International Regulations
International Council for Harmonization (ICH)
Belmont Reports
US Regulations
- Regulations: Good Clinical Practice and Clinical Trials
- 45 CFR Part 46 Protection of Human Subjects
- 21 CFR Part 50 Protection of human subjects and part 56 Institutional Review Boards
- Protection of Human Subjects; Informed Consent (January 27, 1981)
- Protection of Human Research Subjects; Standards for Institutional Review Boards for Clinical Investigations (January 27, 1981)
- Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set Forth in FDA Regulations (January 27, 1981)
- Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations (January 1981)
- Federal Policy for the Protection of Human Subjects (June 18, 1991)
- FDA Policy for the Protection of Human Subjects (June 18, 1991)
- Protection of Human Subjects; Informed Consent; Proposed Rule (September 21, 1995)
- Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules (October 2, 1996)
- Protection of Human Subjects; Informed Consent (December 22, 1995)
- Protection of Human Subjects; Informed Consent Verification; Final Rule (November 5, 1996)
- Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure (November 9, 1998)
- Additional protections for children (66 FR 20589-600, April 24, 2001)
- FDA IRB Registration Rule (21 CFR 56.106)
- IRB Continuing Review After Clinical Investigation Approval (PDF – 145KB) -02/2012
- 21 CFR Part 54 Financial disclosure by Clinical Investigator
- Financial Disclosures by Clinical Investigators (63 FR 5233, February 2, 1998)
- Financial Disclosures by a Clinical Investigator(63 FR 72171-81, December 31, 1998)
- 21 CFR Parts 312 (investigational New Drug Application) and part 314 (Application for FDA Approval to Market A New Drug)
- Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations (June 9, 1983)
- New Drug and Antibiotic Regulations (February 22, 1985)
- New Drug, Antibiotic, and Biologic Drug Product Regulations (March 19, 1987)
- Investigational New Drug Applications and New Drug Applications (September 8, 1995)
- Investigational New Drug Applications and New Drug Applications (February 11, 1998)
- Disqualification of a Clinical Investigator (February 16, 1996)
- Disqualification of a Clinical Investigator (September 5, 1997)
- Expedited Safety Reporting Requirements for Human Drug and Biological Products (October 7, 1997)
- Clinical Hold for products intended for life threatening conditions (65 FR 34963-71, June 1, 2000)
- Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (September 29, 2010)
- Disqualification of a Clinical Investigator (April 30, 2012)
- 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
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