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The roles and functions of hospital-based ethics committees.

Ethics committees ar becoming much more visible on the Canadian health care scene. They range from research-ethics committees that decide whether research projects are ethically sound to case-oriented committees that look at particular issues and give advice. Eike-Henner Kluge says that ethics committees are useful tools, but only when they are appropriately constituted and function in a professional manner. Otherwise, he warns, they become either useless or a liability.

Canada↗

Rationalising public participation in the health service: the case of research ethics committees.

This paper seeks to raise questions about the growing emphasis on public participation in decision-making in the health service. It examines the case study of lay participation on Local Research Ethics Committees (LRECs'). In the light of contested theoretical conceptions of the value of lay participation and an absence of a centrally defined role this paper examines practice. It uses qualitative evidence collected in 45 semi-structured interviews with committee members and observations of twenty committee meetings. It examines members' own conceptualisations of lay involvement and the contributions they are able to make in meetings as a result of these conceptualisations. It concludes that without better-defined roles for lay members on these committees they do not possess the authority or knowledge to challenge the experts' technical rendering of research.

Committee Membership↗

Handling of scientific dishonesty in the Nordic countries. National Committees on Scientific Dishonesty in the Nordic Countries.

Despite a widely recognised need, most countries still have no coherent system to deal with scientific misconduct. Committees have been established by the national medical research councils in Denmark (1992), Norway (1994), and Sweden (1997), and by the Ministry of Education in Finland (1994), to deal with scientific misconduct--ie, to initiate preventive measures, to investigate alleged cases, or both. Each committee includes both scientifically and legally qualified members. The employing institutions are responsible for possible sanctions or punishments. So far, 47 cases have been accepted for investigation, the majority (25) being Danish. Disputed authorship was the most frequent reason for investigation. Junior researchers made complaints in only three of the investigated cases. Investigations have been completed in 37 cases; in nine cases, dishonesty was revealed--two of them were related to the same researchers. Cooperation between the four Nordic committees has shown close agreement on specific issues and cases, despite minor differences in definitions, organisation, and procedures.

Advisory Committees↗

Community bioethics: the health decisions community council.

Health care decision making in modern society can pose a variety of complex issues for consideration by individuals, families, and providers. The Health Decisions Community Council (HDCC), a community-based bioethics committee, was established to offer a noninstitutional forum for discussion of difficult health care dilemmas. Social work skills and values for autonomy and self-determination are essential to the formation of the HDCC as a model for community bioethics discussions.

Bioethical Issues↗

Do committees ru(i)n the bio-political culture? On the democratic legitimacy of bioethics committees.

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.

Advisory Committees↗

Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems.

Analysis of Variance↗

Ethics review of social, behavioral, and economic research: where should we go from here?

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examinees 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES--and in particular, behavioral health--research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.

Behavioral Research↗

The death of a healthy volunteer in a human research project: implications for Australian clinical research.

A healthy 19-year-old United States college student volunteer in a clinical research program underwent a bronchoscopy and died as a result of acute lignocaine toxicity. The major contributing factor in the tragedy was that the research protocol failed to specify an upper dose limit for lignocaine spray, although previous versions of the protocol had done so. We look at the implications of this case for Australian institutional ethics committees.

Adult↗

How ethical dilemmas are resolved.

The prevalence of ethics committees in long-term care facilities has been on the rise since 1970. This study explores the nature of these committees and how ethical dilemmas are resolved where there is no committee.

Committee Membership↗