1. OHRP Update Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP Ivor.Pritchard@hhs.gov May 2, 2015

2. Upcoming Education Events May 6: Baltimore, MD: “Getting through Human Research Reviews without Pain” (with NIH) Research Community Forum: July 28: University Park, IL: “Human Subjects Research: Current Challenges in the Modern Research World” (with Governor’s State University)

3. Secretary’s Advisory Committee on Human Research Protections Newborn Bloodspot Issues and H.R. 1281 Big Data and the Impact on Human Subjects Research Return of Research Results and Emergent CLIA and HIPAA Issues NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research Return of Individual Research Results

4. Ongoing Policy Activities Follow-up to the SUPPORT Trial compliance determination and subsequent controversy Follow-up to the Advance Notice of Proposed Rulemaking (ANPRM), “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators”(July, 2011)

5. Compliance Oversight Activity

6. Overview of Division of Compliance Oversight Office for Human Research Protections Kristina C. Borror, Ph.D. Director, Division of Compliance Oversight

7. Overview For-Cause Compliance Oversight Evaluations Not-For-Cause Compliance Oversight Evaluations Reporting to OHRP

8. Compliance Oversight Evaluation Receive allegation of noncompliance Determine OHRP jurisdiction Written inquiry to appropriate institutional officials Review of institution report and relevant IRB documents Additional correspondence/telephone interviews/site visit as needed Issue final determinations

11. Not-For-Cause (NFC) Compliance Oversight Evaluations

13. These Incidents Need to be Reported to OHRP Under 45 CFR Part 46 Any unanticipated problems involving risks to subjects or others. Any serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB. Any suspension or termination of IRB approval. [45 CFR 46.103(b)(5)]

15. What Does OHRP Look for in Incident Reports? What was the incident? What is the institution’s plan of corrective actions? Is the institution’s plan of corrective actions adequate? Does the research protocol or informed consent document require modification?

16. Questions or Comments?