Human Research Protection Program

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Investigators and Study Staff

Quick Links for
Investigators and Study staff

Working with Froedtert Health System

If you are looking to conduct your research at any Froedtert Health (FH) System entity (Froedtert Hospital, Community Memorial Hospital, St. Joseph West Bend or any of our clinics), and/or utilize any FH resource for your research (not all inclusive- staff, equipment, supplies, images, protected health information) your project must be reviewed by and receive FH Administrative Approval through the FH Office of Clinical Research & Innovative Care Compliance (OCRICC).   OCRICC recommends that you contact OCRICC no later than submission to the IRB. You can contact us by email or visit our SCOUT site.  

New Studies

This page provides access to information that will be helpful as you start a new study submission. Here the IRB answers questions about who can submit new studies, provides links to OHRP decision charts, and more.

Amendments

This page provides access to procedures that will be helpful if you need to change your original study submission. This can occur when study staff changes, study procedures change, when a change is need in a consent form, etc.

Reportable Events

Federal regulations (45 CFR 46.1 03(b)(5) & 21 CFR 56.1 08(b)) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP. The purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to protect subjects from avoidable harm. Investigators must promptly report any Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) associated with their research study according to this procedure.

Continuing Review/Final Report

In accordance with MCW IRB SOPs, a continuing progress report must be submitted for review and approval at intervals appropriate to the degree of risk, but not less than once per year or as determined by the IRB. Factors for making the decision about the frequency of review include the level of risk, location of the project, and any other factors that might affect the welfare of the subjects. Frequency of review is determined by the IRB upon review and approval.

BloodCenter of Wisconsin Projects & Investigators

BloodCenter of Wisconsin has contracted with the Medical College of Wisconsin (MCW) for IRB services. This move was made to provide access to greater IRB resources in terms of regulatory compliance and expertise, IRB staffing and services, and electronic protocol management. This change is intended to help meet the growing needs of BloodCenter researchers. 

Deferral to NCI CIRB

Per 45 CFR 46.114, an institution participating in a cooperative project may enter into a joint review arrangement in an effort to avoid duplication of effort. With this, MCW has entered into an Agreement with NCI CIRB that allows NCI CIRB to provide IRB review and oversight for cooperative group projects. 

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 approval from each institution. In order to provide a more coordinated IRB review for projects that involve multiple institutions under 1 PI; the MCW IRB has developed pathways to request a single IRB review.

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Page Updated 04/17/2014