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.

Medical ethics committees are increasingly called on to assist doctors, patients, and families in resolving difficult ethics issues. Although committees are becoming more sophisticated in the substance of medical ethics, little attention has been given to the processes these committees use to facilitate decision-making. In 1990, the National Institute for Dispute Resolution in Washington, D.C., provided a planning grant from its Innovation Fund to the Institute of Public Law of the (...) University of New Mexico School of Law to look at what ethics committees can learn from facilitation and mediation techniques. The study's thesis was that, if adapted for use by medical ethics committees, facilitation and mediation techniques can be helpful to those bodies in case review consultations and in other internal committee processes. This article reports on that project. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the (...) role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

A review of medical ethics literature relating to the importance of the participation of patients in decision-making introduces the role of rights-based mediation as a voluntary process now being developed innovatively in America. This is discussed in relation to the theory of communicative ethics and moral personhood. References are then made to the work of medical ethics committees and the role of mediation within these. Finally it is suggested that mediation is part (...) of an eirenic ethic already being used informally in good patient care, and that there is a case for developing it further. (shrink)

The ethics of decision making for the critically ill elderly is an area of concern for all those involved in the decision-making process. The number of participants involved in decision making around end-of-life issues may be many: treatment and care decisions often bring together not only the patient and the physician, but the family, an extended medical care team, and impartial members of a hospital or institutional ethics committee. In addition, treatment (...) and care decisions made at the end of life occur in a variety of settings, not just the acute care hospital. Elderly patients who are critically ill, or in the final days or weeks of life, are found in intensive care or medical units of hospitals, in hospital and nursing home based hospice programs, in long-term care settings such as skilled nursing facilities, or at home, where they are tended by family caregivers. Differences in patterns of decision making regarding the care and treatment of critically ill older adults can be found across these settings, and decisions often vary according to the roles of the participants. (shrink)

Abstract Context: Established in 1997, Summa Health System’s Medical Ethics Committee (EC) serves as an educational, supportive, and consultative resource to patients/families and providers, and serves to analyze, clarify, and ameliorate dilemmas in clinical care. In 2009 the EC conducted its 100th consult. In 2002 a Palliative Care Consult Service (PCCS) was established to provide supportive services for patients/families facing advanced illness; enhance clinical decision-making during crisis; and improve pain/symptom management. How these services affect one another (...) has thus far been unclear. Objectives: This study describes EC consults: types, reasons, recommendations and utilization, and investigates the impact the PCCS may have on EC consult requests or recommendations. Methods: Retrospective reviews of 100 EC records explored trends and changes in types of consults, reasons for consults, and EC recommendations and utilization. Results: There were 50 EC consults each in the 6 years pre- and post-PCCS. Differences found include: (1) a decrease in number of reasons for consult requests (133–62); (2) changes in top two reasons for EC consult requests from ‘Family opposed to withdrawing life-sustaining treatment (LST)’ and ‘Patient capacity in question’ to ‘Futility’ and ‘Physician opposed to providing LST’; (3) changes in top two recommendations given by the EC from ‘Emotional Support for Patient/Family’ and ‘Initiate DNR Order’ to ‘Comfort Care’ and ‘Withdraw Treatment.’ Overall, 88% of recommendations were followed. Conclusion: PCCS availability and growth throughout the hospital may have influenced EC consult requests. EC consults regarding family opposition to withdrawing LST and EC recommendations for patient/family support declined. Content Type Journal Article Pages 1-16 DOI 10.1007/s10730-011-9170-9 Authors Jessica Richmond Moeller, Department of Psychiatry and Behavioral Sciences, Akron General Medical Center, 400 Wabash Ave, Akron, OH 44307, USA Teresa H. Albanese, Health Services Research and Education Institute, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Kimberly Garchar, Kent State University, 6000 Frank Ave., N.W, North Canton, OH 44720, USA Julie M. Aultman, Department of Family and Community Medicine, Northeast Ohio Medical University, P.O. Box 95, Rootstown, OH 44272, USA Steven Radwany, Palliative Care and Hospice Services, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Dean Frate, Internal Medicine, Palliative Care and Hospice Services, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737. (shrink)

There has been longstanding interest in the consistency of decisions made by research ethics committees in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on (...) seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of κ = 0.286 , indicating a level of agreement that, although probably better than chance, may be described as “slight”. The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed. (shrink)

