Informed Consent

Informed consent is the legal term for formal permission given by a patient or subject before a medical procedure or clinical research is conducted involving that person.

The process of obtaining informed consent entails supplying the patient with complete and adequate information on the consequences and possible adverse effects inherent to the research or procedure, as well as benefits and alternative treatments, prior to receipt of permission to proceed. Multimedia elements may be used to educate potential patients or participants in research. Patients must fully comprehend information about the medical procedures, and participation must be fully voluntary and free from pressure or coercion. In medical and research settings, paper consent forms are usually used.

In order to consent or decline participation, the individual must be deemed competent, that is, capable of comprehending relevant information. Some examples of situations in which an individual cannot consent include cases of severe mental illness, intellectual or emotional immaturity, intoxication, and coma. In these cases a parent, guardian, or conservator may consent on the individual's behalf.

Research on human subjects presents ethical challenges, especially regarding vulnerable populations such as children or people with mental illness. These individuals may be at higher risk due to their inability to consent, but they also represent populations for which research is lacking and needed. The term informed assent is often used for children who are too young to legally consent but old enough to understand the information.

The need for consent in medical and research settings was brought to light during the Nuremberg war crimes trials following World War II (1939–1945). Unethical experiments and torture performed by Nazi physicians led to the creation of the Nuremberg Code, which requires patient consent prior to participation in research trials. The term informed consent was first used in a medical malpractice case in the United States in 1957.

Resources

BOOKS
PERIODICALS

Leclercq, Wouter K. G., et al. “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions.” World Journal of Surgery 34, no. 7 (July 2010): 1406–15.

Rock, Mary J., and Roberta Hoebeke. “Informed Consent: Whose Duty to Inform?” MEDSURG Nursing 23, no. 3 (May-June 2014): 189–91, 94.

Schrems, Berta. “Informed Consent, Vulnerability and the Risks of Group-Specific Attribution.” Nursing Ethics 21, no. 7 (November 2014): 829–43.

Traynor, Kate. “Informed Consent Remains a Work in Progress.” American Journal Of Health-System Pharmacy 70, no. 24 (December 2013): 2173–74.

WEBSITES

Food and Drug Administration. “Should Your Child Be in a Clinical Trial?” http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048699.htm (accessed July 15, 2015).

ORGANIZATIONS

Association of Clinical Research Professionals, 99 Canal Center Plaza, Ste. 200, Alexandria, VA, 22314, (703) 254-8100, Fax: (703) 254-8101, office@acrpnet.org, http://www.acrpnet.org .