Conducting Reviews

• • Approaching a review
    Approaching an initial review as a primary or secondary reviewer
  • Approaching a change of protocol
    Approaching a change of protocol as a primary or secondary reviewer
  • Communicating during Meeting Preparation & Consult Requests
    Who to contact with review-related questions
  • FDA Basics
    IRB responsibilities specific to FDA studies
  • Making a Motion in a Meeting
    Motions for all review types and voting options for each motion

• • Presenting a review
    Presenting reviews as a primary or secondary reviewer
  • Releasing Results to Participants
    The IRB’s role in considering the release of results
  • Research with Children
    Considerations when reviewing research involving children
  • Reviewing Conflicts of Interest
    What to do with conflicts of interest

• • Reviewing Minutes
    Reviewing IRB meeting minutes

• • Reviewing Modifications
    Reviewing studies Approved with Modifications

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Applying the Regulations

• Minimal Risk and Minor Increment Over
  Categorization of risk level: “minimal risk” and “minor increase over minimal risk”

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Articles

• Article: Tobin, Martin (2022) Fiftieth Anniversary of Uncovering the Tuskegee Syphilis Study – The Story and Timeless Lessons
  Reflections on the Tuskegee Syphilis Study, the study that prompted changes in the infrastructure of research ethics.

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