Informed consent
(
Consent
)
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 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. 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.
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
These standards in medical contexts are formalized in the requirement for decision-making capacity and professional determinations in these contexts have legal authority. 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.
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, intoxication, severe sleep deprivation, dementia, or coma.
Obtaining informed consent is 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 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. , the covenant has 173 parties and six more signatories without ratification.
Assessment
Thus, there is always a degree to which informed consent must be assumed or inferred based upon observation, or knowledge, or legal reliance. This especially is the case in sexual or relational issues. In medical or formal circumstances, explicit agreement by means of signature—normally relied on legally—regardless of actual consent, is the norm. This is the case with certain procedures, such as a "do not resuscitate" directive that a patient signed before onset of their illness.
Brief examples of each of the above:
- A person may verbally agree to something from fear, perceived social pressure, or psychological difficulty in asserting true feelings. The person requesting the action may honestly be unaware of this and believe the consent is genuine, and rely on it. Consent is expressed, but not internally given.
- A person may claim to understand the implications of some action, as part of consent, but in fact has failed to appreciate the possible consequences fully and may later deny the validity of the consent for this reason. Understanding needed for informed consent is present but is, in fact (through ignorance), not present.
- A person signs a legal release form for a medical procedure, and later feels he did not really consent. Unless he can show actual misinformation, the release is usually persuasive or conclusive in law, in that the clinician may rely legally upon it for consent. In formal circumstances, a written consent usually legally overrides later denial of informed consent (unless obtained by misrepresentation).
- Informed consent in the U.S. can be overridden in emergency medical situations pursuant to 21CFR50.24, which was first brought to the general public's attention via the controversy surrounding the study of Polyheme.
Valid elements
- Disclosure requires the researcher to supply each prospective subject with the information necessary to make an autonomous decision and also to ensure that the subject adequately understands the information provided. This latter requirement implies that a written consent form be written in lay language suited for the comprehension skills of subject population, as well as assessing the level of understanding through conversation (to be informed).
- Capacity pertains to the ability of the subject to both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision.
- Voluntariness refers to the subject's right to freely exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence.
Patient understanding
From children
Research on children has benefited society in many ways. The only effective way to establish normal patterns of growth and metabolism is to do research on infants and young children. When addressing the issue of informed consent with children, the primary response is parental consent. This is valid, although only legal guardians are able to consent for a child, not adult siblings. Additionally, parents may not order the termination of a treatment that is required to keep a child alive, even if they feel it is in the best interest. Guardians are typically involved in the consent of children, however a number of doctrines have developed that allow children to receive health treatments without parental consent. For example, emancipated minors may consent to medical treatment, and minors can also consent in an emergency. Information provided to parents/guardians, and to children themselves, as part of clinical research is often written in ways that make them difficult to understand.
Waiver of requirement
Besides studies with minimal risk, waivers of consent may be obtained in a military setting. 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:
- directly benefit subjects
- advance the development of a medical product necessary to the military and
- be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver) including those pertinent to the FDA.
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. The Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) joined to create federal guidelines to permit emergency research, without informed consent. However, they can only proceed with the research if they obtain a waiver of informed consent (WIC) or an emergency exception from informed consent (EFIC).
21st Century Cures Act
Medical sociology
Patients who agree to participate in trials often do so because they feel that the trial was suggested by a doctor as the best intervention. Patients may find being asked to consent within a limited time frame a burdensome intrusion on their care when it arises because a patient has to deal with a new condition. Patients involved in trials may not be fully aware of the alternative treatments, and an awareness that there is uncertainty in the best treatment can help make patients more aware of this. 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.
Medical procedures
Requirements of the professional
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.
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. Too Much Information: Informed Consent in Cultural Context. By Joseph J. Fins and Pablo Rodriguez del Pozo. Medscape 07/18/2011
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.
Obtaining informed consents
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 and digital informed consent have proved to lead to higher patient satisfaction. Integrating patients into treatment decisions (shared decision-making) and increasing transparency leads to better overall treatment adherence.
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. 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).
Competency of the patient
By contrast, '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 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
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.
Abortion
Some informed consent laws have been criticized for allegedly using "loaded language in an apparently deliberate attempt to 'personify' the fetus,"Gold, Rachel and Nash, Elizabeth. State Abortion Counseling Policies and the Fundamental Principles of Informed Consent, Guttmacher Policy Review, Fall 2007, Volume 10, Number 4. but those critics acknowledge that "most of the information in the legally materials about abortion comports with recent scientific findings and the principles of informed consent", although "some content is either misleading or altogether incorrect."Richardson, Chinue and Nash, Elizabeth. "Misinformed Consent: The Medical Accuracy of State-Developed Abortion Counseling Materials", Guttmacher Policy Review Fall 2006, Volume 9, Number 4.
