This policy explains how and when the University of Wisconsin Madison applies the Terms of the Federalwide Assurance when it engages in human participants research supported by the US Department of Human Services.
Regardless of the funding source, the UW-Madison applies the principles of the Belmont Report and protections equal or greater to those under the federal Common Rule and its subparts to human research participants.
The UW-Madison applies the federal Common Rule (45 CFR Part 46, Subpart A or 38 CFR Part 16 for Veterans Affairs research) to all non-exempt human participants research conducted or supported by any federal department or agency that has adopted the Common Rule, unless a department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.
The UW-Madison applies Subparts B through D of the federal Common Rule to non-exempt human participants research funded by the U.S. Department of Health and Human Services (“DHHS research”).
For any federally-conducted or -supported human participants research to which the FWA applies, the UW-Madison also will comply with any additional human participants regulations, policies and requirements of the department or agency which conducts or supports the research and any other applicable federal, state, local, or institutional laws and pertinent regulations, policies and guidelines, such as the Department of Defense, Department of Justice, Department of Veterans Affairs, and Environmental Protection Agency.
Research that is subject to a Certificate of Confidentiality issued by the National Institutes of Health, regardless of funding source, must comply with applicable federal regulations for the protection of human subjects or, if no such federal regulation is otherwise applicable, must comply with 45 CFR Part 46 (the Common Rule).