Ethics committees in Japanese medical schools

The present features and functions of ethics committees in 80 Japanese medical schools were surveyed by employing questionnaires. Seventy-nine schools had already established committees on each campus (however, the ethics committee at Kitasato Medical University was formally established after the completion of this survey). The major role of Japanese ethics committees may be said roughly to correspond to that of Institutional Review Boards (IRB) in the U.S., although ethics committees have other functions as well. Among the ethics committees' many problems, two significant weaknesses should be underscored. The first is the inappropriate composition of the membership of the committees: more non-campus members, younger professionals, and women should be invited to participate. The second concern is the committees' essentially closed review process: this process has not been adequately open to the public even in cases in which the issue of the patient's confidentiality does not arise. However, several schools are now preparing to open their meetings to non-members and this policy should improve the present situation. It is fortunate, however, that the ethics committees in Japan's medical schools were established by members from each campus and not as a response to national directives or legislation.     

Time for professionalising the system of medical ethics review in the Netherlands

In two recent papers, a radical change of the review system for medical ethics review committees was proposed. The current systems in Great Britain and Australia were described and it was suggested that the extended roles and responsibilities of the medical ethics review committees could not be fulfilled by the present committees. It was proposed that professional medical ethics committees be established with full time members who would receive an appropriate honorarium. The Netherlands has a decentralised system of medical ethics review, which is based on peer review. A radical change of the current system of medical ethics review is not warranted. There is however a need for further improvements to the current peer-review system. An important aspect of this improvement is an honorarium for the members as well as a budget for training and for the adequate scientific and administrative support of the committee by a secretariat. The fees levied for reviewing each protocol could in part finance the committee and its secretariat. However, these fees will probably not meet all of the costs. Therefore the centres involved in medical research should consider supporting their committees. It is in their interest to demonstrate their wish to protect those persons who consent to participate as research subjects. This will maintain the confidence of both the public and future participants in clinical trials. Furthermore, an efficient and adequate system of ethical review will support a balanced view towards medical research with human subjects and will also contribute to a positive image of the centre also as an attractive environment for medical professionals.     

Maryland hospitals get plan for creating ethics committees

The Maryland Hospital Association's Advisory Committee on Medical Ethics, charged to assist member hospitals in forming ethics committees, focused on four concerns: study and development, physician support, patient/family participation, and potential issues. The committee recommended as a first step in establishing an ethics committee the creation of a study group. It warned hospitals not to expect a fully operational ethics committee immediately. A start-up period, according to the committee, should be used to develop a process for handling ethical questions and for educating the hospital community about the committee's role. To promote the best possible decision making, the hospital ethics committee should function as a support unit, for physicians as well as for patients, families, and hospital personnel. Clearly stated policies will provide a basis for appropriate intervention and help gain physician cooperation, the committee said. Such policies should encourage ethics committees to anticipate problems and to review decisions already made. While recognizing the need to involve patients' families in decision making, the advisory group agreed that the question of their presence at committee meetings should be addressed by each institution. In cases of controversial treatment or disagreement about the course of treatment, patient/family access to the committee should be clearly defined. The advisory committee suggested that each institution prepare its own list of topics that an ethics committee might consider. It also prepared a "model statement" of an ethics committee's purposes, membership, and procedures.     

Health research ethics review and needs of institutional ethics committees in Tanzania

This study was undertaken to describe the performance of health research ethics review procedures of six research centres in Tanzania. Data collection was done through a self-administered questionnaire and personal interviews. The results showed that there were on average 11 members (range = 8-14) in each Research Ethic Committee. However, female representation in the committees was low (15.2%). The largest proportion of the committee members was biomedical scientists (51.5%). Others included medical doctors (19.7%), social scientists (7.6%), laboratory technologists (10.6%), religious leaders (4.5%), statisticians (3.0%), teachers (1.5%) and lawyers (1.5). Committee members had different capacities to carry out review of research proposals (no capacity = 2%; limited capacity = 15%; moderate capacity = 20%; good capacity = 48%, excellent capacity = 13%). Only half of the respondents had prior ethics review training. Although the majority deemed that ethical guidelines were very important (66%), there were challenges in the use of ethical guidelines which included lack of awareness on the national accreditation mechanisms for ethics committee (59%). Adherence to ethical principles and regulations was influenced by being a scientist (OR = 42.47), being an employee of a professional organization (OR = 15.25), and having an interests in the use of ethical guidelines (OR = 10.85) These findings indicate the need for capacity strengthening (through training and resource support), inclusion of more female representation and other mandatory professions to the research ethics committees.     

State level expert review committees--are they protected?

Recently, the functioning of State-level expert review committees, operating under the auspices of professional medical societies, has become problematic. In particular, an increased number of State maternal mortality review committees have become inactive or disbanded primarily because of concern over liability of committee members and committee proceedings being used in litigation. A study was conducted of legal protection of the expert review process at the State level. The relevant immunity and privilege statutes of each State and the protection afforded by State law were analyzed. Findings show that, in all but a few States, the legal risk of participating in expert review is negligible. Most States have statutes that protect information involved in the review process from disclosure or use in subsequent litigation. Laws in most States also protect participants in the review process (both members of committees and providers of information) from civil liability.     

