Informed consent
Encyclopedia
Informed consent is a phrase often used in law
Law
Law is a system of rules and guidelines which are enforced through social institutions to govern behavior, wherever possible. It shapes politics, economics and society in numerous ways and serves as a social mediator of relations between people. Contract law regulates everything from buying a bus...

 to indicate that the consent
Consent
Consent refers to the provision of approval or agreement, particularly and especially after thoughtful consideration.- Types of consent :*Implied consent is a controversial form of consent which is not expressly granted by a person, but rather inferred from a person's actions and the facts and...

 a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and future consequences of an action. In order to give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts at the time consent is given. Impairments to reasoning and judgment which may make it impossible for someone to give informed consent include such factors as basic intellectual or emotional immaturity, high levels of stress such as PTSD or as severe mental retardation
Mental retardation
Mental retardation is a generalized disorder appearing before adulthood, characterized by significantly impaired cognitive functioning and deficits in two or more adaptive behaviors...

, severe mental illness
Mental illness
A mental disorder or mental illness is a psychological or behavioral pattern generally associated with subjective distress or disability that occurs in an individual, and which is not a part of normal development or culture. Such a disorder may consist of a combination of affective, behavioural,...

, intoxication, severe sleep deprivation
Sleep deprivation
Sleep deprivation is the condition of not having enough sleep; it can be either chronic or acute. A chronic sleep-restricted state can cause fatigue, daytime sleepiness, clumsiness and weight loss or weight gain. It adversely affects the brain and cognitive function. Few studies have compared the...

, Alzheimer's disease
Alzheimer's disease
Alzheimer's disease also known in medical literature as Alzheimer disease is the most common form of dementia. There is no cure for the disease, which worsens as it progresses, and eventually leads to death...

, or being in a coma
Coma
In medicine, a coma is a state of unconsciousness, lasting more than 6 hours in which a person cannot be awakened, fails to respond normally to painful stimuli, light or sound, lacks a normal sleep-wake cycle and does not initiate voluntary actions. A person in a state of coma is described as...

. This term was first used in a 1957 medical malpractice case by Paul G. Gebhard.

Some acts can take place because of a lack of informed consent. In cases where an individual is considered unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., parents or legal guardian
Legal guardian
A legal guardian is a person who has the legal authority to care for the personal and property interests of another person, called a ward. Usually, a person has the status of guardian because the ward is incapable of caring for his or her own interests due to infancy, incapacity, or disability...

s of a child
Child
Biologically, a child is generally a human between the stages of birth and puberty. Some vernacular definitions of a child include the fetus, as being an unborn child. The legal definition of "child" generally refers to a minor, otherwise known as a person younger than the age of majority...

 (though in this circumstance the child may be required to proved informed assent
Informed assent
The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.- Background :...

) and caregivers for the mentally ill.

In cases where an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. Such cases in a clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

 in medical research are anticipated and prevented by an ethics committee or Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

.

Assessment of consent

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.

There is thus 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 which may normally be relied upon legally, regardless of actual consent, is the norm. This is the case with certain procedures, such as DNR.

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 his true feelings. The person requesting the action may honestly be unaware of this and believe the consent is genuine, and rely upon it. Consent is expressed, but not internally given.
  2. A person may state he understands the implications of some action, as part of his consent, but in fact has failed to appreciate the possible consequences fully and later deny the validity of his consent for this reason. Understanding needed for informed consent is stated to be present but is in fact (through ignorance) not present.
  3. A person may move from friendship to sexual contact on the basis of body language and apparent receptivity, but very few people on a date that results in sexual contact have explicitly asked the other if his or her consent is informed, if he does in fact fully understand what is implied, and all potential conditions or results. Informed consent is implied (or assumed unless disproved) but not stated explicitly.
  4. A person below the age of consent
    Age of consent
    While the phrase age of consent typically does not appear in legal statutes, when used in relation to sexual activity, the age of consent is the minimum age at which a person is considered to be legally competent to consent to sexual acts. The European Union calls it the legal age for sexual...

     may agree to sex, knowing all the consequences, but his or her consent is deemed invalid as he is deemed to be a child unaware of the issues and thus incapable of being informed consent. Individual is barred from legally giving informed consent, despite what they may feel (1)
  5. In some countries (notably the United Kingdom
    United Kingdom
    The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...

