Background & History

Human Participants protection began with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis.

In the United States, regulations protecting human participants first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status NIH's Policies for the Protection of Human Participants, which were first issued in 1966. The regulations established the IRB as one mechanism through which human participants would be protected.

In July of 1974, the passage of the National Research Act established the National Commission for the Protection of Human Participants of Biomedical and Social Science Research. The Commission met from 1974 to 1978. In keeping with its charge, the Commission issued reports and recommendations identifying the basic ethical principles that should underlie the conduct of biomedical and Social Science research involving human participants and recommending guidelines to ensure that research is conducted in accordance with those principles. The Commission also recommended DHEW administrative action to require that the guidelines apply to research conducted or supported by DHEW. References for the Commission's reports are listed in Appendix 1 (General Bibliography). The Commission's report setting forth the basic ethical principles that should underlie the conduct of biomedical and Social Science research involving human participants is titled The Belmont Report, and is discussed in depth below.

In 1981, in response to the Commission's reports and recommendations, both the Department of Health and Human Services (DHHS, formerly DHEW) and the FDA promulgated significant revisions of their human participant regulations. As Levine (1986) points out, these revisions "do not alter the general principles of IRB review as they had evolved over the preceding three decades. Rather, they are concerned with some of the details of what the IRB is expected to accomplish and some of the procedures it must follow" [p. 324].

The DHHS regulations are codified at Title 45 Part 46 of the Code of Federal Regulations. Those "basic" regulations became final on January 16, 1981, and were revised effective March 4, 1983, and June 18, 1991. The June 18, 1991, revision involved the adoption of the Federal Policy for the Protection of Human Participants. The Federal Policy (or "Common Rule," as it is sometimes called) was promulgated by the sixteen federal agencies that conduct, support, or otherwise regulate human participants research; the FDA also adopted certain of its provisions. As is implied by its title, the Federal Policy is designed to make uniform the human participants protection system in all relevant federal agencies and departments. The Federal Policy is discussed in depth in Chapter 2, Section A(i).

Additional protections for various vulnerable populations have been adopted by DHHS, as follows:

Subpart B, "Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women and Human in Vitro Fertilization" became final on August 8, 1975, and was revised effective January 11, 1978, and November 3, 1978.

Subpart C, "Additional Protections Pertaining to Biomedical and Social Science Research Involving Prisoners as Participants" became final on November 16, 1978.

Subpart D, "Additional Protections for Children Involved as Participants in Research" became final on March 8, 1983, and was revised for a technical amendment on June 18, 1991.

FDA regulations on the protection of human participants are codified at Title 21 Parts 50 and 56 of the Code of Federal Regulations. Part 50, which sets forth the requirements for informed consent, became final on May 30, 1980, and was revised effective January 27, 1981, March 3, 1989, and June 18, 1991. Subpart C, which provides special protections for prisoners, was adopted on July 7, 1981; the effective date of Subpart C has been stayed until further notice. Part 56, which sets forth the provisions for institutional review boards, was adopted on January 27, 1981, with revisions to some sections effective February 27, 1981, March 3, 1989, and June 18, 1991.

Additional FDA regulations that are relevant to IRB review of research are Parts 312 (Investigational New Drug Application), 812 (Investigational Device Exemptions), and 860 (Medical Device Classification Procedures).

The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Social Science Research, which met from 1980 to 1983, produced numerous reports on various aspects of medical ethics and biomedical and Social Science research. Its mandate with respect to the protection of human participants was, first, to review the federal rules and policies governing human participants research, and second, to determine how well those rules were being implemented or enforced. References for the President's Commission's reports are listed in Appendix 1 (General Bibliography).

Several excellent sources trace the history of human participant research and the development of the IRB system as a mechanism for the protection of human participants. An account of the history of human participants research and the human participants protection system in the United States can be found in David J. Rothman's Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (Chapters 1-5 and Epilogue) and in Dennis Maloney's Protection of Human Research Participants. Rothman details the abuses to which human participants were exposed, culminating in Henry Beecher's 1966 article, "Ethics and Clinical Research," published in the New England Journal of Medicine, and ultimately contributing to the impetus for the first NIH and FDA regulations. Other equally useful sources include Robert J. Levine's Ethics and Regulation of Clinical Research (Chapter 14), Joan E. Sieber's Planning Ethically Responsible Research, Robert M. Veatch's "Human Experimentation Committees: Professional or Representative?," and William J. Curran's "Government Regulation of the Use of Human Participants in Medical Research: The Approaches of Two Federal Agencies."

A Brief History:

Here are some significant dates in the development and history of informed consent.

These events and others have prompted federal action to protect human participants involved in all types of research. In December 1971, the U.S. Department of Health, Education, and Welfare began to require the creation of Institutional Review Boards (IRBs).

The proposed research design of a University faculty, staff, or student must be reviewed by the IRB. The IRBs at The Pennsylvania State University are charged with reviewing plans that protect your participants. The IRBs ensure that human participants do not bear any inappropriate risk and have properly consented to their involvement.

The IRBs at The Pennsylvania State University consist of more than 40 representatives of faculty, staff, and the local community and review all research involving human participants, irrespective of the funding source. This includes research that is funded by Federal agencies, state government, foundations, internal grants, departmental funds, etc.

The chronological order of this history of events was developed by the University of Minnesota.

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