What is Informed Consent?

Introduction

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 the consent that a patient gives is informed, and informed consent can apply to a health care intervention on a person, conducting some form of research on a person, or for disclosing a person’s information. Informed consent is, in fact, a fundamental principle in the field of health protection, obviously wanting to mark the very close and unavoidable connection between the need for consent and the inviolability of the right to health. A health care provider may ask a patient to consent to receive therapy before providing it, a clinical researcher may ask a research participant before enrolling that person into a clinical trial, and a researcher may ask a research participant before starting some form of controlled experiment. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics.

Free consent is a cognate term enshrined in the International Covenant on Civil and Political Rights. The covenant was adopted in 1966 by the United Nations, and intended to be in force by 23 March 1976. Article seven prohibits experiments conducted without the “free consent to medical or scientific experimentation” of the subject. As of September 2019, the covenant has 173 parties and six more signatories without ratification.

Informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts. Impairments to reasoning and judgement that may prevent informed consent include basic 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, Alzheimer’s disease, or coma.

Obtaining informed consent is not always required. If an individual is considered unable to give informed consent, another person is generally authorised to give consent on his behalf, e.g., parents or legal guardians of a child (though in this circumstance the child may be required to provide informed assent) and conservators for the mentally disordered, or consent can be assumed through the doctrine of implied consent, e.g. when an unconscious person will die without immediate medical treatment.

In cases where an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or institutional review board.

Informed consent form templates can be found on the website of the World Health Organisation (WHO).

Refer to Informed Refusal.

Brief History

Informed consent is a technical term first used by attorney, Paul G. Gebhard, in a medical malpractice United States court case in 1957. In tracing its history, some scholars have suggested tracing the history of checking for any of these practices:

  • 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.  They combine to form the modern concept of informed consent – which rose in response to particular incidents in modern research.  Whereas various cultures in various places practiced informed consent, the modern concept of informed consent was developed by people who drew influence from Western tradition.

Medical History

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. It 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. 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 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.

Research History

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

The US 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 US Army Yellow Fever Commission in Cuba that determined mosquitoes 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.

Henrietta Lacks On 29 January 1951, shortly after the birth of her son Joseph, Lacks entered Johns Hopkins Hospital in Baltimore with profuse bleeding. She was diagnosed with cervical cancer and was treated with inserts of radium tubes. During her radiation treatments for the tumour, two samples – one of healthy cells, the other of malignant cells – were removed from her cervix without her permission. Later that year, 31-year-old Henrietta Lacks succumbed to the cancer. Her cells were cultured creating Hela cells, but the family 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 consent.

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.

Assessment

Informed consent can be complex to evaluate, because neither expressions of consent, nor expressions of understanding of implications, necessarily mean that full adult consent was in fact given, nor that full comprehension of relevant issues is internally digested. Consent may be implied within the usual subtleties of human communication, rather than explicitly negotiated verbally or in writing. In some cases consent cannot legally be possible, even if the person protests he does indeed understand and wish. There are also structured instruments for evaluating capacity to give informed consent, although no ideal instrument presently exists.

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:

  1. 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.
  2. 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.
  3. A person signs a legal release form for a medical procedure, and later feels they did not really consent.
    1. Unless the individual can show actual misinformation, the release is usually persuasive or conclusive in law, in that the clinician may rely legally upon it for consent.
    2. In formal circumstances, a written consent usually legally overrides later denial of informed consent (unless obtained by misrepresentation).
  4. Informed consent in the US 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 (a temporary oxygen-carrying blood substitute made from human haemoglobin).

Valid Elements

For an individual to give valid informed consent, three components must be present: disclosure, capacity and voluntariness.

ComponentOutline
DisclosureThis 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).
CapacityThis pertains to the ability of the subject to both understand the information provided and form a reasonable judgement based on the potential consequences of their decision.
VoluntarinessThis refers to the subject’s right to freely exercise their decision making without being subjected to external pressure such as coercion, manipulation, or undue influence.

