How the diversity of membership of research ethics committees is arrived at has, to date, largely been fairly arbitrary. However, a tool to help determine one's moral preference is now available and it is introduced here as, arguably, having the potential to assist with ensuring a more meaningful diversity amongst an ethics committee's membership. The tool is seen to be easily applied – but, it is argued, may be conceived on at least two false premises. Firstly, despite (...) different theories of ethics, none can be proved to give the ‘right’ answer other than in its own terms. Secondly, if there is an ethical hierarchy, as the model suggests, then ethical diversity must become redundant for the possibility of achieving ethical excellence. (shrink)

This study examines the presence and roles of female directors of U.S. Fortune 500 firms, focusing on committee assignments and director background. Prior work from almost two decades ago concludes that there is a systematic bias against females in assignment to top board committees. Examining a recent data set with a logistic regression model that controls for director and firm characteristics, director resource-dependence roles and interaction between director gender and director characteristics, we find that female directors are less likely (...) than male directors to sit on executive committees and more likely than male directors to sit on public affairs committees. There is little if any evidence of systematic gender bias in director assignment to other board committees. We find some evidence that boards evaluate resource dependence differently for women than men. (shrink)

This paper focuses on the REC and its political context to clarify the process of ethical review. The examples initially considered are taken from a Research Ethics Review editorial to develop the social explanation of the membership and function of a research ethics committee. It is suggested that the management and administration of medical matters are not always best understood solely in medical terms. The conclusion of the paper is that the larger political relationships determine the membership (...) and function of the research ethics committee. The REC is defined as the political mechanism for formally socializing medical research and its lay members as similarly socializing the REC. (shrink)

Most clinical ethics committees (CECs) have lay members. Why are they there, how are they chosen, and what do they do? Can their presence make health professionals less prone to jargon and hospital politicking, and can the lay members ever hope to represent the broad sweep of patients when many of them are white, middle class females? As hospital managers embrace CECs and even boast about them, will their informality be lost, with consequent exposure of professional and lay members to (...) public scrutiny and criticism? Will brave, open discussion be stifled, and the purpose of the committees ultimately be lost? (shrink)

In this brief paper I intend to make some distinctions between the activities that research ethics committees are required to undertake as part of their role in protecting research participants. These functions are, identifying ethical issues and risks within research projects, providing advice on how to resolve these issues and risks without compromising the validity of the research and finally, when this cannot be achieved, deciding whether the research should still be allowed to go ahead. Distinguishing these distinct functions allows (...) us to determine what an appropriate membership of a Research Ethics Committee is. I will sketch out the implications of these functions for the appropriate membership of NHS and university based ethics committees in the UK. (shrink)

Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a descriptive (...) study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (χ 2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. Results The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC. Conclusion In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research. (shrink)

Bangladesh Bioethics Society (BBS) is inviting all National and International individuals and institutions from any discipline those who are interessted in bioethicsto to become a member of BBS. Bioethics is interdisciplinary study of philosophical, ethical, social, legal, medical, ethnological, environmental, economic, therapeutic, religious, and other related issues arising from biological sciences and technologies, and their applications in human society and the biosphere. Membership Benefits: Leadership Opportunities: Hold elective committee / Subcommittee of BBS Voting right: Right to vote in (...) BBS election. Networking: Be listed in and access online BBS member directory. Free Journal Subscription Access to attend bioethical meetings/ conferences/ seminars/ workshops on bioethics in county and abroad. Access to attend in research / training on bioethics. Access to attend Annual General Meeting Receiving the Societies Newsletters and other mailings concerning Society activities. Get priority for registration waiver, free accommodation and meals during conferences/ Seminars of BBS, in some cases travel grants. Reviews articles for the Journal and would be invited for lecture, book writing etc Please contact to Bangladesh Bioethics Society. (shrink)

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...) as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project. (shrink)

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 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. (shrink)

