Regulations and Guidance Documents

Department of Health and Human Services (DHHS)

45 CFR Part 46 “The Common Rule” 
Revised List for Expedited Review - Nov. 1998

Food and Drug Administration (FDA)

21 CFR Part 50 (FDA Protection of Human Subjects)
21 CFR Part 56 (FDA Institutional Review Board)
21 CFR Part 312 (FDA IND Regulations)
21 CFR Part 812 (FDA Investigational Device Exemptions)

Guidance Documents for DHHS – OHRP and FDA
Contained in the VCU IRB Written Policies and Procedures (WPPs) - Click on "Search" button in the upper left corner and enter "OHRP and FDA" in the search field.

Guidance for Industry
E6 Good Clinical Practice: Consolidated Guidance

Center for Drug Evaluation & Research (CDER)
Information for Clinical Investigators

FDA guidance for IRB's, Clinical Investigators, and Sponsors