informed consent

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Informed consent is a phrase often used in law to indicate that the consent 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, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease, or being in a coma. 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 guardians of a child (though in this circumstance the child may be required to proved informed assent) 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 in medical research are anticipated and prevented by an ethics committee or Institutional Review Board.

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 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), individuals may not consent to injuries being inflicted upon them, and so a person practicing sadism and masochism upon a consenting partner may be deemed to have caused actual bodily harm 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'.
6. 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 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.

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 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 and countries such as Malaysia and Singapore, 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), 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."

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 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's being said, rather than what is said, which is of relatively more importance in typical "Western" countries.^[1]

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.

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, 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 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.

Abortion

In some U.S. States, informed consent laws (sometimes called "Right To Know" laws) require that a woman seeking an elective abortion 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), before the abortion is performed (usually 24 hours in advance of the abortion). Other countries with such laws (e.g. Germany) require that the information giver not be affiliated with the abortion provider, to avoid giving an economic incentive for handing out faulty information.^{[citation needed]}

Some informed consent laws have been criticized for allegedly using “loaded language in an apparently deliberate attempt to 'personify' the fetus,”^[2] 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.”^[3]

Vaccines

Except for during clinical trials, there is no Federal requirement in the United States for providing informed consent regarding the administration of vaccines. [1]

Sex

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The question of whether informed consent needs to be formally given before sexual intercourse or other sexual activity, and whether this consent can be withdrawn at any time during the act, is an issue that is currently being discussed in the United States regarding rape and sexual assault legislation. For example, people who perform sexual acts on sleeping people are not given consent unless the initiator have given prior informed consent to the act within a reasonable recency,^{[citation needed]} 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 enaction which is often discussed by a "ravishment community" of participants (a subset of the BDSM 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 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 under which a child is deemed unable to give consent. As evaluation of maturity, mental maturity, child development, 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.

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 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 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.^{[verification needed]}

Research

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 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 were imported into the ethical guidelines for the social sciences, informed consent became a common part of the research procedure ^[4]. 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 behavior, 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." ^[5] 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^[6] 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 ^[7]. Researchers often consult with an Ethics Committee or institutional review board to render a decision.

See also

Footnotes

1. ^ Too Much Information: Informed Consent in Cultural Context. By Joseph J. Fins and Pablo Rodriguez del Pozo. Medscape 07/18/2011
2. ^ 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.
3. ^ 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.
4. ^ Homan, R. (1991). The ethics of social research. London; New York: Longman.
5. ^ Levitt, S. D., & List, J. A. (2007). What Do Laboratory Experiments Measuring Social Preferences Reveal about the Real World? Journal of Economic Perspectives, 21(2), 153-174: p. 168
6. ^ List, J. A. (2008). Informed Consent in Social Science. Science, 322(5902), 672. doi: 10.1126/science.322.5902.672a
7. ^ Levitt, S. D., & List, J. A. (2009). Field experiments in economics: The past, the present, and the future. European Economic Review, 53(1), 1-18. doi: 10.1016/j.euroecorev.2008.12.001

Bibliography