Waiver of Requirement

Waiver of the consent requirement may be applied in certain circumstances where no foreseeable harm is expected to result from the study or when permitted by law, federal regulations, or if an ethical review committee has approved the non-disclosure of certain information.

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 Defence if a research project would:

  • Directly benefit subjects.
  • Advance the development of a medical product necessary to the military.
  • Be carried out under all laws and regulations (i.e. Emergency Research Consent Waiver) including those pertinent to the US Food and Drug Administration (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. 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

The 21st Century Cures Act enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing “poses no more than minimal risk” and “includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”

Medical Sociology

Medical sociologists have studied informed consent as well bioethics more generally. Oonagh Corrigan, looking at informed consent for research in patients, argues that much of the conceptualization of informed consent comes from research ethics and bioethics with a focus on patient autonomy, and notes that this aligns with a neoliberal worldview.  Corrigan argues that a model based solely around individual decision making does not accurately describe the reality of consent because of social processes: a view that has started to be acknowledged in bioethics.  She feels that the liberal principles of informed consent are often in opposition with autocratic medical practices such that norms values and systems of expertise often shape and individuals ability to apply choice.

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 randomised control trial can be harmful to the doctor-patient relationship.

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, 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: Bolam v Friern Hospital Management Committee [1957] 1 WLR 582), that is, what risks would a medical professional usually disclose in the circumstances (see Loss of right in English law). 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 [2015] UKSC 11. This moves away from the concept of a reasonable physician and instead uses the standard of a reasonable patient, and what risks an individual would attach significance to.

Medicine in the United States, Australia, and Canada also 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.

The doctrine of informed consent should be contrasted with the general doctrine of medical consent, which applies to assault or battery. The consent standard here is only that the person understands, in general terms, the nature of and purpose of the intended intervention. As the higher standard of informed consent applies to negligence, not battery, the other elements of negligence must be made out. Significantly, causation must be shown: That had the individual been made aware of the risk he would not have proceeded with the operation (or perhaps with that surgeon).

Optimal establishment of an informed consent requires adaptation to cultural or other individual factors of the patient. For example, people from Mediterranean and Arab appear 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.

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 Consent

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, 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.

Electronic consent methods have been used to support indexing and retrieval of consent data, thus enhancing the ability to honour 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

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, ‘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 US), 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 (In law, parens patriae refers the public policy power of the state to intervene against an abusive or negligent parent, legal guardian, or informal caretaker, and to act as the parent of any child, individual or animal who is in need of protection).

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.

Abortion

In some US 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.

Some informed consent laws have been criticised for allegedly using “loaded language in an apparently deliberate attempt to ‘personify’ the fetus,” 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.”

From Children

As children often lack the decision making ability or legal power (competence) to provide true informed consent for medical decisions, it often falls on parents or legal guardians to provide informed permission for medical decisions. This “consent by proxy” usually works reasonably well, but can lead to ethical dilemmas when the judgment of the parents or guardians and the medical professional differ with regard to what constitutes appropriate decisions “in the best interest of the child”. Children who are legally emancipated, and certain situations such as decisions regarding sexually transmitted diseases or pregnancy, or for unemancipated minors who are deemed to have medical decision making capacity, may be able to provide consent without the need for parental permission depending on the laws of the jurisdiction the child lives in. The American Academy of Paediatrics encourages medical professionals also to seek the assent of older children and adolescents by providing age appropriate information to these children to help empower them in the decision making process.

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.[41] 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.[41] 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.

Consent to Research

Informed consent is part of the ethical clinical research as well, in which a human subject voluntarily confirms his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. In medical research, the Nuremberg Code set a base international standard in 1947, which continued to develop, for example in response to the ethical violation in the Holocaust. Nowadays, medical research is overseen by an ethics committee that also oversees the informed consent process.

