OHRP Update Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP [email protected] May...
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Transcript of OHRP Update Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP [email protected] May...
![Page 1: OHRP Update Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP Ivor.Pritchard@hhs.gov May 2, 2015.](https://reader036.fdocuments.us/reader036/viewer/2022062516/56649e705503460f94b6df97/html5/thumbnails/1.jpg)
OHRP Update
Ivor Pritchard, Ph.D.
Senior Advisor to the Director of OHRP
May 2, 2015
![Page 2: OHRP Update Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP Ivor.Pritchard@hhs.gov May 2, 2015.](https://reader036.fdocuments.us/reader036/viewer/2022062516/56649e705503460f94b6df97/html5/thumbnails/2.jpg)
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)
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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
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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)
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Compliance Oversight Activity
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Overview of Division of Compliance Oversight
Office for Human Research Protections
Kristina C. Borror, Ph.D.Director,Division of Compliance Oversight
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Overview
• For-Cause Compliance Oversight Evaluations
• Not-For-Cause Compliance Oversight Evaluations
• Reporting to OHRP
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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
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Not-For-Cause (NFC) Compliance Oversight
Evaluations
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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)]
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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?
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Questions or Comments?