MCW Human Research Protection Program Training and Educational Resources

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:

Register with CITI

1. Choose the Medical College of Wisconsin as your institution (even if your home institution is Froedtert Hospital, Children’s Hospital of Wisconsin, or Versiti Blood Center of Wisconsin). 
2. On the Main Page, choose Group 3 to begin the course. 
3. 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%. 
4. 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 IRB Office for their records or bring a copy to the IRB Committee meeting.

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

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

Research Systems Training offers eBridge System training for new and existing 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.

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Criteria for Approval

• Criteria for Approval (PDF)
• Criteria for Exempt Determination
• Criteria for projects which qualify for Expedited Review

Informed Consent Requirements

• Informed consent-basic elements and additional elements (45 CFR 46.116)
• Criteria for Waiver of Informed Consent Procedure (PDF)
• Criteria for Waiver of Informed Consent Documentation (PDF)

Criteria to grant a waiver of HIPAA authorization

• HIPAA requirements for Human Subject Research

Vulnerable Populations

• 45 CFR 46 Subpart B (additional protections for pregnant women, fetuses and neonates)
• 45 CFR 46 Subpart C (additional protections for prisoners)
• 45 CFR 46 Subpart D (additional protections for children)

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 45 CFR 46 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