As the medical guidelines established in the Nuremberg Code were imported into the ethical guidelines for the social sciences, informed consent became a common part of the research procedure. However, while informed consent is the default in medical settings, it is not always required in the social science. Here, research often involves low or no risk for participants, unlike in many medical experiments. Second, the mere knowledge that they participate in a study can cause people to alter their behaviour, as in the Hawthorne Effect:

“In the typical lab experiment, subjects enter an environment in which they are keenly aware that their behavior is being monitored, recorded, and subsequently scrutinized.”

In such cases, seeking informed consent directly interferes with the ability to conduct the research, because the very act of revealing that a study is being conducted is likely to alter the behaviour studied. List exemplifies the potential dilemma that can result:

“if one were interested in exploring whether, and to what extent, race or gender influences the prices that buyers pay for used cars, it would be difficult to measure accurately the degree of discrimination among used car dealers who know that they are taking part in an experiment.”

In cases where such interference is likely, and after careful consideration, a researcher may forgo the informed consent process. This is commonly done after weighting the risk to study participants versus the benefit to society and whether participants are present in the study out of their own wish and treated fairly. Researchers often consult with an ethics committee or institutional review board to render a decision.

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 Inc. in 2014, and published by that company and Cornell University. Facebook conducted a study 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 analysed 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, supports 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 along but that 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 user that didn’t 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.

Conflicts of Interest

Other, long-standing controversies underscore the role for conflicts of interest among medical school faculty and researchers. For example, coverage of University of California (UC) medical school faculty members has included news of ongoing corporate payments to researchers and practitioners from companies that market and produce the very devices and treatments they recommend to patients.

Robert Pedowitz, the former chairman of UCLA’s orthopaedic surgery department, reported concern that his colleague’s financial conflicts of interest could negatively affect patient care or research into new treatments. In a subsequent lawsuit about whistleblower retaliation, the university provided a $10 million settlement to Pedowitz while acknowledging no wrongdoing. Consumer Watchdog, an oversight group, observed that University of California policies were “either inadequate or unenforced…Patients in UC hospitals deserve the most reliable surgical devices and medication…and they shouldn’t be treated as subjects in expensive experiments.” Other UC incidents include taking the eggs of women for implantation into other women without consent and injecting live bacteria into human brains, resulting in potentially premature deaths.

What is Informed Refusal?

Introduction

Informed refusal is where a person has refused a recommended medical treatment based upon an understanding of the facts and implications of not following the treatment. Informed refusal is linked to the informed consent process, as a patient has a right to consent, but also may choose to refuse.

Refer to Informed Consent, Mature Minor Doctrine, and Gillick Competence.

Background

The individual needs to be in possession of the relevant facts as well as of their reasoning faculties, such as not being intellectually disabled or mentally ill and without an impairment of judgement at the time of refusing. Such impairments might include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems. In cases where an individual is considered unable to give informed refusal, another person (guardian) may be authorised to give consent on their behalf. The concept grew out of and is similar to that of informed consent, but much less commonly used and applied. In the United States, it is recognised in certain state laws (in 2006: California, Nevada, Vermont, and Michigan) as well as in various court decisions.

As applied in the medical field, a physician has made an assessment of a patient and finds a specific test, intervention, or treatment is medically necessary. The patient refuses to consent to this recommendation. The physician then needs to explain the risks of not following through with the recommendations to allow the patient to make an informed decision against the recommendation. While in the past documentation of refusal of treatment has not been important, the widespread use of managed care, cost containment processes, as well as increased patient autonomy have created a situation where documented “informed refusal” is viewed as becoming more important. When refusal of treatment may result in significant damage or death, the interaction needs to be documented to protect the care giver in a potential later litigation against the allegation that the recommendation was either not made or not understood. On occasion, a patient will also refuse to sign the “informed refusal” document, in which case a witness would have to sign that the informed process and the refusal took place.

