Science, politics, and public policy: a legislator's perspective.

Making judgments on priorities in funding is a politican's most difficult task. Scientific information is often necessary to make those judgments, so that good communication between scientist and politican is important. This is, however, difficult because the politician's usual training and working habits are different from those of the scientist. Messages to politicans must therefore be couched differently than in communications between scientists. These messages are more effective when they are concerned with the public need than when they plead for special interests. These messages are most effective when directed to those politicians serving on committees that must deal with the specified issue because Congress makes most political decisions through these committees. Committee members and committee staff members turn to scientists whom they know personally, so that getting to know the members of Congress and the key staff members of committees facilitates communication between science and public policy.     

Diversity in the practice of district ethics committees.

A survey of ethics committees in district health authorities was carried out to find out the size and make up of committees and what information and guidance they offered to scientists who apply to do research. A sample (n = 28) of committees in England (n = 190), half from teaching districts and half from non-teaching districts, was contacted by post requesting this information. A high degree of diversity was found, not only in the methods that committees used but also in the ethical criteria each considered to be pertinent for research. It was also shown that published guidelines have made little impact. It is suggested that issuing more guidelines will be of limited use. Rather, the following are needed: information about why guidelines have been widely ignored, better communication between committees, some form of education for committee members, and a formal register of committees compiled.     

Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability.

The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically by endorsing new research which is unnecessary and by acquiescing in biased under-reporting of research which they have approved. The performance and accountability of research ethics committees would be improved if they required those proposing research to present systematic reviews of relevant previous research in support of their applications; to summarise the results of these reviews in the information prepared for potential participants; to register new controlled trials at inception; and to ensure that the results of these trials are made publicly available within a reasonable period of time after completion of data collection.     

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.     

Publication: an ethical imperative.

Publication of medical research is both a monitor of the researcher''s ethics and an audit of the local or regional ethics committee that approved it. Selectivity of publication or of the intention to publish lessens this audit. Opinions differ about what is ethically allowable in clinical and benchtop medical research. Ethical permission and ethical monitoring of medical research are subject to a hierarchy of pyramidal controls, starting in hospital and ending with the local, institutional, or regional ethics committee. Currently, such committees function with widely varying degrees of efficiency and quality of output, and with differing viewpoints on many ethical issues. Without an a priori insistence by institutional ethics committees that there be an intention to publish all medical research involving human subjects, ethics committees cannot routinely be subject to the scrutiny or audit which they themselves demand of researchers.     

Who should Decide for the Unrepresented?

Unrepresented patients lack the capacity to make medical decisions for themselves, have no clear documentation of preferences for medical treatment, and have no surrogate decision maker or obvious candidate for that role. There is no consensus about who should serve as the decision maker for these patients, particularly regarding whether to continue or to limit life‐sustaining treatment. Several authors have argued that ethics committees should play this role rather than the patient's treating physician, a common current default. We argue that concerns about the adequacy of physicians as surrogates are either empirically unfounded or apply equally to ethics committees. We suggest that physicians should be the primary decision maker for the unrepresented because of their fiduciary duties toward their patients. As part of the process of fulfilling these duties, they should seek the advice of third parties such as ethic committees; but final end‐of‐life decision‐making for the unrepresented should rest with the treating physician.     

Facets of patient complaints: pain, suffering, and the importance of consideration

Patient complaints, as it has often been recognized, serve to express multiple and varied experiences and needs. A number of options for filing complaints and a variety of ways for doing so have arisen recently, among which are ethics committees, support groups, palliative care units, and complaint examination committees. Today patients have many occasions for expressing their experiences, talking about distressing incidents, and making their needs known. Three orally related experiences are examined here, both from the viewpoint of the patient and in light of their cultural meanings: pain, suffering, and the importance of consideration. These are three expectations of care providers, but also three experiences that dispose patients to rethink their individuality and their relationships with others, to take stock of their pasts, and to reflect on who they are and who they want to become. The experience of illness has thus become pivotal in the process of constructing individual identity.     

Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.     

Research ethics committees: differences and moral judgement

Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to 'harmonise' their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, an so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive for complete consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this 'the justice argument.' The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the 'moral pluralism argument.' The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the 'due process argument.' While we fall short of establishing exactly how much variation and on what substantive issues would ethical permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research.     

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.     

