Talk:Informed consent

Question

I'm not sure what the sentence "As a literal matter, in the absence of fraud, it is redundant." is intended to mean. There can instances of failure of information (e.g., reasonable mistake, failure of duty to disclose) that do not rise to the level of the special type of misrepresentation that amounts to fraud. In many such cases, the lack of information could vitiate apparent consent. I suppose this might be what the sentence in question is trying to say (namely, that genuine "consent" implies "informed consent," but the sentence can at least as easily be read to say the opposite (that is, to make the false assertion that, absent fraud, all apparent consent is necessarily or by definition informed consent). 160.253.0.8 (talk) 21:23, 20 October 2010 (UTC)

History

There should be a section on the history of informed consent. I seem to recall that Walter Reed's yellow fever team made some early efforts at this. See the book: Crosby, Molly C. 2006. The American Plague: the untold story of yellow fever, the epidemic that shaped our history. New York: The Berkley Publishing Group. ISBN 978-0-425-21775-7 —Preceding unsigned comment added by Thomas.Hedden (talk • contribs) 03:02, 5 December 2007 (UTC)

MKUltra

In the MKULTRA article, there is a lot of information on the legal issues of informed consent that could be incorporated and expanded upon here. —Psychonaut 13:47, 31 Mar 2004 (UTC)

Surgery

May I recommend changing that heading to "Informed consent in medicine" or something more reflective of the content? Ming-Chih Kao 07:01, 7 June 2006 (UTC) . oooO............. (....)... Oooo..... .\..(.....(....)... ..\_)..... )../.... .......... (_/.....

I had surgery done on my forehead two weeks before going to college. I have ever since not been able to move my face as well as before -- and this after I asked the doctor repeatedly what the complications might be, and he named only one possible complication: infection. If I had known of the daily pain, itching, lack of control over wakefulness, and facial muscle paresis were going to be caused by the surgery, I would not have let it be carried out. I was asymptomatic before surgery and agreed to it out of fear, as you state in the beginning of your article: "A person may ... agree to something from fear, perceived social pressure, or psychological difficulty in asserting their true feelings." It is my opinion that EVERY effect of a medical procedure ought to be considered beforehand, mentioned by the doctor even if never asked about by the patient, including the four mentioned above, and would be most interested in finding out... not what can be done to the offending doctor, but what can be done to me to reverse the ill effects of surgery. It seems like the world is full of laws to protect people, but that these laws are nearly never applicable. Helenetoile (talk) 20:32, 1 November 2008 (UTC)Helene —Preceding unsigned comment added by Helenetoile (talk • contribs)

Self-help

Hello. Some visitors to this article may find themselves in the position of having to make a decision about participate in research and not know how to proceed. May I make a suggestion? I spent twenty years in the field of human research protections within the U.S. government. After retirement a few years back, I perceived a void in information devoted to prospective research subject use. An entity was created to fill the void. I'm the founder. It's resultant website is linked to by self-selected research institutions. The website is an entry level service to the public. There are no gimmicks, just information, tools and references.

An external link to the website might serve as adjunct value to the this Wikipedia article by facilitating access to self-help tools. Such tools include a checklist concerning consent and a flowchart to place the process of consent in a larger decision-making context. You can see what I mean by a quick trip to the site for a look-see, if you're interested. I'm learning the Wikipedia ropes and am conscious of conflict of interest issues. I'd feel more comfortable if others concurred with the idea.

