MCW/FH IRB Committees

For Study Staff

Check the meeting dates for MCW/FH IRBs 1-4

 

Committee Member Rosters

 

IRB Member Checklists

To support compliance with the Federal regulations and MCW/FH HRPP policies and procedures, the following checklists have been developed to assist IRB Members in the review of research being evaluated by the MCW/FH IRB Committees.   If you are unable to access a checklist or have a question as to which checklist should be utilized please contact your IRB Coordinator. 

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  Full Committee Review Checklists
  Minimal Risk (Committee #5) Review Checklists

Minimal Risk (Committee #5) Review Checklists

  Additional Requirements Checklists

These checklists may be required to support the review of a project if it will be using advertisements, requires compliance with ICH Guidelines, or will be supported by federal agency with additional requirements such as DoD, DoE, DoEd, DoJ or BoP

  Vulnerable Populations Checklists

IRB Member Forms and Resources

 

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  IRB Member Forms
  Vistor and/or Consultant Forms

Training and Educational Resources for IRB Members

The MCW HRPP is committed to providing IRB Members with the education and tools necessary to conduct thoughtful and rigorous reviews of human research protocols that come before the MCW/FH IRB Committees. Therefore the MCW HRPP provides various educational opportunities to assist with building knowledge and competence over time. These opportunities include continuing education presentations during the IRB meetings, monthly research education presentations at MCW for the research community, and completion of CITI (Collaborative Institutional Training Initiative) training.  

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  CITI Training Requirements for IRB Members

New IRB Members are required to complete initial CITI training which includes modules covering the history and purpose of IRB regulations, ethical principles related to human subject research, and regulations apply to studies enrolling certain vulnerable populations and to various types of studies.

The initial course can be completed in four to six hours.

All IRB Members are required to maintain on-going human subjects research protections training via CITI.

In order to maintain CITI certification, a refresher course must be completed every three years. The refresher course can usually be completed in less than two hours.

How to complete CITI training:

  1. Register with CITI at: https://www.citiprogram.org/
  2. Choose the Medical College of Wisconsin as your institution (even if your home institution is Froedtert Hospital, Children’s Hospital of Wisconsin, or BloodCenter of Wisconsin).
  3. On the Main Page, choose Group 3 to begin the course.
  4. Complete the required modules and associated quizzes. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%.
  5. Upon successful completion of the modules and quizzes, print a copy of your completion report (either paper or pdf) and send a copy to the MCW/FH IRB Office for their records or bring a copy to the IRB Committee meeting.
  Continuing Education

The IRB Committees review a variety of topics on a monthly basis.   These continuing education moments are discussed along side a PowerPoint presentation.  Please find below the topics reviewed in recent meetings:

  • IRB Approval Criteria 
  • Navigating a Convened Meeting
  • Subtleties of Tabling 
  • Review of Devices 
  • HIPAA 
  • Conduct & Expectations of IRB Members 
  • Primary Reviewer Responsibilities 
  • Continuing Reviews 

 

In addition to the above topics, starting in Feburary 2016, IRB member may now claim 1 hour CME/CE credits for their attendance and participation as an IRB member of the MCW/FH IRB committees.  Credits can only be claimed by logging into the Ethos CE system.  If you have questions about this process, contact the MCW/FH IRB Office

  eBridge Orientation and Navigation

Research Systems Training offers eBridge System training for new committee members.  The one-hour session is scheduled on an as-needed-basis. The training session provides a hands-on opportunity to navigate within eBridge as an IRB Committee Member and demonstrates the IRB Reviewer process.  Contact the MCW/FH IRB office to schedule this session with the eBridge Trainer.

 

  New Member Training and Orientation

New IRB Committee Members are invited to a meeting or series of meetings that provide an orientation to the IRB review process. The topics presented include:

  • Oversight Issues for IRBs
  • Types of IRB Review
  • Continuing Review
  • Key components of 45CFR46 as applied to the review of research, initial and continuing
  • FDA regulations that apply to human subject research
  • HIPAA regulations that apply to human subject research
  • Protected populations
  • IRB Meetings and Record Keeping
  • Informed consent: elements, documentation, waiver of consent, waiver of documentation
  • Conflict of interest: PI and IRB Members
  • Protocol Review and Presentation during an IRB Meeting

 

MCW/FH IRB Committees are always seeking volunteers to join and participate in furthering research taking place at MCW and Froedtert Health.  If you are interested, please contact the MCW/FH IRB Office

  Regulations for IRB Review of Human Subject Research

Criteria for Approval

Informed Consent Requirements

Criteria to grant a waiver of HIPAA authorization

Vulnerable Populations

HRPP Contact Information

Phone: (414) 955-8422

Fax: (414) 955-6575

Email:
IRBOffice@mcw.edu (for general IRB questions)
MCWIRBReliance@mcw.edu (questions about reliance agreements/deferral requests)

Location:  MFRC 3040
MACC Fund Research Center

Office of Research
8701 Watertown Plank Road
Milwaukee, WI  53226-0509

HRPP Staff Contact Info

HRPP Organizational Chart

Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
(414) 955-8296
Directions & Maps
© 2016

Page Updated 07/26/2016
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