The pregnant patient represents a specific dilemma in the field of informed refusal as her action may result in harm or death to the foetus. Ethicists disagree on how to handle this situation.

What is the Mature Minor Doctrine?

Introduction

The mature minor doctrine is a rule of law found in the United States and Canada accepting that an unemancipated minor patient may possess the maturity to choose or reject a particular health care treatment, sometimes without the knowledge or agreement of parents, and should be permitted to do so.

It is now generally considered a form of patients rights; formerly, the mature minor rule was largely seen as protecting health care providers from criminal and civil claims by parents of minors at least 15.

Jurisdictions may codify an age of medical consent, accept the judgment of licensed providers regarding an individual minor, or accept a formal court decision following a request that a patient be designated a mature minor, or may rely on some combination. For example, patients at least 16 may be assumed to be mature minors for this purpose, patients aged 13 to 15 may be designated so by licensed providers, and pre-teen patients may be so-designated after evaluation by an agency or court. The mature minor doctrine is sometimes connected with enforcing confidentiality of minor patients from their parents.

Refer to Gillick Competence, Marion’s Case, Informed Consent, and Informed Refusal.

Statute

In the United States, a typical statute lists: “Who may consent [or withhold consent for] surgical or medical treatment or procedures.”

“…Any unemancipated minor of sufficient intelligence to understand and appreciate the consequences of the proposed surgical or medical treatment or procedures, for himself.”

Medical Emancipation

By definition, a “mature minor” has been found to have the capacity for decisional autonomy, or the right to make decisions including whether to undergo risky medical but potentially life-saving medical decisions alone, without parental approval. By contrast, “medical emancipation” formally releases children from some parental involvement requirements but does not necessarily grant that decision making to children themselves. Pursuant to statute, several jurisdictions grant medical emancipation to a minor who has become pregnant or requires sexual-health services, thereby permitting medical treatment without parental consent and, often, confidentiality from parents. A limited guardianship may be appointed to make medical decisions for the medically emancipated minor and the minor may not be permitted to refuse or even choose treatment.

Brief History

One significant early US case, Smith v. Seibly, 72 Wn.2d 16, 431 P.2d 719 (1967), before the Washington Supreme Court, establishes precedent on the mature minor doctrine. The plaintiff, Albert G. Smith, an 18-year-old married father, was suffering from myasthenia gravis, a progressive disease. Because of this, Smith expressed concern that his wife might become burdened in caring for him, for their existing child and possibly for additional children. On 09 March 1961, while still 18, Smith requested a vasectomy. His doctor required written consent, which Smith provided, and the surgery was performed. Later, after reaching Washington’s statutory age of majority, then 21, the doctor was sued by Smith, who now claimed that he had been a minor and thus unable to grant surgical or medical consent. The Court rejected Smith’s argument: “Thus, age, intelligence, maturity, training, experience, economic independence or lack thereof, general conduct as an adult and freedom from the control of parents are all factors to be considered in such a case [involving consent to surgery].”

The court further quoted another recently decided case, Grannum v. Berard, 70 Wn.2d 304, 307, 422 P.2d 812 (1967): “The mental capacity necessary to consent to a surgical operation is a question of fact to be determined from the circumstances of each individual case.” The court explicitly stated that a minor may grant surgical consent even without formal emancipation.

Especially since the 1970s, older paediatric patients sought to make autonomous decisions regarding their own treatment, and sometimes sued successfully to do so. The decades of accumulated evidence tended to demonstrate that children are capable of participating in medical decision-making in a meaningful way; and legal and medical communities have demonstrated an increasing willingness to formally affirm decisions made by young people, even regarding life and death.

Religious beliefs have repeatedly influenced a patient’s decision to choose treatment or not. In a case in 1989 in Illinois, a 17-year-old female Jehovah’s Witness was permitted to refuse necessary life saving treatments.