If thought suitable, perhaps something like the following external link: GetResearchSmart LLC Website Entry-level self-help information, tools and references for use by prospective research subjects and others. Hope you find this suggestion helpful. Cheers! CCS 15:26, 21 March 2007 (UTC)

The link that your suggesting for this article is not appropriate as it advertises a service rather than a resource about the subject.--Hu12 23:44, 27 March 2007 (UTC)

Please see response at http://en.wikipedia.org/wiki/User_talk:GRS_LLC_Founder#Username. Thanks! CCS 18:33, 28 March 2007 (UTC)

Article flys off topic

There are several problems with this article. First, it confuses informed consent, a tort law issue, with consent the criminal law issue. Any section which begins to discuss the criminal implications of a lack of consent are beyond the scope of this article. Second, the article discusses quite a bit of sexual fetishism. There isn't a legal treatise in the world on the topic of inform consent that goes into the detail that this article does. The authors of this material display a lack of understanding of the law. Third, examples are given of "problems" with informed consent, areas where the outcome may not be clear, such as sex with a sleeping woman. This is blatantly false to anyone with knowledge of criminal law (again off topic). Fourth, the article quite quickly goes off topic to include discussion of consent which is completely different from informed consent. Fifth, the article lacks citations. There are a few sections of material that is actually correct. Unfortunately, it is uncited and surrounded by material that is made up. The legal definition of informed consent is "A person's agreement to allow something to happen, made with full knowledge of the risks involved and the alternatives. • For the legal profession, informed consent is defined in Model Rule of Professional Conduct 1.0(e). 2. A patient's knowing choice about a medical treatment or procedure, made after a physician or other healthcare provider discloses whatever information a reasonably prudent provider in the medical community would give to a patient regarding the risks involved in the proposed treatment or procedure." (Black's Law Dictionary 8th Edition). There do not exist any scholarly works that fit BDSM or sex with a corpse into that definition. Legis Nuntius (talk) 06:40, 20 January 2008 (UTC)

You talk a lot about criminal law and even malign other authors for a "lack of understanding" yet I see not one indication of which nation's law you are talking about and I know for certain there are some where the statements you make are wrong. You quote a legal definition that is far from globally acceptable and even talk of a "Model Rule of Professional Conduct 1.0(e). 2" that I've only heard mention of in the narrow sphere of the USA. If this is an indication of your limited knowledge of scholarly works, perhaps you should learn more before blowing off too much more about how other editors do not know the material. --Interesdom (talk) 13:35, 21 January 2008 (UTC)

Thank you for your response and criticism of my critique of the article as a whole. The criminal law article for this topic is at consent (criminal), which although written mainly from a British perspective, more appropriately addresses the issues this article attempts to put forth without citation. I quote legal definitions. (1) The applicability of one definition says nothing of the veracity of the whole. (2) Rules of Professional Conduct exist in all jurisdictions. (3) By quoting a definition where the article is false, the article necessarily does not express a world-wide view of the subject. (4) If the article does not express a world-wide view of the subject, the author either (a) neglected to take into consideration all jurisdictions or (b) has no knowledge of other jurisdictions. The article as it stands mentions no jurisdiction. Could it be within the "narrow sphere" of the U.K.? I believe that a quotation from a dictionary is not an "indication of (my) limited knowledge of scholarly works." Is my definition wrong because it includes one that applies to the U.S.? The doctrine of informed consent originated in Slater v. Baker and Stapleton 95 Eng. Rep. 860 (K.B. 1767), which is an English case (not American and automatically false). Why this article makes no mention of this case or any other case, I do not know. In the 18th century, the King's Bench still had influence over the colonies and the doctrine emigrated from Britain into the common law of colony jurisdictions. A google search of the case will yield sufficient information that can be obtained outside of a law library. MacDonald, Kaufman, Capron, and Birnbaum Treatise on Health Care Law sec. 17.01(b) refers to the case:

the opinion...does not clearly address the possibility of the patient's refusal of the proposed treatment. Rather, it seems to treat the purpose of informing the patient as being to allow the patient to prepare himself for what the doctor is about to do.

