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IRB Review

This document provides the IRB Review Guidelines for evaluating research protocols based on scientific and ethical principles. It highlights the importance of effective communication, safety considerations, clarity of consent, and addressing any missing or required changes.

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IRB Review

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  1. IRB Review Walter Kraft

  2. Regulatory categories • All RQ forms are in the ‘For IRB Members’ section of the OHR website. • There are also reviewer (RQ) forms for DOD studies, pregnant women, neonates, fetal material, and prisoners. • RQ forms are given to the IRB Secretaries with your other review documentation.

  3. Ethical basis of review We use a scientific and ethical gauge to review protocols Society has decided upon the rules of the road through federal regulation Review is guided by these regulations Your job is the use your scientific and ethical judgement around this framework

  4. Your Review • Communicate to the committee • Quick high level summary • Goals and likelihood of achieving these goals • Safety • Clarity of consent • And other issues… • Communicate to secretaries • Communicate to investigator or sponsor • Required changes • Suggested changes • Missing information

  5. Reviewer • Protocol and OHR 2 are primary sources of information—use BOTH • It is ok to reach out to investigator for clarifications before meeting, but additional information gathered should be in your review • The ask to investigators should be specific and actionable • Electronic written comments to secretaries is mandatory • Clear • Complete • Timely

  6. Oral Presentation

  7. Thank you

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