informed consent

Definition

Informed consent is a legal document in all 50 states. It is an agreement for a proposed medical treatment or non-treatment, or for a proposed invasive procedure. It requires physicians to disclose the benefits, risks, and alternatives to the proposed treatment, non-treatment, or procedure. It is the method by which fully informed, rational persons may be involved in choices about their health care.

Description

Informed consent stems from the legal and ethical right an individual has to decide what is done to his or her body, and from the physician's ethical duty to make sure that individuals are involved in decisions about their own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the individual must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.

It is critical that a patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the medical record. A physician may, at his or her discretion, appoint another member of the health care team to obtain the patient's signature on the consent form, with the assurance that the physician has satisfied the requirements of informed consent.

The law requires that a reasonable physician/patient standard be applied when determining how much information is considered adequate when discussing a procedure or treatment with the patient. There are three approaches to making this discussion: what the typical physician would say about the intervention (the reasonable physician standard); what an average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what a patient would need to know and understand to make a decision that is informed (the subjective standard).

There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians' requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible.

Today, all of the 50 United States have legislation that delineates the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard (what an average patient would need to know to be an informed participant in the decision). This approach ensures that a doctor fulfills all professional responsibilities and provides the best care possible and that patients have choices in decisions about their health care. However, the patient's competence in making a decision is considered. This points to the issue of the patient's mental capacity. Anyone suffering from an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety. It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient's understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.

Although the law requires a formal presentation of the procedure or treatment to the patient, physicians do express doubt as to the wisdom of this. Some believe that informing patients of the risks of treatment might scare them into refusing it, even when the risks of non-treatment are even greater. But patients might have a different view. Without the complete story, for example, a patient might consent to beginning a particular course of chemotherapy. Convinced by the pressures from a pharmaceutical company, it is conceivable that a doctor will use an agent less effective than a newer treatment. By withholding information about treatment alternatives, the physician may be denying the patient a choice and, worse, perhaps a chance of an extended life of greater quality.

Undeniably, physicians in surgery, anesthesia, oncology, infectious disease, and other specialties are faced with issues regarding informed consent. As the federal government takes a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled, more and more health care providers must become educated in what must be conveyed to patients. This is emphasized by the report of a case in which a federal court (Hutchinson vs. United States [91 F2d 560 (9th Cir. 1990)]) ruled in favor of the physician, despite his failure to advise his asthmatic patient, for whom he had prescribed the steroid, prednisone, of the drug's well-known risk of developing aseptic necrosis (bone death), which did occur. The practitioner neglected to inform the patient that there were other drugs available with much less serious side effects that could have treated the asthma. However, a higher appellate court reversed the ruling and found the physician guilty. Apparently, the patient had used more conservative drugs in the past with good results. The court believed that if the physician had merely advised the patient of the more serious side effects of prednisone and offered the patient more conservative treatment, the physician would have avoided liability.

Nursing professionals have a greater role than they might believe in evaluating whether or not consent is informed. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing the details. Rather, the role is to be the patient's advocate, to protect the patient's dignity, to identify any fears, and to determine the patient's degree of comprehension and approval of care to be received. Each patient is an individual, and each one will have a different and unique response depending on his or her personality, level of education, emotions, and cognitive status. If a patient can restate the information that has been imparted, then that will help to confirm that he or she has received enough information and has understood it. The nurse is obligated to report any doubts about the patient's understanding regarding what has been said or any concerns about his or her capacity to make decisions.

Results

The result of informed consent is greater safety and protection for patients, physicians, and society.

See also Do not resuscitate order; Patient confidentiality; Patient rights.

Resources

Books

Berg, J. W., C. W. Lidz, P. S. Appelbaum, and L. S. Parker. Informed Consent: Legal Theory and Clinical Practice, 2nd edition. London: Oxford University Press, 2001.

Donnelly, Mary. Consent. Crosses Green, Ireland: Cork University Press, 2002.

Jonsen, A. R., W. J. Winslade, and M. Siegler. Clinical Ethics:A Practical Approach to Ethical Decisions in Clinical Medicine, 5th edition. New York: McGraw-Hill, 2002.