In the U.S., the case which rang the doctrine into universal acceptance comes from Judge Cardozo in Schloendorff v. Society of New York Hospital 211 N.Y. 125 (1914) (citing Minnesota authority which ultimately cites English common law authority). Refering to the above criticisms of my critique: "I see not one indication of which nation's law you are talking about" The jurisdiction I refer to is English common law, which is the scope of the article (see template of tort law at article side bar). The "Sex" section cites no authority or jurisdiction. "and I know for certain there are some where the statements you make are wrong." This is a little ambiguous, but I believe that this may have had to do with my specific statement concerning consent of a sleeping person. I think it most appropriate to cite authorities from England for that statement, although I could cite from Canada, the U.S., Australia etc.

"However it would seem pretty surprising to couples sharing a bed to be told that the law prohibited either of them from intimately touching the other while asleep, and that they would be potentially liable to prosecution and punishment, for a sexual touch of the sleeping partner as a preliminary to possible sexual activity which the sleeping partner, on awakening, might welcome." Sir Igor Judge, President of the Queen's Bench, R. v. Jheeta 2 Cr. App. R. 34 (2007).

Discussed in that Court of Appeal was the Sexual Offences Act of 2003

"s 75 Evidential presumptions about consent (1) If in proceedings for an offence to which this section applies it is proved- (a) that the defendant did the relevant act,(b) that any of the circumstances specified in subsection (2) existed, and (c) that the defendant knew that those circumstances existed, the complainant is to be taken not to have consented to the relevant act...(2)The circumstances are that (d) the complainant was asleep or otherwise unconscious at the time of the relevant act."

and yet the article states: "For example, people who perform sexual acts on sleeping people are not given consent unless the initiator have given prior informed consent to the act within a reasonable recency, and are assumed to be consenting during the act and to not prosecute for it when waking up." The information directly following the "unless" is false. Of course, this is completely off topic from the jurisprudence which arose from the Stapleton case. There are numerous misunderstandings in the article on the differencs between the law of consent and informed consent in relation to tort law and criminal law. Any additions or subtractions shall be fully justified by appropriate references, I assure you. You need not fear that my limited knowledge of the subject be unsubstantiated. Legis Nuntius (talk) 17:13, 22 January 2008 (UTC)

Use of "able to" and my edit

I removed the parenthesis from this sentence:

The question of whether informed consent needs to be formally given before sexual intercourse or other sexual activity, and whether this consent can (and must be able to) be withdrawn at any time during the act, is an issue which is currently being discussed in the United States in regard to rape and sexual assault legislation.

Edit vs. previous version: [1]

Succinct source on the use of able to: [2]

Jeff Muscato (talk) 09:42, 17 May 2009 (UTC)

Informed Consent in Contract Law

This is a question from a non-lawyer.

I see little here about the idea of informed consent in contract law. Perhaps that is deliberate and justified. I'm asking about it.

In Oil and Gas law a common instrument is the Producer's 88 mineral lease. This lease has been under careful development since the Drake well in PA was drilled in the 1850's. It is a document that blatantly favors the Lessee and supports a standard fraudulent inducement practice. It is both a conveyance and a contract. Oil and Gas lawyers cannot afford to do any thinking outside the box with regard to this instrument. So their approach to a client who is a potential lessor is biased by the traditional interpretations which conceal material facts.

Any potential lessee who relies on the traditional legal interpretation of this document will not understand the implications of this document. There is typically fraud in the inducement, or at least misrepresentation (if that is a lesser offense). So consideration of these matters seems to involve the concept of informed consent, and it seems to involve different kinds of issues than medical/surgical issues. Here we have issues of split estate division of rights, issues of public health and safety, issues of refusal of the lessee to disclose what pollutants he plans to employ or release,issues of the protections afforded by the Accommodation Doctrine, etc. which are material facts that are not disclosed and not discussed in detail with the client (potential lessor).

Does the term "informed consent" have application in these matters?

