Call to action: empowering patients and families to initiate clinical ethics consultations.

Clinical ethics consultations exist to support patients, families and clinicians who are facing ethical or moral challenges related to patient care. They provide a forum for open communication, where all stakeholders are encouraged to express their concerns and articulate their viewpoints. Ethics consultations can be requested by patients, caregivers or members of a patient's clinical or supportive team. Although patients and by extension their families (especially in cases of decisional incapacity) are the common denominators in most ethics consultations, these constituents are the least likely to request them. At many healthcare organisations in the USA, ethics consultations are overwhelmingly requested by physicians and other clinicians. We believe it is vital that healthcare institutions bridge the knowledge gaps and power imbalances over access to ethics consultation services through augmented policies, procedures and infrastructure. With enhanced education and support, patients and families may use ethics consultation to elevate their voices and prioritise their unique characteristics and preferences in the delivery of their healthcare. Empowering patients and families to request ethics consultation can only strengthen the patient/family-clinician relationship, enhance the shared decision-making model of care and ultimately lead to improved patient-centred care.

Operation of a triage committee for advanced life support during the COVID-19 pandemic.

BACKGROUND: During the first weeks of March 2020 in Spain, the cases of severe respiratory failure progressively increased, generating an imbalance between the clinical needs for advanced life support (ALS) measures and the effective availability of ALS resources. To address this problem, the creation of triage committees (TC) was proposed, whose main function is to select the best candidates to receive ALS. The main objective of our study is to describe the clinical characteristics of the patients evaluated by the TC of the Alcorcón Foundation University Hospital (AFUH) during the first wave of SARS CoV-2. Other objectives are to determine if there are differences between the patients considered candidates / not candidates for ALS and to analyze the functioning of the TC. METHODS: Retrospective observational study of all patients assessed by the AFUH TC. RESULTS: There were 19 meetings, in which 181 patients were evaluated, 65.4% male and with a mean age of 70.1 years. 31% had some degree of functional dependence, the Barthel median was 100 and Charlson 4. 58.5% were not considered a candidate for ALS at that time. The patients considered candidates to receive ALS were younger (72 vs 66; p < 0.001), had less comorbidity (Charlson 4 vs 3; p < 0.001) and had a better previous functional situation. A median of 5 physicians participated in each meeting and, after being assessed by the TC, 13.6% received ALS: 29.3% of those considered candidates for ALS and 2% of the non-candidates. CONCLUSIONS: The patients evaluated by the TC had a mean age of 70 years, high comorbidity and almost a third had some degree of functional dependence. More than half were not considered candidates for ALS at that time, these patients being older, with more comorbidity and a worse previous functional situation. TC decisions, based on objective clinical criteria, were almost always respected. Public institutions must get involved in triage procedures, which should and in our opinion must include the creation of TC in health centers. The implementation of Anticipated Decision programs (ADP) would help enable patients affected by triage decisions to participate in them.

Animal researchers shoulder a psychological burden that animal ethics committees ought to address.

Animal ethics committees (AECs) typically focus on the welfare of animals used in experiments, neglecting the potential welfare impact of that animal use on the animal laboratory personnel. Some of this work, particularly the killing of animals, can impose significant psychological burdens that can diminish the well-being of laboratory animal personnel, as well as their capacity to care for animals. We propose that AECs, which regulate animal research in part on the basis of reducing harm, can and ought to require that these harms to researchers are reduced as well. The paper starts by presenting evidence of these burdens and their harm, giving some examples showing how they may be mitigated. We then argue that AECs are well placed to account for these harms to personnel and ought to use their power to reduce their occurrence. We conclude by responding to four potential objections: (1) that this problem should be addressed through health and safety administration, not research ethics administration; (2) that the proposal is unjustifiably paternalistic; (3) that these harms to laboratory animal personnel ought to occur, given their treatment of animals; and (4) that mitigating them may lead to worse treatment of research animals.

Taking the burden off: a study of the quality of ethics consultation in the time of COVID-19.

BACKGROUND: The quality of ethics consults is notoriously difficult to measure. Survey-based assessments cannot capture nuances of consultations. To address this gap, we conducted interviews with health professionals who requested ethics consults during the initial phase of the COVID-19 pandemic. METHOD: Healthcare professionals requesting ethics consultation between March 2020 and May 2020 at a tertiary academic medical centre were eligible to participate. We asked participants to comment on the consults they called and thematically analysed responses to identify features associated with optimal quality consultations. RESULTS: Of 14 healthcare providers, 8 (57%) were women and professions were as follows: 11 (79%) medical doctors, 1 (7%) social worker, 1 (7%) physician assistant and 1 (7%) nurse practitioner. Two aspects of quality emerged: satisfaction and value. Themes within the domain of satisfaction included: responsiveness of the ethics consultant, willingness to consult, institutional role of the ethics service and identifying areas for improvement. When describing value, respondents spoke of the intrapersonal and interpersonal worth of consultation. CONCLUSION: Participants were generally satisfied with ethics consultation services, similar to opinions of those found in pre-COVID-19 survey studies. Our qualitative approach allowed for a richer exploration of the value of ethics consultation during the pandemic and has implications for ethics consultation services more broadly. Ethics consultation-emphasising both the process and outcome-created valuable moral spaces, promoting thoughtful and ethical responses to dilemmas in patient care. Future assessments should incorporate patient and family/surrogate perspectives and explore the domain of education as an additional quality measure.

