Research question and aim Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC’s implementation, to increase knowledge about CEC’s implementation strategy. Research design We collected quantitative data related to number and characteristics of CEC activities (...) carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC’s development and implementation process. Participants and research context The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. Ethical Considerations The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. Findings In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC’s impact on clinical practice. Conclusion Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the (...) research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees. The purpose of this study was to evaluate how the above guidelines are implemented in real practice. There were 111 hospitals selected out of 176 Polish clinical hospitals and hospitals accredited by Center of Monitoring Quality in Health System. The study was conducted by the survey method. There were 56 hospitals that responded to the survey. The number of (...) HECs members fluctuated between 3 and 16 members, where usually 5 members were part of the board committee. The composition of the HECs for professions other than physicians was diverse and non-standardized. Only 55 % of HECs had a professional set of standards. 98 % of HECs had specific tasks. 62 % of HECs were asked for their expertise, and 55 % prepared <6.88 % of the opinions were related to interpersonal relations between hospital personnel, patients and their families with emphasis on the interactions between superiors and their inferiors or hospital staff and patients and their families. Only 12 % of the opinions were reported by the respondents as related to ethical dilemmas. In conclusion, few Polish hospitals have HECs, and the structure, services and workload are not always adequate. To ensure a reliable operation of HECs requires the development of relevant legislation, standard operating procedures and well trained members. (shrink)

Background: Ought nursing homes to establish clinical ethics committees (CECs)? An answer to this question must begin with an understanding of how a clinical ethics committee might be beneficial in a nursing home context – to patients, next of kin, professionals, managers, and the institution. With the present article, we aim to contribute to such an understanding. Aim: We ask, in which ways can clinical ethics committees be helpful to stakeholders in a nursing home context? (...) We describe in depth a clinical ethics committee case consultation deemed successful by stakeholders, then reflect on how it was helpful. Research design: Case study using the clinical ethics committee’s written case report and self-evaluation form, and two research interviews, as data. Participants and research context: The nursing home’s ward manager and the patient’s son participated in research interviews. Ethical considerations: Data were collected as part of an implementation study. Clinical ethics committee members and interviewed stakeholders consented to study participation, and also gave specific approval for the publication of the present article. Findings/results: Six different roles played by the clinical ethics committee in the case consultation are described: analyst, advisor, support, moderator, builder of consensus and trust, and disseminator. Discussion: The case study indicates that clinical ethics committees might sometimes be of help to stakeholders in moral challenges in nursing homes. Conclusions: Demanding moral challenges arise in the nursing home setting. More research is needed to examine whether clinical ethics committees might be suitable as ethics support structures in nursing homes and community care. (shrink)

This text provides a comprehensive and timely examination of the most pertinent factors affecting institutional ethics committees, for ethicists, trustees, administrators, physicians, clergy, nurses, social workers, attorneys and others with an interest in ethics committees.

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC (...) members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

The first clinical ethics committees in Norway were established in 1996. This started as an initiative from hospital clinicians, the Norwegian Medical Association, and health authorities and politicians. Norwegian hospitals are, by and large, publicly funded through taxation, and all inpatient treatment is free of charge. Today, all the 23 hospital trusts have established at least one committee. Center for Medical Ethics , University of Oslo, receives an annual amount of US$335,000 from the Ministry of Health and (...) Care Services to coordinate the committees and to facilitate competency building for committee members. (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and (...) decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (shrink)

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research (...) team took part at six regular voluntary meetings of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all (...) four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)

Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the (...) organizational context in which CECs function in Europe focusing on five aspects. We conclude that in Europe clinical ethics committees need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization. CECs, perhaps particularly in transitional countries, must counter the charge of “alibi ethics”. CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges, but the fact that CECs continue to develop suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs. (shrink)

When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A (...) moral view which can be labelled as a consequentialist interpretation of mid-level principlism is developed, defended and applied to some real-life and hypothetical research proposals. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain (...) different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

Ethics committees have a bad reputation for impeding, rather than facilitating research. Here, I argue that many committees actually improve the quality of the research proposal to such an extent that they deserve credit as authors in any resulting publications, or at least an acknowledgement of the contribution made.

