OHRP Guidance

The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described at 45 CFR 46.

As noted in the UConn IRB Policy and Procedures, all research involving human participants conducted by the faculty, students, and staff of UConn, or research conducted using UConn facilities, is conducted in accordance with federal regulations, regardless of funding source.  Because UConn is engaged in human subjects research that may be conducted or supported by an agency of the U.S. Department of Health and Human Services, UConn has an OHRP approved Federalwide Assurance (FWA).  This FWA is our contract with OHRP whereby the University agrees to conduct all human subjects research in compliance with the HHS regulations.  The UConn Storrs FWA number is 00007125.

If you go to the OHRP website you’ll see that OHRP is comprised of five divisions – Compliance, Education, Policy and Oversight, Secretary’s Advisory Committee, and International Research.  The three most relevant divisions to researchers are the Compliance, Education and International Divisions.

The Compliance division is essentially the auditing arm of OHRP.  If it becomes necessary for the IRB to report unanticipated problems, serious or continuing noncompliance, protocol deviations, suspensions or terminations, the Compliance division reviews the report and the corrective actions.  The Compliance division then determines what, if any, additional action needs to be taken to protect human research subjects.  The Compliance division may also audit the Office of Research Compliance and the UConn IRB with regard to institutional compliance with 45 CFR 46.  As indicated on the OHRP website, the division “evaluates all written substantive allegations or indications of noncompliance with the HHS regulations. If complaints or concerns arise regarding an institution’s human subject protection practices, OHRP opens a formal evaluation and, if necessary, requires corrective action by the institution.”  Any findings of noncompliance are issued in the form of determination letters.  OHRP maintains a list of determinations of institutional noncompliance.  You can access the list here – http://www.hhs.gov/ohrp/compliance-and-reporting/index.html.  You will note that institutional noncompliance covers a wide range of IRB procedures involving: initial and continuing review, expedited review, informed consent, IRB membership, and IRB documentation.

The Education division is responsible for a number of initiatives including: (1) Responding to requests for clarification and guidance regarding ethical issues in biomedical and behavioral research involving human subjects and (2) Developing and conducting quality improvement activities to improve human research protection programs.  The Education division developed the IRB Guidebook (http://www.hhs.gov/ohrp/education-and-outreach/archived-materials/) as well as the Human Subjects Regulation Decision Charts (http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html) which are helpful in determining whether or not the research activity requires IRB review and, if so, what level of review is required.

The International Division provides quality improvement consultation and research ethics training to domestic and foreign institutions involved in international biomedical and behavioral research.  It maintains a compilation of human subjects protections laws, regulations and guidelines governing human subjects research around the world.

March 2009

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