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
Belmont Report
Declaration of Helsinki
The Nuremberg Code

Guidance for California Sites:

Memorandum regarding California Experimental Subject’s Bill of Rights
California Informed Consent Guidelines: State of California Department of Justice, Office of Attorney General
California Experimental Research Subject’s Bill of Rights
California Health & Safety Code Section 24172, Experimental Subject’s Bill of Rights; Contents
California Health & Safety Code Section 24173, Informed Consent