Informed consent holds that patients must, by law, have the risks and benefits of a surgery or other medical procedure explained to them in advance so they are able to act knowledgeably in granting or denying permission to proceed.
"Informed consent is at the heart of shared decision making — a recommended approach to medical treatment decision in which patients actively participate with their doctors,"
the American Medical Association's AMA Journal of Ethics reports.
Here are six noteworthy facts about the origins, history and application of informed consent.
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1. A 1914 U.S. Supreme Court case, Schoendorff v. Society of New York Hospital, "first established that the patient was an active participant in the treatment decision process,"
Peter Murray of the University of Iowa wrote in 1990.
2. The concept of patient consent in medical research arose from the Nuremberg trials after World War II, in which Nazi doctors and public health officials were found guilty of conducting barbaric and unsanctioned experiments on human subjects. The Nuremberg Code of 1947 is "generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent,"
the British Medical Journal (BMJ) reported.
3. A key figure in the development of consent is Henrietta Lacks, a poor Maryland farmer and cancer patient who in 1951 had tissue from her cervix removed for what would prove to be groundbreaking medical research — but without her knowledge or consent,
according to "The Immortal Life of Henrietta Lacks," a 2010 book on Lacks' importance to modern day medicine and medical ethics.
4. The actual phrase, "informed consent," is credited to an American lawyer, Paul G. Gebhard, who represented medical professionals and employed the phrase in medical malpractice cases beginning in 1957,
The New York Times reported.
5. For routine procedures such as drawing blood, written and signed formal consent is not required, and "verbal approval may be adequate,"
according to a guide on the subject published by Temple University Hospital.
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6. Exceptions to the informed consent requirement are most likely to occur in emergency medicine, according to a 1999 article in "Hospital Physician," which states that in many such life-or-death circumstances, in which a patient is not conscious and not accompanied by a legal guardian, "patient consent is presumed."
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