Ethics committees in the time of COVID-19.

BACKGROUND: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. OBJECTIVES: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. DESIGN: cross-sectional survey. SETTING AND PARTICIPANTS: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. MAIN OUTCOME MEASURES: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. RESULTS: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. CONCLUSIONS: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.

[Analysis of a clinical ethics committee activities at a general hospital]. / Experiencia del Comité de Ética Asistencial del Hospital Carlos van Buren entre los años 2007-2020.

BACKGROUND: Clinical Ethics Committees are deliberative groups whose main functions are to assess cases with ethical-clinical conflicts, to generate institutional protocols for preventive purposes, and to train health teams. AIM: To analyze the activity of a clinical ethics committee of a general hospital in the period 2007-2020. MATERIAL AND METHODS: A retrospective analysis of all session records, annual reports, case resolution and documents generated by the Clinical Ethics Committee of Carlos van Buren Hospital in Valparaíso, Chile, between 2007 and 2020, was carried out. RESULTS: On average, 12 cases are analyzed per year. Sixty percent correspond to requests from pediatric units and in 78% of these cases there was at least one neurological disease. In 62% of cases, the main ethical dilemma was adequacy of therapeutic effort, followed by dilemmas related to the exercise of autonomy in 18.2%. In education, two courses are identified aimed to doctors, residents, and other members of the health team. Regarding normative functions, several documents were generated at the request of the Hospital management or in different clinical situations. During COVID-19 pandemia, the active role of the committee was linked to the three main functions, namely evaluating cases, participating in morbidity and mortality meetings for preventive purposes, and issuing guidelines and recommendations for action. The active participation of Pediatric Neurology residents in the Committee, for educational and administrative purposes, stands out. CONCLUSIONS: The three main functions described for the ethics committees were exerted by this Committee during the evaluated period. The impact of our recommendations remain to be objectively evaluated.

Bioethical Concerns During the COVID-19 Pandemic: What Did Healthcare Ethics Committees and Institutions State in Spain?

Objectives: Each new wave of the COVID-19 pandemic invites the possible obligation to prioritize individuals' access to vital resources, and thereby leads to unresolved and important bioethical concerns. Governments have to make decisions to protect access to the health system with equity. The prioritization criteria during a pandemic are both a clinical and legal-administrative decision with ethical repercussion. We aim to analyse the prioritization protocols used in Spain during the pandemic which, in many cases, have not been updated. Method: We carried out a narrative review of 27 protocols of prioritization proposed by healthcare ethics committees, scientific societies and institutions in Spain for this study. The review evaluated shared aspects and unique differences and proffered a bioethical reflection. Results: The research questions explored patient prioritization, the criteria applied and the relative weight assigned to each criterion. There was a need to use several indicators, being morbidity and mortality scales the most commonly used, followed by facets pertaining to disease severity and functional status. Although age was initially considered in some protocols, it cannot be the sole criterion used when assigning care resources. Conclusions: In COVID-19 pandemic there is a need for a unified set of criteria that guarantees equity and transparency in decision-making processes. Establishing treatment indications is not the aim of such criteria, but instead prioritizing access to care resources. In protocols of prioritization, the principle of efficiency must vary according to the principle of equity and the criteria used to guarantee such equity.

COVID-19 underscores the important role of Clinical Ethics Committees in Africa.

BACKGROUND: The COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa. METHODS: Twenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses. RESULTS: Kenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking. CONCLUSIONS: This study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs.

Getting Real: The Maryland Healthcare Ethics Committee Network's COVID-19 Working Group Debriefs Lessons Learned.

Responding to a major pandemic and planning for allocation of scarce resources (ASR) under crisis standards of care requires coordination and cooperation across federal, state and local governments in tandem with the larger societal infrastructure. Maryland remains one of the few states with no state-endorsed ASR plan, despite having a plan published in 2017 that was informed by public forums across the state. In this article, we review strengths and weaknesses of Maryland's response to COVID-19 and the role of the Maryland Healthcare Ethics Committee Network (MHECN) in bridging gaps in the state's response to prepare health care facilities for potential implementation of ASR plans. Identified "lessons learned" include: Deliberative Democracy Provided a Strong Foundation for Maryland's ASR Framework; Community Consensus is Informative, Not Normative; Hearing Community Voices Has Inherent Value; Lack of Transparency & Political Leadership Gaps Generate a Fragmented Response; Pandemic Politics Requires Diplomacy & Persistence; Strong Leadership is Needed to Avoid Implementing ASR … And to Plan for ASR; An Effective Pandemic Response Requires Coordination and Information-Sharing Beyond the Acute Care Hospital; and The Ability to Correct Course is Crucial: Reconsidering No-visitor Policies.

A survey of national ethics and bioethics committees.