Radford, Roger. Informed Consent. Bangor, Maine: Booklocker. com, 2002.

Periodicals

Hanson, L. R. "Informed Consent and the Scope of a Physician's Duty of Disclosure." Specialty Law Digest: Health Care Law 285 (2003): 9–34.

Karpman, A. "Informed Consent: Does the First Amendment Protect a Patient's Right to Choose Alternative Treatment?" New York Law School Journal of Human Rights 16, no. 3 (2000): 933–957.

Luce, J. M. "Is the Concept of Informed Consent Applicable to Clinical Research Involving Critically Ill Patients?" Critical Care Medicine 31, no. 3 (2003): S153–S160.

Marr, S. "Protect Your Practice: Informed Consent." PlasticSurgical Nursing 22, no. 4 (2002): 180–197.

Meadows, M. "Drug Research and Children." FDA Consumer 37, no. 1 (2003): 12–17.

Organizations

American Academy of Family Physicians. 11400 Tomahawk Creek Parkway, Leawood, KS 66211-2672. (913) 906-6000. fp@aafp.org. http://www.aafp.org.

American Bar Association. 750 N Lake Shore Drive, Chicago, IL 60611. 312-988-5000. http://www.abanet.org/home.html.

American College of Physicians. 190 N Independence Mall West, Philadelphia, PA 19106-1572. (800) 523-1546, x2600, or (215) 351-2600. http://www.acponline.org.

American Medical Association. 515 N. State Street, Chicago, IL 60610. 312) 464-5000. http://www.ama-assn.org.

Other

American Academy of Pediatrics. [cited March 23, 2003]. http://www.aap.org/policy/00662.html.

Food and Drug Administration. [cited March 23, 2003]. http://www.fda.gov/opacom/morechoices/fed996.html.

Office for Protection from Research Risks, Department of Health and Human Services. [cited March 23, 2003]. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm.

University of Washington School of Medicine. [cited March 23, 2003]. http://eduserv.hscer.washington.edu/bioethics/topics/consent.html.

— L. Fleming Fallon Jr., MD,DrPH

An agreement by a patient, verbal or written, after being told in sufficient detail of possible risks, to have a procedure performed.

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.

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

Bibliography

Beauchamp, T. L., and Childress, J. F. (1994). Principles of Biomedical Ethics. Oxford: Oxford University Press.

Faden, R. R., and Beauchamp, T. L. (1986). A History and Theory of Informed Consent. Oxford: Oxford University Press.

Giesen, D. (1988). International Medical Malpractice Law. Dordrecht: Nijhoff.

Katz, J. (1984). The Silent World of Doctor and Patient. New York: Free Press.

Mason, J. K., and McCall Smith, R. A. (1999). Law and Medical Ethics. London: Butterworths.

Rozovsky, F. A. (1990). Consent to Treatment: A Practical Guide. Boston: Little, Brown.

— BERNARD M. DICKENS

Assent to permit an occurrence, such as surgery, that is based on a complete disclosure of facts needed to make the decision intelligently, such as knowledge of the risks entailed or alternatives.

The name for a fundamental principle of law that a physician has a duty to reveal what a reasonably prudent physician in the medical community employing reasonable care would reveal to a patient as to whatever reasonably foreseeable risks of harm might result from a proposed course of treatment. This disclosure must be afforded so that a patient — exercising ordinary care for his or her own welfare and confronted with a choice of undergoing the proposed treatment, alternative treatment, or none at all — can intelligently exercise judgment by reasonably balancing the probable risks against the probable benefits.

"Informed Consent" redirects here. For the House episode, see Informed Consent (House). For the website, see Informed Consent (website).

