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Informed consent
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==Medical procedures== The doctrine of informed consent relates to [[professional negligence]] and establishes a breach of the duty of care owed to the patient (see [[duty of care in English law|duty of care]], [[breach of duty in English law|breach of the duty]], and [[respect for persons]]). The doctrine of informed consent also has significant implications for medical trials of medications, devices, or procedures. ===Requirements of the professional=== 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. Arguably, this is "sufficient consent" rather than "informed consent." 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]]''. This moves away from the concept of a reasonable physician and instead uses the standard of a [[Reasonable person|reasonable patient]], and what risks an individual would attach significance to.<ref>{{cite web |title=Montgomery Ruling |url=https://www.informedconsentmatters.co.uk/montgomery-ruling |website=Informed Consent Matters |access-date=7 December 2023 |ref=montgomery |language=en}}</ref> Medicine in the United States, Australia, and Canada takes this patient-centric approach to "informed consent." Informed consent in these jurisdictions requires healthcare providers to disclose significant risks, as well as risks of particular importance to that patient. This approach combines an objective (a hypothetical reasonable patient) and subjective (this particular patient) approach.<ref>{{Cite web |url=https://www.allclinicaltrials.com/blog/questions-to-ask-before-participating-in-clinical-trials |title=Questions to Ask Before Participating in Clinical Trials |website=AllClinicalTrials.com |publisher=Curify, Inc. |access-date=2025-01-27}}</ref> Optimal establishment of an informed consent requires adaptation to cultural or other individual factors of the patient. As of 2011, for example, people from Mediterranean and Arab backgrounds appeared to rely more on the context of the delivery of the information, with the information being carried more by who is saying it and where, when, and how it is being said, rather than ''what'' is said, which is of relatively more importance in typical "Western" countries.<ref>[http://www.medscape.com/viewarticle/746187?src=mp&spon=25 Too Much Information: Informed Consent in Cultural Context]. By Joseph J. Fins and Pablo Rodriguez del Pozo. Medscape 07/18/2011</ref>{{better source needed|date=January 2023}} The informed consent doctrine is generally implemented through good healthcare practice: pre-operation discussions with patients and the use of medical consent forms in hospitals. 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. In one British case, a doctor performing routine surgery on a woman noticed that she had cancerous tissue in her womb. 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. The council stated that the woman should have been informed of her condition, and allowed to make her own decision.{{citation needed|date=January 2023}} ===Obtaining informed consents=== To document that informed consent has been given for a procedure, healthcare organisations have traditionally used paper-based consent forms on which the procedure and its risks and benefits are noted, and is signed by both patient and clinician. In a number of healthcare organisations consent forms are scanned and maintained in an electronic document store. The paper consent process has been demonstrated to be associated with significant errors of omission,<ref>{{Cite journal | last1 = St John | first1 = ER. | last2 = Scott | first2 = AJ. | last3 = Irvine | first3 = TE. | last4 = Pakzad | first4 = F. | last5 = Leff | first5 = DR. | last6 = Layer | first6 = GT. | doi =10.1016/j.surge.2015.11.004 | title = Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms. | journal = The Surgeon | volume = 15 | issue = 4 | pages = 190–195 | year = 2017 | pmid = 26791394}}</ref><ref>{{Cite journal | last1 = St John | first1 = ER. | doi =10.1093/bjs/znaa119 | title = Assessment of the introduction of semi-digital consent into surgical practice | journal = British Journal of Surgery| year = 2021 | volume = 108 | issue = 4 | pages = 342–345 | pmid = 33783479}}</ref> and therefore increasing numbers of organisations are using digital consent applications where the risk of errors can be minimised, a patient's decision making and comprehension can be supported by additional lay-friendly and accessible information, consent can be completed remotely, and the process can become paperless. One form of digital consent is [[dynamic consent]], which invites participants to provide consent in a granular way, and makes it easier for them to withdraw consent if they wish. Patient satisfaction in the context of novel forms of informed consent has been a topic in scientific research. Visual and auditory components in video-assisted informed consent<!