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The concept of informed consent originated with the recognition of individuals' rights to freedom and human dignity. People reduced to conditions of slavery were subjected without their consent to interferences with their freedom. Children and other dependent persons may also be treated in ways to which they do not consent, but those responsible for their care, such as parents or other legal guardians, are bound by ethical and legal limits in the procedures they can authorize.

ETHICAL ORIGIN

The ethical principle of respect for autonomy requires that people capable of responsible independence should not be subjected to others' interventions with their bodily freedom or comfort unless they have consented in advance. Similarly, autonomous people who consent to a procedure that affects them should not be liable to another person's veto or prohibition because the other person considers the procedure to be not in their best interests.

Consent has particular significance concerning health care, because medical or other health care interventions can affect persons' bodies, comfort, and lives in very invasive and irreversible or long-lasting ways. public health initiatives designed to protect or promote the health of individuals as members of population groups or residents of communities can also be intrusive and long-lasting, but consent is often given to these through political or democratic means, such as by legislation permitting inspection of health records to find the incidence and prevalence of preventable diseases. However, some public health strategies, such as vaccination programs, affect individuals so personally that their own consent, or that of their legal guardians, is required before procedures can be undertaken on them.

CONSENT IN LAW

In law, the physical touching of a person's body without authorization or consent is an offense, often called assault in criminal law and battery in civil law directed toward compensation. The person's consent to the touching neutralizes or removes the offense. Consent is an important concept in medical and related health care. Health care personnel act unethically, unprofessionally, and illegally if they directly interfere with a person's body without consent by undertaking unauthorized procedures on the person, exceeding consent the person has given, or performing procedures different from those the person has approved. Consent is often spoken in deliberate language, and for more invasive procedures such as surgery and for research procedures may have to be given or confirmed in writing. For minor procedures, however, consent may be implied by a person's behavior, for example, by consciously permitting an intervention such as vaccination or blood-drawing to occur. Further, because in law "peril invites rescue," emergency interventions when life or enduring health are endangered are considered to have implied consent if they are reasonable under the circumstances.

INFORMED CONSENT

Law and ethics sometimes require more than compliance alone to render an intervention acceptable. The consent must be adequately informed for it to satisfy legal and ethical standards. In medical care law, consent continues to remove liability for assault and battery, but the physician or other care provider has a legal duty to ensure that the person whose consent is required receives information that is material to the choice whether or not to consent. Reasonable efforts must also be made to ensure that the person understands the information to his or her satisfaction. Failure to provide adequate information to a person deciding whether to consent to a proposed intervention or to refuse it constitutes legal negligence when injury results, often called malpractice. This is so even when no assault and battery occurs because the person refuses treatment. "Informed consent" includes informed dissent and is better understood as informed choice or informed decision-making.

ELEMENTS OF INFORMED CONSENT

Whether or not to consent to proposed medical treatment is not itself a medical decision. It is a personal decision that someone makes when adequately informed of medical and nonmedical options and their relevant implications. Health care providers do not have to explain all the physiological, biological, pharmaceutical, and other processes that constitute the procedures among which the person may choose. But they must distill the elements the person will want to understand in order to exercise judgment about what will best serve his or her interests and preserve or promote personal values and goals. For instance, the effect of prospective treatments on capacity to work is often important. A person intending to have a child must understand the impact of treatment options on future fertility and child-rearing. A person who devoutly feels that life must be preserved to the last possible moment must be informed whether a treatment will lead to or risk earlier loss, and a person fearful of pain should be informed whether and how future comfort can be provided.

Accordingly, information must focus on the sort of individual the decision-maker is. This cannot usually be known in intimate detail and must initially be based on a representative reasonable or prudent person in the decision-maker's circumstances. Information may be amplified in light of the person's response, particularly the questions the person asks on initial receipt of information. Informing is often best regarded not as a single event but rather as a continuing process that begins with the provider asking the decision-maker questions about lifestyle, preferences, and intentions in order to direct information toward his or her needs, give information and explanation to serve such needs, answer uncertainties and questions the decision-maker has, and supply material information throughout the course of treatment.

Items to be addressed usually include:

1. Implications of going without treatment and of treatment being postponed for different periods
2. The range of accessible diagnostic or treatment options
3. The extent of public or private insurance coverage for each option and costs patients would personally incur
4. The benefits each option offers
5. The possibilities of diagnostic false results or treatment failures
6. The risks and discomforts of diagnostic or treatment options even when successful
7. Short-term injuries that diagnostic or treatment failures may cause
8. Long-term effects of diagnostic or treatment options, favorable and unfavorable, separating probabilities from possibilities

The more invasive or risk-laden a procedure, the more information should be provided. For the low-risk procedure of blood-sampling, for instance, disclosure of liability to sudden pain, bruising, and easily treated infection is usually adequate in itself, with greater information given about why sampling is proposed and what it may show.

COLLECTIVE OR GROUP CONSENT

Consent is usually requested from individuals proposed to be physically affected by health care procedures, but some decisions justify collective or group consent, such as fluoridation of a municipal drinking water supply. Information is made available, for instance, to democratically elected representatives authorized to make decisions on behalf of local residents. Community hospitals' decisions on what services to offer and what types of equipment to purchase are made by hospitals' boards of governors or trustees. Governors or trustees may be appointed by governments, but are often elected from among residents of areas the hospitals serve who choose to become members of the hospital associations. The decisions affect the water local residents consume and the health services they may receive, but individual consent is replaced by democratic or otherwise political consent. In some communities, hereditary or traditional leaders who make decisions with the permission of those they govern can consent to public health measures. Hereditary or traditional authority to make decisions affecting such groups is legitimate when groups' members identify themselves with each other and acknowledge an internal group structure and hierarchy that appoints chiefs or leaders. However, consent from such leaders to public health programs does not compel individuals to give their consent to personally invasive procedures such as vaccination. When group members do not possess a sense of community with each other but simply meet criteria of a particular study, such as on the effects of giving different dietary combinations to hospitalized single or widowed women aged 65 to 75, there is no representative group member with authority to make decisions on behalf of others.

REFUSAL OF INFORMATION

Competent persons have the autonomous right to consent without information. They have the right, not the duty, to receive information. They must state their preferences for overall care, but they may forgo detailed information that health-service providers prepare to offer. Providers incur no liability for risks that patients freely assume by refusal of offered information.

BERNARD M. DICKENS

(SEE ALSO: Autonomy; Beneficence; Codes of Conduct and Ethics Guidelines; Ethics of Public Health; Nonmaleficence; Paternalism; Public Health and the Law)