1. 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

2. 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

3. What is OHRP?

4. 4 4 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

5. 5 Title 45 Code of Federal Regulations Part 46

6. 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

7. 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)

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

9. 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

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

11. 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)

12. 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!!!

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

14. 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)?

15. 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

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

17. Percentage of Citations of Noncompliance and Deficiencies

18. 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

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

20. 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 http://www.hhs.gov/ohrp/compliance/letters/index.html

21. 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!

22. 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 22