Applicable Laws and Regulations

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Declaration of Helsinki
Belmont Report
FDA Information Sheets
A publication of the Food and Drug Administration (FDA), updated in 1998, that provides guidance to both the Institutional Review Board (IRB) and research investigators in carrying out their responsibilities relative to the protection of human research subjects. It covers clinical investigation requirements for research on drugs and biologicals, and medical devices.
45CFR46
Code of Federal Regulations Title 45: Public Welfare. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Part 46: Protection of Human Subjects. Revised November 13, 2001. Effective December 13, 2001.
Good Clinical Practice: Consolidated Guidance
This is a publication of the DHHS, FDA, Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) which describes the international ethical and scientific quality standard for conducting research in human subjects. This document was endorsed by the International Conference on Harmonisation (ICH) in April 1996 and published in the Federal Register May 1997. This document addresses issues relative to IRBs, investigators, sponsors, clinical trial protocols, investigator brochures, and essential documents for the conduct of a clinical trial.