informed consent

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consent

 [kon-sent´]
in law, voluntary agreement with an action proposed by another. Consent is an act of reason; the person giving consent must be of sufficient mental capacity and be in possession of all essential information in order to give valid consent. A person who is an infant, is mentally incompetent, or is under the influence of drugs is incapable of giving consent. Consent must also be free of coercion or fraud.
informed consent consent of a patient or other recipient of services based on the principles of autonomy and privacy; this has become the requirement at the center of morally valid decision making in health care and research. Seven criteria define informed consent: (1) competence to understand and to decide, (2) voluntary decision making, (3) disclosure of material information, (4) recommendation of a plan, (5) comprehension of terms (3) and (4), (6) decision in favor of a plan, and (7) authorization of the plan. A person gives informed consent only if all of these criteria are met. If all of the criteria are met except that the person rejects the plan, that person makes an informed refusal.

In nonemergency situations, written informed consent is generally required before many medical procedures, such as surgery, including biopsies, endoscopy, and radiographic procedures involving catheterization. The physician must explain to the patient the diagnosis, the nature of the procedure, including the risks involved and the chances of success, and the alternative methods of treatment that are available. Nurses or other members of the health care team may be involved in filling out the consent form and witnessing the signature of the patient or the parent or guardian, if the patient is a minor. In medical research, the patient must be informed that the procedure is experimental and that consent can be withdrawn at any time. In addition, the person signing the consent form must be informed of the risks and benefits of the experimental procedure and of alternative treatments.

in·formed con·sent

(in-fōrmd' kŏn-sent'),
Voluntary agreement given by a person or a patients' responsible proxy (for example, a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of informed consent are that the subject has both knowledge and comprehension, that consent is freely given without duress or undue influence, and that the right of withdrawal at any time is clearly communicated to the patient. Other aspects of informed consent in the context of epidemiologic and biomedical research, and criteria to be met in obtaining it, are specified in International Guidelines for Ethical Review of Epidemiologic Studies (Geneva: CIOMS/WHO 1991) and International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS/WHO 1993).

informed consent

n.
Consent by a person to undergo a medical procedure, participate in a clinical trial, or be counseled by a professional such as a social worker or lawyer, after receiving all material information regarding risks, benefits, and alternatives.

informed consent

EBM
In a clinical trial, an ongoing (in contrast to the “one-off” informed consents of non-trial-related clinical practice) interactive process that provides a trial participant (subject) with explanations to help him or her make educated decisions about whether to begin or continue participating in a trial.

Under 21 CFR 50.20, no informed consent form may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence."

informed consent

Medtalk A voluntary, legally documented agreement by the Pt to allow performance of a specific diagnostic, therapeutic, or research procedure. See Emergency doctrine, Informed decision, Malpractice, Therapeutic privilege doctrine.

in·form·ed con·sent

(in-fōrmd kŏn-sent)
Voluntary agreement given by a person or a responsible proxy (e.g., a parent) for participation in a study, immunization program, or treatment regimen, after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of informed consent are that the subject has both knowledge and comprehension, that consent is freely given without duress or undue influence, and that the right of withdrawal from the entity at any time is clearly communciated to the subject.

informed consent

The formal agreement to a surgical or medical procedure by a patient who has been adequately briefed on what is proposed and who is fully aware of all reasonably possible side effects or complications.

in·form·ed con·sent

(in-fōrmd kŏn-sent)
Voluntary agreement given by a patient or a patient's designated responsible proxy (e.g., a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, or other medical or dental undertaking after being informed of the purpose, methods, procedures, benefits, and risks.
References in periodicals archive ?
Measures, including consideration of their feasibility, practicality and costs, to support compliance with prior informed consent of the Contracting Party providing genetic resources and mutually agreed terms on which access was granted in Contracting Parties with users of such resources under their jurisdiction.
The EU and its member states should take effective measures to ensure that genetic resources have been acquired in accordance with prior informed consent and on mutually agreed terms, in accordance with provider countries' national ABS legislation, as required by the ABS Protocol.
The CBD also requires that any company or country collecting natural products obtain the prior informed consent of the source country.
(PMDC) - began mining operations "without the free and prior informed consent (FPIC) of the affected cultural community and indigenous peoples as required by law."
The governing bodies of three of the United Nations' main conventions in terms of the environment - the Basel Convention on the control of transboundary movements of hazardous wastes and their disposal, the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade and the Stockholm Convention on persistent organic pollutants or POPs - were meeting in Bali (Indonesia), on 22-26 February, with the aim of finding synergies and rationalising their administrative practices to the greatest extent possible.
The regulation transposing into Community law the Rotterdam Convention on the prior informed consent procedure for the trade of hazardous chemicals was formally adopted, on 5 June, by the Environment Council.
Another three hazardous substances - chrysotile asbestos, endosulfan and tributyl tin compounds - could by the end of the year be placed under the Prior Informed Consent (PIC) procedure applicable to international trade in certain hazardous chemicals and pesticides.
The regulation that transposes into EU law the Rotterdam Convention on the Prior Informed Consent Procedure for trade in hazardous products was adopted by the European Parliament on 15 January.

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