99.19.2.161 (talk) 16:02, 21 February 2010 (UTC)

The concept of Unclean hands would cover this and other fraud-like (i.e. uninformed consent) behavior generally. Not sure it's worth adding to the article, though. SDY (talk) 18:21, 21 February 2010 (UTC)

Sentence does not make sense

From the article - i have put in italics the part that is muddled.

The question of whether informed consent needs to be formally given before sexual intercourse or other sexual activity, and whether this consent can be withdrawn at any time during the act, is an issue that is currently being discussed in the United States regarding rape and sexual assault legislation. For example, people who perform sexual acts on sleeping people are not given consent unless the initiator have given prior informed consent to the act within a reasonable recency, and are assumed to be consenting during the act and to not prosecute for it when waking up.

The person sleeping is the one who needs to give prior consent, not the initiator. Very muddled sentence. DMSBel (talk) 16:13, 2 March 2011 (UTC)

Also adding

as there are no citations in this section at all.DMSBel (talk) 16:36, 2 March 2011 (UTC)

I think it is intended to read "unless the initiator have been given prior informed consent". There is some idea like that in American law - that a person is presumed to have consent to have sex with their regular sex partner, even if the partner is sleeping. However, I think this entire section belongs in the Consent article, and has very little to do with "informed consent", which is generally about voluntarily undertaking risks. I suppose there could be a question of informed consent if a person consents to have sex with another, but the other fails to inform them of a sexual disease or similar danger. Animals, of course, can't give "informed" consent to anything, so the question there is really only about consent at all. bd2412 T 17:27, 2 March 2011 (UTC)

Proposal for major revision

I am going do a major revision of this article and wanted to describe my intentions. I propose to turn this article into an article on the concept of informed consent as it relates to medical interventions. I assert that this is the usual meaning of the term "informed consent".

Right now, the article contains a lot of information about the non-medical legal concept of consent. None of this information has references or is sourced in any way. All of the sources for the article currently refer to the consent for medical procedures, especially for clinical research. On Google Scholar all of the front page articles are only about medical informed consent, and I would say most of the articles existing about informed consent are from this perspective.

There is a section on criminal law and consent and partners consent for sexual intercourse - these are not traditional uses of this term and there are no references for this anyway. I propose to move this text to other articles.

In summary, "informed consent" is a technical term which has a certain meaning and a cultural history, and is not an emphatic description of the concept of consent in the field of law. Anything about "consent" I want to move elsewhere; anything about the technical term "informed consent" I will keep and develop here. Any objections? Thoughts? The article has not had any major structural changes since 2005 - see it as it was then and how it looked at the beginning of March 2012. Blue Rasberry (talk) 19:54, 10 March 2012 (UTC)

History of informed consent

I just added content to a history of informed consent section. I used a 1986 book called A History and Theory of Informed Consent for the outline. This book itself is a broad literature review. In the notes, it recommends two other authors which interpreted the pre-modern practice of medical ethics - one is Jay Katz and the other is Martin S. Pernick. A History summarizes their perspectives and integrates much of their work, but those two have written some things which A History did not cover. I thought I would share in case anyone wanted more perspective. Blue Rasberry (talk) 22:17, 10 March 2012 (UTC)

Vaccines

Discussion about Vaccine Information Statements are not really appropriate here; the CDC specifically states that VISs are not informed consent forms ("VISs are written to fulfill the information requirements of the National Childhood Vaccine Injury Act, not as informed consent forms.") they do provide information, but they are not meant to be used for this purpose. Discussion about VISs probably deserve attention in a vaccine specific article, not here. Yobol (talk) 22:44, 20 November 2015 (UTC)

BDSM-related links in "See also" section

Is there a specific reason for two BDSM-related links being in the "See also" section? Specifically, "Consent (BDSM)" and "Safe, sane and consensual." LilySophie (talk) 19:41, 16 August 2018 (UTC)

@LilySophie: These and other Wikipedia articles about types of consent should go into a Wikipedia:Disambiguation page. Anyone could create one. After that happens then these links could be removed for being a different type of consent. Blue Rasberry (talk) 17:06, 11 February 2019 (UTC)

