Editing Informed consent (section)

==History==
{{multiple image
| width             = 150
| footer            = [[Walter Reed]] authored these informed consent documents in 1900 for his research on [[yellow fever]].
| image1            = Informed Consent Agreement Between Antonio Benigno and Walter Reed (Spanish).jpg
| alt1              = old paper document
| caption1          = Spanish
| image2            = Informed Consent Agreement Between Antonio Benigno and Walter Reed (English).jpg
| alt2              = old paper document
| caption2          = English
}}
''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.<ref>{{cite news |url= https://www.nytimes.com/1997/08/26/us/p-g-gebhard-69-developer-of-the-term-informed-consent.html |title=P. G. Gebhard, 69, Developer Of the Term 'Informed Consent' - New York Times |first=Eric |last=Pace |work=[[The New York Times]] |date=26 August 1997 |location=[[New York, NY|New York]] |issn=0362-4331 |access-date=5 March 2014}}</ref> In tracing its history, some scholars have suggested tracing the history of checking for any of these practices:<ref name="historytheory">{{cite book|first1=Ruth R. |last1=Faden |first2=Tom L.|last2= Beauchamp |first3=Nancy M.P.|last3=King |title=A history and theory of informed consent|url=https://archive.org/details/historytheoryofi0000fade |url-access=registration |year=1986|publisher=Oxford University Press |location=New York |isbn=978-0-19-5036862 |edition=Online }}</ref>{{rp|54}}
# A patient agrees to a health intervention based on an understanding of it.
# The patient has multiple choices and is not compelled to choose a particular one.
# The consent includes giving permission.
These practices are part of what constitutes informed consent, and their history is the history of informed consent.<ref name="historytheory"/>{{rp|60}}  They combine to form the modern concept of informed consent—which rose in response to particular incidents in modern research.<ref name="historytheory"/>{{rp|60}}  Whereas various cultures in various places practiced informed consent, the modern concept of informed consent was developed by people who drew influence from [[Western culture|Western tradition]].<ref name="historytheory"/>{{rp|60}}

===Medical history===
[[File:First informed consent document Turkey 1539.png|thumb|right|In this Ottoman Empire document from 1539 a father promises to not sue a surgeon in case of death following the removal of his son's urinary stones.<ref name="Selek 2010"/>]]
Historians cite a series of medical guidelines to trace the history of informed consent in medical practice.

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. Consent by patients as well as several other, now considered fundamental issues, is not mentioned. The [[Hippocratic Corpus]] advises that physicians conceal most information from patients to give the patients the best care.<ref name="historytheory"/>{{rp|61}}  The rationale is a [[Beneficence (ethics)|beneficence]] model for care—the doctor knows better than the patient, and therefore should direct the patient's care, because the patient is not likely to have better ideas than the doctor.<ref name="historytheory"/>{{rp|61}}

[[Henri de Mondeville]], a French surgeon who in the 14th century, wrote about medical practice. He traced his ideas to the Hippocratic Oath.<ref name="historytheory"/>{{rp|63}}<ref>{{cite book|last=Burns|first=Chester R.|title=Legacies in ethics and medicine|year=1977|publisher=Science History Publications|location=New York|isbn=9780882021669}} In this book see Mary Catherine Welborn's excerpts from her 1966 ''The long tradition: A study in fourteenth-century medical deontology''</ref><ref>{{cite book|last=Katz|first=Jay|title=The silent world of doctor and patient|year=2002|publisher=Johns Hopkins University Press|location=Baltimore|isbn=978-0801857805|pages=7–9|edition=Johns Hopkins Paperbacks|author2=Alexander Morgan Capron}}</ref> Among his recommendations were that doctors "promise a cure to every patient" in hopes that the good prognosis would inspire a good outcome to treatment.<ref name="historytheory"/>{{rp|63}} Mondeville never mentioned getting consent, but did emphasize the need for the patient to have confidence in the doctor.<ref name="historytheory"/>{{rp|63}} He also advised that when deciding therapeutically unimportant details the doctor should meet the patients' requests "so far as they do not interfere with treatment".<ref>{{cite book|last=Burns|first=Chester R.|title=Legacies in ethics and medicine|year=1977|publisher=Science History Publications|location=New York|isbn=9780882021669}} In this book see De Mondeville's "On the morals and ethics of medicine" from ''Ethics in Medicine''</ref>

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.<ref name="Selek 2010">{{cite journal |last1=Selek |first1=Salih |title=A written consent five centuries ago |journal=Journal of Medical Ethics |date=1 October 2010 |volume=36 |issue=10 |pages=639 |doi=10.1136/jme.2010.037713|pmid=20817814 |s2cid=30806638 }}</ref> This is the oldest identified written document in which a patient acknowledges risk of medical treatment and writes to express their willingness to proceed.<ref name="Selek 2010"/>

