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PubMed1989

Ethics committees and medical research: the Australian experience.

Australian ethics committees have a central role in the regulation of medical research. Recently this role has come under public criticism despite the fact that there are almost no Australian studies of the workings of ethics committees. This paper looks at the problems and advantages of ethics committees in the light of some studies, including two recent Australian investigations. It concludes by proposing a model of regulation that utilizes the strengths of ethics committees while avoiding the problems which can arise as a result of their self-regulating nature.

Australia↗
PubMed2000

Health researchers' views of ethics committee functioning in New Zealand.

AIMS: To find out, from the perspective of researchers, how ethics committees are dealing with matters of ethical concern in research on humans and to seek the views of researchers on their role in thinking through the ethical issues in research. METHODS: A sample of researchers was selected from the Health Research Council database of grant recipients. Information was sought, using a mailed questionnaire, in relation to essential elements of concern to ethics committees according to the 1996 National Standard, types of study undertaken, codes of practice, national application forms, multicentre review, aspects of committee function and the role of researchers. RESULTS: The response rate was 35/40 (87.5%). Approximately half the respondents commented favourably on most aspects of ethics committee functioning. Major criticisms were directed at the assessment of risks and benefits, scientific validity and handling of consent procedures. Consistent weaknesses in multicentre review, quality of advice and the composition of committees were noted. Positive aspects were: availability of chairpersons for discussion, the protection of vulnerable participants, the handling of the Health Information Privacy Code and the introduction of a national application form. Most researchers expected to take a major role in thinking through the ethical issues in their work. Half reported occasions where ethics committees had unnecessarily impeded research. CONCLUSIONS: The high level of commitment of researchers to ethics should be acknowledged by involving them more in guideline development and education. Perceived deficiencies in the range of expertise on ethics committees, particularly expertise to judge potential harms in experimental research, should be further investigated and addressed. Recommendations to improve the quality of ethical review include reducing the overload on committees by identifying categories of research which might not require full ethics committee review.

Ethics Committees↗
PubMed1992

Research and hospital ethics committees in Switzerland.

This paper presents the situation concerning research and hospital ethics committees (HEC) in Switzerland. In fact, HECs are almost nonexistent. All the so-called "Ethics Committees" deal with the review of research projects. As there is no legislation governing research on human subjects, the Swiss Academy of Medical Sciences (SAMS) has issued guidelines concerning research on human subjects and, more recently, guidelines concerning Research Ethics Committees (REC). There is a wide disparity in the composition and the functioning of these committees, however. Half of them belong to university hospitals. Six of them review two-thirds of all reviewed protocols. Many RECs function more as educational bodies to enhance the quality of submitted protocols than as committees having the task to control and prohibit particular research projects.

Advisory Committees↗
PubMedDate not supplied

The prevalence, composition, and function of ethics committees in nursing facilities: results of a random, national survey of American Health Care Association members.

OBJECTIVES: To determine the prevalence, composition, and function of ethics committees in extended care facilities in the United States. DESIGN: Descriptive survey by mail. SETTING: A 5% random sample (n = 851) of nursing facility members of the American Health Care Association (n = 17,020). Most of these facilities (75%) are intermediate care facilities; the remainder include a varying number of skilled beds. METHODS: An eight-item questionnaire was sent to the randomly selected 851 extended care facilities. The questionnaire inquired about the existence of an ethics committee, plans for formation when applicable, composition of the ethics committee, and its function. Survey data was coded and merged with information on facility characteristics that are part of the American Health Care Association's database. RESULTS: Of the responding facilities (n = 394), 34% reported the presence of a functioning ethics committee, with an additional 19% indicating definite plans for ethic committee formation. Forty-three percent expressed no interest in establishing an ethics committee, and 4% reported having had an ethics committee sometime in the past. The greatest proportion of committee time was spent in case review (39%) with lesser amounts of time expended in areas of policy formation (27%) and education (27%). Forty percent of the ethics committees performed two or fewer case reviews per year. Nearly all committees included the following disciplines in the membership: nurses (96%), physicians (95%), and social workers (89%). Facility administrators (77%) and clergy (70%) were frequently represented. Very few facilities reported representation by residents (8%) and Certified Nursing Assistants (2%). The Medical Director served as a committee member on 75% of the ethics committees, and in more than one-half of those instances, he/she was the sole physician on the committee. CONCLUSION: Ethics committees are currently active in or there are plans for their development in more than 50% of extended care facilities in the U.S. this represents a very significant increase in prevalence during the last decade. This tendency to form ethics committee's may slow considerably in the future. Ethics committees exhibit considerable variability in structure and function.