Hospital chaplains as ethical consultants in making difficult medical decisions.

BACKGROUND AND AIMS: Few 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. METHODS: A survey of 100 Roman Catholic chaplains was conducted, that is, at least 10% of all chaplains currently working in Polish hospitals. RESULTS: Of 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. CONCLUSIONS: In 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.

Framework for evaluation research on clinical ethical case interventions: the role of ethics consultants.

Evaluation of clinical ethical case consultations has been discussed as an important research task in recent decades. A rigid framework of evaluation is essential to improve quality of consultations and, thus, quality of patient care. Different approaches to evaluate those services appropriately and to determine adequate empirical endpoints have been proposed. A key challenge is to provide an answer to the question as to which empirical endpoints-and for what reasons-should be considered when evaluating the quality of a service. In this paper, we argue for an approach that adopts the role of ethics consultants as its point of departure. In a first step, we describe empirical and ethical characteristics of evaluating clinical ethical case. We show that the mode of action and the explicit normative character of the interventions constitute two characteristics which pose challenges to the selection of appropriate quality criteria and require special attention. In a second step, we outline the way in which an analysis of the role of ethics consultants in the context of a clinical ethical case consultation services can account for the existing challenges by linking empirically measurable endpoints with normative theory. Finally, we discuss practical implications of our model for evaluation research.

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.

Human rights and COVID-19 triage: a comment on the Bath protocol.

In their discussion paper of November 2020, Cook et al present a draft protocol for navigating circumstances in which emergency services are overwhelmed. Their paper suggests that COVID-related triage decisions should be based on clinical assessment, patient and family consultation, and a range of ethical considerations. In this response, we note that the protocol exhibits an ambiguity that is likely to result in irresolvable dilemmas when put into practice. This ambiguity is exemplified in the paper's prime ethical imperative (to 'save more lives and more years of life'), which takes the form of an undefined conjunction whose practical implications are left unspecified. We see this ambiguity in the prime imperative as one manifestation of a broader set of tensions in the protocol. We show that the discipline of human rights provides an essential supplement to the ethical framework on which Cook and colleagues rely, providing a framework for understanding and working through triage dilemmas involving age, discrimination and equality.

Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees.

BACKGROUND: This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs' service to the subject of the clinical trial. METHODS: We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC's files and electronic archives. RESULTS: Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval. CONCLUSIONS: Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials' final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.

Mitigating ethical conflict and moral distress in the care of patients on ECMO: impact of an automatic ethics consultation protocol.

AIMS: This study evaluates a protocol for early, routine ethics consultation (EC) for patients on extracorporeal membrane oxygenation (ECMO) to support decision-making in the context of clinical uncertainty with the aim of mitigating ethical conflict and moral distress. METHODS: We conducted a single-site qualitative analysis of EC documentation for all patients receiving ECMO support from 15 August 2018 to 15 May 2019 (n=68). Detailed analysis of 20 ethically complex cases with protracted ethics involvement identifies four key ethical domains: limits of prognostication, bridge to nowhere, burden of treatment and system-level concerns. There are three subthemes: relevant contextual factors, the role of EC and observed outcomes. Content analysis of transcripts from interviews with 20 members of the multidisciplinary ECMO team yields supplemental data on providers' perceptions of the impact of the early intervention protocol. RESULTS: Limited outcome data for ECMO, unclear indications for withdrawal, adverse effects of treatment and an obligation to attend to programme metrics present significant ethical challenges in the care of this patient population. Upstream EC mitigates ethical conflict by setting clear expectations about ECMO as a time limited trial, promoting consistent messaging among multiple services and supporting surrogate decision-makers. When ECMO becomes a 'bridge to nowhere', EC facilitates decision-making that respects patient values yet successfully sets limits on non-beneficial use of this novel therapy. CONCLUSION: Data from this study support the conclusion that ECMO poses unique ethical challenges that necessitate a standardised protocol for early, routine EC-at least while this medical technology is in its nascent stages.

Ethical climate in contemporary paediatric intensive care.

