Consent, informed consent and the consent form.
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Obtaining informed consent for clinical investigations represents a major legal, ethical, and moral consideration in human experimentation. Mechanisms for informing the patient vary widely, and usually no system exists to confirm the degree of information retained by the patient. A Veterans Administration Cooperative Study, begun in 1975, has used a videotape information package in addition to a standard written consent form to ensure uniformity. Each presentation was followed by a questionnaire to assess the amount of material learned before attempting randomization. Repeated showings were occasionally necessary and did not affect the rate of randomization. A videotape presentation, especially in cooperative studies, ensures uniformity, makes allowance for varying educational levels of patients, and provides documentation of the degree of informed consent.
Informed consent has special relevance for patients seeking fertility control services who are not ill in the usual sense. Genuine informed consent requirements should not be confused with spurious ones induced by political pressure.
There is a growing demand for more patient autonomy in the doctor-patient relationship, and legal reformers believe that an expanded dodctrine of informed consent is the key to change. Informed consent is meant to force the doctor to give the patient the knowledge that will make his an equal bargaining partner. However, most evidence demonstrates that the majority of patients do not comprehend or retain medical information. Further, the legal doctrine of informed consent has never been coherently worked out. Informed consent in psychiatry is particularly complicated, because of the constitutional implications of right-to-refuse-treatment litigation and because patients may be incompetent to give informed consent as a result of their illness. One of the special problems for psychiatry is that complex consent requirements have been mandated by those who oppose certain somatic therapies. The author discusses the implications of these legal developments. He lists the kinds of informed-consent and refusal-to-consent situatons psychiatrists face and comments briefly on the most troublesome.
Informed consent is a significant ethical as well as medicolegal issue. Both aspects are summarized in this article, which focuses on the major unresolved problems raised by legal and moral analyses of informed consent. The discussion stresses the effects of the doctrine of informed consent on medical practice, with particular reference to problems encountered in the neurological health field.
Seventy-seven sequential patients referred to a radiation oncology clinic for treatment of malignant neoplasms were tested for their immediate recall of information presented, recorded, and signed on informed consent documents. An experimental group of 40 patients were given the intervention of taking the completed form home before signing. Results support the usefulness of the intervention. The experimental patients were found to possess greater information than the 37 patients who signed the form after the usual clinic procedure in virtually every area required of informed consent. The most significant gains were made in patients' understanding of proposed treatment procedures and appropriate treatment alternatives. Women recalled more information relevant to informed consent than did men. Results also indicated a tendency for younger patients to recall more informed consent information than older patients.
The quality of the consent obtained from 41 volunteer subjects in eight experiments is evaluated. Five subjects (all physicians) gave informed consent; 22 subjects gave partially informed consent; and 14 subjects merely gave consent. It is argued that 'informed' consent is obtainable only from medically trained people, and that lip service to this concept in laymen should cease. The concept of medical competence should instead be introduced and a personal medical referee appointed to adjudicate on behalf of the volunteer.
The author suggests that the frequency and severity of tardive dyskinesia in patients treated with neuroleptic drugs requires that informed consent be obtained from all patients receiving such treatment. The three basic conditions for obtaining informed consent are reviewed with discussion of some of the ethical problems encountered in the informed consent procedure. Most of these problems will be resolved if specific, written, informed consent is obtained from the patient, or his representative, within six weeks of initiating therapy, although in some cases questions may be raised about the very possibility of obtaining consent.
The protection of human subjects in research is a shared responsibility. The informed consent procedure was introduced to implement protection of the subjects. The contents of consent forms have been in dispute, and the impact of the procedure on the human subject has caused concern. It was demonstrated that patients with cancer have poor recall of the contents of a signed consent form.
Bioethics is a multi-dimensional discipline. The traditional aspect being medical ethics, a branch of Western philosophy which, since the time of Hippocrates, has sought to formulate rules of proper conduct for physicians. Ethics and informed consent are interrelated issues. Consent is the central issue on which hangs most of the ethical problems in human experimentation. The informed consent of the human patient is the ultimate protection from the hazards of research and therapy in medicine, the basic premise of this being that every human being has the right to determine what shall be done to his own body. The patient must have full prognosis, complications, sequelae, discomforts, costs, inconveniences, risks and expectations. Medically and ethically what should the patient be told? There appears to be no obvious format, but the patient should be told enough to allow him to make a rational decision. This paper contains an analysis of the reactions of just a few American nurses to this dilemma. The nurse who attempts to use only her scientific training to determine ethical conduct is in a quandary because seldon is there empirical evidence available to support her decision, no matter what it is.
One hundred breast cancer patients, 35 adjuvant and 65 advanced, were interviewed 0-24 months after the start of chemotherapy to assess their knowledge and perceptions of the purposes, risks and benefits of treatment. Prior to therapy, all had been given verbal explanations and had signed informed consent forms explicitly detailing drugs, objectives and possible adverse effects of therapy. Seventeen percent of adjuvant and 29% of advanced patients were unable to name any of their drugs. While most patients recognized distressing side effects such as nausea and hair loss, less than 50% were aware of the potentially lethal complications of infection and bleeding. While the purpose of adjuvant therapy was cure, only 29% of the adjuvant patients were aware of this. In contrast, 35% of the advanced patients incorrectly stated that they were told their therapy was potentially curative. Explanations given by a nurse in addition to a physician were better understood than those given by a physician alone. We conclude that, in spite of intensive efforts at improving informed consent procedures, current results are unsatisfactory.
In summary, the physician's duty to inform has been described and discussed. The minority and majority rule have also been defined and analyzed along with the major causes of physician failure and resistance to disclose risks. In a proper physician-patient relationship, informed consent controversy should be rare. A calm, clear, direct and properly documented disclosure of risks of a procedure is the best defense in any jurisdiction.
This paper describes the counseling program implemented by a social worker and a family planning counselor for female clinic patients requesting sterilization. Rather than limiting counseling to the guidelines for informed consent established by New York City law, a comprehensive approach is utilized. The program combines the provision of information regarding the procedure and contraceptive alternatives, with an opportunity for individuals to examine the psychosocial components of their request for sterilization. It is the authors' assessment that such comprehensive counseling is essential to provide individuals with the full assistance they need in making the decision to eliminate reproductive capacity, and that legal guidelines should be expanded accordingly.
A series of forms has been developed by staff at the Veterans Administration Hospital in Seattle in response to a Washington state law requiring that patients give informed consent to treatment. The forms, which describe the nature of the treatment and possible risks and benefits, follow four models: a single consent form that meets all the needs of a clinical unit; separate consent forms for various services of a clinical unit, such as medication or group or individual therapy; a limited-consent form combined with a brochure or fact sheet; and a consent form combined with a treatment contract. The authors report that use of the forms has required very little additional staff time and has not discouraged patients from entering treatment.
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