Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a (...) categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

Hospital ethics committees (HECs) are expected to play extremely broad and pivotal roles such as case consultation, education of staffs on healthcare ethics, and institutional policy formation. Despite the growing importance of HECs, there are no standards for setup and operation of HECs, and composition and activities of HECs at each institution are rarely disclosed in Japan. In addition, there is also a lack of information sharing and collaboration among HECs. Therefore, the authors established the Consortium of (...) Hospital Ethics Committees (CHEC) in October 2020, which has been regularly hosting a couple of core activities. One is the Healthcare Ethics Forum, held monthly online for CHEC members to freely discuss HECs and healthcare ethics consultation. The other is the Collaboration Conference of Hospital Ethics Committees, intended to provide a place for HEC members and administrative officers from across Japan to exchange information of their HECs, learn from each other, and cooperate to operate HECs appropriately. In this paper, the authors introduced CHEC as well as reported the results of a questionnaire survey conducted at the first conference among participating facilities, suggesting the diverse structures and activities of HECs in Japan. (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)

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to (...) guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned. (shrink)

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, (...) the American Society for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

At the request of the Midwest Bioethics Center (MBC), we surveyed nurses' and physicians' attitudes and needs regarding Hospital Ethics Committees (HECs). The primary objective of this research project was to inform the practices and policies of the Ethics Committee Consortium of the Bioethics Center.Four thousand eight hundred and twenty-nine surveys were distributed to the medical and nursing staff of eight Kansas City metropolitan area hospitals. One thousand and fifty-five surveys were returned, representing a response rate (...) of 21%. (shrink)

Background:Moral courage is defined as courage to act according to one’s own ethical values and principles even at the risk of negative consequences for the individual. In a complex nursing practice, ethical considerations are integral. Moral courage is needed throughout nurses’ career.Aim:To analyse graduating nursing students’ moral courage and the factors associated with it in six European countries.Research design:A cross-sectional design, using a structured questionnaire, as part of a larger international ProCompNurse study. In the questionnaire, moral courage was assessed with (...) a single question (visual analogue scale 0–100), the questionnaire also covered several background variables.Participants and research context:The sample comprised graduating nursing students (n = 1796) from all participating countries. To get a comprehensive view about graduating nursing students’ moral courage, the views of nurse managers (n = 538) and patients (n = 1327) from the same units in which the graduating nursing students practised were also explored, with parallel questionnaires.Ethical considerations:Ethical approvals and research permissions were obtained according to national standards in every country and all participants gave their informed consent.Results:The mean of graduating nursing students’ self-assessed moral courage was 77.8 (standard deviation 17.0; on a 0–100 scale), with statistically significant differences between countries. Higher moral courage was associated with many factors, especially the level of professional competence. The managers assessed the graduating nursing students’ moral courage lower (66.5; standard deviation 18.4) and the patients slightly higher (80.6; standard deviation 19.4) than the graduating nursing students themselves.Discussion and conclusions:In all countries, the graduating nursing students’ moral courage was assessed as rather high, with differences between countries and populations. These differences and associations between moral courage and ethics education require further research. (shrink)

Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries were collected as part of a European Research Project examining human and non-human biobanking. A total of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and (...) interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised. Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project. (shrink)

Cho and Martinez-Martin (2023) provide a compelling critique of the profound influence that data sourcing for artificial intelligence (AI) has on the healthcare sector. They emphasize the need for...

Ethics is a foundational competency in healthcare inherent in everyday nursing practice. Therefore, the promotion of qualified nurses’ and nursing students’ moral competence is essential to ensure ethically high-quality and sustainable healthcare. The aim of this integrative literature review is to identify the factors contributing to the promotion of qualified nurses’ and nursing students’ moral competence. The review has been registered in PROSPERO (CRD42023386947) and reported according to the PRISMA guideline. Focusing on qualified nurses’ and nursing students’ moral competence, (...) a literature search was undertaken in January 2023 in six scientific databases: CINAHL, Cochrane Library, PsycINFO, PubMed Medline, Scopus and Web of Science. Empirical studies written in English without time limitation were eligible for inclusion. A total of 29 full texts were retrieved and included out of 5233 citations. Quality appraisal was employed using Joanna Briggs Institute checklists and the Mixed Method Appraisal Tool. Data were analysed using inductive content analysis. Research about the factors contributing to the promotion of qualified nurses’ and nursing students’ moral competence is limited and mainly explored using descriptive research designs. The contributing factors were identified as comprising two main categories: (1) human factors, consisting of four categories: individual, social, managerial and professional factors, and ten sub-categories; and (2) structural factors, consisting of four categories: educational, environmental, organisational and societal factors, and eight sub-categories. This review provides knowledge about the factors contributing to the promotion of qualified nurses’ and nursing students’ moral competence for the use of researchers, nurse educators, managers, organisations and policymakers. More research about the contributing factors is needed using complex intervention, implementation and multiple methods designs to ensure ethically sustainable healthcare. (shrink)