--Q106414852--> and digital informed consent have proved to lead to higher patient satisfaction.<ref>{{Cite journal |last1=Schulz |first1=Alexandra |last2=Bohnet-Joschko |first2=Sabine |date=2024-08-02 |title=Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital |journal=BMC Health Services Research |volume=24 |issue=1 |pages=879 |doi=10.1186/s12913-024-11225-3 |doi-access=free |issn=1472-6963 |pmc=11295654 |pmid=39095856}}</ref> Integrating patients into treatment decisions ([[Shared decision-making in medicine|shared decision-making]]) and increasing transparency leads to better overall treatment adherence.<ref>{{Cite journal |last1=Bernat |first1=James L. |last2=McQuillen |first2=Michael P. |date=2021 |title=On Shared Decision-making and Informed Consent |journal=Neurology. Clinical Practice |volume=11 |issue=2 |pages=93–94 |doi=10.1212/CPJ.0000000000000823 |issn=2163-0402 |pmc=8032407 |pmid=33842060}}</ref> Electronic consent methods have been used to support indexing and retrieval of consent data, thus enhancing the ability to honor to patient intent and identify willing research participants.<ref name="healthsciencessc">{{cite web|url=http://www.healthsciencessc.org/IT.asp|title=Health Sciences South Carolina|publisher=healthsciencessc.org|access-date=14 September 2014|url-status=dead|archive-url=https://web.archive.org/web/20141011200835/http://healthsciencessc.org/IT.asp|archive-date=11 October 2014}}</ref><ref>{{Cite journal | last1 = Chalil Madathil | first1 = K. | last2 = Koikkara | first2 = R. | last3 = Gramopadhye | first3 = A. K. | last4 = Greenstein | first4 = J. S. | title = An Empirical Study of the Usability of Consenting Systems: IPad, Touchscreen and Paper-based Systems | doi = 10.1177/1071181311551168 | journal = Proceedings of the Human Factors and Ergonomics Society Annual Meeting | volume = 55 | pages = 813–817 | year = 2011 | s2cid = 62362166 }}</ref><ref>{{Cite journal | last1 = Chalil Madathil | first1 = K. | last2 = Koikkara | first2 = R. | last3 = Obeid | first3 = J. | last4 = Greenstein | first4 = J. S. | last5 = Sanderson | first5 = I. C. | last6 = Fryar | first6 = K. | last7 = Moskowitz | first7 = J. | last8 = Gramopadhye | first8 = A. K. | doi = 10.1016/j.ijmedinf.2013.04.008 | title = An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting | journal = International Journal of Medical Informatics | volume = 82 | issue = 9 | pages = 854–863 | year = 2013 | pmid = 23757370 | pmc =3779682 }}</ref><ref>{{Cite journal | last1 = Sanderson | first1 = I. C. | last2 = Obeid | first2 = J. S. | last3 = Madathil | first3 = K. C. | last4 = Gerken | first4 = K. | last5 = Fryar | first5 = K. | last6 = Rugg | first6 = D. | last7 = Alstad | first7 = C. E. | last8 = Alexander | first8 = R. | last9 = Brady | first9 = K. T. | last10 = Gramopadhye | first10 = A. K. | last11 = Moskowitz | first11 = J. | doi = 10.1177/1740774513491338 | title = Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents | journal = Clinical Trials | volume = 10 | issue = 4 | pages = 604–611 | year = 2013 | pmid = 23785065 | pmc = 4213063}}</ref> More recently, [[Health Sciences South Carolina]], a statewide research collaborative focused on transforming healthcare quality, health information systems and patient outcomes, developed an open-source system called Research Permissions Management System (RPMS).<ref name="github">{{cite web|url=https://github.com/HSSC/RPMS|title=HSSC/RPMS · GitHub|date=31 March 2014|publisher=github.com|access-date=14 September 2014}}</ref><ref name="healthsciencessc2">{{cite web|url=http://www.healthsciencessc.org/rpms/index.asp|title=Health Sciences South Carolina|publisher=healthsciencessc.org|access-date=14 September 2014|url-status=dead|archive-url=https://web.archive.org/web/20141011221421/http://healthsciencessc.org/rpms/index.asp|archive-date=11 October 2014}}</ref> ===Competency of the patient=== {{unreferenced section|date=January 2023}} The ability to give informed consent is governed by a general requirement of competency. In common law jurisdictions, adults are presumed competent to consent. This presumption can be rebutted, for instance, in circumstances of mental illness or other incompetence. This may be prescribed in legislation or based on a common-law standard of inability to understand the nature of the procedure. In cases of incompetent adults, a [[health care proxy]] makes medical decisions. In the absence of a proxy, the medical practitioner is expected to act in the patient's best interests until a proxy can be found. By contrast, '[[Minor (law)|minors]]' (which