Informed Consent

Medical intervention and research trials often involve risk, and this risk can be substantial enough to include the death of the participant as one possibility. Even trials with medicines that are thought to have little potential for adverse consequences can lead to unexpected death because of the complex differences among people who are treated or who participate in clinical trials. This vulnerability is one of the more important reasons for the process of informed consent to be carried out with care, and improved through experience. Informed consent refers to an individual's act of acquiescing in an intervention or in research affecting the individual, without coercion and with full understanding of what is entailed by the intervention or research. The fundamental basis of the concept of informed consent is respect for people and respect for their autonomy—their right to self-determination. This concept has been particularly important in bioethics in the 20th and 21st centuries, and it undergirds the maxim that decisions about what is best for a person ought to be made by the one whose life is going to be affected.

The most important reason for the prominence of this concept in recent ethical thought is historical experience in which informed consent was not observed, and in which moral atrocities occurred. These historical events offer an important perspective from which to view the evolution of contemporary notions of informed consent. For example, the Nuremberg Code, which has provided a starting point for understanding the meaning and importance of informed consent, grew out of the trial of German physicians who conducted human experiments in Nazi concentration camps. All subsequent codes and systems of regulation related to informed consent derive in various ways from this code. The issue of informed consent was addressed and refined in several important subsequent documents, such as the Declaration of Helsinki adopted by the World Medical Association as a governing set of research ethics principles. This set of principles established the priority of human subjects' interest over those of science and society.

The U.S. Congress became increasingly concerned about informed consent during the early 1970s in part because of another historical event—the Tuskegee Syphilis Study. This involved poor black men who were not informed participants in the study and who were used as means to gain knowledge about the natural history of untreated syphilis. Though they were told about the fact that they had “bad blood,” they were not told of the penicillin treatment effective against syphilis, a treatment that had become the standard treatment for the disease by 1947. As a result of the details of the Tuskegee study, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed. This led to the production of the Belmont Report in 1979, a report that built upon the principles expressed in the Nuremberg Code. This report embraces three principles that are now familiar and accepted as crucial for research involving human subjects, and which are vital to a robust notion of informed consent: respect for people, beneficence, and justice. For the purposes of understanding informed consent, the principle of respect for people is dominant and comprises two concepts: Individuals are to be treated as autonomous agents, and those individuals with less autonomy are entitled to protection. The latter concept is especially relevant in interventions and research involving children, though it is somewhat fluid in its definition because the autonomy of pediatric patients increases as they approach adulthood.

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