Regulatory Guidance

The federal regulations that relate to Good Clinical Practice, clinical trials and the protection of human subjects in clinical trials are within the Code of Federal Regulations (CFR). Two particular sections of the CFR pertain to the protection of human subjects and IRBs. These are Title 21 (Food & Drugs) and Title 45 (Public Welfare).

These regulations include, but are not limited to:

REGULATION	IRB	INVESTIGATOR	SPONSOR/CRO
Title 21 CFR Part 11 - Electronic Records and Electronic Signatures	•	•	•
Title 21 CFR Part 50 - Protection of Human Subjects	•	•
Title 21 CFR Part 54 - Financial Disclosure by Clinical Investigators		•	•
Title 21 CFR Part 56 - Institutional Review Boards	•
Title 21 CFR Part 312 - Investigational New Drug Application		•	•
Title 21 CFR Part 812 - Investigational Device Exemptions		•	•
Title 45 CFR Part 46 - Protection of Human Subjects	•	•
Title 45 CFR Parts 160 and 164 - Standards for Privacy of Individually Identifiable Health Information		•

Also see CGIRB's Regulatory Guidance for Clinical Trials and the FDA's website for FDA Regulations and Guidelines relating to Good Clinical Practice and clinical trials.

In addition to the regulations, there are also guidance documents that pertain to human subject protection. The primary guidance documents are:

• The Food and Drug Administration (FDA) Information Sheets
• The International Conference on Harmonization E6 Good Clinical Practice (ICH GCP) Guidelines
• Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting - Improving Human Subject Protection
• The Belmont Report
• The Declaration of Helsinki
• The Nuremberg Code

Guidance for California Sites:

• California Experimental Subject's Bill of Rights