Objectives: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment.Design: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons.Setting: Israel five years after the passage of the Patients' Rights Act.Main (...) measurements: Patients' rights and informal ethics committee structure and function.Results: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction.Conclusions: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of (...) two workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials. (shrink)

Hospital ethics committees were created in the United States of America in the 1970s. Their aims were the education of the hospital personnel in the field of ethics, the development of policies and the publication of guidelines concerning ethical issues, as well as consultations and case reviews of hospitalized patients when an ethical concern was present. During the last thirty years, these committees disseminated, particularly in Western Europe. In this manuscript, we describe the benefit, but also (...) some difficulties with these committees, and we propose some solutions. The characteristics of these committees are discussed (i.e. typology of members, functioning and legitimacy). Finally, we carefully describe our local hospital clinical ethics committee in Geneva (Switzerland), which was founded in 1994 and it still very active. After fifteen years of experience, we remain strongly in favour of the implementation of such committees in any modern hospital. (shrink)

In this paper we discuss differing discourses of research ethics committees and the clinical research field. Reflections on our experience of conducting research in a nursing home are used to highlight the tensions and inconsistencies that arise from these discourses and the need to behave ethically in the field. While accepting the need for adherence to guiding principles of duty based ethics, we have found that practical moral decisions in the field required that, as individual researchers, we (...) needed to exercise discretionary judgement, informed by the ethic of care and the concern for the well‐being of research participants. (shrink)

Since Clinical Ethics Consultation has become important in the public health sector in the last decade in Germany, there are on-going questions about effectiveness. Targets have been established by the Ethics Committees, in regard to assisting patients, families and health care teams at times of ethical conflicts during the decision-making process in medical care. Of all the ethics consultations over the last eight years at Erlangen University Hospital the consultations carried out in the pediatric department were (...) chosen to be reviewed by a pediatrician and an ethicist. These were evaluated on the basis of team formation, interdisciplinary orientation, ethical criteria, completeness and methods of documentation. Results of the analysis of those records show a well-organized consultation team with regard to its personnel composition. Discrepancies with ethical questions posed in the literature are revealed, and also some partially incomplete documentation regarding medical facts and descriptions of the patients' or parents' opinion. (shrink)

Failings in patient care and quality in NHS Trusts have become a recurring theme over the past few years. In this paper, we examine the Care Quality Commission’s Guidance about Compliance: Essential Standards of Quality and Safety and ask how NHS Trusts might be better supported in fulfilling the regulations specified therein. We argue that clinical ethics committees (CECs) have a role to play in this regard. We make this argument by attending to the many ethical elements that (...) are highlighted in the Commission’s Regulations and by providing practical examples of how CECs can (and in some case already do) provide ethics support to health professionals and trusts. Although CECs have been traditionally associated with case consultation, i.e., discrete problems caused by individual circumstances, in the previous 10 years the literature suggests that clinical ethics services have become more integrated into the life of the health care organization and are increasing construed as proactive agents of systematic change. We provide evidence from a recent survey of UK clinical ethics services that this trend is present in the UK. (shrink)

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public and bioethicists in (...) Ethics Committees in Japan. Keywords: ethics committees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (shrink)

The term ‘ethics committees’ is used for very different things in different parts of the world. In Europe, ethics committees are generally concerned only with research and (apart from Belgium where the same committees deal with both aspects) do not have anything to do with decision making in clinical situations. This article traces the history of ethics committees in the UK and some of the problems encountered by them. It goes on to detail (...) the situation in a number of other European countries. Some topics of research touched on and published in articles in Nursing Ethics are then highlighted, thus making it clear that it is written from my perspective as the Editor of Nursing Ethics and with the help of some of the members of the Editorial Board. Finally, a number of questions are asked and answers attempted concerning the interests served by ethics committees. (shrink)

