Coordinated IRB Review
Projects or clinical trials that involve more than one institution inherently have extra issues that need to be considered by the study team and the IRB. Some of these issues are related to the logistics of conducting the project at other institutions and some are related to obtaining IRB approvals from each institution. Investigator responsibilities when conducting a multi-site study are listed below. Because the term “multi-site” is used to describe a variety of studies, it’s important to understand the definition from which the IRB is working when considering IRB review of these projects.
Not all projects involving more than one institution are considered multi-site studies.
Examples of multi-site projects:
o Medical College of Wisconsin (MCW) investigator conducting an intervention study at MCW/Froedtert Hospital (FH) and sharing identifiable data collected for that study with researchers at the University of Ohio.
o MCW/FH participating as one site in a multi-site clinical trial, for example cooperative oncology group studies.
o Adjunct faculty from UW-Milwaukee conducting a study at MCW/FH with FH patients and sending data to UW-Milwaukee for analysis.
o MCW investigator conducting retrospective chart review of patients at Children's Hospital of Wisconsin (CHW).
Examples of projects that are NOT multi-site:
o MCW investigator conducting a drug study at the Eye Institute.
o MCW investigator conducting a study at MCW/FH and the MCW Sports Medicine Clinic.
IRB Review of Multi-Site Projects
The IRB is interested in making the IRB review process more efficient whenever possible. To that end, the MCW/FH IRB has developed partnerships with other institutions through which certain types of studies may be eligible for review by a single IRB. IRB Authorization Agreements have been set up between the institutions within these partnerships that allow one IRB to rely upon another for certain studies. In some cases, the MCW/FH IRB may consider IRB Authorization Agreements with institutions outside these partnerships.
Investigators should be aware, however, that there is a formal process for requesting that the IRB consider a single IRB review. Deferral is not automatic and not every request for a single IRB review will be granted. The PI will be notified when the IRB has made its determination.
Requesting a Coordinated IRB Review
Before submitting an application to the IRB, the investigator should submit the Coordinated IRB Review Request Form to the MCW/FH IRB Office.
Established IRB Partnerships With Other Institutions
Southeastern Wisconsin CTSI IRB Consortium (SEWIC)
Research projects must involve at least two of the following institutions:
o Medical College of Wisconsin (MCW)
o Children’s Hospital of Wisconsin (CHW)
o University of Wisconsin at Milwaukee
o Marquette University
o Blood Research Center *As of 05/01/2014 MCW/FH IRB will review all new BCW-engaged projects
o Milwaukee School Of Engineering (MSOE)
Submit the Coordinated IRB Review Request Form to the MCW/FH IRB Office for studies involving any of the above institutions.
Although part of this consortium, Zablocki Veterans Administration (VA) does not defer review or serve as the IRB of Record for other IRBs at this time.
Wisconsin IRB Consortium(WIC)
Research projects must involve at least two of the following:
o Medical College of Wisconsin
o University of Wisconsin at Madison
o Marshfield Clinic
o Aurora Healthcare, Inc.
See WIC Share for instructions and forms for submitting a request to WIC.
Studies involving adults and minors
MCW and CHW have signed an Agreement that allows the MCW/FH IRB to serve as the IRB of Record for some studies involving adults and minors. For studies meeting the following criteria, submit the Coordinated IRB Review Request Form to the MCW/FH IRB Office:
o Studies conducted at MCW/FH involving adults and minors
o Studies conducted at MCW/FH and CHW involving adults and minors.
Requesting a Single IRB Review Not Involving Institutions Listed Above
The MCW/FH IRB is willing to consider a coordinated IRB review with another institution that is not within the SEWIC or WIC groups. The investigator is encouraged to contact the MCW/FH IRB Office or submit a Coordinated IRB Review Request Form to the MCW/FH IRB Office.
Investigator Responsibilities When Conducting a Multi-Site Study Using the Deferral Mechanism
If an IRB has determined that a single IRB review is appropriate, the PI will be notified which IRB will serve as the IRB of Record.
An IRB application must be submitted to the IRB of Record using their submission forms and process.
Investigators conducting research at MCW must follow all MCW corporate policies and MCW HRPP policies including the IRB SOP: Institutional Authorization Agreements & Other Review Mechanisms for Multi-Center Studies.
Investigators conducting research at FH must follow all FH corporate policies.
Unanticipated problems involving risks to subjects or others (UPIRSOs) must be reported to the IRB of Record and the MCW/FH IRB according to the IRB SOP: Requirements for Reporting to the IRB. (should link to the policy page)
The MCW investigator is responsible for assuring that institutional requirements are met in regard to human subject protections training, Safety Committee reviews, OCRICC review (FH Office of Clinical Research and Innovative Care Compliance) and any other MCW or FH institutional requirement.
If the IRB of Record is not MCW/FH IRB, initial and continuing review IRB approval letters from the IRB of Record must be provided to the MCW/FH IRB Office. Institutional and IRB policies of the IRB of Record must be followed.