U.S. Department of Health & Human Services
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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?
No, OHRP's approval of an institution's assurance of compliance does not mean that OHRP has determined that the institution is complying with the requirements of the HHS Protection of Human Subjects regulations, 45 CFR part 46. It means that an institution has submitted all of the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects research conducted or supported by HHS or other research covered by the assurance of compliance. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.
Last Reviewed: 06/17/2011
Related Questions:
- Do the human research regulations apply to non-U.S. institutions?
- 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?
- When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?