BackgroundThe last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries.MethodsSemi-structured interviews were conducted from (...) July to October 2020 to elicit health researchers’ perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs.ResultsAcross the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics—more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding.ConclusionThe broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture. (shrink)

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries (...) and the ethics committee declined to endorse the procedure. These concerns endure. (shrink)

Ethical reality is coextensive with human dignity. Therefore, one essential way to understand ethics is as the systematic effort to discern the imperatives of human dignity. Seeing ethics in this way highlights the fact that health care institutions have many centers of ethical responsibility (CERs) — the Chief Executive Officer, Board of Trustees, senior management team, etc. The Ethics Committee is only one such CER and not the most important one. These other CERs will benefit from identifying: (...) (1) the fact that they are consistently dealing with ethical reality and making ethical decisions; (2) some critical elements of good ethical decision-making: (i) having the appropriate community; (ii) making the guiding value priorities explicit and specific; (iii) gaining skill in using the needed intellectual tools; and (iv) fashioning appropriate process and structure for discernment. (shrink)

Members of a National Health Service, or other recognised Research Ethics Committee (REC), in deciding whether or not to withhold their assent for a clinical trial, must obey the law. If they do not do so, then they may become liable to pay personally negligence claims made by injured trials subjects. It could be no defence to say that members had consulted their own lower ethical standards; or merely that they had acted in good faith; or that they had (...) followed Department of Health (DH) guidelines, which do not have the force of law. The law requires that the rights, safety, and well-being of clinical trial subjects shall prevail over other interests. REC favourable opinion is a powerful endorsement of a trial, and prospective subjects are invited to rely upon it. REC members are legally bound to exercise their power to withhold assent to any clinical trial which does not give subjects the protection the law requires. (shrink)

This chapter contains sections titled: Origins and Development The Functions of Ethics Committees and Ethics Consultants The Significance of Ethics Committees and Ethics Consultation for Bioethics Conclusion Acknowledgments References Further reading.

In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be apt (...) to improve HECs’ accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries. (shrink)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the research, we used a deductive qualitative (...) approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

Background The aim was to explore how the clinical ethics committees in Norway have worked and functioned within mental health care and addiction treatment services. Methods Analysis of 256 annual reports from clinical ethics committees from 2003 to 2012 and a survey to clinicians who had used a clinical ethics committee. Results Dilemmas related to coercion, confidentiality, information, and patient autonomy dominated. The committees established only for psychiatric hospitals, had received more cases from mental (...) health and addiction services than the committees also serving somatic services. Many of the case discussions involved both somatic and mental health care, complicated legal issues as well as ethical dilemmas. Mental health care professionals that have used the clinical ethics committees evaluated the clinical ethics committees deliberation as useful. Conclusion Given the many difficult ethical dilemmas in mental health care ethics work need to be strengthened. The complexity of the cases requires varied and interdisciplinary competence and training among the clinical ethics committee members. (shrink)

The role of Hospital Ethics Committees is to support patients and their relatives as well as medical staff in solving ethical issues that arise in relation to the implementation of medical care. In Poland there are no clearly formulated legal regulations concerning the establishment and functioning of hospital ethics committees. Hospitals applying for accreditation are obliged to present solutions defining the way of solving ethical issues in a given institution, some of them appoint HECs for this (...) purpose. The aim of this study was to analyze information concerning the functioning of hospital ethics committees in Poland on the basis of publicly available data published on the websites of accredited hospitals. Very few accredited hospitals make public information about functioning in their ethics consulting facilities through hospital ethics committees. In most cases, the information provided on the functioning of HECs is general, both in terms of the committees’ functioning, type of cases under consideration and the composition of personnel. (shrink)

