Ethical difficulties in clinical practice: experiences of European doctors.
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BACKGROUND: Ethics support services are growing in Europe to help doctors in dealing with ethical difficulties. Currently, insufficient attention has been focused on the experiences of doctors who have faced ethical difficulties in these countries to provide an evidence base for the development of these services. METHODS: A survey instrument was adapted to explore the types of ethical dilemma faced by European doctors, how they ranked the difficulty of these dilemmas, their satisfaction with the resolution of a recent ethically difficult case and the types of help they would consider useful. The questionnaire was translated and given to general internists in Norway, Switzerland, Italy and the UK. RESULTS: Survey respondents (n=656, response rate 43%) ranged in age from 28 to 82 years, and averaged 25 years in practice. Only a minority (17.6%) reported having access to ethics consultation in individual cases. The ethical difficulties most often reported as being encountered were uncertain or impaired decision-making capacity (94.8%), disagreement among caregivers (81.2%) and limitation of treatment at the end of life (79.3%). The frequency of most ethical difficulties varied among countries, as did the type of issue considered most difficult. The types of help most often identified as potentially useful were professional reassurance about the decision being correct (47.5%), someone capable of providing specific advice (41.1%), help in weighing outcomes (36%) and clarification of the issues (35.9%). Few of the types of help expected to be useful varied among countries. CONCLUSION: Cultural differences may indeed influence how doctors perceive ethical difficulties. The type of help needed, however, did not vary markedly. The general structure of ethics support services would not have to be radically altered to suit cultural variations among the surveyed countries. (+info)
Scientific research on human subjects and ethics procedures at the Istituto Superiore di Sanita: a survey of the articles issued in 2001.
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Principles promoting the protection of subjects involved in biomedical research are interpreted differently within the scientific community. The purpose of this paper is to describe the attitudes of researchers working at the Istituto Superiore di Sanita (ISS) regarding the ethical implications of studies involving human beings, with particular emphasis on aspects concerning informed consent (IC) and ethics committee (EC) review. In 2001, ISS researchers published a total of 733 articles, 93 (12.7%) of which were studies involving human beings. Nearly 2/3 (60/93) were epidemiological, while the remaining 35.5% were based on laboratory data. Half (47/93) reported physical or psychological interventions or treatments on study subjects. 40.9% of articles mentioned that informed consent had been obtained and only 12.9% that approval had been given by an ethics committee. The low proportion of articles on which a protocol had been submitted the EC was due in part to the type of studies, but also to the absence of an institutional EC prior to 2001. Ethical procedures were more present in laboratory than in epidemiologic studies (IC: 69.7% vs 25.0%, p < 0.001) (EC: 27.3% vs 5.0% p = 0.004). Those differences were more likely due to the less interventionist nature of the epidemiologic studies rather than in poor ethical awareness on the part of epidemiologists. Further efforts are needed to develop and enforce clear institutional policies regarding ethical procedures. (+info)
Regulation of healthcare ethics committees in Europe.
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In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be apt to improve HECs' accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries. (+info)
Nephrologists' changing practices in reported end-of-life decision-making.
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Because the dialysis patient population is increasingly composed of older patients with high symptom burden, shortened life expectancy, and multiple comorbid conditions, nephrologists often engage in end-of-life decision-making with their patients. In the 1990s, reported practices of nephrologists' end-of-life decision-making showed much variability. In part as a reaction to that variability, the Renal Physicians Association (RPA) and the American Society of Nephrology (ASN) developed a clinical practice guideline on end-of-life decision-making. To determine whether nephrologists' attitudes and reported practices had changed over time, survey responses from 296 nephrologists completing an online survey in 2005 were compared with 318 nephrologists who completed a similar mailed survey in 1990. In 2005, less variability was noted in reported practices to withhold dialysis from a permanently unconscious patient (90% would withhold in 2005 versus 83% who would withhold in 1990, P < 0.001) and to stop dialysis in a severely demented patient (53% in 2005 would stop versus 39% in 1990, P < 0.00001). In 2005, significantly more dialysis units were reported to have written policies on cardiopulmonary resuscitation (86% in 2005 versus 31% in 1990, P < 0.0001) and withdrawal of dialysis (30% in 2005 versus 15% in 1990, P < 0.0002); nephrologists were also more likely to honor a dialysis patient's do-not-resuscitate order (83% in 2005 versus 66%, P < 0.0002) and to consider consulting a Network ethics committee (52% in 2005 versus 39%, P < 0.001). Nephrologists' reported practices in end-of-life care have changed significantly over the 15 years separating the two surveys, suggesting that the development of the clinical practice guideline was worthwhile. (+info)
Reporting ethical processes in two Indian journals.
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BACKGROUND: In biomedical journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian. AIMS: To determine the proportion of research manuscripts in two pediatric journals published from India reporting on ethical clearance, obtaining of informed consent and/or assent. SETTINGS AND DESIGN: Retrospective study for analysis of research articles published. MATERIALS AND METHODS: Research articles published in the issues of Indian Pediatrics and Indian Journal of Pediatrics in 2006 were reviewed for reporting regarding ethical clearance, obtaining written informed consent from guardians or parents, and obtaining assent from research participants. STATISTICAL ANALYSIS USED: Descriptive statistics was used. The number of articles according to their types; the number of research designs employed according to their types; and the number of research studies mentioning ethical clearance, consent, and assent were expressed as percentages mentioning ethical clearance, consent and assent were expressed as percentages. RESULTS: Of the 132 manuscripts reporting biomedical research, 39 (29.53%) reported having obtained approval from the ethics committee. Forty-six of the 98 (46.94%) manuscripts reporting on prospective studies indicated that informed consent was obtained from parents or lawful guardians. Neither ethical approval nor informed consent was mentioned in 45 (34.10%) published articles reporting prospective studies. A total of 54/98 (55.1%) studies enrolled children aged 7 years or more and hence were assessed for reporting of assent; eight (14.81%) reported that children's assent was obtained. Only four (7.41%) eligible studies reported ethics committee's approval, informed consent, as well as assent. CONCLUSIONS: A significant proportion of research articles published in the two pediatric journals did not provide information regarding ethical approval, written informed consent, and obtaining of assent. (+info)
Informed consent in Sri Lanka: a survey among ethics committee members.
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