Since the 1988 Cartwright Inquiry, lay members of ethics committees have been tasked with ensuring that ordinary New Zealanders are not forgotten in ethical deliberations. Unlike Institutional Review Boards in North America, where lay members constitute a fraction of ethics committee membership, 50% of most New Zealand ethics committees are comprised of lay members. Lay roles are usually defined in very broad terms, which can vary considerably from committee to committee. This research queries who lay representatives (...) are, what they do, and what if anything they represent. Our findings are based on data collection with 12 participants: eight semi-structured interviews with lay members from diverse types of ethics committees who described their roles, and commentary from four ethics committee chairs, three of these lay members who commented on this article’s final draft. Findings indicate that the role of New Zealand lay persons – although distinctively valued – is otherwise similar to the documented role of lay persons within North American ethics committees. Lay members see their role as primarily protecting the research participant and at times offering a corrective to non-lay members’ views and the interests of their institutions. However, in spite of their numbers, most lay members do not see themselves as representing any particular constituent groups or institutionally unaffiliated areas of concern. On tertiary education committees especially, there is a good deal of ambiguity in the lay role. (shrink)

BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC (...) members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants. (shrink)

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. (shrink)

We examine three characteristics of audit committees and their impact on the financial reporting quality for Singapore-listed companies. The main finding is that financial reporting quality will be higher if audit committees have mixed expertise in accounting, finance, and/or supervisory. In addition, we do not find evidence that incremental independence of audit committees enhances financial reporting quality because audit committees already consist of a majority of independent directors. Finally, we fail to find any impact of overlapping membership on audit (...) and remuneration committees on financial reporting quality. Overall, the results have policy implications on improving corporate governance effectiveness in terms of financial reporting quality. (shrink)

In the Philippines, all transplant centers are mandated by the Department of Health (DOH) to have a Hospital Transplant Ethics Committee (HTEC) to ensure that donations are altruistic, voluntary and free of coercion/commercial transactions. This study was undertaken primarily to describe the organizational and functional profile of existing HTECs and identify areas for improvement. This is a descriptive cross‐sectional study. There was variation in their logistical arrangements (support from hospital, filing systems, office spaces), operations (length and frequency of meetings, (...) number of referrals) and membership (composition, qualifications, occupation, training). The approval rate for donor‐recipient pairs is high with the majority of cases made by living non‐related donors. Appropriate reasons were cited for rejection. The perception of HTECs is that they are competent and confident in their decision‐making. However, there is a need to standardize HTEC composition, provide operating procedures and additional training which can be done by the DOH. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs (...) in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

In December 1990, an empirical study assessing hospital ethics committee (HEC) success was completed. Success was measured in terms of the number of interventions undertaken by the committees in four functional areas: education, guidelines development, prospective and retrospective case review. Some commonly quoted success determinants, such as multidisciplinarity, physician chairpersons, and a high institutional status of the chairperson were found not to foster success; the latter two, actually decreased committee success.

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group (...) of individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.4 (2002) 389-390 [Access article in PDF] IOM Report on the System for Protecting Human Research Participants Tom L. Beauchamp* In response to society's concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for reform (...) (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention.The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research.The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring. [End Page 389]The committee recommends that institutions distinguish review aimed at (1) scientific merit, (2) conflict of interest, and (3) general Ethics Review. The distinction should more evenly distribute the work of institutional ethics review. The IRB should not conduct the initial scientific review nor should it be spending the bulk of its time purely in examining either scientific merit—as many IRBs now do—or conflict of interest. Instead, the conclusions of the scientific review should be submitted to the IRB for ethics-focused deliberations. Problems of both financial and nonfinancial conflicts of interest should be handled similarly, preferably by a committee properly distanced from the institution's interests.The committee underscores that consent must be understood on the model of an interactive dialogue between research staff and participants and not merely as a signed form or single-disclosure event. Conversations between the participant and the research staff should begin even prior to the point of enrollment and should be reinforced during each stage of the research. The committee finds that informed consent conversations and documents too often are being conceived as risk management tasks gauged to protect the institution from liability.The committee also believes that the system of protections established by a research program should be open to the public in order to foster and maintain the community's trust. Open communication should occur among all relevant stakeholders. The committee notes that currently no centralized system exists for the dissemination of information about clinical trials and other research activities.It urges reconsideration of present policies regarding compensation, finding that many research organizations provide at least short-term medical care for those who are injured, but that few organizations cover all potential risks and that many organizations have no effective policy of compensation. The report holds that providing reasonable compensation for bona fide instances of research harm is the only just system and is necessary to avoid diminished public trust.The committee holds that establishing the appropriate culture in research institutions will require sustained efforts to educate researchers, research administrators, IRB members, and... (shrink)