Ethics Committees in the Rural Midwest: Exploring the Impact of HIPAA

ABSTRACT:  Context: Confidentiality of personal health information is an ethical principle and a legislated mandate; however, the impact of the Health Insurance Portability and Accountability Act (HIPAA) on ethics committees ethics committees is limited. Purpose: This study investigates the prevalence, activity, and composition of ethics committees located in rural central and southern Illinois. Additionally, the impact of the HIPAA Officer serving on the committee is reported. Methods: Surveys were mailed to the "Administrator or Ethics Committee Chairperson" at rural Illinois hospitals and skilled care facilities. Survey items included committee composition and perception of HIPAA-related involvement. Findings: Over one third (36.7%) of the facilities reported having formal ethics committees. Hospitals were more likely (79.3%) to have ethics committees than skilled nursing facilities (20.7%). Ethics committee members usually include an administrator, nurse, and physician. The smaller the facility (based on number of beds), the more likely it was to have a HIPAA Officer on the committee. Committees with a HIPAA Officer were more likely to be involved in monitoring and/or remediation of HIPAA privacy and security violations. Most respondents, however, did not feel the committee should be involved in these issues. Conclusions: Although the sample size is too small to generalize, HIPAA does seem to have an effect on the issues discussed by ethics committees. Furthermore, ethics committees that include a HIPAA Officer in the membership report increased committee involvement in HIPAA related issues .     

Neuordnung des Verfahrens und der Aufgaben der zuständigen Ethik-Kommissionen

Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).     

Ethics committees in neonatal care: substantive protection or procedural diversion?

The federal government, the American Academy of Pediatrics, and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research have all proposed the establishment of hospital ethics committees to solve decision making dilemmas in neonatal as well as other critical care areas. Annas argues that education, consultation, and policy making are inappropriate committee functions and identifies individual case adjudication as the only role uniquely suited to ethics committees. He concludes that the first priority is the development of substantive standards on which committee decisions can be based.     

A welcome guide for evaluating medical research involving human subjects

In 1999, the Dutch Medical Research Involving Human Subjects Act came into force. The principal aim of this Act is to provide protection for human subjects who take part in medical research. Medical research involving human subjects may only be carried out after it has been approved by a recognised medical ethics committee. A central committee (Dutch acronym: CCMO) regulates the recognition of the local medical ethics committees and monitors their performance. For some types of research the protocol has to be reviewed by the CCMO itself. These are: non-therapeutic research involving children and mentally incompetent patients and research on gene therapy, xenotransplantation and embryos. The CCMO has recently published a guide for the local medical ethics committees. It presents an excellent overview of all the legal and practical aspects of the work of medical ethics committees. The guide is highly recommended.     

Ethics committees and health services research

Ethics committees in Britain were set up to consider clinical research. Increasingly, however, they are receiving applications for health services research which often involves several or many centres. The performance of 23 ethics committees was examined through a case-study of an application for a multi-centre non-experimental study of prostatectomy. Although all the committees approved the study, long delays occurred (mean 11.5 weeks, range 3-32 weeks), particularly in teaching districts which dealt with large numbers of applications. The composition of the committee and the frequency with which it met were not associated with the time taken to reach a decision. Some delays might be reduced by improving the design of the application forms and ensuring that at least one member of the committee has an understanding of health services research methods. Although such measures might improve the performance of committees, applicants are likely to remain in a logistic trap between funding bodies, clinicians, and ethics committees. In addition, until committees temper their concern for individualistic medical ethics with a collective ethic of the common good, health services research may continue to experience delays and difficulties.     

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.     

Evaluation of Viewpoints of Health Care Professionals on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas Based on Practice Environment

We sought to evaluate whether health care professionals’ viewpoints differed on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas based on practice location. We conducted a survey study from December 21, 2013 to March 15, 2014 of health care professionals at six hospitals (one tertiary care academic medical center, three large community hospitals and two small community hospitals). The survey consisted of eight clinical ethics cases followed by statements on whether there was a role for the ethics committee or hospital in their resolution, what that role might be and case specific queries. Respondents used a 5-point Likert scale to express their degree of agreement with the premises posed. We used the ANOVA test to evaluate whether respondent views significantly varied based on practice location. 240 health care professionals (108—tertiary care center, 92—large community hospitals, 40—small community hospitals) completed the survey (response rate: 63.6 %). Only three individual queries of 32 showed any significant response variations across practice locations. Overall, viewpoints did not vary across practice locations within question categories on whether the ethics committee or hospital had a role in case resolution, what that role might be and case specific queries. In this multicenter survey study, the viewpoints of health care professionals on the role of ethics committees or hospitals in the resolution of clinical ethics cases varied little based on practice location.     

