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UK's first hospital ethics committee.
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[Legal repercussions of Clinical Ethics Committees reports].
Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.
Error reduction, patient safety and institutional ethics committees.
Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. In this paper, the author endeavors to fill the gap. As noted in the Hastings Center's recent report, "Promoting Patient Safety," the occurrence of medical error involves complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. This paper builds on the Hastings Center's report in arguing that institutional ethics committees ought to play an integral role in the transformation of a "culture of blame" to a "culture of safety" in healthcare delivery.
The nurse's role on ethics committees and as an ethics consultant.
Nurses share in the moral responsibility of their institution to ensure that the best ethical decision-making process is in place to meet patient needs, uphold the philosophy of the institution, and preserve the integrity of the profession. With health care reform under way, clinical ethical decision making will be even more difficult and complex than it is now. As members of ethics committees, nurses have a role to share their unique perspective. Nursing's prolonged contact with the patient, therapeutic communication skills, and goal-oriented approach facilitate the ethical decision-making process and make nurses well-suited to participate on ethics committees. This article discusses the role of the nurse on an ethics committee and, briefly, the advanced practice nurse as an ethics consultant.
SCIENCE editor challenges ethics committees.
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[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].
Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).
Giving answers or raising questions?: the problematic role of institutional ethics committees.
Institutional ethics committees (IECs) are part of a growing phenomenon in the American health care system. Although a major force driving hospitals to establish IECs is the desire to resolve difficult clinical dilemmas in a quick and systematic way, in this paper we argue that such a goal is naive and, to some extent, misguided. We assess the growing trend of these committees, analyse the theoretical assumptions underlying their establishment, and evaluate their strengths and shortcomings. We show how the 'medical consultation' model is often inappropriately applied to IECs and suggest that IECs must operate under a different framework. Finally, we argue that IECs should be valued for the process they facilitate, and not for the product that they are, often unreasonably, expected to deliver.
Of ethics committees, protocols, and behaving ethically in the field: a case study of research with elderly residents in a nursing home.
In this paper we discuss differing discourses of research ethics committees and the clinical research field. Reflections on our experience of conducting research in a nursing home are used to highlight the tensions and inconsistencies that arise from these discourses and the need to behave ethically in the field. While accepting the need for adherence to guiding principles of duty based ethics, we have found that practical moral decisions in the field required that, as individual researchers, we needed to exercise discretionary judgement, informed by the ethic of care and the concern for the well-being of research participants.
Does legislating hospital ethics committees make a difference? A study of hospital ethics committees in Maryland, the District of Columbia, and Virginia.
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Responses of local research ethics committees to a study with approval from a multicentre research ethics committee.
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Too many ethical committees.
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Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.
The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.
Ethics committees: current research ethics forms are an over-reaction that will stifle research.
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Research ethical committees.
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Practical experiences in the work of institutional ethics committees in Croatia on the example of the Ethics Committee at Clinical Hospital Center Rijeka (Croatia).
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[Task and execution method of an ethics committee with the example of the Tubingen Ethics Committee].
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European experiences of ethics committees.
The term 'ethics committees' is used for very different things in different parts of the world. In Europe, ethics committees are generally concerned only with research and (apart from Belgium where the same committees deal with both aspects) do not have anything to do with decision making in clinical situations. This article traces the history of ethics committees in the UK and some of the problems encountered by them. It goes on to detail the situation in a number of other European countries. Some topics of research touched on and published in articles in Nursing Ethics are then highlighted, thus making it clear that it is written from my perspective as the Editor of Nursing Ethics and with the help of some of the members of the Editorial Board. Finally, a number of questions are asked and answers attempted concerning the interests served by ethics committees.