Federalwide Assurance of Compliance/IRB Registration
Aurora Health Care holds two Federalwide Assurances:
|Institution||FWA Number||Expiration date|
|Aurora Health Care, Inc.||FWA00000414||3/05/2021 *|
|Aurora BayCare Medical Center (Green Bay)||FWA00005239||10/7/2020 *|
* Please be aware that the expiration dates can change frequently and the dates shown may not be current. Please use the following link for the Office for Human Research Protections (OHRP) website to verify the current expiration date.
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 (HHS). The FWA is documentation of an institutional commitment to comply with HHS regulations for the protection of human subjects. It is a binding agreement between HHS 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 federally funded human subject research conducted at Aurora Health Care. In addition, Aurora applies these regulations regardless of the source of funding.
- View the Aurora Health Care FWA documentation
- View the Aurora Baycare Medical Center's FWA documentation
Human Research Protections Program Administration
The Institutional Official (Signatory 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. Andy Anderson, MD, Chief Medical Officer, serves as the Institutional Official for Aurora Health Care. Dr. Anderson may be contacted at firstname.lastname@example.org.
As part of the Assurance process, institutions are asked to provide contact information about its Human Protections Administrator that can serve as a primary point of contact for OHRP. Michelle Maternowski, BS, CIM serves as the Human Protections Administrator. At Aurora, the Human Protections Administrator is responsible for the day-to-day operations of the HRPP, which fall into three greneral areas:
- IRB Communication & Education
- Record Keeping & Reporting
- Monitoring & Oversight
Terms of Assurance
All persons conducting human subject research at Aurora Health Care should be familiar with the Terms of Assurance.
Additionally, research conducted under these assurances must be reviewed and approved by an IRB registered with OHRP and the FDA. All IRBs that review human subject research at Aurora Health Care are properly registered with OHRP and the FDA:
|IRB Name||IRB Registration Number|
|NCI Central IRB #1 (Adult)||IRB00000781|
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.