Few ethics committees were in place when the New Jersey Supreme Court announced its ruling on the Quinlan case in 1976. Today, the vast majority of hospitals have formed ethics committees and their use in nursing homes and other healthcare facilities is growing. Given the increasing commitment to the use of ethics committees and their increasing influence on healthcare decision making, the careful evaluation of committee performance should be a high priority. Yet to date (...) ethics committees appear to have undergone relatively little scrutiny. While professional articles on ethics committees do appear and at least one journal sets aside a regular section for the discussion of “Ethics Committees at Work” articles to date have primarily been limited to essays, philosophical inquiries, reports, case studies, and, occasionally, surveys. The use of more structured research methodologies has been lacking. As a result, it is not yet clear, for example, what characteristics describe the best functioning ethics committee. Indeed, what constitutes best functioning lacks careful definition as well. Committee impact on medical decision making and patient outcomes, while discussed, has not been systematically measured and analyzed. (shrink)

Background: The research on nursing professionals in Clinical Ethics Committees and Nursing Ethics Commissions occurs in different parts of the world; however, little information on this subject is found in the literature. Objective: This study analyzed national and international publications in relation to the participation of nursing professionals in Clinical Ethics Committees. Research design: This was an integrative review of articles published in national and international journals between 1994 and 2016 which described the participation of (...) nursing professionals in ethics commissions. Participants and research context: A total of 35 articles were selected. Discussion and conclusion for this article: The thematic categories were the need for time to discuss ethical issues; ethics committee to reduce the moral suffering of professionals; competencies required for participation; and barriers/difficulties and facilitators for implementation/ performance. It was concluded that professionals recognize the need for ethics committees to foster discussions. However, barriers hamper operation and fundamental competencies for participation. Communication of committee activities to professionals and educational activities may be major allies to improve the functioning of these committees. (shrink)

Animal ethics committees have been set up in many countries as a way to scrutinize animal experimentation and to assure the public that if animals are used in research then it is for a worthwhile cause and suffering is kept to a minimum. The ideals of Refinement, Reduction and Replacement are commonly upheld. However while refinement and reduction receive much attention in animal ethics committees the replacement of animals is much more difficult to incorporate into the (...) committees’ deliberations. At least in Australia there are certain structural reasons for this but it is likely that most of the reasons why replacement is left out apply to other countries as well. (shrink)

OBJECTIVES: To report the outcome of applications to 43 research ethics committees. SETTING: Four regional health authorities in England. FINDINGS: The research ethics committees varied considerably in their practices. The time lapse until notification of the outcome of the approval ranged from just under one week to 23 weeks with a mean of 8.6 weeks. Four research ethics committees failed to notify the research team of an outcome of their request for approval. CONCLUSION: A (...) national research ethics committee is needed to review national and multi-location research studies in the light of the fragmented and variable practice of local research ethics committees. (shrink)

Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and ...

The recent tragic and widely publicised death of Jesse Gelsinger in a gene therapy trial has many important lessons for those engaged in the ethical review of research. One of the most important lessons is that ethics committees can give too much weight to ensuring informed consent and not enough attention to minimising the harm associated with participation in research. The first responsibility of ethics committees should be to ensure that the expected harm associated with participation (...) is reasonable. Jesse was an 18-year-old man with a mild form of ornithine transcarbamylase (OTC) deficiency, a disorder of nitrogen metabolism. His form of the disease could be controlled by diet and drug treatment. On September 13 1999 a team of researchers lead by James Wilson at the University of Pennsylvania's Institute for Human Gene Therapy (IHGT) injected 3.8 X 1013 adenovirus vector particles containing a gene to correct the genetic defect. He was the eighteenth and final patient in the trial. The virus particles were injected directly into the liver. He received the largest number of virus particles in a gene therapy trial.1 Four days later he was dead from what was probably an immune reaction to the virus vector. This was the first death directly attributed to gene therapy. It resulted in worldwide publicity, an independent investigation, the Federal Drug Administration (FDA) suspending all trials at the IHGT, an FDA, and a senate subcommittee investigation. At a special public meeting at the National Institutes of Health (NIH) in December 1999, James Wilson, also the director of the IHGT, said they still did not understand fully what had gone wrong.2 Even though a massive dose had been used, only 1% of transferred genes reached the target cells. (None of the patients in the trial showed significant gene expression. Art …. (shrink)

