U.S. Department of Health & Human Services
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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?
When the Office for Human Research Protections (OHRP) receives a request from an FWA institution for guidance regarding implementation of the Common Rule for human subjects research conducted or supported by another department or agency that has adopted the Common Rule, OHRP will direct the requestor to contact appropriate officials at the other department or agency. When the requestor seeking guidance regarding a specific research project does not identify the conducting or supporting department or agency, OHRP will qualify its response with a statement that if the research is supported by another department or agency the requestor should also consult with appropriate officials at the supporting department or agency. If the requestor at the FWA institution and appropriate officials at the conducting or supporting department or agency mutually agree to seek OHRP input on the matter, OHRP staff will be available to provide guidance.
Last Reviewed: 06/17/2011
Related Questions:
- When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?
- Will the Office for Human Research Protections forward reports received from FWA-holding institutions to non-HHS federal funding agencies or departments?
- How does the Office for Human Research Protections (OHRP) handle allegations or indications of noncompliance when the research is not HHS-supported or conducted?
- 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?
