Challenging misconceptions about clinical ethics support during COVID-19 and beyond: a legal update and future considerations.

The pace of change and, indeed, the sheer number of clinical ethics committees (not to be confused with research ethics committees) has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital for Children NHS Foundation Trust v MX, FX and X ([2020] EWHC 1958 (Fam), [21]-[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK.

Implementation of Japan's First Clinical Research Regulatory Law: Background, Overview, and Challenges.

In April 2018, Japan's first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law's application brings numerous complications, including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field.

An overview of trends in the regulation of clinical ethics committees: an opinion from the Italian National Bioethics Committee article.

In 2017, the Italian National Bioethics Committee (INBC) released an opinion paper titled ″Clinical ethics committees″. Said document advocates for the creation of ″clinical bioethics committees″ in every suitable setting and lays out a set of guidelines aimed at regulating such committees' functions. The recommendations deal primarily with the independence, requirements for counselling, structures, composition, tasks, placement, coordination, requisite competences, regulations. In the opinion's contents there are: a) the need to entrust counselling and training on ethical issues within clinical practice to different committees than those that deal with ethical assessments of scientific trials and experimentation; b) the laying out of all the various functions and related competencies required of the ethics committees' members; c) the necessity that all counselling practices be carried out by each committee as a whole, rather than by a single expert member; d) Committee's independence. The authors elaborate on each one of the above mentioned aspects and highlight the importance of INBC's recommendations in order to improve the quality standards of care delivered ″to each patient's bed″.

Clinical ethics and the role of clinical ethics committees: proposals for a revival. Commentary.

The issue addressed in the paper published by the Italian National Bioethics Committee (NBC) entitled "Clinical ethics committees", is highly significant for many reasons. One of these is the fact that the ethics committees charged with assessing clinical trials have so much responsibility and such a heavy work-load that they have little time available for other tasks such as engaging directly with patients "at the bedside", as a result of which the role of committees responsible for assessing clinical cases is especially important. According to the NBC, the opinions of clinical ethics committees should be formulated jointly and are non-binding. The NBC offers practical proposals not only for the Italian context. While the Italian National Institute of Health (Istituto Superiore di Sanità - ISS) is not involved directly in treating patients, its role in providing guidance is crucial to the national health service and it has always paid special attention to these issues.

\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges.

[Bioethics in medical institutions--new custom or help? The example of clinical ethics consultation at a University Medical Center]. / Bioethik in medizinischen Institutionen--Mode oder Hilfe? Das Beispiel der klinischen Ethikberatung eines Universitätsklinikums.

Although ethics committees are well established in the medical sciences for human clinical trials, animal research and scientific integrity, the development of clinical ethics in German hospitals started much later during the first decade of the twenty-first century. Clinical ethics consultation should be pragmatic and problem-centered and can be defined as an ethically qualified and informed conflict management within a given legal framework to deal with and resolve value-driven, normative problems in the care of patients. Clinical ethics consultations enable shared clinical decision-making of all parties (e.g. clinicians, patients, family and surrogates) involved in a particular patient's care. The clinical ethicist does not act as an ethics expert by making independent recommendations or decisions; therefore, the focus is different from other medical consultants. Ethics consultation was first established by healthcare ethics committees (HEC) or clinical ethics consultation (CEC) groups which were called in to respond to an ethically problematic situation. To avoid ethical dilemmas or crises and to act preventively with regard to ethical issues in individual patients, an ethics liaison service is an additional option to ethics case consultations which take place on a regular basis by scheduled ethics rounds during the normal ward rounds. The presence of the ethicist offers some unique advantages: it allows early recognition of even minor ethical problems and accommodates the dynamics of ethical and clinical goal-setting in the course of patient care. Most importantly, regular and non-authoritative participation of the ethicist in normal ward rounds allows continuous ethical education of the staff within the everyday clinical routine. By facilitating clinical ethical decision-making, the ethicist seeks to empower physicians and medical staff to deal appropriately with ethical problems by themselves. Because of this proactive approach, the ethics liaison service can make a significant contribution to preventative ethics in reducing the number of emerging ethical problems to the satisfaction of all parties involved.

Medical ethics in pediatric critical care.

Ethically charged situations are common in pediatric critical care. Most situations can be managed with minimal controversy within the medical team or between the team and patients/families. Familiarity with institutional resources, such as hospital ethics committees, and national guidelines, such as publications from the American Academy of Pediatrics, American Medical Association, or Society of Critical Care Medicine, are an essential part of the toolkit of any intensivist. Open discussion with colleagues and within the multidisciplinary team can also ensure that when difficult situations arise, they are addressed in a proactive, evidence-based, and collegial manner.

