Informed Consent

Informed consent refers to permission granted by a legally competent person to participate in a research investigation involving human subjects. In health care settings, informed consent also refers to a communication process used when seeking permission to provide physical or psychological health care services. Informed consent promotes human dignity by upholding the ethical principles of autonomy, beneficence, and justice.

Moreover, effective informed consent procedures enhance public trust in the scientific enterprise. From ethical and legal perspectives, consent is not considered to be truly informed unless the following criteria have been met: (a) disclosure, (b) comprehension, (c) voluntary decision, (d) legal competence, and (e) documentation. This article provides a historical overview followed by a discussion of the five criteria necessary for obtaining informed consent.

Legal protection for human research participants is a recent historical development. In the early 20th century, research and medical consent were typically constrained to verbal assent or a brief written permission agreement. Most physicians and researchers operated under the benevolence model, also known as the “doctor knows best” doctrine. From 1900 to the 1940s, it was thought that lay people were unable to fully comprehend complex procedures. Explanations of intended research objectives and procedures were cursory, at best. Human rights abuses sometimes occurred, and ethnic, cultural, and religious minority populations were particularly vulnerable. The Tuskegee experiment illustrates potential problems when consent is not fully informed. From the 1920s to the early 1960s, a longitudinal study examining the naturalistic course of syphilis was conducted at the Tuskegee Institute. Full disclosure was not provided to the 400 African American male volunteers who were offered free medical treatment in exchange for their participation. Although the participants were aware that the purpose of the study was to examine “bad blood” over several years, they were not explicitly informed that some[Page 466] volunteers would be injected with syphilis. Research findings were published in several prestigious medical journals without ethical questions being raised. When eventually confronted, the white investigators argued that they had mistakenly believed that African American recruits understood that “bad blood” specifically referred to syphilis.

During World War II, concentration camp inmates were involuntarily subjected to horrendous medical research, including experimental surgeries, exposure to extreme heat and cold, and other cruel acts. Many painful deaths ensued. These atrocities were later revealed during war crime trials and contributed to the development of the highly influential Nuremberg Code (1946). The Code declared voluntary consent to be a universal human right and also described elements necessary to ensure knowledgeable decision making in what is now known as informed consent. This decisive document had a far-reaching influence on research practice. The Universal Declaration of Human Rights (1948), Declaration of Helsinki (1964), and Belmont Report (1979) further supported human participant rights, including informed consent. Professional ethical codes, such as those developed by the American Psychological Association, also emphasized the need for informed consent. In 1972, government regulation of human research was formalized with the establishment of the Department of Health and Human Services. This agency ensures compliance with federal regulations and policies, including informed consent for human research participation. It also oversees local institutional (or internal) review boards (IRBs) authorized to review research protocols, including informed consent procedures. Currently, informed consent must be obtained before an individual participates in a research protocol unless the project meets federal exemption criteria or has been granted an IRB exception. When written consent is required, the research investigator maintains the responsibility for ensuring that the five fundamental elements of informed consent were met.

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