The Presence of Ethics Programs in Critical Access Hospitals

The purpose of this study was to assess the presence of ethics committees in rural critical access hospitals across the United States. Several studies have investigated the presence of ethics committees in rural health care facilities. The limitation of these studies is in the definition of ‘rural hospital’ and a regional or state focus. These limitations have created large variations in the study findings. In this nation-wide study we used the criteria of a critical access hospital (CAH), as defined by the Medicare Rural Hospital Flexibility Program (Flex Program, 2007), to bring consistency and clarity to the assessment of the presence of ethics committees in rural hospitals. The Flex Monitoring Team conducted a national telephone survey of 381 CAH administrators throughout the United States. The survey covered a wide variety of questions concerning hospitals’ community benefit, impact activities, and whether the hospital had a formally established an ethics committee. About 230 (60%) of the respondents indicated they had a formally established ethics committee or ethics consultation program at their CAH. The prevalence of ethics committees declined as the CAH location became increasingly rural along a rural–urban continuum. Unlike CAHs, all rural Department of Veterans Affairs Medical Centers have ethics committees. The results of this study provide an understanding of the limited presence of ethics committee in rural America and the need to consider new approaches for providing ethics assistance. A virtual ethics committee network may be the most efficient and effective way of providing rural hospitals access to a knowledgeable ethics committee or consultant.     

Taking on organizational ethics. To do so, ethics committees must first prepare themselves

Healthcare ethics committees which have focused almost entirely on clinical ethics, now need to prepare to deal with organizational ethics, a field that is attracting increasing attention. As they did with clinical ethics, ethics committees members must educate themselves in the demands of the newer field. As before, they must respect the perspectives of the actual decision makers while maintaining an independent framework for analyzing the issues at stake. They must ensure that management is properly represented on the committee if they need guidance from a professional ethicist they should seek one with a strong background in business ethics and social justice. Healthcare organizations are likely to need help with a wide range of ethical issues involving patient services (rationing of resources, for example), business and service plans (mergers and joint ventures, for example), business and professional integrity (conflicts of interest, for example), employee rights and responsibilities (downsizing, for example), and the organization's role in in the community (advocacy and lobbying, for example). To be helpful to the organization, the ethics committee must be prepared to say when cost factors trump other considerations and when they do not. An ethics committee will often be asked to give advice on specific occasions-a proposed new policy, for instance. The most important part of its response is its analysis of the issue. Finally, an ethics committee should view its organization as part of the larger social context.     

Ethics that exclude: the role of ethics committees in lesbian and gay health research in South Africa

Prevailing state and institutional ideologies regarding race/ethnicity, gender, and sexuality help to shape, and are influenced by, research priorities. Research ethics committees perform a gatekeeper role in this process. In this commentary, we describe efforts to obtain approval from the ethics committee of a large medical institution for research into the treatment of homosexual persons by health professionals in the South African military during the apartheid era. The committee questioned the "scientific validity" of the study, viewing it as having a "political" rather than a "scientific" purpose. They objected to the framing of the research topic within a human rights discourse and appeared to be concerned that the research might lead to action against health professionals who committed human rights abuses against lesbians and gay men during apartheid. The process illustrates the ways in which heterosexism, and concerns to protect the practice of health professionals from scrutiny, may influence the decisions of ethics committees. Ethics that exclude research on lesbian and gay health cannot be in the public interest. Ethics committees must be challenged to examine the ways in which institutionalized ideologies influence their decision making.     

上海市医院伦理委员会伦理审核工作现状分析

对上海市33所公立医院进行了涉及人体生物医学研究的伦理审核状况的调查，结果显示，绝大多数医院伦理委员会均设有初始审核、快速审核与不良事件审核的相应操作规程和要求，但跟踪审核和不良事件审核需进一步加强，上海市医院伦理委员会的伦理审核程序需进一步统一。     

A survey of national ethics and bioethics committees

ObjectiveTo assess the current state of national ethics committees and the challenges they face.MethodsWe surveyed national ethics committees between 30 January and 21 February 2018.FindingsIn total, representatives of 87 of 146 national ethics committees (59.6%) participated. The 84 countries covered were in all World Bank income categories and all World Health Organization regions. Many national ethics committees lack resources and face challenges in several domains, like independence, funding or efficacy. Only 40.2% (35/87) of committees expressed no concerns about independence. Almost a quarter (21/87) of committees did not make any ethics recommendations to their governments in 2017, and the median number of reports, opinions or recommendations issued was only two per committee Seventy-two (82.7%) national ethics committees included a philosopher or a bioethicist.ConclusionNational ethics (or bioethics) committees provide recommendations and guidance to governments and the public, thereby ensuring that public policies are informed by ethical concerns. Although the task is seemingly straightforward, implementation reveals numerous difficulties. Particularly in times of great uncertainty, such as during the current coronavirus disease 2019 pandemic, governments would be well advised to base their actions not only on technical considerations but also on the ethical guidance provided by a national ethics committee. We found that, if the advice of national ethics committees is to matter, they must be legally mandated, independent, diverse in membership, transparent and sufficiently funded to be effective and visible.