Ethical climate (EC) has been broadly described as how well institutions respond to ethical issues. Developing a tool to study and evaluate EC that aims to achieve sustained improvements requires a contemporary framework with identified relevant drivers. An extensive literature review was performed, reviewing existing EC definitions, tools and areas where EC has been studied; ethical challenges and relevance of EC in contemporary paediatric intensive care (PIC); and relevant ethical theories. We surmised that existing EC definitions and tools designed to measure it fail to capture nuances of the PIC environment, and sought to address existing gaps by developing an EC framework for PIC founded on ethical theory. In this article, we propose a Paediatric Intensive Care Ethical Climate (PICEC) conceptual framework and four measurable domains to be captured by an assessment tool. We define PICEC as the collective felt experience of interdisciplinary team members arising from those factors that enable or constrain their ability to navigate ethical aspects of their work. PICEC both results from and is influenced by how well ethical issues are understood, identified, explored, reflected on, responded to and addressed in the workplace. PICEC encompasses four, core inter-related domains representing drivers of EC including: (1) organisational culture and leadership; (2) interdisciplinary team relationships and dynamics; (3) integrated child and family-centred care; and (4) ethics literacy. Future directions involve developing a PICEC measurement tool, with implications for benchmarking as well as guidance for, and evaluation of, targeted interventions to foster a healthy EC.

In defence of a broad approach to public interest in health data research.

In their response to 'Public interest in health data research: laying out the conceptual groundwork', Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees (IRBs/RECs), we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current frameworks such as that found in the guidelines approved under Australia's Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies.

Problems and development strategies for research ethics committees in China's higher education institutions.

The establishment of research ethics committees (REC) in China's higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in scientific research ethics, as seen in the recent controversies involving a proposed human head transplant and gene-edited babies. At present, the problems for REC in China's HEI include lack of regulation, informal ethics reviews, lack of supervision and insufficient ethics review capacity. To counteract these problems, suggested measures include mandatory formation of formal ethics committee, administrative support from HEI, ethics approval letter prior to funding application, formulation of regulations and standard operating procedures, selecting and training for members and independent consultants, training for secretaries and staff, ethics training for investigators, and learning from the experience of HEI outside of China, such as the USA and Canada. The establishment of REC in China's HEI will greatly enhance the overall quality of ethics reviews in China. In addition to better protecting the rights and welfare of human participants, it is also conducive to maintaining the reputation of China's HEI.

Reconsidering scarce drug rationing: implications for clinical research.

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: (1) clinical use may not have stronger evidence than research use; (2) a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; (3) treatment within the context of a clinical trial may be the standard of care; and (4) research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation.

Ethicists, doctors and triage decisions: who should decide? And on what basis?

We report here an emerging dispute in Italy concerning triage criteria for critically ill covid-19 patients, and how best to support doctors having to make difficult decisions in a context of insufficient life saving resources. The dispute we present is particularly significant as it juxtaposes two opposite views of who should make triage decisions, and how doctors should best be supported. There are both empirical and normative questions at stake here. The empirical questions pertain to the available level of evidence that healthcare professionals would rather not be left alone with their 'clinical judgments' to make triage decisions, and to the accounts of distributive justice that doctors and healthcare professionals rely on, when making triage decisions. The normative questions pertain to how this empirical evidence should inform guidelines on how prioritisation decisions are made in a context of emergency, and who gets to have the authority to do so. This debate goes beyond the discussion of the care of critically ill patients with COVID-19 and has broader implications beyond the national context for the discussion of how to relieve moral distress in contexts of imbalances between healthcare resources and clinical needs of a population.

Ethical guidelines for deliberately infecting volunteers with COVID-19.

Global fatalities related to COVID-19 are expected to be high in 2020-2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods-that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made.

Process of risk assessment by research ethics committees: foundations, shortcomings and open questions.

Risks and burdens in the study participation, as well as an adequate risk-benefit balance, are key concepts for the evaluation of clinical studies by research ethics committees (RECs). An adequate assessment and continuous monitoring to ensure compliance of risks and burdens in clinical trials have long been described as a central task in research ethics. However, there is currently no uniform and solid theoretical approach to risk assessment by RECs. Regulatory standards of research ethics such as the Declaration of Helsinki provide only minimal guidance on how risk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequate risk assessment by RECs remains to be elusive. In this article, we address current definitions of risk and present our own concept of aggregate risk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect to ethics literature and different approaches of risk-benefit assessment. In order to present a comprehensive theoretical approach of risk assessment by RECs, further understanding of the definitions of risk may improve adequate decision-making tasks by RECs. To improve the process of risk assessment by RECs, a dynamic framework will be illustrated, showing step-by-step risk assessment functions. This approach may be a promising tool to ensure adequacy in risk assessment by RECs.

Conflicts of interest in clinical ethics consults.

Although there is wide agreement that ethics consults are at risk for conflicts of interest (COIs), ethics consultants (ECs) have limited guidance with regard to how to identify and approach COIs. We aim to address these concerns and provide practical guidance. We will define and consider four categories of COIs: consult type, team composition, dual clinical roles and other concerns. We will define and consider six actions available for ECs to take in response to COIs: no action, disclosure only, obtaining a second opinion, referring to another EC, referring to an institutional ethics committee or seeking an outside consult. We will then propose a points-based algorithm for ECs to use to determine the appropriate response to COI. Finally, we will discuss the strengths and limitations of our proposed algorithm.