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Session C: What Deans Should Know About the IRB Process

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

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Session C: What Deans Should Know About the IRB Process

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  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 Key Historical Document, the 1979 Belmont Report 7.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, LANovember 11, 2010 Office for Human Research Protections 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)

  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. OHRP’s Organizational Structure HHSKathleen Sebelius, Secretary Office of the Assistant Secretary for Health Howard Koh, Assistant Secretary for Health Other HHS Agencies(FDA, NIH, CDC, etc) OHRP, Office of the Director Jerry Menikoff, Director Melody Lin, Deputy Director Michael Carome, Associate Director for Regulatory Affairs International Activities Melody Lin, Deputy Director 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 11 11

  12. Title 45 Code of Federal RegulationsPart 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? • Does activity involve Research? • Does research involve Human Subjects? • Is human subjects research Exempt? ASK QUESTIONS IN THIS ORDER!

  18. What is Research? Research- a systematic investigation designed to develop or contribute togeneralizable 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/decisioncharts.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 A Assurance of Compliance B Institutional Review Board C Legally Effective Informed Consent

  21. Terms of the Federalwide Assurance (FWA) and the Institutional Official’s RoleAre 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.pdf • Determination letters: http://www.hhs.gov/ohrp/compliance/letters/index.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/ 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

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

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

  32. What about those other departments? 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

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

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

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

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

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

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

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

  40. What’s next? 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

  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

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