U.S. Department of Health & Human Services
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What is an assurance of compliance with human subject protection regulations?
An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS. Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45 CFR part 46. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.
Last Reviewed: 06/17/2011
Related Questions:
- What assurance ofcompliance process for human subject protection is accepted by the Office for Human Research Protections (OHRP) and other Federal agencies?
- When is an institution considered to be “engaged in research”?
- What is a Federalwide Assurance (FWA)?
- What research does the Federalwide Assurance (FWA) cover?
