The current state of clinical ethics and healthcare ethics committees in Belgium

Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by the Belgian Advisory Committee on Bioethics with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation.     

Delays and diversity in the practice of local research ethics committees.

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees.     

Bridging problems and models in medical ethics: four images of local ethics committees

In the context of the continuing debate about how ethics committees in Italy should be structured (see Bulletin 160) Professor Incorvati, from the Comitato Nazionale per la Bioetica in Rome, considers four theoretical models of how such committees may be arranged, and why one in particular looks better placed to face the growing ethical problems that are emerging as a result of current developments in medicine.     

Hospital medical ethics committees: a review of their development

The history of hospital ethics committees (HECs) since the early 1970s is reviewed through literature citations and reports of the experiences of functioning committees. Other types of hospital review committees and their relationship to HECs are described, as well as the problems and successes of early ethics committees. The influence of the American legal system on medical decision making and the formation of ethics committees is discussed, and reasons are given for hospitals' reluctance to establish committees, or to utilize those already in existence. Rosner concludes with a discussion of a proposed model for ethics committees, and urges caution in evaluating the role of committees in resolving ethical dilemmas.     

Issues in bioethics. Teaching research ethics

All research should meet the highest ethical and scientific standards, and so persons who may be involved in conducting research should be fully conversant with the relevant ethical principles of biomedical research and its requirements. Further, scientists, academicians, physician-researchers, student-researchers, and members of research ethics committees should be able to distinguish between therapy and research, evaluate risk and benefit, be sensitive to various forms of conflicts of interest, and be fully aware of the special provisions necessary for vulnerable populations. This article recommends a number of subject areas that should be addressed as a part of this academic process.     

Research on human subjects: Australian ethics committees take tentative steps.

Australian medical researchers are attempting to formulate a response to some of the ethical issues in medical research. The debate over the in vitro fertilisation programme has highlighted some community concern about research ethics and the role of the ethics committee. While very little is known about Australian ethics committees, it appears that a two-tiered approach comprising both ethical review and scientific review is acceptable to the research community. However, this approach plus some problems with the nature of informed consent, begs the question of the role of these committees in the broader context of medical research in the community. Important aspects of a seminar for members of hospital ethics committees are reported.     

Hospital based ethics, current situation in France: between "Espaces" and committees

Unlike research ethics committees, which were created in 1988, the number of functioning hospital based ethical organisations in France, such as clinical ethics committees, is unknown. The objectives of such structures are diverse. A recent law created regional ethical forums, the objectives of which are education, debate, and research in relation to healthcare ethics. This paper discusses the current situation in France and the possible evolution and conflicts induced by this law. The creation of official healthcare ethics structures raises several issues.     

Ethics in a scientific approach: the importance of the biostatistician in research ethics committees

In medical practice and research it is necessary to consider the rights of the researcher or physician and of the subject or patient, to conform to scientific standards and to examine the appropriateness with respect to laws and moral values. Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research on human subjects. Research of no scientific value is also against ethical principles. To obtain valid and reliable results from biomedical research, it is a scientific and ethical obligation to make use of the science of statistics. Therefore, for research to be evaluated using biostatistics intensively from ethical and scientific points of view, a biostatistics expert is necessary on research ethics committees. Developments in Turkey are used as examples.     

Paediatrics at the cutting edge: do we need clinical ethics committees?

OBJECTIVES: To investigate the need for hospital clinical ethics committees by studying the frequency with which ethical dilemmas arose, the perceived adequacy of the process of their resolution, and the teaching and training of staff in medical ethics. DESIGN: Interviews with individuals and three multidisciplinary teams; questionnaire to randomly selected individuals. SETTING: Two major London children's hospitals. RESULTS: Ethical dilemmas arose frequently but were resolved in a relatively unstructured fashion. Ethical concerns included: the validity of consent for investigations and treatment; lack of children's involvement in consent; initiation of heroic or futile treatments; resource allocation. Staff expressed the need for a forum which would provide consultation on ethical issues, develop guidelines for good ethical practice, undertake teaching and training, and provide ethical reflection outside the acute clinical setting. CONCLUSION: Multidisciplinary, accountable and audited clinical ethics committees with predominantly advisory, practice development and educational roles could provide a valuable contribution to UK clinical practice and perhaps in other countries that have not developed hospital clinical ethics committees.     