[[Benjamin Rush]] was an 18th-century United States physician who was influenced by the [[Age of Enlightenment]] cultural movement.<ref name="historytheory"/>{{rp|65}} Because of this, he advised that doctors ought to share as much information as possible with patients. He recommended that doctors educate the public and respect a patient's informed decision to accept therapy.<ref name="historytheory"/>{{rp|65}} There is no evidence that he supported seeking a consent from patients.<ref name="historytheory"/>{{rp|65}} In a lecture titled "On the duties of patients to their physicians", he stated that patients should be strictly obedient to the physician's orders; this was representative of much of his writings.<ref name="historytheory"/>{{rp|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.<ref name="historytheory"/>{{rp|66}}<ref>{{cite book|last=Gregory|first=John|title=Lectures on the Duties and Qualifications of a Physician|url=https://archive.org/details/b30515427|year=1772}}</ref>

[[Thomas Percival]] was a British physician who published a book called ''Medical Ethics'' in 1803.<ref name="historytheory"/>{{rp|68}} Percival was a student of the works of Gregory and various earlier Hippocratic physicians.<ref name="historytheory"/>{{rp|68}} Like all previous works, Percival's ''Medical Ethics'' makes no mention of soliciting for the consent of patients or respecting their decisions.<ref name="historytheory"/>{{rp|68}} Percival said that patients have a right to truth, but when the physician could provide better treatment by lying or withholding information, he advised that the physician do as he thought best.<ref name="historytheory"/>{{rp|68}}

When the [[American Medical Association]] was founded they in 1847 produced a work called the first edition of the ''American Medical Association Code of Medical Ethics''.<ref name="historytheory"/>{{rp|69}} Many sections of this book are verbatim copies of passages from Percival's ''Medical Ethics''.<ref name="historytheory"/>{{rp|69}} A new concept in this book was the idea that physicians should fully disclose all patient details truthfully when talking to other physicians, but the text does not also apply this idea to disclosing information to patients.<ref name="historytheory"/>{{rp|70}} Through this text, Percival's ideas became pervasive guidelines throughout the United States as other texts were derived from them.<ref name="historytheory"/>{{rp|70}}

[[Worthington Hooker]] was an American physician who in 1849 published ''Physician and Patient''.<ref name="historytheory"/>{{rp|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.<ref name="historytheory"/>{{rp|70}} In Hooker's view, benevolent deception is not fair to the patient, and he lectured widely on this topic.<ref name="historytheory"/>{{rp|70}} Hooker's ideas were not broadly influential.<ref name="historytheory"/>{{rp|70}}

The principle of informed consent was not legally binding until first recorded in the ''Salgo v. Leland Stanford Jr University Board of Trustees'' case of 1957. Salgo underwent a procedure to evaluate his aortic arteriosclerosis; a contrast (which is a substance used in medical imaging to differentiate internal structures) was injected into his aorta to find blockages, but his legs ended up permanently paralyzed; however, Salgo had not been informed of this risk. This case was one of the first to draw attention to the need for patients to understand the risks and benefits of their procedures, since at that time a lack of informed consent was not considered negligence.<ref>{{Cite journal |last=Bazzano |first=Lydia A. |last2=Durant |first2=Jaquail |last3=Brantley |first3=Paula Rhode |date=2021 |title=A Modern History of Informed Consent and the Role of Key Information |url=https://pmc.ncbi.nlm.nih.gov/articles/PMC7993430/ |journal=Ochsner Journal |volume=21 |issue=1 |pages=81–85 |doi=10.31486/toj.19.0105 |issn=1524-5012 |pmc=7993430 |pmid=33828429}}</ref>

The US ''[[Canterbury v. Spence]]'' case in 1972 officially established the principle of informed consent in US law. Canterbury underwent a laminectomy to relieve back pain but was not informed of the risk of paralysis. While left by himself, he fell off his bed and was later paralyzed from the waist down; he required further surgeries but was never completely relieved of paralysis in his bowels and bladder.<ref>{{Cite web |title=Canterbury v. Spence |url=https://studicata.com/case-briefs/case/canterbury-v-spence/ |access-date=2025-04-24 |website=Studicata |language=en-US}}</ref> Earlier legal cases had created the underpinnings for informed consent, but his judgment gave a detailed and thought through discourse on the matter.<ref>{{Cite book |url=https://www.worldcat.org/oclc/294067618 |title=Health Law and Bioethics : Cases in Context |date=2009 |publisher=Aspen Publishers/Wolters Kluwer |editor=Sandra H. Johnson |isbn=978-0-7355-7767-1 |location=New York |chapter=Chapter 1: Canterbury vs Spence |oclc=294067618}}</ref> The judgment cites cases going back to 1914 as precedent for informed consent.<ref>{{Cite book |last=Faden |first=Ruth R. |url=https://www.worldcat.org/oclc/228168485 |title=A history and theory of informed consent |date=1986 |publisher=Oxford University Press |others=Tom L. Beauchamp, Nancy M. P. King |isbn=1-4237-6352-1 |location=New York |oclc=228168485}}</ref>{{Rp|page=56}}

===Research history===
Historians cite a series of [[human subject research]] experiments to trace the history of informed consent in research.

