Informed consent is defined as the permission a patient gives a doctor to perform a test or procedure after the doctor has fully explained the purpose. Learn more.
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What Is Informed Consent? Components of Informed Consent. Decision-making capacity is often referred to by the legal term competency. It is one of the most important components of informed consent. Decision-making capacity is not black and white.
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You may have the capacity to make some decisions, but not others. If you are not able to do all of the components, family members, court-appointed guardians, or others as determined by state law may act as "surrogate decision-makers" and make decisions for you. To have decision-making capacity does not mean that you, as the patient, will always make "good" decisions, or decisions that your doctor agrees with. Likewise, making a "bad" decision does not mean that you, as patient, are "incompetent" or do not have decision-making capacity. Decision-making capacity, or competency, simply means that you can understand and explain the options, their implications, and give a rational reason why you would decide on a particular option instead of the others.
In order for you to give your informed consent for treatment or tests, the doctor or health care provider must give or disclose to you enough information so that you can make an informed decision. It is not necessary or expected that you would receive every detail of the test, treatment, or procedure. You need only the information that would be expected by a reasonable person to make an intelligent decision. This information should include the risks and likelihood or probability of each of the risks, and the benefits, and likelihood or probability of benefit.
Any questions you have should be fully explained, in language and terminology that you can understand. For an individual to give valid informed consent, three components must be present: 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. 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.
Informed consent is a technical term first used by attorney, Paul G. Gebhard, in a medical malpractice United States court case in These practices are part of what constitutes informed consent, and their history is the history of informed consent. Historians cite a series of medical guidelines to trace the history of informed consent in medical practice. It advises that physicians conceal most information from patients to give the patients the best care.
Henri de Mondeville , a French surgeon who in the 14th century, wrote about medical practice. He traced his ideas to the Hippocratic Oath.
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Benjamin Rush was an 18th-century United States physician who was influenced by the Age of Enlightenment cultural movement. He recommended that doctors educate the public and respect a patient's informed decision to accept therapy. Thomas Percival was a British physician who published a book called Medical Ethics in Worthington Hooker was an American physician who in published Physician and Patient.
Historians cite a series of human subject research experiments to trace the history of informed consent in research. 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.
Tearoom Trade is the name of a book by American psychologist Laud Humphreys. In it he describes his research into male homosexual acts. The Milgram experiment is the name of a 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. 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.
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.
What Is Informed Consent?
Until 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 , 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. 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. 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'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: 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. To capture and manage informed consents, hospital management systems typically use paper-based consent forms which are scanned and stored in a document handling system after obtaining the necessary signatures.
Hospital systems and research organizations are adopting an electronic way of capturing informed consents to enable indexing, to improve comprehension, search and retrieval of consent data, thus enhancing the ability to honor to patient intent and identify willing research participants. 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. In other jurisdictions e. 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. Treatment refusal may, however, be an indication that it is necessary to pause to discuss further the patient's beliefs and understanding about the decision, as well as your own.
You should do what you can to catch a patient in a lucid state - even lightening up on the medications if necessary and safe - in order to include her in the decision making process. Delirious patients have waxing and waning abilities to understand information. However, if a careful assessment is done and documented at each contact, and during lucid periods the patient consistently and persistently makes the same decision over time, this may constitute adequate decisional capacity for the question at hand.
There is a specific hierarchy of appropriate decision makers defined by state law also see the DNR topic page. If no appropriate surrogate decision maker is available, the physicians are expected to act in the best interest of the patient until a surrogate is found or appointed. In rare circumstances, when no surrogate can be identified, a guardian ad litem may have to be appointed by the court. Confer with social work and risk management if you have trouble finding a legal surrogate for the patient. Children do not have the decision-making capacity to provide informed consent.
Since consent, by definition, is given for an intervention for oneself, parents cannot provide informed consent on behalf of their children. Instead they can provide informed permission for treatment. For older children and adolescents, assent should always be sought in addition to the authorization of legal surrogates. Adolescents and mature minors are legally and ethically authorized to provide informed consent if they are emancipated, and in many states, including Washington, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse.
The primary responsibility of the physician is the well-being of the child. Therefore, if the parental decision places the child at risk of harm then further action may be indicated. When there are differences in opinion between the parents and physicians that cannot be resolved ethics consultation may be pursued, and legal avenues may be pursued when all other means have failed. Children should be included in decision-making at a developmentally appropriate level and assent should be sought when possible.
See Parental Decision Making.
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The patient's consent should only be "presumed," rather than obtained, in emergency situations when the patient is unconscious or incompetent and no surrogate decision maker is available, and the emergency interventions will prevent death or disability. In general, the patient's presence in the hospital ward, ICU or clinic does not represent implied consent to all treatment and procedures. The patient's wishes and values may be quite different from the values of the physician.
While the principle of respect for person obligates you to do your best to include the patient in the health care decisions that affect her life and body, the principle of beneficence may require you to act on the patient's behalf when her life is at stake. New England Journal of Medicine.
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Case 1 Case 2 Core clerkship material for: Write Us Case 1 Case 2. Opportunities to "consent" a patient abound on the wards. What is informed consent? What are the elements of full informed consent? It is generally accepted that informed consent includes a discussion of the following elements: How much information is considered "adequate"?