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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
grants regulations 45 CFR part 75 to provide additional safeguards concerning the use of such tissue in HHS-funded research. This proposed rule would strengthen informed consent requirements in Subpart B and help ensure compliance with the statutory ban on the provision of valuable consideration for human fetal tissue through clarifying recordkeeping and maintenance requirements for the acquisition of human fetal tissue for research.
II. Background U.S. Federal regulations governing the protection of human subjects in research have been in existence for more than three decades. Nearly thirty years have passed since the Common Rule was adopted by 15 U.S. Federal departments and agencies in an effort to promote uniformity, understanding, and compliance with human subject protections. HHS adopted the Common Rule in Subpart A of 45 CFR part 46.
The history of contemporary human subjects protections began in 1947 with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis.3 The Nuremberg Code set forth many of the basic principles governing the ethical conduct of human subjects research. Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects Helsinki Declaration, first adopted in 1964 and subsequently revised many times.4
Basic regulations governing the protection of human subjects in research supported or conducted by HHS then the Department of Health, Education and Welfare were first published in 1974, after a series of highly publicized research abuses. The enactment of the 1974 National Research Act Pub. L. 93
348 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research National Commission. One of the charges of the National Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to assure that such 3 See Nuremberg Code, available at https
history.nih.gov/display/history/Nuremberg+Code.
4 See World Medical Association, Declaration of HelsinkiEthical Principles for Medical Research Involving Human Subjects, available at www.wma.net/policies-post/wma-declaration-ofhelsinki-ethical-principles-for-medical-researchinvolving-human-subjects/.

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research is conducted in accordance with those principles. In 1979, the National Commission published Ethical Principles and Guidelines for the Protection of Human Subjects of Research, also known as the Belmont Report http www.hhs.gov/ohrp/
policy/belmont.html. The Belmont Report identified three fundamental ethical principles for all human subjects research: Respect for persons, beneficence, and justice. Like the Nuremberg Code and Helsinki Declaration, the Belmont Report stressed the importance of obtaining informed consent before engaging in human subjects research.
Based on the Belmont Report and other work of the National Commission, HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations are codified at 45 CFR part 46, subparts A through E:
Subpart A: Basic HHS Policy for Protection of Human Research Subjects Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D: Additional Protections for Children Involved in Research Subpart E: Registration of Institutional Review Boards The statutory authority for the HHS
regulations derives from 5 U.S.C. 301;
42 U.S.C. 300v1b; and 42 U.S.C. 289.
In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, known as the Common Rule, identical to subpart A
of 45 CFR part 46 of the HHS
regulations.
The Common Rule requires that Federally funded investigators in most instances obtain and document the informed consent of research subjects;
requires Federally funded research be reviewed by an institutional review board IRB; and describes the requirements for IRB membership, function, operations, research review, and recordkeeping. The regulations also delineate criteria for, and levels of, IRB
review. Currently, except for human subjects research that is determined to be exempt from the regulations, Federally funded research involving human subjects is reviewed by an IRB
in one of two ways: 1 By a convened IRB, or 2 through an expedited review process.

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Since the Common Rule was first developed, the landscape of research activities has changed dramatically, accompanied by a marked increase in the volume of research. It is estimated that total spending on health-related research and development by the drug industry and the Federal government has more than tripled since 1990.5
While traditional biomedical research conducted in academic medical centers continues to flourish, many studies are now also conducted at community hospitals, outpatient clinics, or physician-based practices. Clinical research is regularly conducted at multiple institutions across the U.S. and other countries. Recruitment firms, bioinformatics specialists, clinical trial coordinating centers, protocol developers, data analysts, contract research organizations CROs, data and safety monitoring boards, communitybased organizations, and other entities have joined investigators and sponsors as part of the clinical research enterprise.
The rapid growth and expansion of human subjects research generated many questions about whether the regulatory framework is adequate and appropriate for the protection of human subjects in the 21st century.
Furthermore, decades of experience have revealed a great deal about the functioningand limitationsof existing regulations, and prompted critical evaluations by the Institute of Medicine IOM,6 7 the U.S. Government Accountability Office,8 9 10 and many scholars.11 12 13 Federal consideration of such revisions to the regulatory schema, 5 Congressional Budget Office. Research and Development in the Pharmaceutical Industry.
October 2006.
6 Federman DD, Hanna KE, Rodriguez LL, eds.
Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC:
National Academies Press; 2002.
7 Nass SJ, Levit LA, Gostin LO, eds. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC:
National Academies Press; 2009.
8 Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain.
GAO01775T, May 23, 2001.
9 Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. THEHS
96102, Mar 12, 1996.
10 Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. HEHS96
72, Mar 8, 1996.
11 Kim S, Ubel P, De Vries R. Pruning the regulatory tree: For human-subjects research, maximum regulation does not mean maximum protection. Nature 2009;457: 534535.
12 Emanuel EJ, Wood A, Fleischman A, et al.
Oversight of human participants research:
Identifying problems to evaluate reform proposals.
Ann Int Med 2004; 1414: 282291.
13 Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality improvement methods in health care. Ann Int Med 2007;1469:666 673.

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