Tort law

Part of the common law series

Intentional torts

Assault · Battery False imprisonment Intentional infliction of emotional distress (IIED)

Property torts

Trespass (land · chattels) Conversion Detinue · Replevin · Trover

Defenses

Consent · Necessity Defense of self · of others · of property

Negligence

Duty of care · Standard of care Proximate cause · Res ipsa loquitur Calculus of negligence Rescue doctrine · Duty to rescue

Specific types Negligent infliction of emotional distress (NIED) Employment-related · Entrustment Malpractice (legal · medical)

Liability torts

Product liability Ultrahazardous activity

Nuisance

Public nuisance Rylands v. Fletcher

Dignitary torts

Defamation · Invasion of privacy False light · Breach of confidence Abuse of process Malicious prosecution Alienation of affections · Seduction

Economic torts

Fraud · Tortious interference Conspiracy · Restraint of trade

Liability, defences, remedies

Comparative / contributory negligence Last clear chance · Eggshell skull Vicarious liability · Volenti non fit injuria Ex turpi causa non oritur actio Neutral reportage · Damages Injunction · Torts and conflict of laws

Duty to visitors

Trespassers · Licensees · Invitees Attractive nuisance

Other common law areas

Contracts · Criminal law · Evidence Property · Wills, trusts and estates

Portals

Law

v • d • e

Informed consent is a legal condition whereby a person can be said to have given consent 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 judgement which would make it impossible for someone to give informed consent include such factors 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 cannot legally 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 and caregivers for the mentally ill. However, if a severely injured person is brought to hospital in an unconscious state and no-one is available to give informed consent, doctors will give whatever treatment is necessary to save their life (according to the Hippocratic oath), which might involve major surgery, e.g., amputation.

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.

Contents 1 Assessment of consent 2 Surgery 2.1 Competency 2.2 Abortion 3 Sex 4 No-victim laws 5 Research 6 See also 7 References 8 External links

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.

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.

Surgery

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).

In the United Kingdom and countries such as Malaysia and Singapore, informed consent 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).

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.

The doctrine of informed consent also has significant implications for medical trials of new medications.

Competency

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' (which may be defined differently in different jurisdictions) are generally presumed incompetent to consent. 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.

Sex

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, 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 (although advocates and some ethologists argue they have the capability to agree and strongly solicit such activity), 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]}

Further information: Victimless crime

Research

Informed consent is also important in social research. For example in survey research, people need to give informed consent before they participate in the survey. In medical research the Nuremberg Code has set a base standard since 1947, and most research proposals are reviewed by ethics committees in the 21st century.

See also

• World Medical Association
• Human experimentation
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Declaration of Geneva
• Declaration of Helsinki
• Belmont Report
• Safe, sane and consensual
• Consent (BDSM)
• Consent (criminal)
• Consensual crime
• Parental consent
• Minors and abortion
• Informed refusal

References

This article includes a list of references, related reading or external links, but its sources remain unclear because it lacks inline citations. Please improve this article by introducing more precise citations where appropriate. (July 2007)

• Atkinson, J. (2006) Private and Public Protection: Civil Mental Health Legislation, Edinburgh, Dunedin Academic Press
• Druml C., Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive, Curr Opin Crit Care. 2004 Dec;10(6):570-3.
• Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, & Saks ER, Assessing decisional capacity for clinical research or treatment: A review of instruments. Am J Psychiatry, 163(8):1323-1334.
• Fisher, JA., Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry, Kennedy Institute of Ethics Journal. 2006; 16(3): 251-268.
• Holmes-Rovner M, Wills CE., Improving informed consent: insights from behavioral decision research, Med Care. 2002 Sep;40 (9 Suppl):V30-8.
• Solomon RC., Ethical issues in medical malpractice, Emerg Med Clin North Am. 2006 Aug;24(3):733-47.
• Wang CE, Huch MH., Protecting human research subjects: an international perspective, Nurs Sci Q. 2000 Oct;13(4):293-8.
• Informed Consent: Legal Theory and Clinical Practice by Jessica W. Berg, Paul S. Appelbaum, Lisa S. Parker, and Charles W. Lidz, Oxford University Press, 2001
• A History and Theory of Informed Consent by Ruth Faden and Thomas Beauchamp

External links

• Informed Consent (University of Washington School of Medicine)
• A Guide to Understanding Informed Consent (National Cancer Institute, USA)
• Informed Consent and Clinical Research(Johns Hopkins University)

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