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U.S. Department of Health and Human Services

Science & Research

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Preambles to GCP Regulations

Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal. The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal. Any comments that are submitted are addressed in subsequent publications that are part of the agency's decision-making process.

The "preamble" to each of these publications includes all of the printed information immediately preceding the codified regulation. The preamble provides information about the regulation such as why the regulation is being proposed, the FDA's interpretation of the meaning and impact of the proposed regulation, and in those cases where the agency has solicited public comment, the agency's review and commentary on those comments . The preamble can also include an environmental impact assessment, an analysis of the cost impact, comments related to the Paperwork Reduction Act, and the effective date of the implementation or revocation (as the case may be) of the regulation.

The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials.

 

Parts 50 and 56

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 (November 1988)

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, Part II (October 2, 1996) [html]

Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules (October 2, 1996) [text]

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)

Protection of Human Subjects; Informed Consent, Exception from general requirements (October 5, 1999)

Additional protections for children (66 FR 20589-600, April 24, 2001)

Exception from General Requirements for Informed Consent (71 FR 32827, June 7, 2006) [PDF]

Part 54

Financial Disclosures by Clinical Investigators (63 FR 5233, February 2, 1998)

Financial Disclosures by a Clinical Investigator(63 FR 72171-81, December 31, 1998)

Part 210 

Current Good Manufacturing Practice Regulations and Investigational New Drugs (63 FR 5233, February 2, 1998)

Parts 312 and 314

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)

Part 320

Retention of BE and BA testing samples (April 28, 1993)

Part 812

Quality System Regulations (October 7, 1996)

Treatment Use of Investigational Devices (September 18, 1997)

Withdrawal of Intraocular Lenses Regulation (Part 813) (January 29, 1997)

Disqualification of Clinical Investigators (March 14, 1997)

Modifications to the List of Recognized Standards (July 12, 1999)

Modifications to the Medical Device and/or Study Protocol (November 23, 1998)

Part 814

Medical Devices; Humanitarian Use Devices Part V (June 26, 1996)

30-Day Notices and 135-Day PMA Supplement Review (October 8, 1998)

Humanitarian Use of Devices (November 3, 1998)

Miscellaneous

Part 11 Electronic Records; Electronic Signatures (March 20, 1997)

Use of BMIS (63 FR 55873-6, October 19, 1998)

Presiding officer (66 FR 45317-8, August 28, 2001)