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OHRP Update
Ivor Pritchard, Ph.D.
Senior Advisor to the Director of OHRP
May 2, 2015
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)
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
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)
Compliance Oversight Activity
Overview of Division of Compliance Oversight
Office for Human Research Protections
Kristina C. Borror, Ph.D.Director,Division of Compliance Oversight
Overview
• For-Cause Compliance Oversight Evaluations
• Not-For-Cause Compliance Oversight Evaluations
• Reporting to OHRP
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
0
2
4
6
8
10
12
2008 2009 2010 2011 2012 2013 2014
DCOI Opened '08-'14
DCOI Opened
0
20
40
60
80
100
120
140
160
2008 2009 2010 2011 2012 2013 2014
NA Received '08-'14
NA Received per year
Not-For-Cause (NFC) Compliance Oversight
Evaluations
0
1
2
3
4
5
6
2008 2009 2010 2011 2012 2013 2014
NFC Opened '08-'14
NFC Opened per year
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)]
0
200
400
600
800
1000
1200
2008 2009 2010 2011 2012 2013 2014
IRPT Received '08-'14
IRPT Received per year
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?
Questions or Comments?