Journal Article↗
PubMedDate not supplied

Ethics committees and achievement of good clinical practice.

Local ethics committees (institutional review boards, or similar bodies) were established during the last decades at (bio)medical research institutions worldwide to serve as review bodies of the proposed research projects (inclusive protocols of clinical trials), and also to monitor if the ethical principles, including the requirements of good practice (clinical, laboratory, and scientific) are respected and fulfilled during the conduct of research projects. Existing pluralism of the philosophical background on which contemporary bioethics theories are developed is questioning seriously the ancient traditions of Hippocratic, non-utilitarian medical ethics, trying to promote more utilitarian and secular approaches. Individual physicians, or researchers, as well as the ethics committee itself, are faced today with complicated ethical dilemmas, that frequently have to be solved in the atmosphere of considerable social, collegiate, economical, and time pressures, and sometimes without helpful guidance of appropriate legislation. An interesting possibility of how to overcome some of the pitfalls of the ethics review process is to express a common ethical responsibility for the research project or trial protocol in a statement of most (or all) parties involved (such as the principal investigator, sponsor, ethics committee, the patient, "society'). Such an approach has proven helpful in enhancing concrete deliberations of ethics committees-established in Slovakia since 1991 according to the requirements of the national guidelines issued by the Slovak Ministry of Health.

Clinical Trials as Topic↗
PubMed1993

Today's ethics committees face varied issues. A CHA survey reveals committees' functions, authority, and structure.

In a survey of Catholic Health Association member hospitals, 92 percent indicated they have formal ethics committees at their institutions. Sixty-two percent said their ethics committees were formed between 1983 and 1989. The survey found that current ethics committees are still committed to their traditional roles--education, policy development, and case review--but the education is directed to more diverse audiences than in the past. Support for medical and nursing staffs may be emerging as another possible function of ethics committees. The issues that precipitated the formation of institutional ethics committees have become more complex. In particular, questions involving the appropriate use of technology, the renewed awareness of patients' rights, changing relationships among healthcare providers, and conflicting social values have continued to require the intervention of ethics committees. However, the frequency with which respondents said their committees provide case consultations seems lower than it should be if committees were used to their full advantage. The institutional ethics committee can play a part in enlarging the current healthcare reform debate and promoting moral values. It can address such important questions as, Should the well-being of individuals take precedence over the well-being of communities?

Bioethical Issues↗
PubMed1991

Medical ethics committees in Hungary.

Hungarian medical ethics committees were established at the end of the 1950s. They came into being on the Communist Party's initiative. They could hardly be called "interdisciplinary" since their membership was made up of high-ranking physicians and a few head nurses. Their main task was to counter the practice of "tipping." Medical ethics and "tipping" were practically synonymous. These committees did not confront or try to resolve ethical problems concerning such issues as patient rights, informed consent, refusal of treatment, human experimentation, abortion, etc. These committees - whether it is believable or not - belonged to the Physicians Health Workers Trade Union. They were under the guidance and supervision of this social organization. The public was excluded from their meetings, and the committees' duty was to follow the health laws which were supposed to have given excellent ethical guidance. Even in a textbook on medical ethics used at one of the medical universities, written by a psychiatrist, the health laws were presented and explained back and forth. Of the 88 pages only 23 dealt with morals in general and the Hippocratic tradition. The Hungarian National Health Service as well as its medical ethics committees are similar in many respects to the Soviet and Eastern European countries' health care system and ethics committees. Since radical changes have taken place in these so-called "former" communist countries, it can only be hoped that these committees will eventually develop into groups who will deal directly with the moral questions or medicine and health care.

Communism↗
PubMed1989

Ethics committees for "high tech" innovations in Japan.

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public and bioethicists in Ethics Committee in Japan.

Advisory Committees↗
PubMed1991

Present status of ethics committees of the medical schools in Japan.

Present features and functions of ethics committees in 80 Japanese medical schools were surveyed through inquiries to those institutes by the author. Seventy nine schools have already started their own committees in each campus by the end of 1990, and the remaining one is preparing for its start in near future. The major role of the ethics committee may be said to roughly correspond to that of the Institutional Review Boards (IRB) in the USA, although a role of the hospital ethics committee has been played in addition to its proper functions in many schools. Among many problems two major drawbacks seem necessary to be removed urgently. The first one is an inappropriate composition of the committee in the majority of schools. More members from the outside of the campus, younger generations, and female reviewers should be added to the committee. The second point is the essentially closed review systems in most schools. The process of the review has not been effectively opened to the public yet, even in case in which no privacy of the patients or volunteers appears in the discussion. Several schools are preparing for opening now and the situation will be improved gradually. It was fortunate that the ethics committees in Japanese medical schools were founded by wills and efforts of members of each campus without having any suggestions, recommendations, or orders from the national government or other officials.