This discussion paper considers how seldom recognised theories influence clinical ethics committees. A companion paper examined four major theories in social science: positivism, interpretivism, critical theory and functionalism, which can encourage legalistic ethics theories or practical living bioethics, which aims for theory–practice congruence. This paper develops the legalistic or living bioethics themes by relating the four theories to clinical ethics committee members’ reported aims and practices and approaches towards efficiency, power, intimidation, justice, equality and children’s interests (...) and rights. Different approaches to framing ethical questions are also considered. Being aware of the four theories’ influence can help when seeking to understand and possibly change clinical ethics committee routines. The paper is not a research report but is informed by a recent study in two London paediatric cardiac units. Forty-five practitioners and related experts were interviewed, including eight members of ethics committees, about the work of informing, preparing and supporting families during the extended process of consent to children’s elective heart surgery. The mosaic of multidisciplinary teamwork is reported in a series of papers about each profession, including this one on bioethics and law and clinical ethics committees’ influence on clinical practice. The qualitative social research was funded by the British Heart Foundation, in order that more may be known about the perioperative views and needs of all concerned. Questions included how disputes can be avoided, how high ethical standards and respectful cooperation between staff and families can be encouraged, and how minors’ consent or refusal may be respected, with the support of clinical ethics committees. (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)

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. (shrink)

A significant amount of discussion in the bioethics community has been devoted to the question of whether individuals performing ethics consultations in healthcare institutions have any special expertise. In addition, articles in the lay press have questioned the “added value” that bioethicists bring to ethical dilemmas. Those at the forefront of the bioethics community have argued repeatedly that those doing ethics consults cannot simply be well-intentioned individuals, that some training in bioethics, group process, and facilitation is necessary to (...) competently execute a consult. As one bioethicist commented:if you approach any endeavor as an amateur activity, you will get, in the end, an amateurish version of the activity. Without a sufficient commitment of personnel, time, support, and financial resources, a healthcare organization will get the ‘ethics’ program … it set out to create: an inept, unskilled, inefficient, and highly risky ‘program’ in healthcare ethics and bioethics. (shrink)

This clinical ethics case examines whether to provide a blood transfusion to a severely injured Jehovah's Witness patient who initially agreed to the transfusion but changed her mind after speaking with a friend. The ethics committee analyzed several key issues: how to handle information from friends about a patient's religious beliefs when unconscious, the validity of advance directives, concerns about potential coercion in the patient's change of mind, and how to balance respect for religious beliefs against immediate medical (...) needs. The committee recommended that while unconscious, life-saving treatment should proceed given limited verifiable information about the patient's wishes. Once conscious, if the patient maintains a competent refusal after thorough discussion of risks and consideration of possible coercion, her decision should be respected even if it conflicts with medical recommendations. They emphasized the importance of consulting hospital Jehovah's Witness liaison services and documenting all discussions while exploring non-blood alternatives when possible. (shrink)

Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion (...) at a European level.Methods: A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models. (shrink)

IOS Prexs, 2002 Introduction This book is the final project report of the BIOMED II project Ethical Function in Hospital Ethics Committees Commission,-2001 ...

The question of whether Do Not Resuscitate orders should be sustained in the operating room was brought to our ethics committee by a pulmonologist and involved one of his patients for whom he serves as a primary care physician. His patient, a woman with chronic obstructive lung disease was electing, for comfort purposes, to have a hip pinning following a fracture. At the same time, she wished to have a DNR order covering her entire hospital stay. The anesthesiologist described (...) her direction as “improper” and refused to participate in surgical procedures if DNR orders extended to the operating room. The patient refused to rescind the order during surgery. As a result, the surgery was canceled to the great chagrin of the patient. (shrink)

This paper reports an initiative from the National Research Ethics Service (UK) and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach.