Informed Consent

History

Today, protecting human research participants through informed consent is common practice. That was not always the case. Unethical and harmful studies conducted in the past led to the creation of a regulatory board and current ethical principles that are in place to protect the rights of human participants.

The Nazis conducted a great deal of inhuman research during World War II. As a result, in 1947 the Nuremberg Military Tribunal created the Nuremberg Code, which protected human participants in medical experiments. The code required researchers to obtain voluntary consent and minimize harm in experiments that would provide more benefits to the participants than foreseen risks. In 1954, the National Institutes of Health (NIH) established an ethics committee that adopted a policy that required all human participants to provide voluntary informed consent. Furthermore, the Department of Health, Education, and Welfare issued regulations in 1974 that called for protection of human research participants. The department would not support any research that was not first reviewed and approved by a committee, which is now known as the Institutional Review Board (IRB). The IRB would be responsible for determining the degree of risk and whether the benefits outweighed any risk to the participants. It was noted in the regulations that informed consent must be obtained.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created in 1974, and this organization was charged to identify basic ethical principles within research with human subjects and make recommendations to improve the policies in place. As a result, the Belmont Report was created, which identifies and defines the three basic principles for research, and it is still in use today. The basic principles of the Belmont report include respect for persons, beneficence, and justice. Beneficence is the process of maximizing good outcomes from science, humanity, and the research participants, while avoiding or minimizing unnecessary risk, harm, or wrong. Respect encompasses the overall protection of an individual's autonomy, through courtesy and respect for everyone, including individuals who are not autonomous (children, [Page 603]mentally handicapped, etc.). Justice ensures reasonable, nonexploitative, and carefully considered procedures through fair administration.

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