informed consent


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Related to informed consent: Informed Consent Form

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 In medical research, the patient must be informed that the procedure is experimental and that consent can be withdrawn at any time.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

Etymology: L, informare, to give form, consentire, to sense
permission obtained from a patient to perform a specific test or procedure. Informed consent is required before most invasive procedures are performed and before a patient is admitted to a research study. The document used must be written in a language understood by the patient and be dated and signed by the patient and at least one witness. Signed consent should be obtained by the person performing the procedure. Included in the document are clear, rational statements that describe the procedure or test. Also required is a statement that care will not be withheld if the patient does not consent. Informed consent is voluntary. By law, informed consent must be obtained more than a given number of days or hours before certain procedures, including therapeutic abortion and sterilization, and must always be obtained when the patient is fully competent. An individual must be of a certain legal age to give consent; laws vary from state to state. Compare implied consent.

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.

consent

permission granted by an adult patient (or the parent/carer) for examination or treatment; the patient should be previously informed of the nature, risks and benefits of the proposed procedure and given opportunity to seek further information from the clinician or another source in order to grant permission to the procedure freely and without duress or persuasion; consent to treatment can be implied (i.e. patient has sought treatment), verbal (i.e. patient has listened to the explanation of indications, risks and benefits of proposed procedure and has given verbal consent) or in writing by the patient, who signs and keeps a copy of signed consent form (i.e. a written document delineating the nature, risks and benefits of the proposed procedure); a copy of the signed consent must be retained within the case notes; the exact age at which a non-adult patient (i.e. a patient aged <18 years of age) can give consent is not absolutely clear (see age of consent)
  • informed consent rational consent to a treatment based on the facts provided

informed consent,

n 1. an aspect of research in which the consent of the subject is obtained and the subject is informed of possible risks and benefits from participating in the research.
2. consent to medical procedures/treatment given by a patient after the potential risks, hazards, and benefits of the treatment have been explained.

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.

informed consent,

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

consent

in law, voluntary agreement with an action proposed by another, e.g. agreement to treat, to euthanatize. Consent is an act of reason so that the person consenting must be sane and of sufficient age to be capable of giving consent. Written consent is an agreement in writing.

informed consent
agreement to a proposition when the consenting person is in possession of all of the facts relevant to the decision. In the eyes of the law the consent of a client to a surgical operation, to a financial expenditure, to euthanasia carries no authority unless the client is fully informed about what is to be done and what the alternatives are. If this is not done the client is entitled to sue for damages if the outcome is unsatisfactory.
References in periodicals archive ?
The informed consent process is designed as a mechanism for the participant to protect themselves.
The US Supreme Court recently defined Informed Consent as a protected rightif affirmatively asserted or it is waived (Missouri v.
An individual authorized to practice medicine and surgery or osteopathic medicine and surgery may use alternative medical treatments if the individual has provided the information necessary to obtain informed consent from the patient and the treatment meets the standards enforced by the state medical board pursuant to section 4731.
As a consequence of researchers ignoring participants' human rights New Zealand guidelines on informed consent have been developed.
A lawyer shall not reveal information relating to representation of a client except as stated in subdivisions (b), (c), and (d), unless the client gives informed consent.
25) Refresher doctors already possess licenses to practice and are legally competent to fulfill the obligation of informing a patient, however, because they do not have employment contracts with the training hospitals, they should not be independently responsible for seeking informed consent from patients.
Informed consent was obtained from all participants.
The Informed Consent Form is a very critical step in the study trial process that involved human subjects and may well serve as a veritable source of maintaining compliance with stipulated regulations.
The ophthalmologist argued the ectasia did not result from any action or inaction on his part, however, a jury awarded the patient $875,000 in damages, contending the ophthalmologist negligently performed surgery without informed consent.
Numerous services directed toward aging consumers require some form of informed consent prior to or in the process of service being administered.
The FDAAA additionally requires FDA to update its informed consent regulations to require inclusion in the informed consent documents and processes for applicable clinical trials a statement that information about the trial will be posted on www.
It is apparent that, as a field which constitutes a building block in a larger process, there is some confusion among radiographers about informed consent.