Research Microscope Lab

Human Research Protection Program

Human Subject Research Resources

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Project Team Resources

Various MCW IRB information and resources for local project teams in support of their research projects.

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Local Milwaukee Institutions

There are a number of local Milwaukee institutions where MCW Faculty may practice clinically and wish to conduct research. 

The following institutions have their own IRB and should be consulted prior to the initiation of any human subject research at that location.

These institutions are under MCW IRB oversight 

 

Federalwide assurances

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).  MCW IRBs are in compliance with this requirement.

Evidence of an institution's FWA and IRB registration can be obtained by accessing the HHS database.

Medical College of Wisconsin - FWA#00000820, expiration date: 02/24/2021

Froedtert Hospital - FWA#00002157, expiration date: 11/30/2021

Blood Center of Wisconsin - FWA#00005505, expiration date: 07/16/2020

MCW IRB Registration Numbers

OHRP and FDA requires that institutions register each of their IRB committees. Please find below the registration numbers for each of the MCW IRBs

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

MCW Local Context Information

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.

Resources for Sponsors

Open Letter for Sponsors   MCW HRPP has drafted an open letter to Sponsors to address many of the common concerns and questions the HRPP office handles from MCW Investigators regarding the IRB practices and procedures. Please feel free to download a copy of this letter to your Sponsors.

Certificate for 21 CFR 11 for Electronic Health Records MCW and Froedtert have drafted the following attestation to describe MCW and Froedtert's compliance with 21 CFR 11 criteria regarding electronic records, and electronic signatures in EPIC electronic health record (EHR) system.