    ), individuals may not consent to injuries being inflicted upon them, and so a person practicing sadism and masochism
    Sadism and masochism
    Sadomasochism broadly refers to the receiving of pleasure—often sexual—from acts involving the infliction or reception of pain or humiliation. The name originates from two authors on the subject, Marquis de Sade and Leopold von Sacher-Masoch...

     upon a consenting partner may be deemed to have caused actual bodily harm
    Actual bodily harm
    Assault occasioning actual bodily harm is a statutory offence of aggravated assault in England and Wales, Northern Ireland, the Australian Capital Territory, New South Wales, Hong Kong and the Solomon Islands...

     without consent, actual consent notwithstanding. Individual is barred from legally giving informed consent, despite what they may feel (2). See also Spanner case and 'consensual non-consensuality
    Consent (BDSM)
    Consent within BDSM is an issue that attracts much attention in the field. Practitioners' interests are in ensuring appropriate consent for personal, ethical, and legal reasons...

    '.
  6. A person signs a legal release
    Legal release
    A legal release is a legal instrument that acts to terminate any legal liability between the releasor and the releasee, signed by the releasor. A release may also be made orally in some circumstances...

     form for a medical procedure
    Medical procedure
    A medical procedure is a course of action intended to achieve a result in the care of persons with health problems.A medical procedure with the intention of determining, measuring or diagnosing a patient condition or parameter is also called a medical test...

    , 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 will usually legally override later denial of informed consent (unless obtained by misrepresentation)
  7. A person or institution (e.g., a school or childcare professional) exposes a minor to non-age-appropriate material, in any media format, without the expressed informed consent of the minor's parent or legal guardian. Informed consent in this instance goes to the argument of competency on the part of the minor. An example would be the showing of an R rated movie to a 12-year-old by an educational institution without the informed consent of the parent or legal guardian.
  8. 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
    PolyHeme
    PolyHeme is a temporary oxygen-carrying blood substitute made from human hemoglobin that is currently in development for emergency treatment of trauma situations where large volumes of blood are lost, with emphasis on situations where fresh blood for transfusion is not readily available...

    .

Medical procedures

The doctrine of informed consent relates to professional negligence
Professional negligence
In the English law of tort, professional negligence is a subset of the general rules on negligence to cover the situation in which the defendant has represented him or herself as having more than average skills and abilities. The usual rules rely on establishing that a duty of care is owed by the...

 and establishes a breach of the duty of care owed to the patient (see duty of care
Duty of care in English law
In English tort law, an individual may be owed a duty of care by another, to ensure that they do not suffer any unreasonable harm or loss. If such a duty is found to be breached, a legal liability is imposed upon the duty-ower, to compensate the victim for any losses they incur...

, breach of the duty
Breach of duty in English law
In English tort law, there can be no liability in negligence unless the claimant establishes both that they were owed a duty of care by the defendant, and that there has been a breach of that duty...

, and causation English law). The doctrine of informed consent also has significant implications for medical trials of new medications.

Requirements of the professional

In the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...

 and countries such as Malaysia and Singapore
Singapore
Singapore , officially the Republic of Singapore, is a Southeast Asian city-state off the southern tip of the Malay Peninsula, north of the equator. An island country made up of 63 islands, it is separated from Malaysia by the Straits of Johor to its north and from Indonesia's Riau Islands by the...

, informed consent in medical procedures requires proof as to the standard of care to be expected as a recognised standard of acceptable professional practice (the Bolam Test
Bolam Test
Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 is an English tort law case that lays down the typical rule for assessing the appropriate standard of reasonable care in negligence cases involving skilled professionals : the Bolam test...

