Reviewer Toolkit

2018 Common Rule Guidance:

Reviewer Guidance:

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:

  • 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:

Member Guidance

*Please see the Reportable Events section of the IRB website for guidance documents regarding protocol deviations, potential noncompliance or unanticipated events, and related matters.

Additional FDA Guidance:

Tips for Successful Review:

  • Allow adequate time for review prior to meeting

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

eIRB Instructional Videos

IRB Webinars

OHRP Instructional Videos