Hospital health committees in Turkey review medical reports from clinical practitioners and decide whether or not they are justified. As a rule, each HHC member is expected to observe and examine each patient and then evaluate the report. If the report from the patient's doctor is approved, then the Social Security Administration, a state organisation, will meet all of the patient's expenses covering treatment, medication and operations. Justification of health expenditure is crucial for the state because health resources (...) have to be carefully allocated. Conflicts of obligation also generate ethical issues which have to be resolved as well. However, HHCs are not designed to make ethical decisions. An overall concept of organisational ethics needs to be developed. (shrink)

The number of admissions to hospitals of patients without a proxy decision maker is rising. Very often these patients need fairly immediate medical intervention for which informed consent—or informed refusal—is required. Many have recommended that there be a process in place to make these decisions, and that it include a variety of perspectives. People are particularly wary of relying solely on medical staff to make these decisions. The University Hospitals Case Medical Center recruits community members from (...) its Ethics Committee to serve on a subcommittee, the Patients Without Proxies (PWP) Committee, which works with medical staff during the decision-making process for these patients. Generally, the community members go to the bedside to observe patients. This article looks at how those unused to observing hospitalized patients who are sick and/or dying are affected, comparing them to mock jurors in a research study who are exposed to graphic photographs related to a fabricated crime scene. Judgments made by the mock jurors are affected by viewing such images. The personal experience of witnessing unfamiliar and shocking scenes affects their subsequent judgments. While it may be difficult to tease out whether observing patients causes PWP members to be benefited or harmed, they are affected by what they see. If a variety of perspectives is desirable to reduce possible bias or error, this article argues that at least one community member should refrain from seeing the patient in order to add a different and valuable voice to the decision-making process. Members of the subcommittee base their judgments on the various kinds of information available. Sometimes the things they see, hear, or feel may affect them particularly deeply, and affect their judgments as well. In this article I explore the idea that something like this may be happening in a particular kind of clinical ethics case consultation. (shrink)

Background:Emergency care providers are frequently faces with situations in which they have to make decisions quickly in stressful situations. They face barriers to ethical decision-making and recognizing and finding solutions to these barriers helps them to make ethical decision.Objectives:The purpose of this study was to identify barriers of ethical decision-making in Iranian Emergency Medical Service personnel.Methods:In this qualitative research, the participants (n = 15) were selected using the purposive sampling method, and the data were (...) collected by deep and semi-structured interviews. Finally, the data are analyzed using the content analysis approach.Ethical considerations:Permission to conduct the study was obtained from the Ethics Committee of the Shahid Beheshti University of Medical Sciences. The objectives of the study were explained to the participants and written consent was received from them. Also, participants were assured that necessary measures were taken to protect their anonymity and confidentiality.Findings:The results of the analysis are classified in five main categories. It encompasses the following areas: perception of situation, patient-related factors, input and output imbalance, uncoordinated health system, and paradoxes.Conclusion:Emergency Medical Service personnel make ethical decisions every day. It is important that prehospital personnel know how to manage those decisions properly so that clients’ moral rights are respected. Hence, by identifying the dimensions and obstacles of ethical decision-making in Emergency Medical Service personnel, it is possible to enhance the moral judgment and ethical accountability of the personnel and develop the strategies necessary for ethical decision-making in them. (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)

BackgroundDeciding whether to resuscitate extremely preterm infants (EPIs) is clinically and ethically problematic. The aim of the study was to understand neonatologists’ clinical–ethical decision-making for resuscitation of EPIs.MethodsWe conducted a qualitative study in Belgium, following a constructivist account of the Grounded Theory. We conducted 20 in-depth, face-to-face, semi-structured interviews with neonatologists. Data analysis followed the qualitative analysis guide of Leuven.ResultsThe main principles guiding participants’ decision-making were EPIs’ best interest and respect for parents’ autonomy. Participants agreed that (...) justice as resource allocation should not be considered in resuscitation decision-making. The main ethical challenge for participants was dealing with the conflict between EPIs’ best interest and respect for parents’ autonomy. This conflict was most prominent when parents and clinicians disagreed about births within the gray zone (24–25 weeks). Participants’ coping strategies included setting limits on extent of EPI care provided and rigidly following established guidelines. However, these strategies were not always feasible or successful. Although rare, these situations often led to long-lasting moral distress.ConclusionsParticipants’ clinical–ethical reasoning for resuscitation of EPIs can be mainly characterized as an attempt to balance EPIs’ best interest and respect for parents’ autonomy. This approach could explain why neonatologists considered conflicts between these principles as their main ethical challenge and why lack of resolution increases the risk of moral distress. Therefore, more research is needed to better understand moral distress in EPI resuscitation decisions.Clinical Trial Registration: The study received ethical approval from the ethics committee of UZ/ku Leuven (S62867). Confidentiality of personal information and anonymity was guaranteed in accordance with the General Data Protection Regulation of 25 May 2018. (shrink)

