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).

These regulations include, but are not limited to:

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 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:

Please go to the Forms tab for CGIRB’s California Experimental Subject’s Bill of Rights template
California Informed Consent Guidelines: State of California Department of Justice, Office of Attorney General
California Health & Safety Code Section 24172, Experimental Subject’s Bill of Rights; Contents
California Health & Safety Code Section 24173, Informed Consent