Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “informed consent”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 73 records · Page 4Linked to original sources
PubMed1998

Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances.

This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that arose surrounding the application of these regulations to emergency research circumstances, and the methods by which the regulations were changed. The new regulations introduced by the U.S. Food and Drug Administration (FDA) also are reviewed.

Disclosure↗
PubMed2006

Informed consent in radiation oncology: is consenting easier than informing?

The patient's right to be informed has been universally recognized and reflected in the legal system of many countries. This right to correct and complete information on behalf of the patient and his admission to proceed with the recommended diagnostic or therapeutic procedure is formalized in the document commonly known as informed consent. Although the legal and bioethical considerations regarding this document have been exhaustively discussed and consensuated, its content continues to create certain doubts and uncertainties. The formal content and the manner in which the consent is obtained are the most difficult aspects. In this article, we analyze what should be included in the written informed consent, with regard to the totality of the information which the patient receives, who should inform, and how the consent should be obtained, as well as how to reflect the different aspects of the variety of radiotherapeutic procedures in the informed consent.

Comprehension↗
PubMed1998

[Informed consent in cardiology. The Committee on Informed Consent of the Commission on Professional Matters of the Sociedad Española de Cardiología].

In the last thirty years, the clinical relationship between physicians and patients has been rather modified. There are several factors that have contributed to this change: a) New ways to execute medical practises, specially referred to the development of new techniques; b) Cultural changes in our western society, mainly in the mediterranean area, where there has been progress in the recognition of patients' autonomy to decide about their own lives, health and their own bodies; c) The increasing number of lawsuits, complaints and judgements about the problems that clinical information involves, particularly the informed consent in clinical practise. We consider it necessary to make an extensive and deep discussion from all of the areas in Medicine and Law, to analyze the different ethical and legal parts of the informed consent. For that reason the Spanish Society of Cardiology offers their members a basic document in order to reflect about these facts, developing arguments, justifications and supports. This document has also considered models, conditions to their applicability according to Spanish law, and the experience we have had. Finally, there is a list of diagnostic procedures and interventional practises in cardiology that might be preceded by a written informed consent document. We considered them by the name of Spanish Society of Cardiology recommendations.

Cardiology↗
PubMed2002

Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

BACKGROUND: Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. METHODS: Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. RESULTS: Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. CONCLUSIONS: The issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed-consent process.

Adult↗
PubMed1987

Circumcision and informed consent. Is more information always better?

This study observes that physicians routinely inform parents about a small minority of the medical complications and risks associated with elective circumcisions. When selecting which medical complications to mention to parents, physicians appeared to use a policy based on their subjective assessment of the frequency and seriousness of the complications' occurrence. Subsequent analyses revealed that the physicians' probability estimates were biased and their seriousness assessments were consistently less than those expressed by mothers of newborn sons. Replacing the physicians' policy of partial disclosure with a comprehensive disclosure of "unbiased" information of possible risks and complications had no effect on the mothers' decisions to have their sons circumcised but did generate numerous influences on the mothers' attitudes. Among the effects observed in mothers were a reduction in their confidence in the appropriateness of their decision and a dissatisfaction with their physician's behavior. The implications of these findings to informed consent are discussed, and a greater flexibility in providing informed consent is advocated.

Adult↗
PubMed1999

The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group.

UNLABELLED: In the clinical trial of diaspirin cross-linked hemoglobin (DCLHb), optimal therapy required the immediate enrollment of patients with severe, uncompensated, traumatic hemorrhagic shock. When it was not feasible to obtain prospective consent, an exception to informed consent was used according to FDA regulation 21 CFR 50.24. OBJECTIVES: To examine the informed consent process and the use of the consent exception and consent to continue (CTC), and to describe the patients for whom this process was used. METHODS: This was a multicenter, randomized, controlled, single-blinded efficacy trial of DCLHb as an adjunct to standard therapy in the treatment of severe, traumatic hemorrhagic shock. Patients with unstable vital signs or a critical base deficit were treated, with a primary study endpoint of 28-day mortality. RESULTS: During the 11-month study period, 112 patients were randomized in 18 U.S. trauma centers, and data from 98 of the infused patients were analyzed. Prospective consent was obtained from two patients, three family members, and one legally authorized representative (LAR) (6%). Consent to continue was requested for 89 patients (89%), and full participation was granted for 87 of these patients (98%). Consent to continue was provided by 54 (98%) of the 55 patients approached. The mean number of days for family/LAR CTC was 1.1 +/-3.8 days, and 50% of the time it was obtained on the day of study enrollment. Patient CTC was obtained in an average of 13 +/- 23 days, with a median of four days. Patients treated in this protocol were more likely to have sustained penetrating trauma than the overall trauma patient population treated in these trauma centers (44% vs 21%, p = 0.002). CONCLUSIONS: Informed consent in this study of an emergent therapy most often involved the use of the consent exception and consent to continue, the latter of which occurred in a timely manner. Nearly all of those who were approached for CTC approved full participation in the study, suggesting acceptance of the process outlined in the new regulations. Patients treated in a hemorrhagic shock clinical trial may differ from the general trauma patient population.

Adult↗
PubMed2005

An audit of informed consent in gastroscopy: investigation of a hospital's informed consent procedure in endoscopy by assessing current practice.

