Related Pages Protecting Participants in Clinical Trials A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study. Protecting Human Research Participants A free, on-line tutorial offered by the National Institutes of Health (NIH) Office of Extramural Research, for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.

The History of Informed Consent and the System of Protections

Over the past half-century, the international and U.S. medical communities have taken numerous steps to protect people who take part in clinical research. The following timeline provides an overview of some of the key events that have contributed to the development of the current system.

1947 — The Nuremberg Code

Developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II, the Code was the first major international document to provide guidelines on research ethics. It made voluntary consent a requirement in clinical research studies, emphasizing that consent can be voluntary only if:

• participants are able to consent;
• they are free from coercion (i.e., outside pressure); and
• they comprehend the risks and benefits involved.

The Code also states that researchers should minimize risk and harm, make sure that risks do not significantly outweigh potential benefits, use appropriate study designs, and guarantee participants' freedom to withdraw at any time. The Nuremberg Code was adopted by the United Nations General Assembly in 1948.

1964 — Declaration of Helsinki

At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction between medical care that directly benefits the patient and research that may or may not provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo, Japan), 1983 (Venice, Italy), and 1989 (Hong Kong).

1974 — The National Research Act

The U.S. Congress signed this act into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged with:

1. identifying the basic ethical principles that should govern medical research involving people, and then
2. recommending steps to improve the Regulations for the Protection of Human Subjects.

1979 — The Belmont Report

After four years of work, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research:

1. respect for persons: recognizing the autonomy and dignity of individuals, and the need to protect those with diminished autonomy (i.e., impaired decision-making skills), such as children, the aged, and the disabled;
2. beneficence: an obligation to protect persons from harm by maximizing benefits and minimizing risks;
3. justice: fair distribution of the benefits and burdens of research.

The Belmont Report explains how these apply to research practices; for example, it identifies informed consent as a process that is essential to the principle of respect. In response to the report, both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration revised their regulations on research studies that involve people.

1991 — Federal Policy for the Protection of Human Subjects

This policy was adopted to ensure a uniform system of protections in all federal agencies and departments that conduct research.

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