Background and aimsFew Polish hospitals have Hospital Ethics Committee (HECs) and the services are not always adequate. In this situation, the role of HECs, in providing, among others, ethical advice on the discontinuation of persistent therapies, may be taken over by other entities. The aim of our research was to investigate, how often and on what issues hospital chaplains are asked for ethical advice in reaching difficult medical decisions.MethodsA survey of 100 Roman Catholic chaplains was conducted, that is, (...) at least 10% of all chaplains currently working in Polish hospitals.ResultsOf the participants, 29% confirmed receiving requests for advice in making a morally difficult medical decision. Receiving this type of request was not conditional on the place of their service, duration of their pastoral mission or HEC membership. The largest group of chaplains (21%) encounter questions concerning the ethical dilemmas associated with discontinuing persistent therapy. Patients and their families most often raise issues related to the methods of birth control, and the medical staff raise the issue of termination of pregnancy—as reported by 9% and 15% of chaplains, respectively. Most of the chaplains asked for help (79%) experience a deficit of specialist knowledge in the area of medicine or ethics.ConclusionsIn order to improve the quality of ethical consultations in Polish hospitals, in addition to further development of HECs, it is postulated to develop a system for bioethical education of chaplains. (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)

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)

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)

Shared decision-making is a well-recognized model to guide decision-making in medical care. However, the shared decision-making concept can become exceedingly complex in adolescent patients with varying degrees of autonomy who have most of their medical decisions made by their parents or legal guardians. The complexity increases further in ethically difficult situations such as terminal illness. In contrast to the typical patient-physician dyad, shared decision-making in adolescents requires a decision-making (...) triad that also includes the parents or guardians. The multifactorial nature of these cases can overwhelm treatment teams, with minimal guidance on how to best approach the patient–parents–physician dynamic in an ethically appropriate manner. Estimated time left to live is the paramount ethical consideration for such cases with respect to shared decision-making. This paper offers a sliding scale to serve as a grounding reference for clinicians who care for terminally ill adolescents and hospital ethics committee members for initiating and guiding the ethical discussion for these patients. This paper also elucidates several other ethically salient features inherent to many of these cases, including quality of life, treatability of disease, cultural influences, among others. Yet how each of these variables is weighed is dependent upon the specific circumstances of each individual case. Ultimately, shared decision-making in adolescent patients with terminal illnesses must be a collaborative and ongoing process that thoughtfully weighs the values and ethical responsibilities of the patient, parents, and physician to ideally reconcile differences and come to a consensus on the best management option for each individual patient. (shrink)

Despite increased calls for hospital ethics committees to serve as default decision-makers about life-sustaining treatment for unrepresented patients who lack decision-making capacity or a surrogate decision-maker and whose wishes regarding medical care are not known, little is known about how committees currently function in these cases. This was a retrospective cohort study of all ethics committee consultations involving decision-making about LST for unrepresented patients at a large academic hospital from (...) 2007 to 2013. There were 310 ethics committee consultations, twenty-five of which involved unrepresented patients. In thirteen cases, the ethics consultants evaluated a possible substitute decision-maker identified by social workers and/or case managers. In the remaining cases, the ethics consultants worked with the medical team to contact previous healthcare professionals to provide substituted judgement, found prior advance care planning documents, or identified the patient’s best interest as the decision-making standard. In the majority of cases, the final decision was to limit or withdraw LST or to change code status to Do Not Resuscitate/Do Not Intubate. Substitute decision-makers who had been evaluated through the ethics consultation process and who made the final decision alone were more likely to continue LST than cases in which physicians made the final decision. In our centre, the primary role of ethics consultants in decision-making for unrepresented patients is to identify appropriate decision-making standards. In the absence of other data suggesting that ethics committees, as currently constituted, are ready to serve as substitute decision-makers for unrepresented patients, caution is necessary before designating these committees as default decision-makers. (shrink)

Clinical Ethics and the Dynamics of Group Decision-Making: Applying the Psychological Data to Decisions Made by Ethics Committees Content Type Journal Article Pages 207-228 DOI 10.1007/s10730-009-9096-7 Authors Erica K. Rangel, Saint Louis University Department of Health Care Ethics 6333 North Rosebury Ave #3W St. Louis MO 63105 USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 2.

