Human Research Protection Program

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Federalwide Assurances

 

The Medical College of Wisconsin

FWA#00000820
Expiration date 03/20/2019

MCW/FH IRB Registration numbers

MCW/FH IRB #1 IRB00001395
MCW/FH IRB #2 IRB00001396
MCW/FH IRB #3 IRB00001564
MCW/FH IRB #4 IRB00000078
MCW/FH IRB #5 IRB00006380

Froedtert Hospital

FWA#00002157
Expiration date 12/01/2017

Blood Center of Wisconsin

FWA#00005505
Expiration date 06/12/2017

The Federal Policy (Common Rule) for the protection of human subjects Section 103(a) requires that each institution engaged in federally supported human subject research file an Assurance of Protection for Human Subjects. The Assurance documents the commitment of the Medical College of Wisconsin and Froedtert to protect human subjects.

Under Federal Policy (Common Rule) Section 102(f), awardees and their collaborating institutions become engaged in human subject research whenever their employees or agents intervene or interact with living individuals for research purposes or obtain, release or access individually identifiable private information for research purposes. In addition, awardee institutions are automatically considered to be engaged in human subject research whenever they receive an HHS award to support such research.

The Food and Drug Administration (FDA) issued a final rule in the Federal Register (Vol. 74, No. 10, 1/15/09) that required institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The MCW/FH IRBs are in compliance with this requirement. Evidence of an institution's FWA and IRB registration can be obtained by accessing the HHS database.

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Page Updated 09/02/2014