Engagement in Human Subjects Research hhs.gov/ohrp/humansubjects/guidance/engage08.html CALL US!!!

20. Basic Protections Assurance of Compliance Institutional Review Board Legally Effective Informed Consent

21. Terms of the Federalwide Assurance (FWA) and the Institutional Official’s Role Are you an Institutional Official? If so, do you know the Terms of the Assurance (FWA)?

22. Responsibilities of Institutional (FWA Signatory) Officials Providing sufficient resources, space, and staff to support the IRB's review and record keeping duties Setting the "tone" for an institutional culture of respect for human subjects Ensuring that investigators fulfill their responsibilities Implementing appropriate oversight mechanisms to ensure compliance with HHS regulations and effective administration of the HRPP

23. Common Determinations of Non-Compliance What should you worry about?

24. Percentage of Citations of Noncompliance and Deficiencies

25. Solutions to Correct/Prevent Noncompliance Education Adequate IRB staff and resources Adequate IRB documentation (in particular, adequate minutes of IRB meetings) Periodic self-assessment of institutional system for protecting human subjects & self reporting Adequate written procedures

26. What Can Happen? Restriction Suspension Termination of FWA Institution/IO Held Responsible, Not IRB

27. Common Areas of Noncompliance-Reference Recent Compliance Oversight Determinations: http://www.hhs.gov/ohrp/compliance/findings.p df Determination letters: http://www.hhs.gov/ohrp/compliance/letters/ind ex.html http://www.hhs.gov/ohrp/compliance/letters/ind ex.html

28. Key Points Know what the regulations are and when they apply Understand your responsibilities under the regulations and your Federalwide Assurance Be compliant Keep in touch!

29. Contact Information OHRP website: http://www.hhs.gov/ohrp/http://www.hhs.gov/ohrp/ OHRP telephone: 1-866-447-4777 OHRP e-mail: ohrp@hhs.gov JOIN THE OHRP LISTSERV! Michelle Feige: Telephone: 240-453-8207 E-mail: Michelle.Feige@hhs.gov 29

30. 2010 CCAS Annual Meeting, November 11, 2010 The Other Things Deans Should Know About IRB David Bozak Associate Dean College of Liberal Arts and Sciences SUNY Oswego david.bozak@oswego.edu

31. 2010 CCAS Annual Meeting, November 11, 2010 The Other Things Deans Should Know About IRB David Bozak Associate Dean College of Liberal Arts and Sciences SUNY Oswego david.bozak@oswego.edu

32. The psychology department will be willing participants The further “away” from psychology, the less likely researchers will have appropriate training or even recognize their need for IRB review 2010 CCAS Annual Meeting, November 11, 2010 What about those other departments?

33. What is the definition of “research”? AAUP’s Committee A, Academic Freedom, and IRBs Oral historians? Journalists? 2010 CCAS Annual Meeting, November 11, 2010 Just who/what are exempt?

34. osw3go.net – simulations on a non- campus computer 2010 CCAS Annual Meeting, November 11, 2010 What does Web 2.0 do to/for us?

35. 2010 CCAS Annual Meeting, November 11, 2010 osw3go.net

36. 2010 CCAS Annual Meeting, November 11, 2010 osw3go.net

37. 2010 CCAS Annual Meeting, November 11, 2010 osw3go.net

38. Second Life – can an avatar give informed consent? 2010 CCAS Annual Meeting, November 11, 2010 Second Life – can an avatar give informed consent?

39. 2010 CCAS Annual Meeting, November 11, 2010 Second Life

40. RockMelt.com – the newest browser, integrating social media Augmented reality browsers (acrossair, for example) And many, many more.. 2010 CCAS Annual Meeting, November 11, 2010 What’s next?

41. The “TOP 10” Things Deans Can Do About the IRB Laura M. Argys Associate Dean for Research and Creative Activities College of Liberal Arts and Sciences University of Colorado Denver

42. Process for assuring responsible conduct of Human Subjects Research 1. Establish and convene an Institutional Review Board 2. Develop and follow written procedures 3. Review protocols for exempt status, under expedited review or under full board review. 4. IRB may approve protocols, require modifications, or disallow the research. 5. Review protocols at least annually. 6. Maintain records of IRB activities.

43. Institutional IRB Priorities Minimizing risk to subjects Assuring subject privacy/confidentiality/consent Complying with federal and state regulations Avoiding delays to research faculty Using employee time effectively on IRB

44. 1. Have the right people on the IRB Diversify the faculty on the IRB – Race/ethnicity/gender – disciplines/types of research Biomedical/Clinical trials Focus groups/conducting surveys Ethnography/qualitative research Behavioral experiments Educational research Use of secondary data – Include research active faculty – Experience with vulnerable populations – Scientific/non-scientific concerns

45. 2. Provide resources for a successful IRB Provide dedicated staff – Manage paper submissions – To take minutes – Point of contact Remote or physical presence Provide sufficient time to the chair of the IRB

46. 3. Promote responsible Human Subjects research Establish the expectations that all researchers undergo human subjects review Provide education on human subjects research – For researchers – For students Training on submission procedures

47. 4. Maintain a knowledgeable IRB Maintain continuity of IRB members Provide Human Subjects and HIPAA training Make experts available to the IRB – International experts – Disciplinary experts

48. 5. Ensure compliance Have a quick process for evaluation of exempt status – Not research – Not human subjects – De-identified data Provide expedited review by designated committee member Make the full board process efficient

49. 6. Effective communication between the IRB and researchers Ask the questions that will elicit the information needed by the committee. Embed explanations in the application materials Build logical skip patterns into the application Ensure that the committee has the expertise to understand what can be expected of the researcher.

50. 7. Make the process interactive Provide opportunities for Principal Investigators to meet with committee members: – To answer questions that arise during the committee review – To get clarification regarding modification requests

51. 8. Save time: Conduct business between meetings Provide advice and consultation for applications in preparation Evaluate exempt research Conduct expedited reviews Consult on modifications

52. 9. Create focused review panels Clinical panels Behavioral and Social Science Panels Education Research Panels

53. 10. Improve record keeping: Adopt/devise an electronic record system Provide faculty access to records of all of their protocols. Provide notification of scheduled reviews Provide feedback from committee