Introduction Ethical climate in medical contexts is referred to the organizational environment consisting of medical staff interpersonal relationships regarding patient care. This element affects staff behavior in an organization. The investigation and comparison of the effects of the interventions promoting ethical climate are among important nursing challenges that should be considered by researchers. The present study was conducted to compare the effect of nurses’ ethical decision-making skills and interpersonal communication training on their ethical climate. Materials and (...) methods This experimental study was performed on 90 nurses working in the general teaching hospitals of Mashhad, Iran. The sampling process was conducted in two stages. Nurses were divided into three groups: intervention 1, intervention 2 and control group. The intervention was separate 12-h workshops for each of the intervention groups. The ethical climate questionnaire by Victor and Cullen was used to assess the score of ethical climate in the three groups both at the beginning and 4 weeks after the workshop. The data were analyzed in Statistical Package for Social Sciences software using descriptive statistics, analysis of variance, Kruskal–Wallis, paired sample t-test, Wilcoxon test, and post hoc Tukey’s test. Ethical considerations were as follows: The study design was approved by the Research Ethics Committee of Mashhad University of Medical Sciences. Informed consent was obtained from all subjects, and they were ensured about the confidentiality terms. Results The mean scores of the ethical climate test at the first stage were obtained as 66.0 ± 5.5, 67.8 ± 6.9, and 67.7 ± 7.2 in the ethical decision-making, interpersonal communication, and control groups, respectively. Accordingly, the three groups were not significantly different in terms of this variable. However, after the intervention, a significant difference was observed among the three groups regarding the mean scores of the ethical climate test In this regard, the calculated mean scores in the ethical decision-making, interpersonal communication, and control groups were 99.3 ± 6.3, 90.4 ± 7.7, and 67.4 ± 7.9, respectively. Conclusion Training workshops about ethical decision-making skills and interpersonal communication on the ethical professional climate of nurses was effective. Nonetheless, the effect of ethical decision-making skill training was found to be higher than interpersonal communication skill training. Therefore, it is recommended that nursing managers hold training workshops to improve the ethical climate for nurses. (shrink)

IntroductionClinical ethics committees (CECs) support and enhance communication and complex decision making, educate healthcare professionals and the public on ethical matters and maintain standards of care. However, a consistent approach to training members of CECs is lacking. A systematic scoping review was conducted to evaluate prevailing CEC training curricula to guide the design of an evidence-based approach.MethodsArksey and O’Malley’s methodological framework for conducting scoping reviews was used to evaluate prevailing accounts of CEC training published in six (...) databases. Braun and Clarke’s thematic analysis approach was adopted to thematically analyse data across different healthcare and educational settings.Results7370 abstracts were identified, 92 full-text articles were reviewed and 55 articles were thematically analysed to reveal four themes: the design, pedagogy, content and assessment of CEC curricula.ConclusionFew curricula employ consistent approaches to training. Many programmes fail to provide CEC trainees with sufficient knowledge, skills and experience to meet required competencies. Most programmes do not inculcate prevailing sociocultural, research, clinical and educational considerations into training processes nor provide longitudinal support for CEC trainees. Most CEC training programmes are not supported by host institutions threatening the sustainability of the programme and compromising effective assessment and longitudinal support of CEC trainees. While further reviews are required, this review underlines the need for host organisations to support and oversee a socioculturally appropriate ethically sensitive, clinically relevant longitudinal training, assessment and support process for CEC trainees if CECs are to meet their roles effectively. (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)

Research shows that the physician’s personal attributes and social characteristics have a strong association with their end-of-life decision making. Despite efforts to increase patient, family and surrogate input into EOL decision making, research shows the physician’s input to be dominant. Our research finds that physician’s social values, independent of religiosity, have a significant association with physician’s tendency to withhold or withdraw life sustaining, EOL treatments. It is suggested that physicians employ personal social values in their EOL (...) medical coping, because they have to cope with existential dilemmas posed by the mystery of death, and left unresolved by medical decision making mechanisms such as advanced directives and hospital ethics committees. (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 Israeli law of abortions (1977) legally authorises hospital committees to decide upon women's requests for selective abortion. One of the law's clauses determines that abortions can be approved in cases of an embryopathy. However, the law does not provide any clear definitions of those fetal ‘physical or mental defects’ in terms of severity and/or likelihood, which remain open to interpretation by the committee members. This paper aimed to determine which ethical methodologies are used by committee members and advisors (...) as they face the dilemma of abortion approval due to mild to moderate possible embryopathy. Twenty interviews demonstrated that they use mainly a combination of deontology and a contextual–relational model. Their ethical considerations are both contextual such as the family's/woman's relational network and are influenced by the ethical principles of autonomy and in cases of late abortions the value of life. The findings reveal a paradoxical picture: on the one hand, committee members hold liberal perceptions and in practice abortion requests are very seldom rejected. On the other hand, the Israeli abortion law and practice of abortion committees is still problematical from liberal and feminist rights perspectives. This paradox is discussed further by reflecting upon the relevant theory as well as the Israeli context. The paper concludes by suggesting that within the specific Israeli sociopolitical climate the requirement for committee approval of what should be a private decision might be necessary in order to placate religious or other opposition to abortion. (shrink)

