Editing Informed consent (section)

{{Short description|Ethical principle}}
{{About|consent to medical or research procedures|consent in other contexts|Consent|the ''House'' episode|Informed Consent (House)}}
{{Medical ethics sidebar}}[[File:PARAMOUNT Eli Lilly Informed Consent Document.djvu|thumbnail|right|Example of informed consent document from the [[PARAMOUNT trial]]]]
'''Informed consent''' is an [[applied ethics]] principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their [[Right to refuse medical treatment|right to refuse treatment]]. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. 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.

Within the United States, definitions of informed consent vary, and the standard required is generally determined by the state.<ref>{{cite journal |last1=Shah |first1=Parth |last2=Thornton |first2=Imani |last3=Turrin |first3=Danielle |last4=Hipskind |first4=John E. |title=Informed Consent |journal=StatPearls |date=2022 |url=https://www.ncbi.nlm.nih.gov/books/NBK430827/ |access-date=12 September 2022 |publisher=StatPearls Publishing|pmid=28613577 }}</ref> As of 2016, nearly half of the states adopted a reasonable patient standard, in which the informed consent process is viewed from the patient's perspective. <ref>
  Spatz, E. S., Krumholz, H. M., & Moulton, B. W. (2016). The New Era of Informed Consent: Getting to a Reasonable-Patient Standard Through Shared Decision Making. JAMA : The Journal of the American Medical Association, 315(19), 2063–2064. https://doi.org/10.1001/jama.2016.3070
</ref> These standards in medical contexts are formalized in the requirement for decision-making capacity and professional determinations in these contexts have legal authority.<ref>{{cite book |last=Kim |first=Scott Y. H. |date=Dec 1, 2009  |title=Evaluation of Capacity to Consent to Treatment and Research |url=https://books.google.com/books?id=ISBN0199747075 |publisher=Oxford University Press |page=18 |isbn=978-0199747078}}</ref> This requirement can be summarized in brief to presently include the following conditions, all of which must be met in order for one to qualify as possessing decision-making capacity:
#Choice, the ability to provide or evidence a decision.
#Understanding, the capacity to apprehend the relevant facts pertaining to the decision at issue.
#Appreciation, the ability of the patient to give informed consent with concern for, and belief in, the impact the relevant facts will have upon oneself.
#Reasoning, the mental acuity to make the relevant inferences from, and mental manipulations of, the  information appreciated and understood to apply to the decision at hand.<ref>{{cite web |url=https://plato.stanford.edu/entries/decision-capacity/ |title=Decision-Making Capacity |last=Hawkins |first=Jennifer |date=Fall 2020 |editor-last=Zalta |editor-first=Edward N. |publisher=Stanford |website=Stanford Encyclopedia of Philosophy |access-date=July 19, 2024}}</ref>

Impairments to reasoning and judgment that may preclude informed consent include intellectual or emotional immaturity, high levels of stress such as [[post-traumatic stress disorder]] or a severe [[intellectual disability]], severe [[mental disorder]], [[substance intoxication|intoxication]], severe [[sleep deprivation]], [[dementia]], or [[coma]].

Obtaining informed consent is [[#Waiver of requirement|not always required]]. If an individual is considered unable to give informed consent, another person is generally authorized to give consent on the individual's  behalf—for example, the parents or [[legal guardian]]s of a child (though in this circumstance the child may be required to provide [[informed assent]]) and conservators for the [[mentally disordered]]. Alternatively, the doctrine of [[implied consent]] permits treatment in limited cases, for example when an unconscious person will die without immediate intervention. Cases in which an individual is provided insufficient information to form a reasoned decision raise serious ethical issues. When these issues occur, or are anticipated to occur, in a [[clinical trial]], they are subject to review by an [[ethics committee]] or [[institutional review board]].

Informed consent is codified in both national and international law. '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. Article 7 of the covenant prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject.<ref name="junod05">{{cite book |last1=Junod |first1=Valérie |url=http://archive-ouverte.unige.ch/unige:43019 |title=Clinical drug trials Studying the safety and efficacy of new pharmaceuticals |date=2005 |publisher=Schulthess |isbn=9783725550227 |location=Genève |pages=545}}</ref> {{as of|2019|09}}, the covenant has 173 parties and six more signatories without ratification.<ref name="reservations">{{cite web |title=UN Treaty Collection - International Covenant on Civil and Political Rights |url=https://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV-4&chapter=4&clang=_en |quote=Status of ratification}}</ref>