Informed consent


Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research, to disclose a person's medical information, or to participate in high risk sporting and recreational activities.
Within the United States, definitions of informed consent vary, and the standard required is generally determined by the state. As of 2016, nearly half of the states adopted a reasonable patient standard, in which the informed consent process is viewed from the patient's perspective. These standards in medical contexts are formalized in the requirement for decision-making capacity and professional determinations in these contexts have legal authority. This requirement can be summarized in brief to presently include the following conditions, all of which must be met in order for one to qualify as possessing decision-making capacity:
  1. Choice, the ability to provide or evidence a decision.
  2. Understanding, the capacity to apprehend the relevant facts pertaining to the decision at issue.
  3. Appreciation, the ability of the patient to give informed consent with concern for, and belief in, the impact the relevant facts will have upon oneself.
  4. Reasoning, the mental acuity to make the relevant inferences from, and mental manipulations of, the information appreciated and understood to apply to the decision at hand.
Impairments to reasoning and judgment that may preclude informed consent include intellectual or emotional immaturity, high levels of stress such as post-traumatic stress disorder or a severe intellectual disability, severe mental disorder, intoxication, severe sleep deprivation, dementia, or coma.
Obtaining informed consent is [|not always required]. If an individual is considered unable to give informed consent, another person is generally authorized to give consent on the individual's behalf—for example, the parents or legal guardians of a child and conservators for the mentally disordered. Alternatively, the doctrine of implied consent permits treatment in limited cases, for example when an unconscious person will die without immediate intervention. Cases in which an individual is provided insufficient information to form a reasoned decision raise serious ethical issues. When these issues occur, or are anticipated to occur, in a clinical trial, they are subject to review by an ethics committee or institutional review board.
Informed consent is codified in both national and international law. 'Free consent' is a cognate term in the International Covenant on Civil and Political Rights, adopted in 1966 by the United Nations, and intended to be in force by 23 March 1976. Article 7 of the covenant prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject., the covenant has 173 parties and six more signatories without ratification.

Assessment

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. For example, if a doctor asks a patient to take their blood pressure, a patient may demonstrate consent by offering their arm for a blood pressure cuff. 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, not present.
  3. A person signs a legal release form for a medical procedure, and later feels he did not really consent. Unless he can show actual misinformation, the release is usually persuasive or conclusive in law, in that the clinician may rely legally upon it for consent. In formal circumstances, a written consent usually legally overrides later denial of informed consent .
  4. Informed consent in the U.S. can be overridden in emergency medical situations pursuant to 21CFR50.24, which was first brought to the general public's attention via the controversy surrounding the study of Polyheme.

    Valid elements

For an individual to give valid informed consent, three components must be present: disclosure, capacity and voluntariness.
  • Disclosure requires the researcher to supply each prospective subject with the information necessary to make an autonomous decision and also to ensure that the subject adequately understands the information provided. This latter requirement implies that a written consent form be written in lay language suited for the comprehension skills of subject population, as well as assessing the level of understanding through conversation.
  • Capacity pertains to the ability of the subject to both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision.
  • Voluntariness refers to the subject's right to freely exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence.

    Patient understanding

An often-overlooked aspect of valid informed consent is the patient's understanding of terminology and outcomes. The physician must explain the procedure, benefits, risks, and alternatives in words the patient can understand, as well as ensure that the patient does understand the information being relayed. The process of explanation is meant to ensure the patient has considered the options carefully and grasps the possible risks associated without feeling pressured or rushed to agree to the procedure. Exceptions to the typical consent process are only made during severe emergencies.

From children

As children often lack the decision-making ability or legal power 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 Pediatrics 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. Additionally, parents may not order the termination of a treatment that is required to keep a child alive, even if they feel it is in the best interest. Guardians are typically involved in the consent of children, however a number of doctrines have developed that allow children to receive health treatments without parental consent. For example, emancipated minors may consent to medical treatment, and minors can also consent in an emergency. Information provided to parents/guardians, and to children themselves, as part of clinical research is often written in ways that make them difficult to understand.

Waiver of requirement

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 Defense if a research project would:
  1. directly benefit subjects
  2. advance the development of a medical product necessary to the military and
  3. be carried out under all laws and regulations including those pertinent to the FDA.
While informed consent is a basic right and should be carried out effectively, if a patient is incapacitated due to injury or illness, it is still important that patients benefit from emergency experimentation. The Food and Drug Administration and the Department of Health and Human Services 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 or an emergency exception from informed consent.