In 1990, the United States Congress passed the Patient Self-Determination Act; even though key provisions apply only to patients over age 18, the legislation advanced patient involvement in decision-making. The West Virginia Supreme Court, in Belcher v. Charleston Area Medical Centre (1992) defined a “mature minor” exception to parental consent, according consideration to seven factors to be weighed regarding such a minor: age, ability, experience, education, exhibited judgment, conduct, and appreciation of relevant risks and consequences.

The 2000s and 2010s experienced a number of outbreaks of vaccine-preventable diseases, such as the 2019-2020 measles outbreaks, which were fuelled in part by vaccine hesitancy. This prompted minors to seek vaccinations over objections from their parents. Beginning in the 2020s during the COVID-19 pandemic, minors also began seeking out the COVID-19 vaccine over the objections of their vaccine-hesitant parents.

Laws by Jurisdiction

Canada

The Supreme Court of Canada recognised mature minor doctrine in 2009; in provinces and territories lacking relevant statutes, common law is presumed to be applied.

Province/TerritoryMinimum AgeOutline
AlbertaNoneThe Child, Youth and Family Enhancement Act does not establish a minimum age. In practice, children at 16 are generally considered capable of consent to medical procedures; in some cases, the doctrine has been applied to children as young as 14.
British ColumbiaNoneThe Infants Act does not set an age at which a child becomes capable of consent to medical procedures, but the child must be capable of understanding the procedure and its risks in order to consent.
ManitobaNoneIt is presumed minors 16 and older can provide consent; minors 15 and younger and presumed to be incapable of consent but this can be rebutted.
New BrunswickNoneUnder the Medical Consent of Minors Act, minors 16 and older can consent to medical procedures. Minors under 16 can consent to treatment if they can demonstrate an understanding of the procedure and its consequences.
Newfoundland and LabradorNoneThe Advanced Health Care Directives Act presumes minors 16 and older are capable of consent to treatment.
Northwest TerritoriesNoneNo statute exists in Northwest Territories dictating an age of consent; absent a statute, common law applies.
Nova ScotiaNoneMedical procedures can be performed on any person capable of providing informed consent.
NunavetNoneNo statute exists in Nunavut dictating an age of consent.
OntarioNoneThe Health Care Consent Act allows all persons capable of informed consent to agree to treatment. The Substitute Decisions Act presumes all persons 16 or older can give or withhold consent to care.
Prince Edward IslandNoneMedical procedures can be performed on any person capable of providing informed consent.
Quebec14Minors 14 and older may consent to medical care but still require parental consent for optional procedures that involve significant risks, e.g. cosmetic surgery.
SaskatchewanNoneMedical procedures can be performed on any person capable of providing informed consent.
YukonNoneMedical procedures can be performed on any person capable of providing informed consent.

United States

Several states permit minors to legally consent to medical treatment without parental consent or over parental objections. In addition, many other states allow minors to consent to medical procedures under a more limited set of circumstances. These include providing limited minor autonomy only in enumerated cases, such as blood donation, substance abuse, sexual and reproductive health (including abortion and sexually transmitted infections), or for emergency medical services. Many states also exempt specific groups of minors from parental consent, such as homeless youth, emancipated minors, minor parents, or married minors. Further complicating matters is the interaction between state tort law, state contract law, and federal law, depending on if the clinic accepts federal funding under Title X or Medicaid.

