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.
The Medical College of Wisconsin
- FWA#00000820, expiration date: 02/24/2021
- FWA#00002157, expiration date: 11/30/2021
Blood Center of Wisconsin
- FWA#00005505, expiration date: 07/16/2020
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
PRIM&R - Public Responsibility in Medicine and Research
ACRP - Association of Clinical Research Professionals
SoCRA - Society of Clinical Research Associates
RAPS - Regulatory Affairs Professionals Society
As collaborative research continues grow, MCW IRB has received requests to describe our local context and state laws which need to be followed if MCW IRB is not serving as the IRB of record for a project. The following document has been developed as a resource for investigators. MCW Office of General Counsel should be consulted for questions regarding Wisconsin State and local laws.