The U.S. Army Yellow Fever Commission "is considered the first research group in history to use consent forms."<ref>{{Cite journal|last=Cutter|first=Laura|title=Walter Reed, Yellow Fever, and Informed Consent|journal=Military Medicine|volume=181|issue=1|pages=90–91|doi=10.7205/milmed-d-15-00430|pmid=26741482|year=2016|doi-access=free}}</ref> In 1900, Major [[Walter Reed]] was appointed head of the four man U.S. Army Yellow Fever Commission in [[Cuba]] that determined [[mosquito]]es were the vector for [[yellow fever]] transmission. His earliest experiments were probably done without formal documentation of informed consent. In later experiments he obtained support from appropriate military and administrative authorities. He then drafted what is now "one of the oldest series of extant informed consent documents."<ref name="U.S. Army Yellow Fever Commission">{{Cite news|url=http://exhibits.hsl.virginia.edu/yellowfever/yellow-fever-commission-work/|title=The U.S. Army Yellow Fever Commission in Cuba - U.S. Army Yellow Fever Commission|work=U.S. Army Yellow Fever Commission|access-date=2017-08-01|language=en-US}}</ref> The three surviving examples are in Spanish with English translations; two have an individual's signature and one is marked with an X.<ref name="U.S. Army Yellow Fever Commission"/>

''[[Tearoom Trade]]'' is the name of a book by American psychologist [[Laud Humphreys]]. In it he describes his research into male [[homosexual]] acts.<ref name="babbie">{{cite book|last=Babbie|first=Earl|title=The practice of social research|url=https://archive.org/details/isbn_9780495598428|url-access=registration|year=2010|publisher=Wadsworth Cengage|location=Belmont, Calif|isbn=978-0495598411|edition=12th}}</ref> In conducting this research he never sought consent from his research subjects and other researchers raised concerns that he violated the right to [[privacy for research participants]].<ref name="babbie"/>

On January 29, 1951, shortly after the birth of her son Joseph, Henrietta Lacks entered Johns Hopkins Hospital in Baltimore with profuse bleeding. She was diagnosed with aggressive cervical cancer and was treated with inserts of radium tubes. During her radiation treatments for the tumor, two samples—one of healthy cells, the other of malignant cells—were removed from her cervix without her knowledge or permission. There is no evidence that the doctor checked the cells for other conditions before passing them on for research. Later that year, 31-year-old Henrietta Lacks died from the cancer. Her cells were capable of surviving and dividing indefinitely when cultured, creating HeLa cells,<ref name=":1">{{Cite journal |last=Beskow |first=Laura M. |date=2016-08-31 |title=Lessons from HeLa Cells: The Ethics and Policy of Biospecimens |url=https://pmc.ncbi.nlm.nih.gov/articles/PMC5072843/ |journal=Annual Review of Genomics and Human Genetics |volume=17 |pages=395–417 |doi=10.1146/annurev-genom-083115-022536 |issn=1545-293X |pmc=5072843 |pmid=26979405}}</ref> but the family, which was living in poverty, was not informed until 1973; the family learned the truth when scientists asked for DNA samples after finding that HeLa had contaminated other samples. In 2013, researchers published the genome without the Lacks family's consent. As a result of this incident, pushes were made for major changes in the US's process for informed consent in biospecimen research.<sup><ref name=":1" /></sup>

The [[Milgram experiment]] is the name of a 1961 experiment conducted by American psychologist [[Stanley Milgram]]. In the experiment Milgram had an authority figure order research participants to commit a disturbing act of harming another person.<ref name="baumrind">{{Cite journal | last1 = Baumrind | first1 = D. | title = Some thoughts on ethics of research: After reading Milgram's "Behavioral Study of Obedience." | doi = 10.1037/h0040128 | journal = American Psychologist | volume = 19 | issue = 6 | pages = 421–423 | year = 1964 }}</ref> After the experiment he would reveal that he had deceived the participants and that they had not hurt anyone, but the research participants were upset at the experience of having participated in the research.<ref name="baumrind"/> The experiment raised broad discussion on the ethics of recruiting participants for research without giving them full information about the nature of the research.<ref name="baumrind"/>

[[Chester M. Southam]] used HeLa cells to inject into cancer patients and [[Ohio State Penitentiary]] inmates without informed consent to determine if people could become immune to cancer and if cancer could be transmitted.<ref>{{cite book|last1=Skloot|first1=Rebecca|title=[[The Immortal Life of Henrietta Lacks]]|date=2010|publisher=Broadway Paperbacks|location=New York|page=130}}</ref>