U.S. Department of Health & Human Services
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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