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection (...) of research participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)

We have followed with interest the commentaries arising from Moore and Donnellys1 argument that authorities in charge of research ethics committees should focus primarily on establishing code-consistent reviews.1 We broadly agree with Savulescu’s2 argument that ethics committees should become more expert, but in a different way and for a different reason. We have recently been working with the UK Health Research Authority analysing the outcomes of their ‘Shared Ethical Debate’ exercises.3 Each ShED exercise involves the circulation (...) of a single research project to a number of RECs. The resulting minutes from each REC are compared along with the final decisions made by each REC on the project under consideration. This process was originally an administrative exercise designed to promote greater consistency among the 60 or so ethics committees that were brought under the HRA ) umbrella within the UK National Health Service. Over 20 ShEDs have been run, and although the process has significant weaknesses and has not always been run consistently, the results of the exercises are fascinating. Broadly speaking, NHS RECs have been getting more consistent over time in terms of their decision-making, but the reasons for the final decisions as described in the committee minutes continue to vary widely. Qualitative research now needs to be done to understand why different committees can have such different discussions in relation to exactly the same research project and yet come to essentially the same conclusion. As part of our analysis of the ShED data, we looked at …. (shrink)

Issues concerning patients' rights are at the center of bioethics, but the political basis for these rights has rarely been examined. In Bioethics in a Liberal Society: The Political Framework of Bioethics Decision Making , Thomas May offers a compelling analysis of how the political context of liberal constitutional democracy shapes the rights and obligations of both patients and health care professionals. May focuses on how a key feature of liberal society -- namely, an individual's right to make (...) independent decisions -- has an impact on the most important relational facets of health care, such as patients' autonomy and professionals' rights of conscience. Although a liberal political framework protects individual judgments, May asserts that this right is based on the assumption of an individual's competency to make sound decisions. May uses case studies to examine society's approach to medical decision making when, for reasons ranging from age to severe mental disorder, a person lacks sufficient competency to make independent and fully informed choices. To protect the autonomy of these vulnerable patients, May emphasizes the need for health care ethics committees and ethics consultants to help guide the decision-making process in clinical settings. Bioethics in a Liberal Society is essential reading for all those interested in understanding how bioethics is practiced within our society. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do (...) all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

Objectives—To investigate the factors considered by staff, and the practicalities involved in the decision making process regarding the withdrawal or withholding of potential life-sustaining treatment in a children's hospital. To compare our current practice with that recommended by the Royal College of Paediatrics and Child Health guidelines, published in 1997.Design—A prospective, observational study using self-reported questionnaires.Setting—Tertiary paediatric hospital.Patients and participants—Consecutive patients identified during a six-month period, about whom a formal discussion took place between medical staff, nursing staff (...) and family regarding the withholding or withdrawal of potentially life-sustaining treatments. The primary physician and primary nurse involved in the discussion were identified.Method—Two questionnaires completed independently by the primary physician and nurse.Results—Twenty-two patients were identified . In 20 cases treatment was withdrawn or withheld, in two cases treatment was continued. Nursing staff considered family wishes and family perceptions of patient suffering as significantly more important factors in decision making than medical staff, who considered prognostic factors as most important. In only two cases were the patient's expressed wishes apparently available. In most cases staff considered the patient's best interests were served and the process would not be enhanced by the involvement of an independent ethics committee. The exceptions were those cases in which treatment was continued following disagreement between parties.Conclusions—Our current practice is consistent with that recommended by the RCPCH. The contribution of the patient, provision of staff counselling and general practitioner involvement were identified as areas for improvement. (shrink)

