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Results for “informed consent”

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PubMed2002

Informed consent and the process of cadaver donation.

CONTEXT: Informed consent entails more than signing a document. Ideally, it should involve a process in which individuals are given sufficient information to make a voluntary decision. Little is known about the process of informed consent for cadaver donation. OBJECTIVE: To assess existing consent procedures for cadaver donation in a sample of US medical schools. DESIGN: Cross-sectional survey and content analysis of informational brochures and consent forms given to potential cadaver donors. SETTING AND PARTICIPANTS: The 22 largest medical schools in the United States, as ranked by the number of medical students in the Association of American Medical Colleges Institutional Profile System Annual Report 1995-1996. MAIN OUTCOME MEASURES: Description of dissection procedure, information provided about dissection, and the process for obtaining consent. RESULTS: Of the 22 schools studied, 18 schools (82%) mentioned the altruistic nature of cadaver donation. Twenty-one schools (96%) specified that bodies would be used to teach students, and 16 schools (73%) specified that bodies would be used for research. One school (4%) noted that organs could be permanently preserved for teaching purposes. Only 2 schools (9%) provided any description of the dissection procedures to be performed on the cadavers. Seven schools (32%) used the term dissect at least once. None of the schools offered to provide a complete account of the dissection procedure. CONCLUSIONS: The existing consent procedures for cadaver donations at US medical schools do not provide sufficient information to potential donors to constitute a fully informed consent.

Cadaver↗
PubMed1979

Informed consent: special problems for psychiatry.

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.

Ethics, Medical↗
PubMed2005

Informed consent in schizophrenia: the use of cues in the assessment of understanding.

The purpose of this study was to determine if providing cues could facilitate participant understanding for consent form information. Understanding scores were measured in a group of participants diagnosed with schizophrenia and a control group using cued recognition and uncued recall methods. When understanding was measured with uncued methods, persons with schizophrenia showed lower scores compared to the control group. However, when cues were provided, there was no difference between the two groups on understanding scores, and persons with schizophrenia showed normal levels of understanding. The results suggest that cued methods may be a better alternative to measure participant understanding.

Adolescent↗
PubMed2002

[Information cards and informed consent. A proposal of 12 information cards for plastic and esthetic surgery].

Obligation to deliver full information and obtaining enlightened assent are now, for the whole french practitioner, a necessary preliminary to each operation. Henceforth, in case of suit, the practitioner must prove the reality and the quality of preoperative information. The National Medical French Council (CNOM) called scientific societies attention to propose to their members some index standard cards, corresponding to main medical and surgical records. The National Agency for Accreditation and Evaluation in Health (Anaes) defined the main characteristics of these documents. The authors propose twelve information cards corresponding to the most currently operations of plastic and aesthetic surgery. They will being clear and simple, with a large agreement, strictly informative and yearly up to date. They have the label and therefore the scientific guaranty of French Society of Plastic Reconstructive and Aesthetic Surgery.

Humans↗
PubMed1991

Informed consent: study of quality of information given to participants in a clinical trial.

OBJECTIVE: To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN: About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING: Eight different centres in Sweden. SUBJECTS: 43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES: Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS: All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION: Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.

Clinical Trials as Topic↗
PubMed1993

Informed consent.

Under the law of informed consent, physicians must disclose to patients certain information about their medical condition and potential courses of treatment, and must obtain their consent to proceed. This article delineates the basic standards that govern such disclosure, with special reference to legal cases that have dealt with ophthalmic concerns. It concludes by discussing a number of special issues that have recently arisen in this area.

Consent Forms↗
PubMedDate not supplied

Informed consent and home birth.

The history and purpose of informed consent are explored and its legal components are detailed. Recommendations are given to meet the criteria for informed decision-making at home, including discussion of unusual circumstances. The nature of assistance at childbirth, especially at home, is explored in relation to legal obligations. The article includes some observations on cultural dissonance regarding informed consent. Finally, the authors recommend a focus on a therapeutic alliance with the client as the best outcome of effective informed consent and as the second best preventive measure against malpractice, the first being competent care.

Culture↗
PubMedDate not supplied

Informed consent in dentistry.

This paper analyzes the concept of informed consent in dentistry from a bioethical and philosophical perspective. It is the author's contention that informed consent, as presently used in daily practice, might be illusory at best. After analyzing the concept in general to derive a philosophical underpinning, this basis is applied to common dental scenarios in order to illustrate an approach that is respectful of the patient's autonomy and that can achieve a truly meaningful informed consent.

Dentist-Patient Relations↗
PubMed2003

Informed consent in gerontology.

The aim of this study was to assess the use and adequacy of informed consent in research involving the elderly in Brazil. Using a reading index, we observed that in 83% of informed consent forms, the text was considered difficult, and demanded a higher schooling level than that presented by the subjects. Whereas 100% of the investigators considered the text in informed consent forms accessible, 75% of the subjects considered it hard to understand. This difference was statistically significant. 94% percent of the elderly participating in research protocols made the decision to participate in the study before reading the term of consent. More attention should be given both to the writing of informed consent forms and to the entire informed consent process, which in gerontology research, should be reviewed at each encounter with study participants.

Aged↗
PubMed2001

Informed consent for population-based research involving genetics.