StateMinimum AgeOutline
Alabama14Minors 14 years or older or who have graduated high school can consent to medical procedures. No evaluation of maturity required. Parental consent is required for abortion but can be bypassed.
AlaskaNoneNo evaluation of maturity required. Parental consent is not required for abortion, as this violates the Constitution of Alaska’s clause protecting privacy.
ArkansasNoneAny minors capable of informed consent.
California12CA Family Code 6926 permits minors to consent to immunization against sexually transmitted infections.
DelawareNone“Reasonable efforts” must have first been made to secure parental consent. Minors can consent to vaccinations for sexually transmitted infections.
IdahoNoneAny minors capable of informed consent.
IllinoisNoneAny minors capable of informed consent, but informed refusal of medical treatment can be overruled.
Kansas16Minors aged 16 are permitted de jure to consent to medical treatment when no parent is available. Mature minors are permitted to consent to medical treatment, but maturity must be assessed on a case-by-case basis.
LouisianaNoneMinors are allowed to consent to any medical procedure they deem necessary.
MaineNoneA mature minor’s wishes expressed in a living will must be considered.
MassachusettsNoneMature minors meeting are permitted to consent to medical treatment, but only if their “best interests … will be served by not notifying his or her parents of intended medical treatment.”
MinnesotaNoneMinnesota Statutes §144.3441 permits minors to consent to immunisation against Hepatitis B.
MontanaNoneAny minors who have completed high school are able to consent to medical treatment.
NevadaNoneMature minors meeting are permitted to consent to medical treatment, but only if the healthcare worker believes the minor would risk a “serious health hazard” absent treatment.
New YorkNoneNY Public Health Law §2305 permits minors to consent to treatment for and immunization against sexually transmitted infections.
Oregan15Minors aged 15 and up have the authority to consent to (but not necessarily refuse) medical treatment.
Pennsylvania18Minors aged 18 or who have completed high school can consent to medical treatment.
South Carolina16Minors aged 16 and up can consent to any medical treatment other than “operations”.
Tennessee7Any mature minors capable of informed consent can consent to medical procedures. The courts make the rebuttable presumption that minors aged 7 to 13 are not mature, while minors 14 and up are.
WashingtonNoneMature minors may consent to medical procedures, including immunisations.
Washington D.C.12Minors 12 and older may consent to immunisation with CDC-approved vaccines, even over parental objections. The law compels healthcare providers to seek payment directly from insurance companies without notifying parents.
West VirginiaNoneAny minors capable of informed consent can consent to medical procedures.

United States

In the United States, bodily integrity has long been considered a common law right; the United States Supreme Court, in 1891’s Union Pacific Railway Company v. Botsford, found, “No right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority of law.” The Supreme Court in 1990 (Cruzan v. Director, Missouri Department of Health) allowed that “constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred” in the Due Process Clause of the Fourteenth Amendment to the United States Constitution, but the Court refrained from explicitly establishing what would have been a newly enumerated right. Nevertheless, lower courts have increasingly held that competent patients have the right to refuse any treatment for themselves.

In 1989, the Supreme Court of Illinois interpreted the Supreme Court of the United States to have already adopted major aspects of mature minor doctrine, concluding:

Although the United States Supreme Court has not broadened this constitutional right of minors beyond abortion cases, the [Illinois] appellate court found such an extension “inevitable.” …Nevertheless, the Supreme Court has not held that a constitutionally based right to refuse medical treatment exists, either for adults or minors. …[U.S. Supreme Court] cases do show, however, that no “bright line” age restriction of 18 is tenable in restricting the rights of mature minors, [thus] mature minors may possess and exercise rights regarding medical care… If the evidence is clear and convincing that the minor is mature enough to appreciate the consequences of her actions, and that the minor is mature enough to exercise the judgment of an adult, then the mature minor doctrine affords her the common law right to consent to or refuse medical treatment [including life and death cases, with some considerations].

An ongoing case of Z.M is being heard in Maryland regarding the minor’s right to refuse chemotherapy.

In Connecticut, Cassandra C. a seventeen-year-old, was ordered by the Connecticut Supreme Court to receive treatment. The court decided that Cassandra was not mature enough to make medical decisions.

Canada

In 2009, the Supreme Court of Canada ruling in A.C. v. Manitoba [2009] SCC 30 (CanLII) found that children may make life and death decisions about their medical treatment. In the majority opinion, Justice Rosalie Abella wrote:

“The result of this [decision] is that young people under 16 will have the right to demonstrate mature medical decisional capacity. …If, after a careful analysis of the young person’s ability to exercise mature and independent judgment, the court is persuaded that the necessary level of maturity exists, the young person’s views ought to be respected.”

