The Catholic University of America

Summary of Federal Laws

Research

Federal Food, Drug and Cosmetic Act

21 U.S.C. § 301 et seq.; 21 C.F.R. § 50.1, § 56.101, § 312.1, § 600.3 et seq., and § 812.1 et seq.; 61 Fed. Reg. 51,498 (Oct. 2, 1996)

This law applies to research on any product under its regulatory purview. The protection of human subjects is covered in 21 C.F.R. Parts 50 and 56. An exception from informed consent requirements for emergency research was added in October 1996, effective November 1, 1996. See 21 C.F.R. § 50.24.

The Office for Good Clinical Practices (OGCP) was established on Oct. 26, 2001 to improve the conduct/oversight of clinical research governed by FDA, and to ensure protection of human subjects. See "Mission" for more on the oversight of this office.

21 CFR Part 58 contains the Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations prescribe good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

Reporting Information Regarding Falsification of Data; Proposed Rule 75 Fed. Reg. 7412 (Feb. 19, 2010)
The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. FDA is using the term "sponsor" in this document to refer to petitioners submitting food additive, color additive, nutrient content claim, and health claim petitions; anufacturers or distributors submitting new dietary ingredient notifications; and sponsors as defined in Sec. Sec. 58.3(f), 312.3(b), 510.3(k), and 812.3(n) (21 CFR 58.3(f), 312.3(b), 510.3(k), and 812.3(n)). The term "sponsor" as used in this document does not include a Federal agency that sponsors research or investigations through funding or contracts or an entity identified as a sponsor under other Federal programs (e.g., a recipient of funding from the National Institutes of Health), except to the extent that any such Federal agency or entity is a petitioner, manufacturer, distributor, or sponsor as specified in the preceding sentence.

Resources

FDA Information Sheet Guidances for IRBS, Clinical Investigators, and Sponsors: Includes link to related regulations.

Laws enforced by the FDA and related statutes: Includes links to laws and related resources.

 

CCR updated CFR links 6/15/15