National Research Act

US law

42 U.S.C. ch. 6A, subch. I § 218
42 U.S.C. ch. 6A, subch. II § 241
42 U.S.C. ch. 6A, subch. III §§ 289l-1, 289l-3

Legislative history

Introduced in the House as H.R. 7724 by Paul G. Rogers (D–FL) on May 10, 1973
Committee consideration by House Interstate and Foreign Commerce, Senate Labor and Public Welfare
Passed the House on May 31, 1973 (354-9)
Passed the Senate on September 11, 1973 (81-6)
Reported by the joint conference committee on June 24, 1974; agreed to by the Senate on June 27, 1974 (72-14) and by the House on June 28, 1974 (311-10)
Signed into law by President Richard Nixon on July 12, 1974

The National Research Act is an American law enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974. The law was passed following a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy.^[1]

The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines for human subject research and to oversee and regulate the use of human experimentation in medicine. The National Research Act gained traction as a response to the infamous Tuskegee syphilis study.^[2]

Provisions

The National Research Act issued Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects. The National Research Act is overseen by the Office of Human Research Protections. The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections.^[3]

References

^ National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979). "The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research". Regulations and Ethical Guidelines. Department of Health, Education and Welfare. Retrieved 2014-03-28.
^ Chadwick, G.L. (January 1997). "Historical perspective: Nuremberg, Tuskegee, and the radiation experiments". Int Assoc Physicians AIDS Care. 3 (1): 27–28. PMID 11363960.
^ Rice, Todd (October 2008). "The Historical, Ethical, and Legal Background of Human-Subjects Research". Respiratory Care. 53 (10): 1325–1329. PMID 18811995.