Sources to develop article

I asked a subject matter expert, my colleague Tim Clark, for suggestions on which sources to include to develop this article. I wanted the sources which experts on the concept would present as fundamental for understanding the concept. Here is what he suggested at a first pass:

1. Adashi, EY; Walters, LB; Menikoff, JA (October 2018). "The Belmont Report at 40: Reckoning With Time". American journal of public health. 108 (10): 1345–1348. doi:10.2105/AJPH.2018.304580. PMID 30138058.
2. Emanuel, EJ; Wendler, D; Grady, C (May 24, 2000). "What makes clinical research ethical?". JAMA. 283 (20): 2701–11. doi:10.1001/jama.283.20.2701. PMID 10819955.
3. Friesen, P; Kearns, L; Redman, B; Caplan, AL (July 2017). "Rethinking the Belmont Report?". The American journal of bioethics : AJOB. 17 (7): 15–21. doi:10.1080/15265161.2017.1329482. PMID 28661753.
4. Merz, JF (2 January 2018). "The Nuremberg Code and Informed Consent for Research". JAMA. 319 (1): 85–86. doi:10.1001/jama.2017.17704. PMID 29297070.
5. Moreno, JD; Schmidt, U; Joffe, S (5 September 2017). "The Nuremberg Code 70 Years Later". JAMA. 318 (9): 795–796. doi:10.1001/jama.2017.10265. PMID 28817743.
6. Department of Health, Education, and, Welfare.; National Commission for the Protection of Human Subjects of Biomedical and Behavioral, Research. (2014). "The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research". The Journal of the American College of Dentists. 81 (3): 4–13. PMID 25951677.{{cite journal}}: CS1 maint: multiple names: authors list (link)
7. Nijhawan, LP; Janodia, MD; Muddukrishna, BS; Bhat, KM; Bairy, KL; Udupa, N; Musmade, PB (July 2013). "Informed consent: Issues and challenges". Journal of advanced pharmaceutical technology & research. 4 (3): 134–40. doi:10.4103/2231-4040.116779. PMID 24083200.{{cite journal}}: CS1 maint: unflagged free DOI (link)
8. Shuster, E (13 November 1997). "Fifty years later: the significance of the Nuremberg Code". The New England journal of medicine. 337 (20): 1436–40. doi:10.1056/NEJM199711133372006. PMID 9358142.
9. Sims, JM (2010). "A brief review of the Belmont report". Dimensions of critical care nursing : DCCN. 29 (4): 173–4. doi:10.1097/DCC.0b013e3181de9ec5. PMID 20543620.
10. Wendland, Claire L. (18 October 2013). "Research, Therapy, and Bioethical Hegemony: The Controversy over Perinatal AZT Trials in Africa". African Studies Review. 51 (03): 1–23. doi:10.1353/arw.0.0084.

Blue Rasberry (talk) 17:19, 11 February 2019 (UTC)

Tim says, "Emanuel lists the core biomedical ethics “framework” documents as of 2000. It is interesting to read up on the “Short-course AZT trials” conducted in Uganda and the controversy over use of placebo (Wendland), which led to (1) WMA revising its Helsinki guidelines c. 2004 (2) FDA influenced by pharmas dropping all reference to the Helsinki guidelines after c. 2006." Blue Rasberry (talk) 17:21, 11 February 2019 (UTC)

In the opening sentence, our article is defined as primarily focusing on healthcare interventions. However, the general principle of informed consent also applies to other forms of human subject studies, including psych investigations, neuroscience research, online experiments, and so on. The original inspiration provided by the Belmont Report has now been supplemented, at least in part, by the broader-based vision in the Menlo Report, and a variety of changes have recently been introduced to the US Common Rule, although that specific WP article still remains significantly out of date.

