果冻影院

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Human Research Protection Program

果冻影院 Human Research Protection Program Training and Educational Resources

Education and tools for conducting thoughtful and rigorous protocol reviews.聽

The 果冻影院 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 果冻影院 IRB Committees. Therefore the 果冻影院 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 果冻影院 for the research community, and completion of CITI training.
 

Regulatory Resources

Links to various Human Subject Research regulations and other resources. 

  • Criteria for Approval (PDF): The eight regulatory criteria which must be met for IRB approval
  • : Regulatory criteria and types of activities which may qualify for exempt determination
  • : Criteria and types of activities which qualify for expedited review
  • : The general requirements and additional elements for informed consent when conducting human subject research
  • : Overview of HIPAA regulations and their impacts when conducting human subject research

Training and Educational Resources

The 果冻影院 HRPP provides various educational opportunities to assist with building knowledge and competence over time. These resources may be accessed by both new IRB Members and current Members. 
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CITI Training Requirements

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 果冻影院 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 "果冻影院 IRB Committee Member" 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 果冻影院 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

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

eBridge Training

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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HSR Regulations and Resources

Criteria for Approval

Informed Consent Requirements

Criteria to grant a waiver of HIPAA authorization

Vulnerable Populations

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 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

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