U.S. Department of Health & Human Services
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Do the human research regulations apply to non-U.S. institutions?
Yes, whenever non-U.S. institutions are engaged in non-exempt HHS-supported or -conducted human subjects research, the HHS human subjects protection regulations, 45 CFR part 46, apply.
Please see: http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html
Last Reviewed: 06/17/2011
Related Questions:
- Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?
- 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 does 45 CFR part 46 relate to the human subjects regulations used by non-HHS federal funding agencies?
- How does the Office for Human Research Protections (OHRP) handle allegations or indications of noncompliance when the research is not HHS-supported or conducted?
- Will the Office for Human Research Protections forward reports received from FWA-holding institutions to non-HHS federal funding agencies or departments?