may be defined differently in different jurisdictions) are generally presumed incompetent to consent, but depending on their age and other factors may be required to provide [[Informed assent]]. In some jurisdictions (e.g. much of the U.S.), this is a strict standard. In other jurisdictions (e.g. England, Australia, Canada), this presumption may be rebutted through proof that the minor is 'mature' (the '[[Gillick competence|Gillick standard]]'). In cases of incompetent minors, informed consent is usually required from the parent (rather than the 'best interests standard') although a [[parens patriae]] order may apply, allowing the court to dispense with parental consent in cases of refusal. ===Deception=== Research involving deception is controversial given the requirement for informed consent. Deception typically arises in social psychology, when researching a particular psychological process requires that investigators deceive subjects. For example, in the [[Milgram experiment]], researchers wanted to determine the willingness of participants to obey authority figures despite their personal conscientious objections. They had authority figures demand that participants deliver what they thought was an electric shock to another research participant. For the study to succeed, it was necessary to deceive the participants so they believed that the subject was a peer and that their electric shocks caused the peer actual pain. 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]]. The [[Ethical Principles of Psychologists and Code of Conduct]] set by the [[American Psychological Association]] says that psychologists may conduct research that includes a deceptive compartment only if they can both justify the act by the value and importance of the study's results and show they could not obtain the results by some other way. Moreover, the research should bear no potential harm to the subject as an outcome of deception, either physical pain or [[emotional distress]]. Finally, the code requires a debriefing session in which the experimenter both tells the subject about the deception and gives subject the option of withdrawing the data.<ref>{{cite web|last=2. American Psychological Association. (2002)|title=2010 Amendments to the American Psychological Association ethical principles of psychologists and code of conduct.|url=http://www.apa.org/ethics/code/index.aspx|access-date=30 April 2012}}</ref> ===Abortion=== In some U.S. states, informed consent laws (sometimes called "right to know" laws) require that a woman seeking an elective [[abortion]] receive information from the abortion provider about her legal rights, alternatives to abortion (such as [[adoption]]), available public and private assistance, and other information specified in the law, before the abortion is performed. Other countries with such laws (e.g. [[Germany]]) require that the information giver be properly certified to make sure that no abortion is carried out for the financial gain of the abortion provider and to ensure that the decision to have an abortion is not swayed by any form of incentive.<ref>{{cite book |last1=Taupitz |first1=Jochen |last2=Weschka |first2=Marion |date=2009 |title=CHIMBRIDS - Chimeras and Hybrids in Comparative European and International Research: Scientific, Ethical, Philosophical and Legal Aspects. Volume 34 of Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim |publisher=Springer Science & Business Media |page=298 |isbn=9783540938699 }}</ref><ref>{{cite web |url=http://www.aicgs.org/issue/the-legal-framework-of-abortions-in-germany/ |title=The Legal Framework of Abortions in Germany |author=Dieper, Susanne |date=23 February 2012 |website=American Institute for Contemporary German Studies |publisher=Johns Hopkins University |access-date=3 April 2015}}</ref> Some informed consent laws have been criticized for allegedly using "loaded language in an apparently deliberate attempt to 'personify' the fetus,"<ref>Gold, Rachel and Nash, Elizabeth.[http://www.guttmacher.org/pubs/gpr/10/4/gpr100406.html State Abortion Counseling Policies and the Fundamental Principles of Informed Consent], Guttmacher Policy Review, Fall 2007, Volume 10, Number 4.</ref> but those critics acknowledge that "most of the information in the [legally mandated] materials about abortion comports with recent scientific findings and the principles of informed consent", although "some content is either misleading or altogether incorrect."<ref>Richardson, Chinue and Nash, Elizabeth. [http://www.guttmacher.org/pubs/gpr/09/4/gpr090406.html "Misinformed Consent: The Medical Accuracy of State-Developed Abortion Counseling Materials"], Guttmacher Policy Review Fall 2006, Volume 9, Number 4.</ref>
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