The purpose of this article is to provide a short overview of the condition of clinical ethics committees (CECs) and other forms of the so-called "ethics support" infrastructure. This includes but is not limited to CECs because some countries also have ethics consultation services that function independently from the CECs. It seems that properly structured CECs and other types of ethics support have a potential to act as facilitators of ethically sensitive healthcare decision-making. (...) This goal can be achieved if the ethics support infrastructure becomes an integral part of the healthcare institution where the majority of ethical dilemmas and the need for ethical debate arise. At the same time, CECs can become a useful tool for implementing bioethical standards developed at both national and international levels, including those established by the Council of Europe instruments. This is the main reason why the issue of developing clinical ethics support services might be very important for the Steering Committee on Bioethics (CDBI) of the Council of Europe. More specifically, the question is what special role ethics support services can play in the context of the follow up to the Council of Europe Symposium in the decision-making process regarding medical treatment in end-of-life situations (Strasbourg, 30 November-1 December). Very often, cases to be considered by the CECs and ethics consultants deal with the difficult end-of-life treatment choices. (shrink)

Background: Dementia care at home often involves decisions in which the caregiver must weigh safety concerns with respect for autonomy. These dilemmas can lead to situations where caregivers provide care against the will of persons living with dementia, referred to as involuntary treatment. To prevent this, insight is needed into how family caregivers of persons living with dementia deal with care situations that can lead to involuntary treatment. Objective: To identify and describe family caregivers’ experiences regarding care decisions for situations (...) that can lead to involuntary treatment use in persons living with dementia at home. Research design: A qualitative descriptive interview design. Data were analysed using the Qualitative Analysis Guide of Leuven. Participants and research context: A total of 10 family caregivers providing care for 13 persons living with dementia participated in in-depth semi-structured interviews. Participants were recruited by registered nurses via purposive sampling. Ethical consideration: The study protocol was approved by the Ethics Committee of the University Hospitals Leuven and the Medical Ethical Test Committee Zuyderland. Findings: Family caregivers experience the decision-making process concerning care dilemmas that can lead to involuntary treatment as complicated, stressful and exhausting. Although they consider safety and autonomy as important values, they struggle with finding the right balance between them. Due to the progressive and unpredictable nature of dementia, they are constantly seeking solutions while they adapt to new situations. Family caregivers feel responsible and experience social pressure for the safety of persons living with dementia. They may be blamed if something adverse happens to the persons living with dementia, which increases an already stressful situation. Their experience is influenced by characteristics of the care triad such as practical and emotional support, knowledge, and previous experiences. Discussion and conclusion: To prevent involuntary treatment, professionals need to proactively inform family caregivers, and they need to support each other in dealing with complex care situations. (shrink)

BackgroundThe participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements (...) is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants’ motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi.MethodsWe conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation.FindingsThe findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role.ConclusionThese findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants’ concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants’ needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups.Trial Registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451). (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)

Objective: The objectives of this study are to understand the current functions, structure and operation of hospital ethics committees (HECs) in Shanghai and to facilitate their improvement. Methods: (1) A questionnaire survey, (2) interviews with secretaries and (3) on-site document reviews of HECs in Shanghai were used in the study, which surveyed 33 hospitals. Results: In Shanghai, 57.56% of the surveyed hospitals established HECs from 1998 to 2005. Most HECs used bioethical review of research involving human subjects as (...) well as bioethical review or consultation regarding medical care services and administrative decision- making. Of the surveyed HECs, 14.3% did not provide any formal bioethical training to the HECs’ members and many HECs had no standard operating procedures. Some HECs had no clear definition of what was “conflict of interest” that should be considered by the HECs, while 44.4% of the HECs did not perform continuing review. Discussion: After the issues of related national regulations, more and more hospitals established HECs in Shanghai, but the functions of HECs need to be further developed and formal training on bioethics should be provided to HEC members. To assure the independence and good performance of HECs, the conflict of interest procedure, the standard operating procedures and bioethical review should be improved. Conclusion: HECs in Shanghai had developed in the preceding 10 years and they played great roles in protecting the rights and welfare of human subjects and patients; some areas need improvement. (shrink)

For some time, clinical ethics committees (CECs) have been a prominent feature of hospitals in North America. Such committees are less common in the United Kingdom and Europe. Focusing on the UK, this paper evaluates why CECs have taken so long to evolve and assesses the roles that they should play in health care policy and clinical decision making. Substantive and procedural moral issues in medicine are differentiated, the former concerning ethicolegal principles and their paradigmatic (...) application to clinical practice and the latter dealing with how such application should be negotiated in the face of disagreement and/or uncertainty. It will be argued that the role of CECs is both substantive and procedural. Provided that they do not overstep their appropriate moral and professional boundaries, CECs will be shown to have an important and positive function in improving hospital care within the UK and elsewhere. (shrink)