From a culture of blame to a culture of safety--the role of institutional ethics committees

Institutional ethics committees are largely absent from the literature on patient safety, but if health service organizations are adequately to address medical error and patient safety, they must change internally from a "culture of blame" to a "culture of safety." This paper (1) looks at the concept of organizational culture as it currently exists and its components (jobs, people, and situations); (2) describes the safety culture in other high risk industries and (3) makes concrete suggestions to the health services industry. In particular, the author suggests that the functions and roles of ethics committees (ethics education, policy review and development, and case consultation) lend themselves perfectly to the development of those organizational characteristics that would support the creation and maintenance of patient safety culture in the healthcare industry.     

Examination of the Distinctive Awards System.

When they stopped secrecy, the consultants of an internationally-famous postgraduate teaching centre in psychiatry--not a designated teaching hospital--discovered that they had one-tenth the national average of distinction awards. Subsequent investigation of the whole system suggests that this is not an isolated case. Moreover, official figures are scanty and misleading. This paper explores the difficulties in understanding, investigating, and influencing the system. The composition of the committees involved, the de facto quota system, the method of collecting information, and the convention of secrecy are examined and critized.     

On the Alleged Right to Participate in High‐Risk Research

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non‐minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there should be limits of permissible risks in non‐therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high‐risk research’. I argue that this idea is ill‐founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees.     

The Selection of Medical Students in Western Canada

The methods employed in the selection of medical students for the 1964-65 class of freshmen at the four Western medical schools are described and recommendations are made for improving the procedure. The structure and functions of the various selection committees varied from school to school but their prime purpose was the same—the selection of “good students” who would later become “good physicians”. Not surprisingly, academic achievement and confidence in estimating this ranked highest in importance, and while non-intellectual characteristics ranked almost as high, committee members had no confidence that they could evaluate these qualities.It is suggested that the ideal selection committee would be a “high-priority” committee consisting of six to eight members who would meet at least twice a year, have tenure of at least four years, be trained in interviewing applicants, consider Medical College Admission Test scores, review applications before each meeting, and establish research committees to investigate the students they choose.     

A critical analysis of Australian clinical ethics committees and the functions they serve

The predominant function of Australian clinical ethics committees (CECs) is policy formation. Some committees have an educational role. Few committees play any direct role in advising on ethics in the management of individual patients and this occurs only in exceptional circumstances. There is a tendency to exaggerate both the number and function of committees. It is suggested that studies of ethics committees, based on questionnaire surveys, should be interpreted cautiously. An examination of ethical issues indicates that there is a role for a critical analysis of power relations in Australian hospitals that is not fulfilled by CECs.     

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

ObjectiveTo assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.DesignProspectively 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.SettingA single multicentre research ethics committee and 125 local ethics committees from six regions of England.ResultsOnly 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.ConclusionsThe 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.     

What are health authorities doing about the health problems caused by unemployment?

Unemployment is over three million in Britain, and unemployment is known to be associated with poor health. It has been suggested that health authorities should produce a comprehensive response to the health problems caused by unemployment, and a survey was undertaken to find how many had done so. All the regional and district health authorities in England, the health boards of Wales, Scotland, and Northern Ireland, and the family practitioner committees of England and Wales were asked by letter what they were doing to respond to the health problems of unemployment. A list of suggestions of what they might be doing was enclosed. The overall response rate was 77% (255/331), and 50% (127/255) of the respondents were doing something--33.3% (3/9) of the regional health authorities, 64% (101/158) of the district health authorities and health boards, and 26% (23/88) of the family practitioner committees. The paper describes what they were doing. A relation was sought between the level of unemployment in an area and the extent of the response, and a significant association was found. Half of Britain''s health authorities are now responding in some way to the health problems associated with unemployment.     

Should society allow research ethics boards to be run as for-profit enterprises?

BACKGROUND TO THE DEBATE: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval.     

CAPACITY BUILDING OF ETHICS REVIEW COMMITTEES ACROSS AFRICA BASED ON THE RESULTS OF A COMPREHENSIVE NEEDS ASSESSMENT SURVEY

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31).
In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems.
Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.     

生命伦理学委员会

生命伦理学委员会是从伦理学角度审查人体试验研究,保护受试者权益的决策咨询组织。该委员会一般由来自法学、伦理学、医学、药学等领域的专家学者组成,其审查遵循的重要依据是世界医学会制订的《赫尔基辛宣言》。近年来,伦理委员会快速发展,但各伦理委员会审查质量参差不齐。因此,相关部门尚需加强对伦理委员会成员的培训,并加强对伦理委员会的监管,方能促进我国伦理委员会的良性发展。