), that is, what risks would a medical professional usually disclose in the circumstances (see Loss of right in English law
Loss of right in English law
In the English law of tort, loss of right is a new heading of potential liability arising as a matter of policy to counteract limitations perceived in the more traditional rules of causation.-References:...

). Arguably, this is "sufficient consent" rather than "informed consent."

In the United States, Australia, and Canada, a more patient-centered approach is taken and this approach is usually what is meant by the phrase "informed consent." Informed consent in these jurisdictions requires that significant risks be disclosed, as well as risks which would be of particular importance to that patient. This approach combines an objective (the 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
Assault (tort)
In common law, assault is the tort of acting intentionally, that is with either general or specific intent, causing the reasonable apprehension of an immediate harmful or offensive contact. Because assault requires intent, it is considered an intentional tort, as opposed to a tort of negligence...

 or battery
Battery (tort)
At common law, battery is the tort of intentionally and voluntarily bringing about an unconsented harmful or offensive contact with a person or to something closely associated with them . Unlike assault, battery involves an actual contact...

. 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's 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
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...

 to have acted negligently. The council stated that the woman should have been informed of her condition, and allowed to make her own decision.

Competency of the patient

The ability to give informed consent will be 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, informed consent—from the patients or from their families—is not required. Rather, the medical practitioner must simply act in the patient's best interests in order to avoid negligence liability.

By contrast, 'minors
Minor (law)
In law, a minor is a person under a certain age — the age of majority — which legally demarcates childhood from adulthood; the age depends upon jurisdiction and application, but is typically 18...

' (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
Informed assent
The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.- Background :...

. 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
Gillick competence
Gillick competence is a term originating in England and is used in medical law to decide whether a child is able to consent to his or her own medical treatment, without the need for parental permission or knowledge....

’). In cases of incompetent minors, informed consent is usually required from the parent (rather than the 'best interests standard') although a parens patriae
Parens patriae
Parens patriae is Latin for "parent of the nation." In law, it refers to 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 or individual who is in need of protection...

 order may apply, allowing the court to dispense with parental consent in cases of refusal.

Abortion

In some U.S. State
U.S. state
A U.S. state is any one of the 50 federated states of the United States of America that share sovereignty with the federal government. Because of this shared sovereignty, an American is a citizen both of the federal entity and of his or her state of domicile. Four states use the official title of...

s, informed consent laws (sometimes called "Right To Know" laws) require that a woman seeking an elective abortion
Abortion
Abortion is defined as the termination of pregnancy by the removal or expulsion from the uterus of a fetus or embryo prior to viability. An abortion can occur spontaneously, in which case it is usually called a miscarriage, or it can be purposely induced...

 be given factual information by the abortion provider about her legal rights, alternatives to abortion (such as adoption), available public and private assistance, and medical facts (some of which are disputed—see fetal pain
Fetal pain
Neonatal perception is the study of the extent of somatosensory and other perceptual systems during pregnancy. In practical terms, this means the study of fetuses; none of the accepted indicators of perception are present in embryos....

), before the abortion is performed (usually 24 hours in advance of the abortion). Other countries with such laws (e.g. Germany
Germany
Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...

) require that the information giver not be affiliated with the abortion provider, to avoid giving an economic incentive for handing out faulty information.

Some informed consent laws have been criticized for allegedly using “loaded language in an apparently deliberate attempt to 'personify' the fetus,” but those critics acknowledge that abortion information provided pursuant to informed consent laws “most of the information in the materials about abortion comports with recent scientific findings and the principles of informed consent, some content is either misleading or altogether incorrect.”

Vaccines

Except for during clinical trials, there is no Federal requirement in the United States for providing informed consent regarding the administration of vaccines.
http://www.cdc.gov/vaccines/pubs/vis/vis-facts.htm

Sex

The question of whether informed consent needs to be formally given before sexual intercourse
Sexual intercourse
Sexual intercourse, also known as copulation or coitus, commonly refers to the act in which a male's penis enters a female's vagina for the purposes of sexual pleasure or reproduction. The entities may be of opposite sexes, or they may be hermaphroditic, as is the case with snails...

