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A national study of ethics committees.

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they have played compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent of ethics committees report that they played a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies.

Data Collection↗

The new system of review by multicentre research ethics committees: prospective study.

OBJECTIVE: To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. DESIGN: Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. SETTING: A single multicentre research ethics committee and 125 local ethics committees from six regions of England. MAIN OUTCOME MEASURES: Time to reply, time to approval, and number of non-local changes to the application requested. RESULTS: Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. CONCLUSIONS: The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.

Costs and Cost Analysis↗

Ethics committees: time to experiment with standards.

Ethics committees now exist in most hospitals. Their recent establishment in many institutions was a response to a 1991 mandate by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Proposed or new legislation in a few states is elevating the status of these committees, either requiring their use in certain cases, allowing them to substitute for judicial review, or granting immunity to those who follow their advice. Despite these recent JCAHO and legislative developments, it is widely recognized that there is a significant lack of data on the effectiveness of these committees and that committee members often lack the requisite education and skills for effective participation in case consultation. We argue that before granting ethics committees additional authority, there is a need for more research on their performance and a period of experimentation with quality standards governing their membership and operations.

Bioethical Issues↗

Ethics committees in critical care.

Ethics committees have emerged as a way for institutions to evaluate and resolve some of the difficult decisions facing critical care medicine. This article examines their origin, scope, function, and potential problems.

Critical Care↗

Ethics consultants and ethics committees.

To address moral questions in patient care, hospitals and health care systems have enlisted the help of hospital ethicists, ethics committees, and ethics consultation services. Most physicians have not been trained in the concepts, skills, or language of clinical ethics, and few ethicists have been trained in clinical medicine, so neither group can fully identify, analyze, and resolve clinical ethical problems. Some ethics committees have undertaken clinical consultations themselves, but liability concerns and variable standards for membership hinder their efforts. An ethics consultation service comprising both physician-ethicists and nonphysician-ethicists brings complementary viewpoints to the management of particular cases. If they are to be effective consultants, however, nonphysician-ethicists need to be "clinicians": professionals who understand an individual patient's medical condition and personal situation well enough to help in managing the case. Ethics consultants and ethics committees may work together, but they have separate identities and distinct objectives: ethics consultants are responsible for patient care, while ethics committees are administrative bodies whose primary task is to advise in creating institutional policy.

Consultants↗

Unequal protection for patient rights: the divide between university and health ethics committees.

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health resarchers and their patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process.

Codes of Ethics↗

Hospital ethics committees: problems in evaluation.

Hospital ethics committees continue to proliferate, despite the fact that their impact upon practice has not been rigorously evaluated. This paper investigates the reasons why the often recommended evaluation has not yet occurred. One reason cited is that three different roles - education, policy formulation, and case review - need to be assessed. The principal reason why the most novel of the roles, case review, has not been evaluated is because of unresolved dispute over the goals of review.

Conflict, Psychological↗

What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics.

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should have the power to prohibit the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations.

Attitude to Health↗

[Do ethics committees hinder progress in medicine?].

Research Ethics Committees are instruments which allow the medical profession to control the research with human subjects. In this context, some medical researchers criticize the increasing bureaucracy and the hindrance of research which interfere with the ability to compete in international research. On the other hand, the public criticizes the missing transparency, independence and democratic legitimization of Research Ethics Committees as well as the possible conflicts of interests of their members. The medical research with human subjects who are incompetent to give informed consent serves as an example to show the necessity of quality control and standardized criteria of assessment. By comparison with the development of Institutional Review Boards in the United States, ideas for the necessary changes of Research Ethics Committees in Germany regarding their work, assembly and transparency are developed.

Cross-Cultural Comparison↗

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.

Attitude of Health Personnel↗

[Ethics committees: medical treatment counseling or prescribing?].

Ethics committees react to the crisis of justification of both research and treatment in modern medicine. Their composition, functioning, task, and identity depend on the question if they consider themselves as instruments of controller consultation. The more moral thinking in medicine is oriented towards support for reasoning, towards consultation for solving conflicts of motivation, and in elucidation interests the more ethics committees will succeed in becoming institutions of consultation by ethical reasoning in medicine.

Ethics Committees↗

Two models of ethics committees.

A distinction is made between two models of ethics committees. According to the Mirror Model, ethics committees ought to reflect the values of society. The Critical Model says committees are to critically examine these standards rather than merely reflect them. It is argued that the Critical Model should be accepted because a society's ethical standards can be mistaken and a society that has Critical rather than merely Mirror ethics committees is more likely to have such mistakes revealed. Some implications of the Critical Model are discussed.

Animal Care Committees↗

St. Louis system has Corporate Ethics Committee. Sisters of Mercy Health System has developed an approach for assisting in the integration of ethics and operations.

Despite the relatively recent advent of organizational ethics committees--created to address operational concerns that are not always appropriate for a clinical ethics committee to take on--there remain impediments (such as time constraints, limited ethical expertise, lack of senior leaders at the table, and waning interest of members) to the impact such a group might have. Committed to addressing operational concerns in a meaningful and "value-added" way, and mindful of the challenges that can limit the effectiveness of organizational ethics committees, the St. Louis-based Sisters of Mercy Health System developed an approach that has proven successful. Without changing the committee's goals-education, policy, and consultation-Mercy's renewed Corporate Ethics Committee was restructured to include ethical experts, people knowledgeable about particular issues, and people with authority.

Ethics Committees↗

Research ethics committees: a comparative study of assessment of ethical dilemmas.

Research ethics committees (REC) constitute an important instrument for the regulation of biomedical research involving human beings. The purposes of this work were to study the ethical reasoning in RECs and to ascertain whether the composition of RECs has any bearing on the decisions subsequently made by them. We used a postal questionnaire, containing authentic cases of research ethical dilemmas, sent to the ten RECs in Sweden (n = 124) and to comparison groups consisting of 200 randomly selected medical researchers, 200 randomly selected healthcare politicians and 200 randomly selected district nurses. The average response rate was 68%. A difference was found in how REC members assess a project in comparison with researchers, healthcare politicians and district nurses. Differences depended on the type of project assessed. The study indicates that membership in RECs may exert a normative influence on its members. It is proposed that this investigation should be followed up by a study with a qualitative design.

Adult↗

[Clinical ethics committees are tested in Norway].

Health care ethics committees are now established at three hospitals in Norway as a result of a three year project in cooperation with the Centre for Medical Ethics and the Ministry of Health and Social Affairs. This article describes the project and discusses various difficulties regarding the establishment and functioning of health care ethics committees, such as their mandate and membership, the understanding of ethics and methodology, the role of ethical expertise and the relation between physicians' decision-making responsibility and a health care ethics committee.

Clinical Competence↗

The benefits of serving on a hospital ethics committee: a faculty perspective.

Community hospitals ethics committees rarely have formal support from persons within the academic community. The author discusses a liaison between a suburban hospital system and a nearby university school of nursing that garners positive educational, service, and programmatic benefits, related to ethics, for both. The lessons learned and insights gained by a faculty member serving on the ethics committee are examined.

Altruism↗