Informed consent
This principle applies more broadly than healthcare intervention, for example to conduct research, to disclose a person's medical information, or to participate in high risk sporting and recreational activities.
Alternatively, the doctrine of implied consent permits treatment in limited cases, for example when an unconscious person will die without immediate intervention.
'Free consent' is a cognate term in the International Covenant on Civil and Political Rights, adopted in 1966 by the United Nations, and intended to be in force by 23 March 1976.
This "consent by proxy" usually works reasonably well, but can lead to ethical dilemmas when the judgment of the parents or guardians and the medical professional differ with regard to what constitutes appropriate decisions "in the best interest of the child".
[12] Waiver of the consent requirement may be applied in certain circumstances where no foreseeable harm is expected to result from the study or when permitted by law, federal regulations, or if an ethical review committee has approved the non-disclosure of certain information.
According to 10 USC 980, the United States Code for the Armed Forces, Limitations on the Use of Humans as Experimental Subjects, a waiver of advanced informed consent may be granted by the Secretary of Defense if a research project would:[14] While informed consent is a basic right and should be carried out effectively, if a patient is incapacitated due to injury or illness, it is still important that patients benefit from emergency experimentation.
[15] The 21st Century Cures Act enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.
[17]: 770 Corrigan argues that a model based solely around individual decision making does not accurately describe the reality of consent because of social processes: a view that has started to be acknowledged in bioethics.
[17]: 771 She feels that the liberal principles of informed consent are often in opposition with autocratic medical practices such that norms values and systems of expertise often shape and individuals ability to apply choice.
[17]: 784 Corrigan notes that patients generally expect that doctors are acting exclusively in their interest in interactions and that this combined with "clinical equipose" where a healthcare practitioner does not know which treatment is better in a randomized control trial can be harmful to the doctor-patient relationship.
Until 2015 in the United Kingdom and in countries such as Malaysia and Singapore, informed consent in medical procedures requires proof as to the standard of care to expect as a recognised standard of acceptable professional practice (the Bolam Test), that is, what risks would a medical professional usually disclose in the circumstances (see Loss of right in English law).
The UK has since departed from the Bolam test for judging standards of informed consent, due to the landmark ruling in Montgomery v Lanarkshire Health Board.
However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk.
He took the initiative to remove the woman's womb; however, as she had not given informed consent for this operation, the doctor was judged by the General Medical Council to have acted negligently.
For example, in the Milgram experiment, researchers wanted to determine the willingness of participants to obey authority figures despite their personal conscientious objections.
Nonetheless, research involving deception prevents subjects from exercising their basic right of autonomous informed decision-making and conflicts with the ethical principle of respect for persons.
[43] Others say the experiment is just a part of Facebook's current work, which alters News Feeds algorithms continually to keep people interested and coming back to the site.
Others pointed out that this specific study is not unique but rather news organizations constantly try out different headlines using algorithms to elicit emotions and garner clicks or Facebook shares.
[45] The Facebook study controversy raises numerous questions about informed consent and the differences in the ethical review process between publicly and privately funded research.
For example, in 2014 coverage of University of California (UC) medical school faculty members has included news of ongoing corporate payments to researchers and practitioners from companies that market and produce the very devices and treatments they recommend to patients.
[49] Robert Pedowitz, the former chairman of UCLA's orthopedic surgery department, reported concern that his colleague's financial conflicts of interest could negatively affect patient care or research into new treatments.
[50] Consumer Watchdog, an oversight group, observed that University of California policies were "either inadequate or unenforced...Patients in UC hospitals deserve the most reliable surgical devices and medication…and they shouldn't be treated as subjects in expensive experiments.
[52] Informed consent is a technical term first used by attorney, Paul G. Gebhard, in the Salgo v. Leland Stanford Jr. University Board of Trustees court case in 1957.
The Hippocratic Oath, a Greek text dating to 500 B.C.E., was the first set of Western writings giving guidelines for the conduct of medical professionals.
[58] In Ottoman Empire records there exists an agreement from 1539 in which negotiates details of a surgery, including fee and a commitment not to sue in case of death.
[55] This is the oldest identified written document in which a patient acknowledges risk of medical treatment and writes to express their willingness to proceed.
[54]: 65 John Gregory, Rush's teacher, wrote similar views that a doctor could best practice beneficence by making decisions for the patients without their consent.
[54]: 68 Like all previous works, Percival's Medical Ethics makes no mention of soliciting for the consent of patients or respecting their decisions.
[54]: 70 This medical ethics book was radical demonstrating understanding of the AMA's guidelines and Percival's philosophy and soundly rejecting all directives that a doctor should lie to patients.
Earlier legal cases had created the underpinnings for informed consent, but his judgment gave a detailed and thought through discourse on the matter.