OBJECTIVE: To assess the current state of national ethics committees and the challenges they face. METHODS: We surveyed national ethics committees between 30 January and 21 February 2018. FINDINGS: In total, representatives of 87 of 146 national ethics committees (59.6%) participated. The 84 countries covered were in all World Bank income categories and all World Health Organization regions. Many national ethics committees lack resources and face challenges in several domains, like independence, funding or efficacy. Only 40.2% (35/87) of committees expressed no concerns about independence. Almost a quarter (21/87) of committees did not make any ethics recommendations to their governments in 2017, and the median number of reports, opinions or recommendations issued was only two per committee Seventy-two (82.7%) national ethics committees included a philosopher or a bioethicist. CONCLUSION: National ethics (or bioethics) committees provide recommendations and guidance to governments and the public, thereby ensuring that public policies are informed by ethical concerns. Although the task is seemingly straightforward, implementation reveals numerous difficulties. Particularly in times of great uncertainty, such as during the current coronavirus disease 2019 pandemic, governments would be well advised to base their actions not only on technical considerations but also on the ethical guidance provided by a national ethics committee. We found that, if the advice of national ethics committees is to matter, they must be legally mandated, independent, diverse in membership, transparent and sufficiently funded to be effective and visible.

Employee Perceptions on Ethics, Racial-Ethnic and Work Disparities in Long-Term Care: Implications for Ethics Committees.

This study explored the perceptions of ethics among long-term care employees (N275) in order to test two hypotheses. A cohort cross-sectional survey examined employees' perceptions of an ethics environment, racial-ethnic, and position disparities (HO1; ANOVA), and, secondarily, ethics in relationship to select, research-grounded work features measured as manage disagreements, effectiveness, work satisfaction, and opinions of care, the latter including intention to remain (HO2; Pearson Correlations). Established questionnaires with robust psychometrics were employed. Response rate was 51%. Non-significant differences between sample and population on key variables supported extrapolation of results. Statistically significant differences between racial-ethnic (p < 0.03; F 2.42) and work positions (p <0.0001; F 6.24) were revealed on ethics (3.16; HO1). Statistically significant relationships (p <0.0001; r = 0.26-0.68; HO2) between ethics and employees' work features also were found, confirming both hypotheses. Perceptions of ethics based on racial-ethnic and position disparities, as well as the robust links with employee work features, offered potential avenues for decreasing disparities at work and improving the quality of long-term care. Noted further on ethics item scoring were relatively low scores indicating less involvement in, and access to, ethics discussions and decisions. In contrast, the literature review substantiated the importance of empowerment and retention, which were enhanced by employee involvement in work, notably, discussions and decisions. Thus, implications of ethics committees in long-term care sites as ways to potentially enhance employees' work and quality of care, especially work satisfaction and retention, were explored; relevant concerns raised by the Covid pandemic were, briefly, discussed.

[Ethical reflections on the Measures Taken in Nursing Homes During Pandemic]. / Reflexiones éticas en torno a las Medidas tomadas en las Residencias durante la Pandemia.

The crisis in the health system caused by COVID-19 has left some important humanitarian deficits on how to care for the sick in their last days of life. The humanization of the dying process has been affected in three fundamental aspects, each of which constitutes a medical and ethical duty necessary. In this study, I analyze why dying accompanied, with the possibility of saying goodbye and receiving spiritual assistance, constitutes a specific triad of care and natural obligations that should not be overlooked - even in times of health crisis - if we do not want to see human dignity violated and violated some fundamental rights derived from it.

[Bioethics, Human Rights and COVID-19]. / Bioética, Derechos Humanos y COVID-19.

In this paper present, from a bioethical perspective, a reflection on how to reconcile efforts to combat the COVID-19 pandemic with the safeguard of human rights. To do this, I develop three points. First, the regulatory framework that justifies the restriction or suspension of rights in the face of serious threats to public health. Second, the declarations of the international bioethics committees on the way in which human rights should be protected during public health crisis. And third, a review of the main rights threatened both by the public health crisis and by the means adopted to combat it. Before going into each of these points, I offer a preliminary note to clarify certain legal concepts and underline the need to overcome disjunctive approaches in considering human rights.

Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic.

PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.

[Ethical recommendations for a difficult decision-making in intensive care units due to the exceptional situation of crisis by the COVID-19 pandemia: A rapid review & consensus of experts]. / Recomendaciones éticas para la toma de decisiones difíciles en las unidades de cuidados intensivos ante la situación excepcional de crisis por la pandemia por COVID-19: revisión rápida y consenso de expertos.

In view of the exceptional public health situation caused by the COVID-19 pandemic, a consensus work has been promoted from the ethics group of the Spanish Society of Intensive, Critical Medicine and Coronary Units (SEMICYUC), with the objective of finding some answers from ethics to the crossroads between the increase of people with intensive care needs and the effective availability of means.In a very short period, the medical practice framework has been changed to a 'catastrophe medicine' scenario, with the consequent change in the decision-making parameters. In this context, the allocation of resources or the prioritization of treatment become crucial elements, and it is important to have an ethical reference framework to be able to make the necessary clinical decisions. For this, a process of narrative review of the evidence has been carried out, followed by a unsystematic consensus of experts, which has resulted in both the publication of a position paper and recommendations from SEMICYUC itself, and the consensus between 18 scientific societies and 5 institutes/chairs of bioethics and palliative care of a framework document of reference for general ethical recommendations in this context of crisis.