2. Office for Protection from Research Risks (OPRR) Department of Health and Human Services National Institutes of Health OPRR Dissolved June, 2000

3. Office for Human Research Protections (OHRP) Department of Health and Human Services Office of Public Health and Science Director: Greg Koski, Ph.D. M.D.

4. OHRP Responsibilities n Implementation and interpretation of federal regulations and policy n Educational programs n Negotiation of assurances n Evaluation of compliance

5. OHRP Electronic Access n E-mail: ohrp@osophs.dhhs.gov n Web Site: http://ohrp.osophs.dhhs.gov

6. Federal Regulations and Policy 45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects - Subpart A Originally adopted January 13, 1981 Revised June 18, 1991 The Common Rule - Federal Policy for the Protection of Human Subjects June 18, 1991 Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.

7. Food and Drug Administration Regulations: n IRB - 21 CFR 56 n Informed Consent - 21 CFR 50

8. OHRP Organization n Office of the Director Greg Koski – Director Melody Lin – Deputy Director –Division of Education Jeffrey Cohen – Director –Division of Assurance Support & Quality Improvement George Gasparis – Acting Director –Division of Compliance Oversight Michael Carome - Director

9. Education

10. Education n Presentations and Training Programs n Workshops and Town Meetings –For further information on both of the above contact Darlene Ross (dr20a@nih.gov) n Educational Materials –IRB Guidebook http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm –Videotape Series: "Protecting Human Subjects http://ohrp.osophs.dhhs.gov/references/resource.htm

11. OHRP/FDA/VA Workshops n "Current Human Research Issues & Solutions: Regulatory Overview & Investigator/Institutional Sponsor Partnerships ", May 10-11, 2001, Newark, NJ. n "Evolving Concern for Protection of Human Subjects, June 8, 2001, St. Louis MO. (Town Meeting) n "Current Human Research Issues & Solutions: Regulatory Overview & Hot Topics", June 21-22, 2001, Charleston, SC n "Current Human Research Issues & Solutions: Regulatory Overview & Social/Behavioral Research" July 16-17, 2001, Los Angeles, CA. n "Current Human Research Issues & Solutions: Regulatory Overview & TBD", September 20-21, 2001, Minneapolis, MN.

12. Assurance Support & Quality Improvement

13. OHRP Federalwide Assurance n Single Assurance Document - Federalwide Assurance (FWA) –MPAs, CPAs, SPAs, CAs, IIAs, AIIs, NIAs eliminated –FWAs will cover all of the institutions Federally-supported human subject research. –No OHRP review of individual applications, protocols, consent documents http://ohrp.osophs.dhhs.gov/irbasur.htm

14. OHRP Federalwide Assurance n Each legally separate institution will need its own FWA n International Standards OK n All Institutions Eligible – no longer limited to those receiving Federal funds n Web-Based Application Process n IRB Registration n Rely on own institutional IRB, other institutional IRB, commercial

15. OHRP Federalwide Assurance n Current Status –Currently in pilot phase –FWA is voluntary –OHRP will continue to accept SPAs and CPAs –All MPAs extended until FWA becomes mandatory

16. OHRP Federalwide Assurance n Required completion of OHRP Assurance Training Modules –The Institutional Signatory Official –The Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person) –IRB Chairperson(s) n Institutions must establish education programs for IRB members and investigators –Completion by investigators must be documented

17. URL: ohrp-ed.nih.gov

18. IRB/Investigator Education Recommended Features: n Ongoing –One-time presentations inadequate n Broad based –Institutional Officials –IRB members –Investigators –Staff n Not voluntary

19. IRB/Investigator Education Content: n Ethical principles of human subject research n Requirements of the Federal regulations n Applicable state law n Provisions of Institutional Assurance n Institutional policies and procedures for the protection of human subjects

20. Quality Improvement n Consultation to improve institutional programs of human subjects protections –Voluntary –Separate from Compliance Oversight n Multiple methodologies –Self evaluation tools –Teleconference/Videoconference consultations –Site visits

21. Compliance Oversight

22. Compliance Process n OHRP discovers or receives an allegation or indication of non- compliance COMPLAINT(S) –PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC. SELF REPORTING –INSTITUTION, PI MEDIA OTHER INCIDENT REPORT –FDA INSPECTION –NIH PSV REPORT –COOPERATIVE GROUP AUDIT

23. Compliance Process n OHRP determines if it has jurisdiction n OHRP notifies institution and requests institutional response (may include additional documentation, institutional investigation and report, etc.) n OHRP may take immediate action if protection of human subjects warrants

24. Compliance Process n OHRP evaluates institutional response n OHRP issues a report of findings OR n OHRP performs site visit

25. Compliance Process Most compliance oversight evaluations can be resolved through correspondence with the institution and do not require an on-site review or a formal report of findings.

26. Compliance Concerns OPRR Compliance Activities: Common Findings and Guidance http://ohrp.osophs.dhhs.gov/ references/findings.pdf

27. Does the institution support and respect the IRB and its mission? Is there a culture of compliance? Are IRB members and investigators knowledgeable about regulatory requirements? Is there adequate documentation of IRB findings and actions?