Bioethical Issues↗
PubMed1989

A survey of Army clinicians on hospital ethics committees.

The use of hospital ethics committees (HECs) has increased over the previous 5 to 8 years. A recent survey of physician-administrators in Army Medical Centers and community hospitals revealed that most favored the existence and utilization of these committees within their own hospitals. A follow-up survey was conducted to ascertain the perceptions that clinicians in Army Medical Centers have of these committees and their current or potential utilization in Army hospitals. The results indicate that clinicians as well as physician-administrators in the Army view these committees as beneficial.

Bioethical Issues↗
PubMed2006

Ethics committees in Croatia in the healthcare institutions: the first study about their structure and functions, and some reflections on the major issues and problems.

OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the healthcare institutions (excluding pharmacies and homecare institutions) to identify all ethics committees. SETTING: Croatia six years after the implementation of the Law on the Health Protection. MAIN MEASUREMENTS: Structure and function of ethic committees in the healthcare institutions. RESULTS: 46% of the healthcare institutions in Croatia (excluding pharmacies and homecare institutions) have an ethics committee; 89% of ethics committees have 5 members 3 of whom are from medical professions and 2 come from other fields; 49% of those committees stated that their main function is the analysis of research protocols. Only a small fraction of those ethics committees sent in standing orders, working guidelines or other documents that are connected with their work. CONCLUSIONS: Although there are legal provisions for ethics committees in the healthcare institutions in Croatia, there is an evidence of discrepancies between the practice and the "Law on the Health Protection," suggesting the need for revision of the law. There is a need for creating separate networks of HECs and IRBs in Croatia. In comparison with other countries, the development of ethics committees in Croatia has some similarities with other transitional societies in Europe. Additional research should be undertaken in the work of ethics committees in Croatia in order to understand committees' group dynamics, attitudes, and knowledge.

Croatia↗
PubMed2002

Are gastroenterologists aware of the role of ethics committees?

BACKGROUND/AIMS: A hospital ethics committee (EC) is an organized body of people, convened to identify, analyze and help resolve moral problems that arise in the care of patients. The aim of this study was to investigate the need to educate endoscopists about the role of the ECs in European and Mediterranean countries. METHODS: A structured questionnaire concerning the role of ECs was sent to the representatives of endoscopy societies, which are also members of the European Society of Gastrointestinal Endoscopy. RESULTS: The response rate was 59% (26/44). About half of the responding representatives had attended more than 1 lecture or read more than 1 article about ethics during the previous 10 years. The percentage of hospitals with an established EC varied between countries. In 15% of the countries <20% but in 58% of the countries >60% of the hospitals have established ECs. Sixty-five percent of the responders believe that the EC is an advisory committee and 31% an executive committee. Endoscopists believe that ECs have been of great help to their specialty in their country. CONCLUSIONS: The roles of the ECs are not clear to endoscopists and there is a need for education in this field.

Endoscopy, Gastrointestinal↗
PubMed1998

Hospital ethics committees and nurses' participation.

The hospital ethics committee's mandates of patient care review, policy formation, and education make them central to nurses and healthcare delivery. In a study examining nurses' communication exchange frequency and perceived effectiveness as members of hospital ethics committees, nurses represented the largest proportion, were moderately active, and rated their participation effectiveness the highest: they are more involved in discussions regarding patients than policy formation and education. Nurse administrators can provide strategies and education for nurses that enhance nurses' participation in all three committee functions. Policies affect patient care; therefore, policy decisions, too, benefit from nurses' participation.

Communication↗
PubMed1992

An ethics committee for a HMO an oxymoron? Certainly not!

In developing a plan-wide ethics committee for a health maintenance organization (HMO), one will inevitably be faced with the numerous differences between a HMO and any other health care facility. These differences offer advantages and disadvantages with regard to the formation of an ethics committee and strongly influence the logistics and functions of such a committee. Managed health care is a new arena for an ethics committee, one in which the role of an ethics committee is beginning to unfold.

Ethics Committees↗