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Office for Human Research Protections (OHRP)AssurancesVersion Date 7/09/2009 Obtaining an approved assurance from OHRP is a two-step process. First, you must ensure that the IRB(s) you designate under the Assurance are registered with OHRP. If not, submit the registration. Second, you must complete the Assurance application, below. Please note: the fact that the Office for Human Research Protections (OHRP) has approved an institution's assurance does not mean that OHRP has determined that the institution is complying with the requirements of the Department of Health and Human Services (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. The Federalwide Assurance is the only type of assurance accepted and approved by OHRP. LIST OF APPROVED ASSURANCES AND REGISTERED IRBs Basic Assurance RequirementIf your institution is engaged in human subjects research (not otherwise exempt) that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), then your institution must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects. Tracking the Status of an FWA SubmissionOnce you have submitted an FWA, you may track the progress of your document until the FWA is approved. Once your institution's FWA is approved, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/.
Assurance Submission
OHRP Recommended FWA Training Modules Other Forms
Who to Contact re: Assurances Steps to File a Domestic (U.S.) Federalwide Assurance (FWA)
Tracking the Status of an FWA SubmissionOnce you have submitted an FWA, you may track the progress of your document until the FWA is approved. Once your institution's FWA is approved, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/. Steps to File an International (non-U.S.) Federalwide Assurance (FWA)(Note that covered research conducted or supported by HHS is expected to comply with the requirements of 45 CFR part 46. See the July 7, 2006 Notice on Interpretation of Assurance Requirements [PDF - 57.2KB])
Tracking the Status of an FWA SubmissionOnce you have submitted an FWA, you may track the progress of your document until the FWA is approved. Once your institution's FWA is approved, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/. |