What significant regulatory framework for human subjects research began in 1981?

The Common Rule is a significant regulatory framework for human subjects research that was established in 1981. It refers to the Federal Policy for the Protection of Human Subjects and is crucial for ensuring ethical standards in research involving human participants. The Common Rule outlines the requirements for institutional review boards (IRBs), informed consent, and additional protections for vulnerable populations. This framework applies to a variety of federal agencies and has influenced policies both in the United States and globally.

The Declaration of Helsinki, although critical in guiding medical research ethics, was first adopted by the World Medical Association in 1964, making it prior to the 1981 date referenced in the question. The Belmont Report, published in 1979, lays out ethical principles and guidelines for research involving human subjects but is not a regulatory framework itself. The NIH Guidelines refer specifically to the National Institutes of Health policies and practices regarding certain types of research but do not encompass the broader set of protections codified in the Common Rule.