Clinical ethics committees in Norway: what do they do, and does it make a difference?

The first clinical ethics committees (CEC) 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 (providing specialized and hospital-based healthcare services to the Norwegian population of 4.9 million people) have established at least one committee. Center for Medical Ethics (SME), 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.

Evolution of hospital clinical ethics committees in Canada.

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

Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees.

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.

[Hospital clinical ethics committees]. / Los comités hospitalarios de ética clínica.

The scientific and technological advances have been surprising, more in the two last decades, but they don't go united with to the ethical values of the medical professional practice, it has been totally escaped, specially when the biological subsistence, the maintenance of the life through apparatuses and the mechanisms that prolong the existence are who undergoes an alteration that until recently time was mortal shortly lapse. It is common listening that exist a crisis in the medical profession, but what really is it of human values, which as soon and taken into nowadays, actually professional account, which gives rise to a dehumanization towards the life, the health, the disease, the suffering and the death. The ideal of the doctor to give to service to the man in its life and health, as well to be conscious that the last biological process that must fulfill is the death, and when it appears, does not have considered as a actually professional failure. It has protect to the patient as the extreme cruelty therapeutic, that it has right a worthy death. It's taking to the birth of the hospital ethics committees, they have like function to analyze, to advise and to think about the ethical dilemmas that appear actually clinical or in the biomedical investigation. In 1982 in the UEA only 1% of its hospitals had a ethics committees; by 1988, it was 67% and the 100% in 2000. In Mexico the process of the formation by these committees begins, only in the Military Central Hospital, to count the ethics committee on 1983, also the Hospital no. 14 of the IMSS in Guadalajara, it works with regularity from 1995, with internal teaching of bioethic. The Secretariat of Health has asked the formation of the bioethical committees in each hospital, and order the it was be coordinated by the National Committee of Bioética. The integration of these committees is indispensable that their members have the knowledge necessary of bioética. The Mexican Society of Ortopedia, conscious of the responsibility that will have these Committees, presents/displays the following article, with the bioética commite and the support to this in other hospitable units.

Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting?

BACKGROUND: As cancer survival is improving approximately by 1-2% per year, delays in the clinical trials that lead to that improvement could cost lives. AIMS: To review the process of ethics committee approval for a multicentre clinical trial of cancer treatment and to estimate the delay it will cause in obtaining the results and the effects of such delays on survival for all cancers in Australia. METHODS: A survey was sent to each of the 15 centres participating in the study to obtain details about submissions they had made to their ethics committees and the replies received from them. RESULTS: The survey response rate was 100%. The average time required to complete an ethics submission was 12 h, and the average length of time for a final reply was 70 days. Wide variation was noted in the replies, 40% were considered constructive. Most centres said the effort in ethics submissions is sufficient to limit participation in other clinical trials that are available. CONCLUSION: The multicentre system of ethics approval has significantly delayed this multicentre trial and may delay advances in cancer care. Extrapolating this delay to determine an influence on improvements in cancer survival suggests that it may be responsible for 60 cancer deaths per year. A method for measuring the effect on the shape of the accrual curve is defined, and the term DIABOLECAL (Delays in Accrual Brought On Largely by Ethics Committee Activity Lag-time) is proposed to describe it. Attempts to overcome this problem have been introduced overseas.

[Foundation of a Health Care Ethics Committee (HEC) in a nonconfessional hospital. Initial experiences and prospects of the future]. / Etablierung eines Klinischen Ethikkomitees an einem nichtkonfessionellen Schwerpunktklinikum: Erste Erfahrungen und Perspektiven.

BACKGROUND: Whereas Health Care Ethics Committees (HECs) are well established in the USA, they are still an exception in Germany. In this study, the authors report of the implementation of an HEC at the SLK Hospital Heilbronn, Germany, and discuss the further development within the first 2 years. IMPLEMENTATION AND PROJECTS: After a 1-year preparatory period the official establishment of the HEC followed in March 2004. The hospital management was implicated in the implementation from the beginning. 17 HEC members were recruited proportionally to the own four hospital locations. An ethics forum existing besides the HEC represents an institution open to all clinic employees. After training of moderators with a specially developed training concept, an individual case consultation was established. In a next step, working groups were founded for the projects "advance directive", "dying in hospital", "limitation of treatment" and "patient advocate" in order to develop guidelines. Education in ethics is offered in the ethics forum. CONCLUSION: This report elucidates that a great readiness of committee members and a tight integration of the clinic management are essential for a successful establishment of an HEC. The structure converted within the authors' HEC permits a discussion of ethical problems beyond existing hierarchies and occupational groups. In this new institution the authors see a great potential for improvement in dealing with ethical problems within the hospital.