 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
Rape
Rape is a type of sexual assault usually involving sexual intercourse, which is initiated by one or more persons against another person without that person's consent. The act may be carried out by physical force, coercion, abuse of authority or with a person who is incapable of valid consent. The...

 and sexual assault
Sexual assault
Sexual assault is an assault of a sexual nature on another person, or any sexual act committed without consent. Although sexual assaults most frequently are by a man on a woman, it may involve any combination of two or more men, women and children....

 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. This is also an issue in rape fantasy
Rape fantasy
A rape fantasy or a ravishment is a sexual fantasy involving imagining or pretending being coerced or coercing another into sexual activity. In sexual role-play it involves acting out roles of coercive sex...

 enaction which is often discussed by a "ravishment community" of participants (a subset of the BDSM
BDSM
BDSM is an erotic preference and a form of sexual expression involving the consensual use of restraint, intense sensory stimulation, and fantasy power role-play. The compound acronym BDSM is derived from the terms bondage and discipline , dominance and submission , and sadism and masochism...

 community) who advocate extensive prior negotiation and planning.

While children may be able to give consent, a more complex question applies in terms of informed consent: whether children are developmentally
Developmental psychology
Developmental psychology, also known as human development, is the scientific study of systematic psychological changes, emotional changes, and perception changes that occur in human beings over the course of their life span. Originally concerned with infants and children, the field has expanded to...

 and otherwise able to give informed consent, in particular to an adult, bearing in mind power relationships, maturity, experience and mental development. For this and other reasons most states have an age of consent
Age of consent
While the phrase age of consent typically does not appear in legal statutes, when used in relation to sexual activity, the age of consent is the minimum age at which a person is considered to be legally competent to consent to sexual acts. The European Union calls it the legal age for sexual...

 under which a child is deemed unable to give consent. As evaluation of maturity
Sexual maturity
Sexual maturity is the age or stage when an organism can reproduce. It is sometimes considered synonymous with adulthood, though the two are distinct...

, mental maturity, child development
Child development
Child development stages describe theoretical milestones of child development. Many stage models of development have been proposed, used as working concepts and in some cases asserted as nativist theories....

, child communication, and child intelligence are further explored, this may be based on psychological and medical evaluation of status for sexual activity instead of chronological age
Ageing
Ageing or aging is the accumulation of changes in a person over time. Ageing in humans refers to a multidimensional process of physical, psychological, and social change. Some dimensions of ageing grow and expand over time, while others decline...

.

Animals are not usually considered able to give informed consent in a legal sense, and partly for this reason, but more usually due to concerns for morality, bestiality
Zoophilia
Zoophilia, from the Greek ζῷον and φιλία is the practice of sex between humans and non-human animals , or a preference or fixation on such practice...

 is illegal in many jurisdictions.

No-victim laws

It may not be legally possible to give consent to certain activities in certain jurisdictions; see the Operation Spanner
Operation Spanner
Operation Spanner was the name of an operation carried out by police in the United Kingdom city of Manchester in 1987, as a result of which a group of homosexuals were convicted of assault occasioning actual bodily harm for their involvement in consensual sadomasochism over a ten year period.The...

 case for an example of this in the UK which involved sadomasochistic activities such as branding. There are currently several legal challenges underway to address these issues of legality in several nations.

Research

In medical research, the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...

 set a base international standard in 1947, which continued to develop, for example in response to the ethical violation in the Tuskegee syphilis experiment. 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
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...

 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 (or should be 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 behavior, as in the Hawthorne Effect
Hawthorne effect
The Hawthorne effect is a form of reactivity whereby subjects improve or modify an aspect of their behavior being experimentally measured simply in response to the fact that they know they are being studied, not in response to any particular experimental manipulation.The term was coined in 1950 by...

: "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 behavior 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 make a determination.
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