U.S. Department of Health & Human Services
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How does the Office for Human Research Protections (OHRP) handle allegations or indications of noncompliance when the research is not HHS-supported or conducted?
When the allegations or indications of noncompliance (complaints) are limited solely to the research activities conducted or supported by another Common Rule department or agency, for Human Research Protections (OHRP) will refer the matter to appropriate officials at the other department or agency for further investigation and action, as appropriate. OHRP’s Division of Compliance Oversight (DCO) will not be involved in the conduct of the investigation unless the relevant department or agency requests OHRP’s involvement. When the other department or agency completes its investigation without OHRP involvement, a report on the outcome of the investigation should be provided to OHRP.
Last Reviewed: 07/07/2011
Related Questions:
- How does 45 CFR part 46 relate to the human subjects regulations used by non-HHS federal funding agencies?
- Do the human research regulations apply to non-U.S. institutions?
- Does approval of an institution's assurance of compliance by the Office for Human Research Protections (OHRP) mean that the institution is in full compliance with the Department of Health and Human Services (HHS) Protection of Human Subjects regulations?
- How will I know when my institution’s Federalwide Assurance (FWA) is approved?
- How will the Office for Human Research Protections (OHRP) respond to queries from an FWA institution about human subjects research conducted or supported by a non-HHS department or agency?
