MCW IRB Project Team Resources
Various MCW IRB information and resources for local project teams in support of their research projects.
Project Team Resources
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.
- Clement J. Zablocki VA Medical Center
- VA Zablocki Medical Research Services - General information on research being conducted under the Department of Veteran Affairs
- Children's Wisconsin
- Columbia St. Mary's Hospital (Ascension)
- Marquette University
- Milwaukee County Behavioral Health Division
- Milwaukee School of Engineering (MSOE)
- University of Wisconsin - Milwaukee
These institutions are under MCW IRB oversight
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: 5/5/2026
Froedtert Health, Inc. - FWA#00002157, expiration date: 3/28/2027
Versiti Wisconsin, Inc. - FWA#00005505, expiration date: 11/15/2026
Children's Wisconsin - FWA#00001809, expiration date: 8/31/2028
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
IRB #6 IRB00011716
IRB #7 IRB00013550
IRB #8 IRB00013551
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.
There are three instances where the MCW IRB Office will assess a fee for the review of a research project:
- an industry sponsored clinical trial
- when MCW is serving as the single IRB for a study
- when MCW relies on an external IRB for an industry sponsored study
Details of these fees are outlined in the MCW IRB Fees (PDF) guidance. Not only does this document detail the three scenarios where research projects will be assessed a review fee, but it also includes a justification statement regarding these fees that can be provided to sponsors.
All IRB fees will be invoiced in iLab by the MCW IRB office.
Open Letter for Sponsors (PDF) 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.
Letter for Sponsors - Revised Common Rule Consent Form Revisions (PDF) This memo is meant to aid in the required consent form transition process to comply with the Revised Common Rule by providing Sponsors with a description and rationale for the changes made in the current consent form template. Please use this memo as a resource when negotiating the required consent template updates with Sponsors, CROs, and etc.
Certificate for 21 CFR 11 for Electronic Health Records (PDF) 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.
Banking Guidance (PDF) This document aims to provide guidance for clinical trial sponsors on how MCW defines “banking” as well as the institutional requirements for this research activity.