Federalwide Assurance of compliance & IRB registration
Every institution that conducts research involving human subjects must have a Federalwide Assurance (FWA). Aurora Health Care holds two FWAs from the Office for Human Research Protection (OHRP) in the U.S. Department of Health and Human Services (HHS).
The FWAs verify our commitment to complying with HHS regulations that protect human research subjects. They assure the federal government that we will meet all regulations contained in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46).
FWA is a binding agreement between HHS and Aurora. We update the agreement at regular intervals.
Learn more about Aurora RSPP/IRB.
Our Federalwide Assurance numbers
Aurora holds two FWAs:
* Expiration dates change frequently, and the dates shown may not be current. Please verify the current expiration date with the Office for Human Research Protections (OHRP).
View our FWA documentation
Our FWA documentation is available for anyone to view:
Questions about our FWA
If you have questions about our FWAs or whether the FWAs include a specific Aurora facility, you can contact the Research Subject Protection Program (RSPP) office by emailing irboffice@aah.org.
What to know about terms of Federalwide Assurance
Everyone who does human subject research at Aurora should be familiar with the Terms of Federalwide Assurance.
Before getting an FWA, institutions must register an institutional review board (IRB) with the OHRP. IRBs review all proposed research to make sure it meets ethical standards.
An IRB that is registered with OHRP and the U.S. Food and Drug Administration (FDA) must review and approve all research conducted under the Terms of Assurance. Our IRB is registered with both agencies.
Our IRB registration & compliance
The IRB that reviews human subject research at Aurora are registered with OHRP and the FDA. Our IRB name and number is:
The requirements for IRB membership outlined in 45 CFR 46.107 are identical to FDA regulations found at 21 CFR 56. Our IRB also satisfies FDA requirements for IRB membership.
Additionally, paragraph (e) of these regulations states, "No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB." Our IRB complies fully with this regulation.
View the AAH IRB Statement of Compliance [PDF]
Read more about the FWA and IRB registration.
Human Research Protections Program administration
As part of the FWA process, our IRB has two listed administrative officials:
- Institutional Official (signatory official): The individual who signs the FWA has legal authority to act and speak for Aurora. He or she ensures that we fulfill our research oversight and responsibility. Our Institutional Official is Jacob Bidwell, MD, DIO & VP, Academic Affairs, President, Aurora UW Medical Group.
- Human Protections Administrator: Michelle Maternowski, BS, Director, RSPP, is our Human Protections Administrator. She is responsible for the day-to-day operations of the Human Research Protections Program (HRPP), including:
- IRB communication and education
- Recordkeeping and reporting
- Monitoring and oversight
Contact the RSPP/IRB office
We’re here to answer your research documentation questions. Contact us
Policies
Want to know about our research policies and procedures? Learn about our policies
IRB approval of research
Find out the steps you need to take to get IRB approval of research. IRB approval process
Resources
Download templates for IRB application, informed consent and more. IRB forms and templates