Hospital ethics committees. Administrative aspects

Two physicians with experience in setting up hospital ethics committees (HECs) review some of the administrative and legal aspects of the committees' formation and operation. They identify HECs as having an advisory function rather than a regulatory or decision making role, and explore the rationale for these committees and their relationship to institutional review boards. Advice is offered to hospitals planning to establish ethics committees on defining their goals, selecting members, deciding about patient and family participation, opening meetings to all interested persons, and keeping records. Fost and Cranford also discuss the questions of access to committees, their jurisdiction, whether consultation should be optional or mandatory, and the effect of committee consultations on legal liability. They conclude that, if properly formed and administered, hospital ethics committees can help promote ethically defensible decisions about life-sustaining care.     

Snapshots of five clinical ethics committees in the UK

Each of the following papers gives an account of a different UK clinical ethics committee. The committees vary in the length of time they have been established, and also in the main focus of their work. The accounts discuss the development of the committees and some of the ethical problems that have been brought to them. The issues raised will be relevant for other National Health Service (NHS) trusts in the UK that wish to set up such a committee.     

Hospital ethics committees in Israel: structure,function and heterogeneity in the setting of statutory ethics committees

OBJECTIVES: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment. DESIGN: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons. SETTING: Israel five years after the passage of the Patients' Rights Act. Main measurements: Patients' rights and informal ethics committee structure and function. RESULTS: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction. CONCLUSIONS: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement.     

Education of ethics committee members: experiences from Croatia

OBJECTIVES: To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. DESIGN: Before/after cross-sectional study using a self administered questionnaire. SETTING: Educational workshop for members of hospital ethics committees, Zagreb, 2003. Main outcome measurements: Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. RESULTS: The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions-education, case analysis, guidelines formation-were neglected. Members' level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. CONCLUSIONS: The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees' work in Croatia especially in the hospital setting.     

Is there a future for clinical ethics services in Australia?

Clinical ethics refers to the consideration of ethical issues arising directly in the context of patient care. Health professionals are generally adept at effectively and sensitively managing ethical issues in clinical care. However, in some settings, multidisciplinary clinical ethics services may enhance clinical practice by assisting clinicians, patients and others to identify, understand and manage ethical issues. Clinical ethics services may be particularly valuable for situations in which moral perspectives diverge or communication has deteriorated. Such services may facilitate discussion and help the parties find mutually satisfactory solutions. Clinical ethics services may take various forms, including clinical ethics committees, ethics consultants, patient advocates or other mechanisms for responding to complaints and grievances. There is considerable disagreement about key aspects of clinical ethics services, including who should conduct them, how they should be run and what role they should play in decision-making.     

A proposed rural healthcare ethics agenda

The unique context of the rural setting provides special challenges to furnishing ethical healthcare to its approximately 62 million inhabitants. Although rural communities are widely diverse, most have the following common features: limited economic resources, shared values, reduced health status, limited availability of and accessibility to healthcare services, overlapping professional-patient relationships and care giver stress. These rural features shape common healthcare ethical issues, including threats to confidentiality, boundary issues, professional-patient relationship and allocation of resources. To date, there exists a limited focus on rural healthcare ethics shown by the scarcity of rural healthcare ethics literature, rural ethics committees, rural focused ethics training and research on rural ethics issues. An interdisciplinary group of rural healthcare ethicists with backgrounds in medicine, nursing and philosophy was convened to explore the need for a rural healthcare ethics agenda. At the meeting, the Coalition for Rural Health Care Ethics agreed to a definition of rural healthcare ethics and a broad-ranging rural ethics agenda with the ultimate goal of enhancing the quality of patient care in rural America. The proposed agenda calls for increasing awareness and understanding of rural healthcare ethics through the development of evidence--informed, rural-attuned research, scholarship and education in collaboration with rural healthcare professionals, healthcare institutions and the diverse rural population.     

