Reviewer Toolkit

In this section we are providing guidance documents to our IRB members.  If you have any suggestion to add or modify documents in this section, please email Regina Drake or the IRB QA and Education Team.

Tips for Successful Review

  • Allow adequate time for review prior to meeting

  • Communicate with the facilitator and/or analysts regarding questions, concerns, or conflicts

Member Guidance

e-IRB Instructional Videos

  • Reviewing Amendments:Walks through the steps for completing reviews for amendments. 
  • Continuing Review: Touches on important considerations for the reviewer at the time of study renewal.

Regulatory Guidance: OHRP

  • Code of Federal Regulations 45 CFR 46 Basic HHS policy for protection of research subjects
    • Subpart B- Additional protections for pregnant women, human fetuses, and neonates involved in research
    • Subpart C- Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects
    • Subpart D- Additional protections for children involved as subjects in research

Waiver Worksheets

Regulatory Guidance: FDA

Videos and Webinars