Within research
Medicine
Social sciences
The birth of new online media, such as social media, has complicated the idea of informed consent. In an online environment people pay little attention to Terms of Use agreements and can subject themselves to research without thorough knowledge. This issue came to the public light following a study conducted by Facebook in 2014, and published by that company and Cornell University. Facebook conducted a study without consulting an Ethics Committee or IRB where they altered the Facebook News Feeds of roughly 700,000 users to reduce either the amount of positive or negative posts they saw for a week. The study then analyzed if the users' status updates changed during the different conditions. The study was published in the Proceedings of the National Academy of Sciences. The lack of informed consent led to outrage among many researchers and users. Many believed that by potentially altering the mood of users by altering what posts they see, Facebook put at-risk individuals at higher dangers for depression and suicide. However, supporters of Facebook claim that Facebook details that they have the right to use information for research in their terms of use. 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. They say this Facebook study is no different from things people already accept. Still, others say that Facebook broke the law when conducting the experiment on users that did not give informed consent. The Facebook study controversy raises numerous questions about informed consent and the differences in the ethical review process between publicly and privately funded research. Some say Facebook was within its limits and others see the need for more informed consent and/or the establishment of in-house private review boards.
Duty to share findings
Conflicts of interest
History
- 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.
Medical history
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. The rationale is a 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.
Henri de Mondeville, a French surgeon who in the 14th century, wrote about medical practice. He traced his ideas to the Hippocratic Oath. In this book see Mary Catherine Welborn's excerpts from her 1966 The long tradition: A study in fourteenth-century medical deontology 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. Mondeville never mentioned getting consent, but did emphasize the need for the patient to have confidence in the doctor. 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". In this book see De Mondeville's "On the morals and ethics of medicine" from Ethics in Medicine
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. This is the oldest identified written document in which a patient acknowledges risk of medical treatment and writes to express their willingness to proceed.
Benjamin Rush was an 18th-century United States physician who was influenced by the Age of Enlightenment cultural movement. 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. There is no evidence that he supported seeking a consent from patients. 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. John Gregory, Rush's teacher, wrote similar views that a doctor could best practice beneficence by making decisions for the patients without their consent.
Thomas Percival was a British physician who published a book called Medical Ethics in 1803. Percival was a student of the works of Gregory and various earlier Hippocratic physicians. Like all previous works, Percival's Medical Ethics makes no mention of soliciting for the consent of patients or respecting their decisions. 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.
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. Many sections of this book are verbatim copies of passages from Percival's Medical Ethics. 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. Through this text, Percival's ideas became pervasive guidelines throughout the United States as other texts were derived from them.
Worthington Hooker was an American physician who in 1849 published Physician and Patient. 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. In Hooker's view, benevolent deception is not fair to the patient, and he lectured widely on this topic. Hooker's ideas were not broadly influential.
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.
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. Earlier legal cases had created the underpinnings for informed consent, but his judgment gave a detailed and thought through discourse on the matter.
Research history
The U.S. Army Yellow Fever Commission "is considered the first research group in history to use consent forms." In 1900, Major Walter Reed was appointed head of the four man U.S. Army Yellow Fever Commission in Cuba that determined 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." The three surviving examples are in Spanish with English translations; two have an individual's signature and one is marked with an X.
Tearoom Trade is the name of a book by American psychologist Laud Humphreys. In it he describes his research into male homosexual acts. 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.
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, 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.
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. 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. The experiment raised broad discussion on the ethics of recruiting participants for research without giving them full information about the nature of the research.
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.
New areas
Artificial intelligence (AI) became widespread in the 21st century. It raises many ethical concerns in the medical field, such as the patients’ awareness that they may be interacting with an AI system, as it is being gradually integrated into scanning, surgery, and diagnoses. A number of companies, inspired by the ChatGPT3 system that was released in December 2022, developed AI therapists, which are mental health chatbots that can provide treatment information and perform mental health therapy. Patients must be educated about AI usage to promote trust in the systems.
See also
- Anti-psychiatry
- Belmont Report
- Consent (BDSM)
- Consent (criminal law)
- Consensual crime
- Declaration of Geneva
- Declaration of Helsinki
- Deliberative democracy
- Dynamic consent
- Free, prior and informed consent
- Human experimentation
- Informed assent
- Informed refusal
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Involuntary treatment
- Minors and abortion
- Parental consent
- Patient safety
- Safe, sane and consensual
- World Medical Association
- Therapeutic misconception
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