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)

Visual research is a fast-growing interdisciplinary field. The flexibility and diversity of visual research methods are seen as strengths by their adherents, yet adoption of such approaches often requires researchers to negotiate complex ethical terrain. The digital technological explosion has also provided visual researchers with access to an increasingly diverse array of visual methodologies and tools that, far from being ethically neutral, require careful deliberation and planning for use. To explore these issues, the Symposium on Exploring Ethical Frontiers of Visual (...) Methods was held at the University of Melbourne, Australia, on 4 March 2014. The symposium was hosted by the Visual Research Collaboratory, a consortium of Australian and Canadian visual researchers, with support from Melbourne Social Equity Institute, University of Melbourne. The symposium represented the culmination of a process to develop a resource outlining principles of ethical practice for visual researchers and ethics committee members, the Guidelines for Ethical Visual Research Methods, which were launched at the event. The Guidelines present a framework for considering ethical matters in visual research, distinguishing six groups of issues united by an overarching theme: confidentiality; minimizing harm; consent; fuzzy boundaries; authorship and ownership; and representation and audiences. (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.

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)

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)

Ethics and ethical behaviour are the fundamental pillars of a civilised society. The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law. In fact, ethics gets precedence with anything that would include, affect, transform, or influence upon individuals, communities or any living creatures. Many institutions within Europe have set up their own committees to focus on or approve activities that have ethical impact. In contrast, lesser-developed countries are trying to set up these (...) committees to govern their academia and research. As the first European consortium established to assist academic integrity, European Network for Academic Integrity, we felt the importance of guiding those institutions and communities that are trying to conduct research with ethical principles. We have established an ethical advisory working group within ENAI with the aim to promote ethics within curriculum, research and institutional policies. We are constantly researching available data on this subject and committed to help the academia to convey and conduct ethical behaviour. Upon preliminary review and discussion, the group found a disparity in understanding, practice and teaching approaches to ethical applications of research projects among peers. Therefore, this short paper preliminarily aims to critically review the available information on ethics, the history behind establishing ethical principles and its international guidelines to govern research.The paper is based on the workshop conducted in the 5th International conference Plagiarism across Europe and Beyond, in Mykolas Romeris University, Lithuania in 2019. During the workshop, we have detailed a) basic needs of an ethical committee within an institution; b) a typical ethical approval process ; and c) the ways to obtain informed consent with some examples. These are summarised in this paper with some example comparisons of ethical approval processes from different universities. We believe this paper will provide guidelines on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes. (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 ...

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)

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)

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)

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)

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)

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

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)

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)

Having scandalous unethical research practices in the mid and late 20th century, study protocols of biomedical research reviewed by the Ethics Committee (EC) has become the accepted international standard. The Declaration of Helsinki uniformly requires that all biomedical research involving human participants, including research on identifiable human material or data, should be approved by the EC. Today, concerns over the quality of the EC functions worldwide. There are research globally in this regard but no data are available from (...) Bangladesh. Hence, we conducted a questionnaire based pilot study on knowledge and attitude of EC members on bioethics and structure & function of EC in Bangladesh. (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)

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)

In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent individuals are (...) epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the (...) complex ethical issues that arise in clinical and organizational settings. Handbook for Health Care Ethics Committees is the first resource designed to address the range of work performed by ethics committees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (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)

The purpose of the paper is to present the challenges and difficulties that may be encountered in the process of the evaluation of qualitative research on sex workers by ethics committees. Such research is usually subject to review by ethics committees because of the risk of harm to participants, who are considered “vulnerable”. At the same time, due to the social stigma arising from the provision of sex services, researchers, research participants, and ethics committee members may (...) have their own ideas and expectations about how ethical research in this area should be conducted. Referring to the experience of researchers from common law countries, this paper will discuss how these expectations and the requirements of ethics committees collide, confronting the researcher with the need to meet the divergent or even contradictory expectations of various social actors. I will also propose alternative procedures for Polish ethics committees to ensure that the process of obtaining their approval is more democratic and open to the diverse needs of both researchers and research participants. (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)

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.