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.