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Assurance of Compliance/IRB RegistrationAurora Health Care holds three Federal wide Assurances:
If you have questions about Aurora's FWAs, or whether a specific Aurora facility is included on the FWA, please contact Angela Carpenter in the RSPP office by calling 414-219-7280. About the Federalwide Assurance (FWA)As noted above, the Aurora IRB holds two Federalwide Assurances (FWA) from the Office For Human Research Protection (OHRP) in the Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and Aurora Health Care and is updated at regular intervals. In this document, Aurora Health Care assures the federal government that it will meet all regulations contained in 45, Part 46 of the Code of Federal Regulations (45 CFR 46) for all human subject research conducted at Aurora Health Care, regardless of the source of funding. The Institutional Official is the individual who signs the FWA representing Aurora Health Care. The Institutional Official has the legal authority to act and speak for the institution, and ensures that Aurora Health Care will effectively fulfill its research oversight function and responsibility. Gail Buenger, JD, Vice President Project Management, for Aurora Health Care, serves as the Institutional Official for Aurora Health Care. Ms. Buenger may be contacted at gail.buenger@aurora.org. All persons conducting human subject research at Aurora Health Care should be familiar with the Terms of Assurance. Click here to read the Terms of Assurance. Additionally, research conducted under these assurances must be reviewed and approved by an IRB registered with OHRP. All three IRBs that review human subject research at Aurora Health Care are properly registered with OHRP:
The requirement for IRB membership outlined in 45 CFR 46.107 is identical to FDA regulations found at 21 CFR 56; therefore, the Aurora IRB also satisfies FDA requirements for IRB membership. Additionally, paragraph (e) of both of these sections of the regulations state: "No IRB may have a member participate in the IRB's initial of continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB." The Aurora IRB is in full compliance with this regulation. Click here to read more about the FWA and IRB registration.
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