Human subjects research has increased in Myanmar since 2010 and, accordingly, the establishment of research ethics committees has increased review of these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. To assess the structures and processes of RECs at medical institutions in Myanmar, we used a self-assessment tool for RECs operating in low- and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements (...) and materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 medical institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate and multivariate statistics to analyse the data. Out of a maximum 200 points, the total mean score for Myanmar medical institutions was 112.6 ± 12.77, which is lower compared with the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but lacked essential policies. The results show that for Myanmar RECs, there is significant room for improvement in their “structures and processes” as well as the extent of institutional commitment. The self-assessment tool proved to be a valuable method to assess the quality of RECs. (shrink)

Ethics consultation is a novel paradigm in European health-care institutions. In this paper, patient involvement in all clinical ethics activities is scrutinized. It is argued that patients should have access to case consultation services via clearly defined access paths. However, the right of both health-care professionals and patients indicates that patients should not always be notified of a consultation. Ethics education, another well-established function of an ethics committee, should equally be available for patients, lay people and hospital staff. Beyond (...) access and utilization, lay membership on a clinical ethics service is a matter of transparency, equal participation, empowerment and democratization. Lay and patient perspectives will contribute to the quality of ethics services on all levels from case consultations to ethics education and policy development. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving institutional healthcare ethics committees. This topic has been the subject of recent articles in JCE. Healthcare ethics committees have also recently been the subject of significant public policy attention. Disturbingly, Bobby Schindler and others have described ethics committees as “death panels.” But most of the recent attention has been positive. Over the past several months, legislatures and courts have expanded the use of ethics committees and clarified their roles concerning both (...) end-of-life treatment and other issues. These developments are usefully grouped into the following eight categories: 1. Existence and availability2. Membership and composition3. Operating procedures4. Advisory roles5. Decision-making and gate-keeping roles6. Confidentiality7. Immunity8. Litigation and court cases. (shrink)

Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee (REC) member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.

In June 1992, a national mail survey was directed to 204 state inpatient psychiatric institutions. This study was implemented following the 1992 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirement that hospitals put in place some means with which to address ethical issues. The goals of the study were: 1. to examine state mental hospital characteristics and their response to the JCAHO requirements; 2. to describe healthcare ethics committee (HEC) composition, function, and role; 3. to study patient and (...) family access to a HEC; and 4. to discover ethical issues most frequently addressed. The survey response rate was 71%. Of the 145 responders, 62 had HECs in place, and 53 were in the process of implementing HECs. There were no differences between JCAHO accredited institutions and non-accredited facilities with regard to having HECs. Physicians accounted for 22% of HEC membership, followed by nurses (15%), and administrators (12%). Twenty-six percent of facilities systematically notified patients about existence of the HEC; 71% of facilities had no patient request for HEC services in the last year. A patient's danger to others, and resuscitation policy were issues most frequently (23%) heard by HECs. (shrink)

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following (...) the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

Objective Our objective was to evaluate whether those individuals with previous involvement with formal clinical ethics processes differ in their attitudes towards the resolution of prototypical clinical ethics cases than general health care professionals. We hypothesized that those individuals with previous participation in ethics consultation would have significantly different attitudes on the appropriate role of ethics committees in the assessment and resolution of clinical ethical dilemmas than those who have not. Methods We conducted a case-based survey of health care professionals (...) at six US hospitals. We administered the survey to health care professionals in a variety of clinical roles at each center and further sub-categorized these by respondents reporting or not reporting their membership on an ethics committee or participation as an ethics consultant/requestor of ethics consult services. Using the analysis of variance test, we present the variation in attitudes using a 5-point Likert scale with 95% confidence intervals and significance set at p ≤ 0.05. Results A total of 240 respondents completed the survey (response rate: 63.6%) from all six surveyed centers (128 respondents with involvement with ethics consultation, 112 respondents without). Health care professionals not previously involved with formal clinical ethics processes were less likely to view the ethics committee as having a role in resolving the presented clinical ethical dilemmas ( p = 0.01 for analysis of variance comparison). Conclusion In this multi-center survey study, health care providers without previous involvement with formal clinical ethics processes were less likely than those with previous involvement to support a role for ethics committees aiding in ethical case resolution. (shrink)

