Federal Regulations

All Studies

45 CFR 46

OHRP Guidance by Topic

Categories of Research That May Be Reviewed by the IRB Through an Expedited Review Procedure

OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

Comparison of FDA and HHS Human Subject Protection Regulations

Studies Using Investigational Drugs, Devices, or Biologics

21 CFR 50

21 CFR 56

21 CFR 312 (IND studies)

21 CFR 812 (IDE studies)

FDA Guidances, Information Sheets, and Notices

FDA Guidance for Industry and Investigators:  Safety Reporting Requirements for INDs and BA/BE Studies  (Issued December 2012)

FDA Guidance for Clinical Investigators, Sponsors, and IRBs:  Adverse Event Reporting to IRBs -- Improving Human Subject Protection (Issued January 2009)

FDA Guidance for Sponsors, IRBs, Clinical Investigators, and FDA Staff:  Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that Are Not Individually Identifiable (Issued April 2006)

21 CFR 312.2(b)  IND Exemption Criteria

HIPAA Regulations

45 CFR 160, 162, and 164

Department of Defense (DoD) policies and links to the DoD Components policies may be found at:  http://www.dtic.mil/whs/directives/.  See especially DoD Directive (DoDD) 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research.”

Department of the Navy (DON) Training and Education Guidance for DON-Supported Extramural Performers (2013)