Guidance for IRB Members and Reviewers

Regulatory Essentials

  • 45 CFR46 OHRP – Human Subjects

  • 21 CFR50 FDA – Human Subjects

  • 21 CFR56 – IRBs

Codes of Ethics

  • The Belmont Report

    • Respect for Persons

    • Beneficence

    • Justice

  • Declaration of Helsinki

  • Nuremberg Code

Information for IRB Members (slides)

  • Presentations and Guidance for members

  • Blinding, Rater Bias, and Risk

  • Conflict of Interest

  • Understanding Minimal Risk for Subpart A

  • SACHRP (Secretary's Advisory Committee on Human Research Protections) Recommendations on Research with Individuals with Impaired Consent Capacity

Guidance for Reviewers (slides)

  • Categories of Research that May Be Reviewed Using Expedited Procedures

  • Understanding Minimal Risk (case studies)

  • Conducting Continuing Review

  • Continuing Review Checklist

Literature (PDF)

  • "The Research Protocol Ethics Assessment Tool (RePEAT)." Dr. Laura Weiss Roberts.

  • "The Ethical Basis of Psychiatric Research: Conceptual Issues and Empirical Findings Ethics and Clinical Research." Dr. Laura Weiss Roberts.