In light of the foregoing, we conclude that hospital attorneys, risk managers, and other advocates despite the immense contribution which they may make to the process and deliberations of ethics committees—have a unique role in the bioethical decision-making process, but one that neither requires nor precludes membership on such committees. This is not to deny in any way appropriate access to committees or their deliberations by such advocates. Indeed, we would argue strongly that hospital attorneys and risk managers, where (...) there are reasons for including them in committee discussions, should be invited as consultants and participant-observers. Furthermore, we concur wit Gibson, who suggests that hospital attorneys have a teaching role which enhances the committee's understanding of relevant legal issues, cases, and decisions. this is especially true in individual case consultation. Ethics committees and institutional advocates both have important roles within health care institutions, but patients and hospitals are best served when these two agents collaborate without weakening or undermining their mutually distinct functions and priorities. This conclusion is based primarily on the widely acknowledged concern about conflict of interest as well as the more peripheral concern about loss of attorney/client privilege. However, we would argue that in all aspects of committee work, including self-education, policymaking and case review and consultation, these specialists in health law may often give expert advice and counsel to persons regarding a vast arrays of subjects. These include but are hardly limited to the following: Durable Power of Attorney for Health Care, Living Will Legislation, Malpractice Law, Orders Not to Resuscitate, Forgoing Life-Sustaining Treatment, Withholding Nutrition and Hydration, Treatment for Incompetent Patients, Proportionate vs. Disproportionate Treatment, and Suicide and the Law. HECs need to know how attorneys think and especially how hospital attorneys frame bioethical issues, just as they need to know how physicians and nurses think and respond. Even if hospital attorneys are not formally seated on HECs, they should participate in charting the currents in bioethics. Gibson feels that we need to re-examine the roles of the hospital attorney. Perhaps these advocates should be encouraged to wear more than just one “hat,” and for the rest of us to generalize about institutional advocates is both premature and prejudicial. When we stereotype attorneys with a generic label such as “institutional advocates,” we open ourselves to the dangers of an even narrower kind of “reflex advocacy” (11).To achieve open and honest dialogue, all voices and viewpoints must be heard. HECs that arbitrarily and totally exclude hospital attorneys from participation may exhibit the very close-mindedness they are seeking to eliminate. Yet this situation is at its core a paradoxical one: We cannot proscribe the advocate's role without constraining his or her effectiveness. Yet for the sake of their effectiveness we need to protect them from conflict-of-interest situations. Moreover, we also need to be certain that all points of view, including those that derive from the law, are given an adequate hearing by HECs. (shrink)

As society becomes more aware of the rights of individuals, ethical issues become of increasing importance. Many research funders, including the research councils, increasingly emphasise research governance and ethical review in their consideration of submitted proposals. Little is known, however, about what universities do over ethical scrutiny and in order to find out the authors undertook a national study of all universities in the United Kingdom. The focus of the study was on human volunteers for research outside the remit of (...) the National Health Service. The key questions being: to what extent do universities undertake ethical scrutiny of research and, if so, how? The broad conclusion is that when this survey was carried out in the autumn of 2003, the majority of universities were aware of the need for the ethical scrutiny of research on human subjects although in many of those universities the scrutiny system was being developed at the time of completion of the questionnaire. In some cases practice appeared to lag behind awareness and whilst there were some very good examples there were also some which were below an ‘acceptable’ standard. Recommendations are made concerning structures, coverage and membership for systems of ethical scrutiny within the university sector. (shrink)

This survey describes in detail ethics committees (ECs) at acute care hospitals in Upstate New York. It finds that in just two years (1984 and 1985), following the Baby Doe controversy and the Report of the President’s Commission, 40% of urban ECs and 37% of university ECs were formed. One half of rural ECs formed in 1992–1995, following the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirement of access to ethics consultation. Generally, ECs are committees of the powerful within (...) the hospital; the administration or the medical staff is the organizational parent of 73% of ECs. These groups appoint 80% of EC chairs and 79% of members; they constitute 45% of the membership. Most EC members (81%) lack even rudimentary formal training in bioethics, yet only 18% of ECs consider member education a major role. Many ECs are rather inactive: 53% meet less than every other month and 61% have fewer than six case consultations in the prior year. On the basis of this survey’s findings, suggestions are offered to improve the credibility of these ubiquitous committees as stewards of bioethics, rather than of the powerful within the hospital. (shrink)