The French medical context is characterized by institutionalization of the ethical reflection in health care facilities and an important disparity between spaces of ethical reflection. In theory, the healthcare professional may mobilise an arsenal of resources to help him in his ethical reflection. But what happens in practice? We conducted semi-structured interviews with 22 health-care professionals who did and did not have recourse to clinical ethical committees. We also implemented two focus groups with 18 professionals involved in various (...) spaces of ethical reflection in order to let them debate about a better way to organize ethical reflection in their institutional contexts. The qualitative analysis allows to us to underline the coexistence of different conceptions of ethics among health care professionals. We also observed that the participants in our study shared the experience of ethically problematic situations as roadblocks in the process of communication and decision-making. We therefore report the factors which favour or inhibit the ethical course leading to the resolution or at the very least soothing of the situation at hand. Finally, we discuss methodological issues and underline the fact that while the patient is at the heart of the professional’s ethical preoccupations, this does not imply that they are actors in decisions that concern them. (shrink)

While principle-based ethics is well known and widely accepted in psychiatry, much less is known about how decisions are made in clinical practice, which case scenarios exist, and which challenges exist for decision-making. Protocols of the central ethics committee responsible for four psychiatric hospitals over 7 years (N=17) were analysed. While four cases concerned suicide risk in the case of intended hospital discharge, the vast majority (N=13) concerned questions of whether the responsible physician should or should (...) not initiate the use of coercion in patients lacking mental capacity. The committee’s recommendations were non-uniform. Forced feeding and electroconvulsive therapy were endorsed in each one case. In two cases of intermittent loss of capacity due to heavy drinking or intermittent severe suicidal ideation, a self-binding contract was recommended and the use of coercion was considered as justified for a very limited period. In all other cases, most of which involved involuntary treatment, the use of coercion was not endorsed. Without exception, the recommendations were accepted with relief by the physicians and their treatment teams, who feared liability in the event of harm to the patient. Eventually, a model of a decision algorithm was derived from the ethical arguments in the protocols. (shrink)

Moore and Donnelly argue in the paper ‘The job of “ethics committees”’ that research ethics committees should be renamed and that their job should be specified as “review of proposals for consistency with the duly established and applicable code” only.1 They raise a large number of issues, but in this comment I briefly want to suggest that two of their arguments are fundamentally flawed. The first flawed argument is the argument related to the separation of powers. (...) Moore and Donnelly proceed from the premise that it is pro tanto better to have an institutional arrangement that separates code-making powers and decisional powers, and then proceed to argue that this separation is not feasible for what they call ‘ethics consistency review’ because “no matter who established any prespecified review standards, the review decision maker must be empowered at review to revise those standards when this would make for an ethical improvement. This is because any understanding of ethics-consistency standards themselves and of their implications for any case is fallible and improvable in …. (shrink)

Mental disorders in university students are very frequent, therefore higher education institutions have established in-campus mental healthcare centres. These clinics have particular characteristics that differ from other mental health centres, as they report to and represent an educational institution, while at the same time looking after the interests and well-being of patients requesting assistance, thus generating unique bioethical conflicts. Ethics Committees are useful tools to offer support to mental health professionals in making ethical decisions. In order to (...) respond to these issues, it was decided that an Ethics Committee would be created in the mental health clinic of a private university in Mexico City. This article describes the implementation process for this Committee, its duties and scope, as well as the case work and review methodology. A list of the most frequent ethical conflicts is attached, jointly with the ethical analysis of the cases treated throughout the year and a half or work by the Committee. (shrink)

BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting (...) an end of study declaration to the Hampshire A research ethics committee between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications.ResultsOut of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32 %. Original Research Ethics Committee applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 of the published studies.ConclusionsThis study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research. (shrink)

The American term Bioethics has been adopted over the last ten years and the development of Bioethics committees on the American model testifies this influence, even before the official appointment of a National Committee in 1983. This phenomenon acknowledged as the emergence of French bioethics is in fact the final outcome of a long-lasting crisis in the medical profession, in quest for a new style of ethics, breaking with the traditional professional ethics (French Déontologie, through the (...) Ordre des Médecins). Among other factors of conceptual and institutional change, the increase of biomedical research comes first: a major consequence is the sharing of moral responsibilities in decision-making with outsider scientists and finally the involvement of the whole population as potential moral subjects.The designation of these events as the emergence of French bioethics is hardly appropriate for an account of this dramatic shift in ethical norms and roles in medicine. This paper attempts to review the intellectual roots of the recent evolution and to summarize present and prospective trends. (shrink)

