The Evolution of Informed Consent

by Mary Beth Nierengarten •

Dr. Grady suspects that physicians could use more education on why informed consent is important. During a recent experience she had talking to a group of surgeons about informed consent, she found that while most surgeons understood that a document needed to be signed prior to a procedure, the surgeons appreciated little beyond that.

“Maybe the form is just one little piece of what they should be doing when they are talking to their patients,” she said, adding that they should also be giving the patient the opportunity to understand the details of what is going on, and giving him or her a choice about it.

Mary Beth Nierengarten is a freelance medical writer based in Minnesota.

Milestones in Informed Consent

1900: Written contracts between researchers and participants are used in Walter Reed’s Yellow Fever Experiment, an intentional exposure study of the mechanism of yellow fever transmission. This is the first documented instance of use of the informed consent process in a major research study.

1914: Mary Schloendorff sues the Society of New York Hospitals for performing surgery on her without prior consent. She won the case, which established that the patient was an active participant in the treatment decision process.

1947: Nuremberg Code requires informed consent for all experiments, and specifies that experiments must be scientifically necessary and conducted by qualified personnel. Additionally, human trials should be preceded by animal studies and surveys of a disease’s natural history.

1957: Salgo v. Leland Stanford Jr. Board of Trustees. This malpractice case is the first time the phrase “informed consent” is used.

1962: Kefauver-Harris amendments to the Federal Food, Drug and Cosmetics Act are passed and signed into law in response to the thalidomide tragedy; from this point forward, clinical drug testing requires informed consent.

1972: Canterbury v. Spence determines the Informed Consent/Reasonable Person Standard, which mandates that physicians disclose information a reasonable person would want to know. This standard is currently adopted in about 50% of U.S. states.

Source: JAMA. 2016;315:2063–2064; NIH