In many countries the debate over the role that physicians may play in ending life has been limited to the judiciary and other law making institutions, professional medical organizations; and academics. Because of their multidisciplinary and diverse membership, ethics committees may be a particularly appropriate venue through which these discussions can be expanded to include a much larger community. In addition, ethics committees generally act in only advisory capacities because they do not actually make decisions, so they may provide (...) a forum for open discussions in ways that the court and the medical boards cannot. (shrink)

A growing body of research has demonstrated significant heterogeneity of hospital ethics committee (HEC) size, membership and training requirements, length of appointment, institutional support, clinical and policy roles, and predictors of self identified success. Because these studies have focused on HECs at a single point in time, however, little is known about how the composition of HECs changes over time and what impact these changes have on committee utilization. The current study presents 20 years of data on (...) the evolution of the Massachusetts General Hospital HEC. Between 1993 and 2012, the average number of committee members per year was 38 ± 3 and the average length of membership was 4.8 ± 0.4 years. During that time, the committee performed 934 consults, averaging 47 ± 3 per year. Attendance rates fell from 61.5 to 23.8 % over the study period and were inversely correlated with the total number of members. Between 1993 and 2012, the committee saw substantial growth in the diversity of the professional backgrounds of its members. Multivariate analysis, however, suggests that substantial changes in committee composition did not impact its utilization and that other factors are more likely to explain fluctuations in consultation volume. (shrink)

Next SectionIn response to public outrage stemming from exposés of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of animal (...) pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare. (shrink)

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks (...) the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and (c) the committee's operational base of authority is alien to academic culture and violates essential aspects of academic freedom. In addition, he found that the system is burdensome, requiring enormous expenditures of time and money that inappropriately diverts resources away from the business of scientific discovery. We dispute several aspects of Steneck's historical account and the coherence of his proposals. We believe his proposals, if followed, would be a step back into a failed past. (shrink)

To investigate the current status of hospital clinical ethics committees (CEC) and how they have evolved in Canada over the past 20 years, this paper presents an overview of the findings from a 2008 survey and compares these findings with two previous Canadian surveys conducted in 1989 and 1984. All Canadian hospitals over 100 beds, of which at least some were acute care, were surveyed to determine the structure of CEC, how they function, the perceived achievements of these committees and (...) opinions about areas with which CEC should be involved. The percentage of hospitals with CEC in our sample was found to be 85% compared with 58% and 18% in 1989 and 1984, respectively. The wide variation in the size of committees and the composition of their membership has continued. Meetings of CEC have become more regularised and formalised over time. CEC continue to be predominately advisory in their nature, and by 2008 there was a shift in the priority of the activities of CEC to meeting ethics education needs and providing counselling and support with less emphasis on advising about policy and procedures. More research is needed on how best to define what the scope of activities of CEC should be in order to meet the needs of hospitals in Canada and elsewhere. More research also is needed on the actual outcomes to patients, families, health professionals and organisations from the work of these committees in order to support the considerable time committee members devote to this endeavour. (shrink)

As support for clinical ethics committees in the UK grows, care must be taken to define their function, membership and method of working and the status of their decisions.The modern practice of medicine raises a plethora of complex issues—medical, ethical and legal. Doctors and other healthcare professionals increasingly must try to resolve these and may sometimes have to do so in the face of contrary opinion expressed by patients and/or their surrogates. While clearly qualified in the medical arena, and (...) although there is now more ethics teaching in the medical curriculum, healthcare professionals are seldom qualified to adjudicate on ethical or legal matters, or even, perhaps, to recognise them when they arise. Yet, as Doyal says, “clinical life must go on and moral and legal indeterminacy within medicine cries out for practical resolution.”1 Meanwhile, the expectations of patients and their families—and, indeed, of wider society—are that decisions about patient care, resources and therapeutic regimes should be soundly based on appropriate ethicolegal, as well as scientific, principle.Recognition of these additional burdens on healthcare professionals has generated some interest in the provision of ethics consultation. In the USA this has been undertaken by a variety of tribunals and individuals. Hospital ethics committees and ethics consultants feature in many US hospitals and perform a variety of roles. In Europe, a number of countries have also established clinical ethics committees and they are becoming more common in the UK—primarily in England and Wales for the moment. Whereas, however, “[i]n North America, CECs have … become an integral part of the organisational infrastructure of hospitals ...”,1 in the United Kingdom they remain essentially ad hoc bodies, generated for a variety of reasons and with different goals, structures, membership, methods of working and functions. The initial impetus for the …. (shrink)

Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, (...) class='Hi'>membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs. (shrink)

BackgroundBrazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics and 779 Research Ethics Committees, in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study (...) aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC’s Chairs to compose their membership. MethodsAll 779 Brazilian RECs’ chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. ResultsThe results showed a predominance of members from the biomedical area, while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were PhD and masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees.ConclusionThe RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC’s specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols. (shrink)

Objective: To determine whether bioethicists are distributed along a rural-to-urban continuum in a way that reflects potential need of those resources as determined by the general population, hospital facilities and hospital beds.Methods: US members of a large, multidisciplinary professional society, the American Society of Bioethics and Humanities , the US population, hospital facilities and hospital beds were classified across a four-tier rural-to-urban continuum. The proportion of each group in rural settings was compared with that in urban settings, and odds ratios (...) were calculated with 95% confidence intervals.Results: Although 91% of ASBH members live or work in urban settings, only 66% of the US population did so. In contrast, 2% of ASBH members live or work in rural settings compared with 13% of the population. ASBH members were 10.7 times as likely to be represented in urban than in rural settings when compared with the general population, 25.6 times and 6.9 times as likely with regard to hospital facilities and hospital beds, respectively.Conclusions: Using various comparisons it was found that ASBH members are under-represented in rural as compared with urban settings. Although not all bioethicists are ASBH members, these findings suggest that the availability of professional bioethical resources may be inadequate in rural America. The disparities that were found may have considerable effect on ethics scholarship, research, ethical committees and education, and adds to the argument that rural American communities are under-served. (shrink)

Hospital ethics committees must be knowledgeable if they are to perform consultations, advise administrators on policy, or offer educational programs. Because the membership of the committee is interdisciplinary, with most drawn from the healthcare professions, the individuals who join cannot be expected to bring knowledge of bioethies with them. Therefore, a new committee must spend time developing expertise before it can appropriately serve the hospital community. Although the need for committee self-education is generally recognized, it is (...) seldom discussed in any detail. When discussed at all, expertise in bioethies is usually described as composed of a familiarity with an identifiable body of knowledge and mastery over techniques of moral reasoning. It is assumed that a committee can develop this expertise early in its life through a short course of study. (shrink)

As men and women increasingly share access to state power, there has been a question of whether women’s rising descriptive representation leads to substantive change, and a sizable body of literature suggests it does. As a mechanism for this effect, I theorize legislatures as gendered organizations that build gender into their institutional operation, as enmeshed in legislative committee systems. Using case studies of Germany, Sweden, and the United States, I examine 40 years of data collected on legislative committees and (...) memberships. This study reveals some similarities, where all committee systems emphasize gender-typed roles, particularly female legislators’ greater segregation into social issue committees. Yet, gender is constructed differentially across these organizations, and the nations vary in the gender structure of their committee systems, degree of gender segregation and typing, and gendered relations of power and prestige. Implications for integrating theories of gender as an institution, gendered organizations, and feminist institutionalism are discussed. (shrink)

This joint response from the National Research Ethics Advisors' Panel (NREAP) and the Association of Research Ethics Committees (AREC) has been formulated on the basis of detailed in depth discussion between the two organizations, in consultation with their membership. NREAP is a body that was constituted by the United Kingdom Ethics Committee Authority (UKECA) in order to provide guidance to, and strategic oversight of the NHS Research Ethics Service. AREC represents all sectors of the Research Ethics Committee (...) (REC) community and serves to engage in discussion and debate concerning best practice and to serve the best interests of REC membership. (shrink)