Background Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Main text Aided by two frameworks for legitimate priority setting, we discuss how (...) CECs can contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC’s deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. Conclusions On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions. (shrink)

To date no one has identified or described the population of incapacitated patients being treated in an inpatient setting who lack proxy decision-makers. Nor, despite repeated calls for protocols to be developed for decision-making, has any institution reported on the utilization of such a protocol. In 2005, our urban tertiary care hospital instituted a protocol utilizing community members of the ethics committee to meet with the medical providers and engage in shared decision-making for (...) patients without proxies. We conducted a retrospective chart review and in this paper describe nearly 200 patients who were identified and treated according to the protocol over a 12 year period. After an aggressive search, family members were located for a surprising number of patients, leaving 80 patients who needed decisions to be made utilizing the PWP committee. We review the decisions required, the results of the shared decision-making meetings, and the patient outcomes. Our experience has shown that a protocol involving community volunteers to make decisions for PWPs in a timely manner is feasible and ethically defensible. The protocol has been accepted by physicians and utilized with increasing frequency. Because it was possible to gather at least minimal information on most patients, a standard of “informed best interest” was used to make decisions. PWP committee recommendations varied, but in all cases agreement was reached with the attending physicians. (shrink)

This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring broad (...) representation across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of ‘collusion’, we made every effort to maintain ‘moral distance’ and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material. (shrink)

This article presents standards for setting up and educating institutional ethics committees (IECs). These standards are based on experiences in the Netherlands, where IECs have been established in a large number of health care institutions. Though the IEC has become a generally accepted institution within Dutch health care, there are concerns over its effectiveness regarding the improving of the moral quality of clinical decision making. Health care practitioners and members of IECs too, experience a gap between (...) the IEC and the reality of the clinical environment. At this moment, there is interest in developing programmes which educate practitioners in moral issues and how to deal with them, using the method of a structured debate on the ward. The IEC will not be made obsolete by this development, but can play a guiding role in the implementation of such programmes. Current concerns are the lack of patient representation in the Dutch IEC, and the loss of contact with the local community of health care practitioners because of the merger of hospitals into bodies similar to UK National Health Service (NHS) trusts. (shrink)

Bioethical dilemmas can emerge in research and clinical settings, from end-of-life decision-making to experimental therapies. The COVID-19 pandemic raised serious ethical challenges for healthcare organizations, highlighting the need to conduct needs assessments of the bioethics infrastructures of healthcare organizations. Clinical ethics committees (CECs) also create equitable policies, train staff on ethics issues, and play a consultative role in resolving the difficulty of complex individual cases. The main objective of this project was to conduct a needs (...) assessment of the bioethics infrastructure within a comprehensive hospital system. A cross-sectional anonymous online survey, including quantitative and qualitative formatted questions. The survey was sent to five key leaders from the organization’s hospitals. Survey questions focused on the composition, structure, function, and effectiveness of their facilities’ bioethics infrastructure and ethics-related training and resources. Positive findings included that most facilities have active CECs with multidisciplinary membership; CECs address critical issues and encourage team members to express clinical ethics concerns. Areas of concern included uncertainty about how CECs function and the process for resolving clinical ethics dilemmas. Most reported no formal orientation process for CEC members, and many said there was no ongoing ethics education process. The authors conclude that if CECs are a critical institutional resource where the practice of medicine and mission intersect, having well-functioning ethics committees with trained and oriented members demonstrates an essential commitment to the mission. The survey revealed that more needs to be done to bolster the bioethics infrastructure of this institution. (shrink)

A new Clinical Ethics Advisory Group was created to contribute to NHS Trust policies and guidelines in response to ethical issues arising from the COVID-19 pandemic. An ethical analysis framework used in medical education, the CoRE-Values Compass and Grid, was adapted to form a step-wise ‘ABC’ decision-making process. CEAG members found the framework simple to understand and use and the model facilitated time-efficient decisions that were explicitly justifiable on moral, ethical, professional and legal grounds. The adapted (...) CoRE-Values framework might help facilitate decision-making processes for similar new clinical ethics advisory or support committees. (shrink)