OBJECTIVE: To investigate, by assessing current practice, whether a UK general hospital's informed consent procedure in endoscopy was implemented for all patients, because informed consent is central to the proper conduct of endoscopic procedures. METHODS: A retrospective study of patients' medical notes, in which information written on the UK National Health Service (NHS) consent form and on a departmental leaflet on the gastroscopy procedure completed by the patient was assessed. Sampling began from 9 October 2003 until 100 patients were recorded. For each patient's record, a data collection sheet was completed. RESULTS: Of the 67 patient records assessed (33 were unavailable), all contained the NHS consent form with signatures from the practitioner and patient. The departmental leaflet was present for only 31 patients, and of these, 20 had a signature from the patient and one leaflet had a signature from the practitioner. The multiple choice test was completed for 28 of the 31 departmental leaflets and full marks were awarded for 17 of 28. Although 11 patients answered one or more questions incorrectly, a discussion of the correct answers was only found in two records. CONCLUSION: To achieve improved performance, a training/induction programme should explain the informed consent procedure and its importance. This should be supported by 'booster' training sessions to avoid the emergence of bad practice. These sessions should take advantage of evidence-based medicine via feedback from audits and discussions of litigation cases. Departmental leaflets and NHS consent forms should also be provided in other languages.

England↗
PubMed1989

Informed consent in theory and practice: legal and medical perspectives on the informed consent doctrine and a proposed reconceptualization.

The theoretical, legal, and medical doctrines of informed consent are analyzed. The elements of informed consent include disclosure of information, competency, understanding, voluntariness, and decision-making. The doctrine is ground in deference to individual autonomy and recognition that the exercise of self-determination in matters of health is a liberty interest honored by our history and traditions. The exceptions to informed consent including emergency, incompetency, therapeutic privilege, and waiver are especially important in critically ill patients and reflect a balancing of autonomy values and society's interest in the promotion of health. Legal decisions inevitably are based on atypical physician-patient encounters and focus on a particular problem or procedure rather than on overall medical care. In addition, they often reflect an artificial view of the doctor-patient relationship. Medical decision-making is a complex, evolving pursuit of a diagnosis and proper treatment regimen. Moreover, patients are not always interested in the role assigned to them by law. A reconceptualization of informed consent doctrines utilizing sliding scale standards based on variables pertinent to each individual patient is suggested.

Comprehension↗
PubMed1990

Readability of pediatric biomedical research informed consent forms.

Informed consent forms are used in biomedical research as a mechanism to convey study information to potential subjects so that they may arrive at a decision concerning their willingness to participate. Although the Department of Health and Human Services Regulations for the Protection of Human Subjects require the presentation of specific study information at a level that is easily understood, according to research concerning adult biomedical consent forms, the typical form is not readily comprehensible. Unfortunately, no data exist concerning the readability of informed consent forms that are used in the context of pediatric biomedical research. In the present study, readability analyses were conducted on a large sample (N = 238) of pediatric biomedical informed consent forms obtained during a 10-year period from a large midwestern children's hospital. For the entire sample, results derived from two readability estimates (Fry grade equivalent and Flesch Reading Ease methods) indicated that the consent forms were written at the college graduate level. Although there was a linear increase in the length of the consent document during the 10-year period evaluated, expanded length was not associated with improved readability. According to analyses, a differential pattern of reading difficulty was associated with specific sections of the informed consent document. Findings are highly consistent with those from studies of adult biomedical consent form and document that the purpose of the informed consent form is being compromised, in part, by a readability factor. Suggestions for solving this critical problem are advanced.

Comprehension↗
PubMed1993

Informed consent: using a structured interview changes patients' attitudes towards informed consent.

Patients want to know more about their condition and its proposed treatment. Gaining patients' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome. As part of a prospective study of informed consent for surgery we have assessed the attitudes of patients towards informed consent when different types of consent interview are used. We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information; they also want to know about most, but not all, complications of the procedure. One quarter worried about the anaesthetic, about one eighth worried about 'not waking up' and similar proportions worried about complications and other things such as pain and nausea. Most patients think that the consent form is a legal document. In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implications. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate.

Adult↗
PubMed1998

Informed consent: how much information is enough?

BACKGROUND: Recent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent. The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and/or written information improved their understanding. It was further determined whether the provision of more extensive information altered patients' anxiety levels. METHODS: Patients undergoing femoral popliteal bypass or carotid surgery were randomized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent. Patients undertook a pre-operative risk and complication questionnaire, a pre- and postoperative anxiety and depression evaluation and a follow-up questionnaire 6 weeks after discharge. RESULTS: Thirty-two patients were included in the trial. The comprehension questionnaire resulted in a correct percentage response of 48% for the routine information only, 59% with added verbal information, 59% with added written information and 55% with added written and verbal information. Twenty-five per cent of patients stated that they had a poor understanding of the risks and complications of the procedure. CONCLUSIONS: Additional written or verbal information did not improve a patient's understanding of risks and complications of the procedure. It also did not improve patients' perceived understanding of the operation or its complications. Patients' anxiety levels were unaltered by the increase in the information they were given. The information provided to patients should be simple, easy to understand and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure.

Adaptation, Psychological↗
PubMed2006

[Ethical opinion survey on the periodical health examination among workers: privacy protection and informed consent on the information of the heath examination among workers in small and medium-sized enterprises].

We investigated the ethical opinions concerning the information on legal regular health examinations with a questionnaire for 757 workers in enterprises that contracted a part-time occupational physician as there were no full-time occupational health professionals. Thirty to 50% of the workers answered that the information on their health examination was known to their superiors and their colleagues. Also, 20 to 40% of the workers answered that the information was made known to other people without obtaining their agreement. This tendency among the group of sick workers was stronger than in the group of healthy workers. On the other hand, the workers who suspected that the information on their health examination might be made available to other people exceeded the majority. In these enterprises, there seemed to be ethical problems from the point of the protection of privacy. It was also shown that the consideration of ethics concerning the protection of the privacy of the information on worker's health examinations was not high. However, it was suggested that the ethical opinion concerning worker's informed consent was high, as there were 85% or more workers who answered that agreement of the workers themselves was necessary for disclosing the information on their medical examination.

Confidentiality↗