This editorial examines the evolving role of patients in European clinical ethics consultation services. While patient involvement has been theoretically supported in North America but often neglected in practice, European approaches show varying levels of patient participation - from committee membership to consultation involvement to full participation in ethical deliberations. Through analysis of a case involving end-of-life care and several commissioned papers exploring different national contexts, the authors highlight how patient involvement varies across Europe based on different healthcare (...) systems and cultural contexts. They note that while no single model of patient involvement is superior, ethics consultation without patient and family participation may miss critical perspectives needed for inclusive ethical deliberation. The authors conclude that practical considerations around consent, participation procedures and documentation need to be addressed as patient involvement increases, while acknowledging that cultural diversity across Europe will lead to different mechanisms for including patient voices. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Annual Meeting of the Society for Buddhist-Christian StudiesSan Diego, California, USA November 21–23, 2014Sandra Costen Kunz, SBCS Secretary and Jonathan A. Seitz, Newsletter EditorThe annual meeting is an opportunity to meet, to reconnect, and to share our work. As a “Related Scholarly Organization” of the American Academy of Religion, the Society for Buddhist-Christian Studies holds its meetings concurrently with the AAR’s national conference. The SBCS normally organizes two (...) panels and holds board and members meetings. This year’s panels were “Liberation Theology and Engaged Buddhism: Challenging Each Other, Learning from Each Other,” and “Old Buddhist Texts: New Womanist Thought.” The papers from panels are often published in this journal.board meetings (officer and committee reports)The society’s annual board meeting was held on Friday, November 21, and its members meeting Sunday, Nov. 23. The board approved officer reports submitted by the treasurer, Denise Yarbrough, the interim journal editors, Terry Muck and Rita Gross, and the newsletter editor, Jonathan Seitz and the minutes submitted by secretary Sandra Kunz. An extended discussion treated the history of the relationship between the society, the journal, and the University of Hawai’i Press. The board voted to continue publishing with UHP while working out a new memorandum of understanding.We reviewed reports from the Nominating Committee, Streng Book Award Committee, Graduate Student Award Committee, Membership Committee, Social Media and Website Committee, and Program Committee.Nominating CommitteeThe Nominating Committee reported that the governing board terms of Yifa and John Makransky end with this board meeting. John remains on the board as vice president. We discussed nominees for these two board positions.Streng Book Award CommitteeThe Streng Book Award Committee noted that it would be helpful to receive nominations. Thomas Hastings joined the committee and J. Abraham Vélez de Cea was elected to another term. [End Page 207]Graduate Student Award CommitteeKaren Enriquez reported for the Graduate Student Award Committee, noting that although a good paper was selected this year, the problem of paper quality remains. Rita Gross suggested that members with students working in Buddhist-Christian studies should encourage them to present papers at regional AAR meetings and submit these to the award committee. Judith Simmer-Brown suggested we start a subsidiary online journal that would publish, among other things, commentaries on BCS articles, including grad student commentaries. John Makransky suggested that we also post important articles from past issues we see as classics in the field. In light of the board’s enthusiasm about this idea for publishing grad student papers online, and in light of the difficulties of scheduling graduate student award papers within our sessions, John moved that we discontinue the oral presentation of graduate student award papers. Judith seconded the motion, which passed unanimously. John later moved, and Judith seconded the motion, that the board charge Karen, Glenn Willis, and Sarah Swenson to develop a proposal by March for a website that would host a subsidiary peer-reviewed online journal, being sure to articulate how this could promote the society among younger scholars. It passed unanimously.Membership CommitteeReminding us of Jonathan Seitz’s list of past members, John Makransky suggested we send out a membership mailing to them. Sarah Swenson and Alice Keefe were charged with creating a comprehensive distribution list and sending out a mailing asking everyone to join, rejoin, or renew their membership.Social Media and Website CommitteeIn light of our proposal to start a subsidiary online journal, Judith Simmer-Brown was gratefully charged with chairing a new committee with David Gardiner and Glenn Willis, who has been handling Facebook publicity. They will get bids for hiring a professional website designer who can configure it in such a way that we could maintain it ourselves.Program CommitteeJohn Makransky reported briefly on the potential session topics suggested at the lunch meeting. We discussed pros and cons of forming panels of known experts and using AAR’s blind submission process. The discussion ended with general exhortation to scout out scholars with pertinent work to enlarge our pool of presenters.We briefly discussed the pros and cons of organizing an international conference and reviving and regularizing the... (shrink)

We attempt to understand the personal incentives that motivate corporate insiders to engage in unethical behavior such as delayed trade disclosure. Delayed disclosure affects corporate transparency and other shareholders in the firm potentially suffer investment losses because they are unaware of insiders’ activities. Using archival data from the 300 largest Australian firms between 2007 and 2011, the results show that risk factors such as insider age and tenure and wealth effects in the form of insider shareholdings affect the likelihood of (...) delayed reporting. Governance positions such as committee membership mitigate this behavior. Our study highlights the importance of considering individual insider’s wealth and risk factors. The self-monitoring role of governance positions is also indicative of the effectiveness of internal corporate governance in the prevention of illegal insider behavior. (shrink)