Ethics, Regulations, and Policies
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The Belmont Report: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Between 1974 and 1978, the Commission met on numerous occasions and issued several reports dealing with various aspects of research with human subjects. During this period, the Commission held one particularly intensive retreat from February 13-16, 1976 at Belmont House, a conference center of the Smithsonian Institution in Elkridge, Maryland, to focus on the foundational ethical principles underlying the use of humans as subjects in research studies. Based upon the ideas that emerged from that retreat, the Commission developed the Belmont Report, which was published in the Federal Register (Vol. 44, No. 76) (7 pp, 141K, About PDF) by the Department of Health, Education, and Welfare on April 18, 1979. The Belmont Report set forth three basic ethical principles and discussed their regulatory applications. The three principles, respect for persons, beneficence, and justice, are now accepted worldwide as the ethical basis for research with human subjects, and they serve as the ethical foundation and justification for the Federal regulations for the protection of human subjects, including those of EPA.
EPA Regulation 40 CFR 26 (Protection of Human Subjects):The first Federal regulations for the protection of human research subjects were promulgated by the Department of Health, Education, and Welfare in 1974 at 45 CFR 46. In 1977, EPA began requiring that certain human research conducted or supported by the Agency conform to the requirements of 45 CFR 46 as a matter of Agency policy. The regulations at 45 CFR 46, as revised from time to time, were developed in parallel with the development of the Belmont Report, and the latter came to serve as the ethical foundation and justification. Then, in 1991, multiple Federal departments and agencies together adopted a common version of the basic regulatory structure of 45 CFR 46 that incorporated reliance on review by an independent committee (called an institutional review board or IRB) and informed consent as the two pillars of protection. This regulatory document, which became known as the Common Rule, was promulgated by each participating department or agency in its regulations for the protection of human subjects. EPA was an original participant and codified the Common Rule at 40 CFR 26 in 1991 along with the other participating Federal departments and agencies. In 2006, EPA promulgated an expanded version of 40 CFR 26 (35 pp, 480K, About PDF) that retained the Common Rule at Subpart A and added a series of additional subparts. This expanded version of 40 CFR 26 now includes EPA-specific additional protections and prohibitions for children, pregnant women and fetuses, and nursing women in research conducted or supported by the Agency at Subparts B-D. It also contains regulations for third-party human research for pesticides and rules for data use, compliance oversight, and other matters at Subparts K-Q.
EPA Order 1000.17 Change A1 (Policy and Procedures on Protection of Human Research Subjects in EPA Conducted or Supported Research): The prior policy of adherence to 45 CFR 46 was established in 1977 by EPA Order 1000.17. In 1999, this policy was replaced with EPA Order 1000.17 Change A1 (41 pp, 344K, About PDF), which was revised in 2011. The new policy, which remains in force at the present time, requires that all covered human research conducted or supported by EPA be compliant with 40 CFR 26, and it sets forth procedures designed to help assure such compliance. The policy defines the position of Human Subjects Research Review Official (HSRRO) and the requirements for HSRRO review of human research conducted or supported by the Agency. Details of the HSRRO review requirements and procedures are available on the Project Review page. EPA personnel involved in conducting or supporting human research should also refer to Conducting HSR or Making Funding Awards and Other Agreements that Support HSR for additional information.