Bridging the gap between gene discovery and our ability to use genetic information to benefit health requires population-based knowledge about the contribution of common gene variants and gene-environment interactions to the risk of disease. The risks and benefits associated with population-based research involving genetics, especially lower-penetrance gene variants, can differ in nature from those associated with family-based research. In response to the urgent need for appropriate guidelines, the Centers for Disease Control and Prevention formed a multidisciplinary group to develop an informed consent approach for integrating genetic variation into population-based research. The group used expert opinion and federal regulations, the National Bioethics Advisory Commission's report on research involving human biological materials, existing consent forms, and literature on informed consent to create suggested language for informed consent documents and a supplemental brochure. This language reflects the premise that the probability and magnitude of harm, as well as possible personal benefits, are directly related to the meaning of the results for the health of the participant and that appropriate disclosures and processes for obtaining consent should be based on an assessment at the outset of the likelihood that the results will generate information that could lead directly to an evidence-based intervention. This informed consent approach is proposed to promote discussion about how best to enable potential participants to make informed decisions about population-based research involving genetics and to suggest issues for consideration by research sponsors, institutional review boards, and investigators.

DNA↗
PubMed1978

Informed consent in medical practice. With particular reference to neurology.

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.

Comprehension↗
PubMed1995

Informed consent--a survey of doctors' practices in South Africa.

OBJECTIVE: To examine doctors' practices with regard to informed consent. DESIGN: Cross-sectional, descriptive survey. PARTICIPANTS AND SETTING: All full-time consultants and registrars in the Departments of Medicine, Obstetrics and Gynaecology, Paediatrics and Child Health, Paediatric Surgery and Surgery at the University of Cape Town were included. The overall response rate was 63% (160/254). MEASUREMENT: Data were collected by means of self-administered, semi-structured questionnaires. RESULTS: Most doctors (79%) felt it was their responsibility to ensure that patients and parents were fully informed about diagnostic and therapeutic interventions. Many (62%) supported a patient-centred standard for determining the type and amount of information to disclose. Doctors disclose most of the legally required information except for information about alternative forms of treatment and remote serious risks. They almost never provide information on medical costs. The most common reasons for not obtaining informed consent were the doctors' tendency to 'tell' patients/parents what they intend doing and their belief that patients/parents expect doctors to know what is medically best for them. Language, inadequate communication skills and lack of time were, surprisingly, seldom viewed as obstacles to the obtaining of informed consent. Findings were independent of discipline (medical or surgical) and doctors' status (consultant or registrar). Doctors who treat children were significantly less likely to obtain consent for certain interventions. CONCLUSION: Doctors meet many, but not all, of the legal requirements for informed consent. The findings question whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent.

Comprehension↗
PubMed1996

Documenting informed consent for treatment with neuroleptics: an alternative to the consent form.

Clinicians can comply with Ohio state regulations for documenting patients' informed consent for treatment with neuroleptic medication by checking a box in the medical record stating that a periodic discussion of informed consent has occurred and writing a note about the discussion in the narrative record. The authors discuss clinicians' experience with this alternative to the conventional consent form in a large community support agency. Although the approach has been largely successful, implementation has been hindered by some clinicians' incomplete understanding of the informed consent process. Continued training is needed to bring the ideal of informed consent into clinical practice.

Antipsychotic Agents↗
PubMed2003

Informed consent for psychotherapy: a look at therapists' understanding, opinions, and practices.

Forensic experts agree that the doctrine of informed consent now applies to psychotherapy. The optimum level of detail and content in this interaction remains nebulous. This study examines opinions and practices of therapists. The authors administered a survey regarding this subject to 231 psychotherapists. Six scales were constructed from this survey. High scores on these scales suggest more positive opinions regarding the application of the doctrine of informed consent to psychotherapy. Psychiatrists scored significantly lower on the Informed Consent (p = 0.005), Written Consent (p < 0.001), and Self-Disclosure (p = 0.026) scales than other types of therapists (suggesting a more negative opinion of the application of this doctrine to psychotherapy). Interpersonal therapists scored significantly higher than psychodynamic psychotherapists on the Informed Consent (p = 0.003) and Patient (p = 0.003) scales. Psychodynamic psychotherapists scored significantly lower than therapists with different modalities on the Written Consent scale. This paper suggests that opinions and practices of informed consent for psychotherapy vary with the characteristics of the therapist. More research in this area could serve as a guide for therapists embarking on the process of informed consent or for professional organizations who wish to establish guidelines.

Adult↗
PubMed1998

Informed consent: ideal or reality?

Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.

Decision Making↗
PubMed1984

Applying the principles of informed consent to patient care. Legal and ethical considerations for physical therapy.

This paper presents legal and ethical considerations regarding informed consent for the evaluation and treatment of patients in physical therapy practice. Therapists traditionally think of informed consent in relation to clinical research, but as the trend toward independent practice and private practice increases in physical therapy, the physical therapist must understand the process of informed consent in relation to patient care. Legal concepts of battery, self-determination, and the fiduciary relationship create a legal foundation for informed consent. The patient's moral right to self-determination and the corresponding duty of health professionals to "do no harm" create a strong moral basis for gaining a patient's informed consent. Practical suggestions are offered to physical therapists to help them assess their need for obtaining informed consent.

Ethics, Professional↗