But the more pertinent question here is whether we should try to expand this article to cover that broader scope. An alternative - perhaps more practical - approach might be to craft a supplementary article that focuses more on the broader aspects of informed consent that apply in this extended research domain. Any thoughts?? jxm (talk) 07:14, 13 February 2019 (UTC)

Nested "including" / "such as" for the birds, including flightless land birds, such as the ostrich

More and more I begin to loath these nested "includes / such as" lists.

Current version:

Impairments to reasoning and judgment that may prevent informed consent include basic intellectual or emotional immaturity, high levels of stress such as posttraumatic stress disorder (PTSD) or a severe intellectual disability, severe mental disorder, intoxication, severe sleep deprivation, Alzheimer's disease, or being in a coma.

As expanded for my own notes:

Impairments to reasoning and judgment that may prevent informed consent include:

• basic intellectual or emotional immaturity
• high levels of stress such as:
  • PTSD
  • severe intellectual disability
• severe mental disorder
• intoxication
• severe sleep deprivation
• Alzheimer's disease
• being in a coma.

So basically, the grammar of the current version has implicitly associated "severe intellectual disability" under the sub-head "high levels of stress".

And why is "severe mental disability" listed under this subhead, when "severe mental disorder" is not?

From personal experience, I strongly suspect that mental disorder is more stressful than the mental disability (unless the disorder involves believing in Peter Pan, because you see him or her—sometimes manifesting as Peterless Pan—in the mirror each morning).

Pretty much nobody properly proofreads this kind of sentence, because everyone has been exposed to that high-school textbook authored by an anodyne committee of blithering, summarizing, non-committal idiots, purchased by the school system only because the "package" includes a turnkey buffet of multiple choice test questions that barely scratch the surface, but suffice to prove that you proved something (this being entirely orthogonal to improving something, including education outcomes such as student comprehension).

I've expanded dozens of these that exploded on first close examination, properly unpacked. Enough already. Just saying. — MaxEnt 13:15, 21 May 2021 (UTC)

Definition in Lead

I feel the lead is a bit process- and "healthcare worker-" centric. I'm sourcing some other definitions to work out what the best thing to do / justify any changed. Talpedia

Informed consent is a process for getting permission before conducting a health care intervention on a person, for conducting some form of research on a person, or for disclosing a person's information

(talk) 00:42, 27 November 2021 (UTC)

Caption

Source	Type	Definition	Added by
Medical ethics: a reference guide for guaranteeing principled care and quality	Medical ethics textbook - clinical	"Informed consent is a shared decision-making process that requires the physician to disclose an adequate amount of information, including alternative strategies for diagnosis and treatment, with the risks and benefits of each outlined. The physician has an ethical responsibility to make reasonable efforts to ensure the patient’s comprehension by asking questions."	Talpedia
Autonomy, Rationality, and Contemporary Bioethics	Bioethics treatise (deep but the authors philosophy)	"The fundamental idea that we aim to capture when we claim that ‘A morally ought to obtain B’s informed consent to A’s doing x to B’, is that the moral permissibility of A’s doing x to B, is at least partly dependent on the following conditions being met:(i) B must be sufficiently informed with regards to the relevant facts concerning x to understand what x is (and what consequences are likely to occur as a result of x) (ii) On the basis of this information, B herself makes the decision to allow A to do x.³" || Talpedia

Okay I've switched over to definition

Informed consent is a principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care. A healthcare provider is often held to have a responsibility to ensure that that the consent that a patient gives is informed

Talpedia (talk) 01:03, 27 November 2021 (UTC)

References

Page is a mess

Camme here to insert something and found this to be a real mess, structure wise, information wise ( repetition ) , and also poor or absent sourcing. Style is horrible at times, with blatant prejudicial statements (e.g. Arabs and Mediterraneans accept info more like ...) looks like nobody looks after this page ? Wuerzele (talk) 20:19, 22 January 2023 (UTC)