In praise of unprincipled ethics

In this paper a plea is made for an unprincipled approach to biomedical ethics, unprincipled of course just in the sense that the four principles are neither the start nor the end of the process of ethical reflection. While the four principles constitute a useful "checklist" approach to bioethics for those new to the field, and possibly for ethics committees without substantial ethical expertise approaching new problems, it is an approach which if followed by the bioethics community as a whole would, the author believes, lead to sterility and uniformity of approach of a quite mindbogglingly boring kind. Moreover, much of bioethics is not concerned with identifying the principles or values appropriate to a particular issue, but rather involves analysing the arguments that are so often already in play and which present themselves as offering solutions in one direction or another. Here, as I try to show in discussion of these four scenarios, the principles allow massive scope in interpretation and are, frankly, not wonderful as a means of detecting errors and inconsistencies in argument.     

Evaluation of research ethics committees in Turkey

In Turkey, there was no legal regulation of research on human beings until 1993. In that year "the amendment relating to drug researches" was issued. The main objectives of the regulation are to establish a central ethics committee and local ethics committees, and to provide administrative control. There are no compulsory clinical ethics lectures in the medical curriculum, so it is also proposed that research ethics committees (RECs) play a central educational role by helping physicians to be aware of moral problems and by contributing to the training of research teams.     

医院伦理委员会建设若干问题的探讨

通过介绍上海几家有代表性医院的伦理委员会建设成就,阐明了我国的医院伦理委员会建设应具有自己的特点。对人才培养成为医院伦理委员会建设的瓶颈、缺乏针对伦理委员会委员的系统化培训、缺乏可操作性强的操作指南、伦理委员会的建设发展不平衡、伦理委员会的工作缺乏较高的独立性和透明度、缺乏利益冲突的管理机制等医院伦理委员会建设中存在的问题进行了探讨,提出了加快医学伦理学的人才培养、探索实行伦理委员会注册和伦理委员资格认定、尝试建立联合伦理委员会、广泛开展保护受试者和患者安全和权益的社会宣传、明确利益冲突的防范和管理原则等对策。     

Current status of regulation of ethics in health care in the English-speaking Caribbean

Clinical ethics committees are poorly developed in the English-speaking Caribbean. There is no lack of recognition that there is a problem in the conduct of some health professionals; however, there is a lack of administrative will to deal with the problems. Why there is such a lack of will can be speculated upon and may involve the feeling of a loss of control, and in small communities, the fact that Caesar may be asked to stand in judgement on Caesar. However, the public is increasingly impatient with the stalemate of misconduct and the lack of regulation and is seeking legal remedies or indulging in vilification of the profession to obtain some satisfaction of their grievances. For their own professional health, professionals should demand from administrators that ethical expertise and guidance be made available or they should bypass the administrators and seek to find the necessary expertise and guidance to ensure that this area is no longer ignored and does not remain a convenient and readily available weapon against them.     

A syllabus for research ethics committees: training needs and resources in different European countries

This paper reports a European Forum for Good Clinical Practice workshop held in 2011 to consider a research ethics committee training syllabus, subsequent training needs and resources. The syllabus that was developed was divided into four competencies: committee working; scientific method; ethical analysis and the regulatory framework. Appropriate training needs for each, with possible resources, were discussed. Lack of funding for training was reported as a major problem but affordable alternatives were debated. Strengths and weaknesses of this approach were discussed and the resultant proposal will be disseminated through the European Forum for Good Clinical Practice and the research ethics committees of member states.