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. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. In the United States, a series of highly publicized abuses in research led to the enactment of the 1974 National Research Act, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to 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 research is conducted in accordance with those principles.
In 1978, the Commission published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report. The Belmont Report identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice. The federal regulations found at 45 CFR part 46 are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted. In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.”
--What is the historical basis for the current human research regulations, 45 CFR part 46?. Office for Human Research Protections. Retrieved 2008-01-16.
To ensure adherence and attention to the regulatory and ethical principles of human research, the federal regulations establish a self-oversight mechanism for all research institutions; this oversight is through the Institutional Review Board for the Protection of Human Subjects (IRB).
All researchers have a professional responsibility and moral obligation to adhere to the human protection regulations and to consider the ethical principles of respect for persons, beneficence, and justice in their research design. The ultimate responsibility for compliance with regulations and policies for the protection of human subjects lies with the researchers themselves; thus, it is of paramount importance to have knowledge of the regulatory requirements and local policies. Every person involved in a human subject research project, whether investigator, technician, student, or instructor, must be aware of and abide by their attendant obligations to assure that the ethical principles of human subject research are upheld.
Available Training
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The University of Texas at Arlington: Online Training Instructions |
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Additional Resources
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The University of Texas at Arlington: IRB Standard Operating Procedures |
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Federal Regulations: Protection of Human Subjects, 45 CFR 46 |
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Investigator Responsibility: Frequently Asked Questions |
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The Belmont Report |
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Human Subject Regulations Decision Charts |
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Federal Regulations: Protection of Human Subjects, 21 CFR 50 |
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Federal Regulations: Institutional Review Boards, 21 CFR 56 |
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Tips on Informed Consent |
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Available Forms
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The University of Texas at Arlington: Electronic IRB Protocol Application |
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