A “dissenting” opinion by Justice Ian Binnie would have gone further:

“At common law, proof of capacity entitles the ‘mature minor’ to exercise personal autonomy in making medical treatment decisions free of parental or judicial control. …[A] young person with capacity is entitled to make the treatment decision, not just to have ‘input’ into a judge’s consideration of what the judge believes to be the young person’s best interests.”

Analysts note that the Canadian decision merely requires that younger patients be permitted a hearing, and still allows a judge to “decide whether or not to order a medical procedure on an unwilling minor”.

What is Marion’s Case (1982)?

Introduction

Secretary of the Department of Health and Community Services v JWB and SMB, commonly known as Marion’s Case, is a leading decision of the High Court of Australia, concerning whether a child has the capacity to make decisions for themselves, and when this is not possible, who may make decisions for them regarding major medical procedures.

It largely adopts the views in Gillick v West Norfolk Area Health Authority, a decision of the House of Lords in England and Wales.

Refer to Mature Minor Doctrine, Informed Consent, and Informed Refusal.

Background

“Marion”, a pseudonym for the 14-year-old girl at the centre of this case, suffered from intellectual disabilities, severe deafness, epilepsy and other disorders. Her parents, a married couple from the Northern Territory sought an order from the Family Court of Australia authorising them to have Marion undergo a hysterectomy and an oophrectomy (removal of ovaries). The practical effect would be sterilisation and preventing Marion from being able to have children and many of the hormonal effects of adulthood.

Under the Family Law Act the primary concern for matters involving children is that the court must act in the child’s best interests. The majority of the High Court made it clear that it was merely deciding a point of law and that the decision about what was in the child’s “best interests” would be left to the Family Court of Australia after the case.

The main legal debate that arose was who has the legal authority to authorise the operation. Three options existed: the parents (as legal guardians of their daughter), Marion or an order of a competent court, such as the Family Court of Australia. The Full Court of the Family Court was asked to decide:

  1. Could the parents, as joint guardians authorise the sterilisation procedure;
  2. If not, does the Family Court have jurisdiction to:
    (a) authorise the carrying out of such a procedure;
    (b) enlarge the powers, rights or duties of the parents to enable them to authorise such a procedure; or
    (c) approve the consent of the Applicants, as to the proposed procedure.

The majority of the Family Court, Strauss and McCall JJ held that the parents, as joint guardians could authorise the sterilisation procedure. Nicholson CJ held that the Family Court had jurisdiction to authorise the procedure.

The department, together with the Attorney-General for Australia, argued that only a court could authorise such a major operation and that the Family Court jurisdiction included any matter relating to the welfare of a child even if it was not a dispute about custody, guardianship or access.

The parents, however, “argued that the decision to sterilise a child is not significantly different from other major decisions that parents and guardians have to make for children and that the involvement of the Family Court is optional and only of a ‘supervisory nature’. Their argument was that, provided such a procedure is in the best interests of the child, parents as guardians can give lawful consent to a sterilisation on behalf of a mentally incompetent child.”

Judgement

The High Court recognised the right of everyone to bodily integrity under national and international law, and made a distinction between therapeutic and non-therapeutic surgical procedures as well as the duty of surrogates to act in the best interests of the incompetent patient.

In the case, the High Court ruled that while parents may consent to medical treatment for their children, the authority does not extend to treatment not in the child’s best interests. Also, the Court held that if medical treatment has sterilisation as its principal objective, parents do not have the authority to consent on behalf of their child.

Obiter Dictum

The statement by Deane J that parents may grant surrogate consent for the non-therapeutic circumcision of male children is obiter dictum and not part of the judgment. Male circumcision was not at issue in the case and no evidence or testimony was offered regarding male circumcision.