Emerging Experiences with Virtual Clinical Ethics Consultation: Case Studies from the United States and Malaysia.

AbstractThe COVID-19 pandemic has inspired numerous opportunities for telehealth implementation to meet diverse healthcare needs, including the use of virtual communication platforms to facilitate the growth of and access to clinical ethics consultation (CEC) services across the globe. Here we discuss the conceptualization and implementation of two different virtual CEC services that arose during the COVID-19 pandemic: the Clinical Ethics Malaysia COVID-19 Consultation Service and the Johns Hopkins Hospital Ethics Committee and Consultation Service. A common strength experienced by both platforms during virtual delivery included improved ability for local practitioners to address consultation needs for patient populations otherwise unable to access CEC services in their respective locations. Additionally, virtual platforms allowed for enhanced collaboration and sharing of expertise among ethics consultants. Both contexts encountered numerous challenges related to patient care delivery during the pandemic. The use of virtual technologies resulted in decreased personalization of patient-provider communication. We discuss these challenges with respect to contextual differences specific to each service and setting, including differences in CEC needs, sociocultural norms, resource availability, populations served, consultation service visibility, healthcare infrastructure, and funding disparities. Through lessons learned from a health system in the United States and a national service in Malaysia, we provide key recommendations for health practitioners and clinical ethics consultants to leverage virtual communication platforms to mitigate existing inequities in patient care delivery and increase capacity for CEC globally.

Ethical medical repatriation of guest workers: Criteria and challenges.

Healthcare facilities in receiving countries regularly encounter guest workers whose need for acute or subacute care triggers the prospect of termination of employment and repatriation. In these scenarios, country-specific migration and employment policies and norms of medical professionalism and ethics offer some guidance, but also create tensions. It is not clear under what conditions such medical repatriation is ethically permissible. This paper analyses the application of a previously articulated criteria for the ethical medical repatriation of undocumented immigrants, to the situation of documented guest workers, with focus on the context of Singapore. We examine how these standards could be adapted and applied to the provision of care for guest workers, and argue that healthcare institutions and medical professionals have a duty to intervene in employers' decisions to repatriate guest workers for medico-economic reasons when repatriation essentially amounts to 'patient dumping'. Barriers and challenges in implementing the criteria, and their possible solutions will be discussed.

Ethical considerations in clinical trials: a critique of the ICH-GCP guideline.

This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form.

Governance of research involving people with psychosocial disabilities.

Health-related research with human participants is governed by research ethics regulations in most jurisdictions. Globally, the 2016 International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), are especially influential and widely held as an international standard. The CIOMS guidelines support the inclusion of people with psychosocial disabilities in research and offer clear guidance to promote their recruitment, including by outlining provisions for substitute decision-making. The CIOMS guidelines sit alongside the United Nations' Convention on the Rights of Persons with Disabilities (CRPD). Adopted in 2006 and ratified in 2008, the CRPD offers a robust framework for recognizing the rights of persons with disabilities, including individuals with psychosocial disabilities. Though the CRPD does not explicitly reference research inclusion, its core principles-especially pertaining to the right to universal legal capacity-have clear implications for research ethics governance, specifically with respect to the use of substitute decision-making for research participation. In this paper, we review the extent to which existing research ethics regulations across selected jurisdictions concord with each of these two frameworks, offering first a broad analysis of regulations across 26 African countries, and then exploring two country-specific case studies from Malaysia and Peru. We find that, while many countries' research ethics regulations align with key aspects of the CIOMS guidelines, core principles of the CRPD are absent. Given the shortcomings of existing regulations, we analyse a key point of tension between CIOMS and the CRPD-the right to participate in research-and offer a proposal for revised regulations that aims to bridge this tension and meet the standards of both frameworks.

Migration health ethics in Southeast Asia: a scoping review.

Background: Asia hosts the second-largest international migrant population in the world. In Southeast Asia (SEA), key types of migration are labour migration, forced migration, and environmental migration. This scoping review seeks to identify key themes and gaps in current research on the ethics of healthcare for mobile and marginalised populations in SEA, and the ethics of research involving these populations. Methods: We performed a scoping review using three broad concepts: population (stateless population, migrants, refugees, asylum seekers, internally displaced people), issues (healthcare and ethics), and context (11 countries in SEA). Three databases (PubMed, CINAHL, and Web of Science) were searched from 2000 until May 2023 over a period of four months (February 2023 to May 2023). Other relevant publications were identified through citation searches, and six bioethics journals were hand searched. All searches were conducted in English, and relevant publications were screened against the inclusion and exclusion criteria. Data were subsequently imported into NVivo 14, and thematic analysis was conducted. Results: We identified 18 papers with substantial bioethical analysis. Ethical concepts that guide the analysis were 'capability, agency, dignity', 'vulnerability', 'precarity, complicity, and structural violence' (n=7). Ethical issues were discussed from the perspective of research ethics (n=9), clinical ethics (n=1) and public health ethics (n=1). All publications are from researchers based in Singapore, Thailand, and Malaysia. Research gaps identified include the need for more research involving migrant children, research from migrant-sending countries, studies on quality of migrant healthcare, participatory health research, and research with internal migrants. Conclusions: More empirical research is necessary to better understand the ethical issues that exist in the domains of research, clinical care, and public health. Critical examination of the interplay between migration, health and ethics with consideration of the diverse factors and contexts involved is crucial for the advancement of migration health ethics in SEA.

The importance of getting the ethics right in a pandemic treaty.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical-they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

Public acceptability of COVID-19 control measures in Singapore, Hong Kong, and Malaysia: A cross-sectional survey.

BACKGROUND: Several countries have implemented control measures to limit SARS-CoV-2 spread, including digital contact tracing, digital monitoring of quarantined individuals, and testing of travelers. These raise ethical issues around privacy, personal freedoms, and equity. However, little is known regarding public acceptability of these measures. METHODS: In December 2020, we conducted a survey among 3635 respondents in Singapore, Hong Kong, and Malaysia to understand public perceptions on the acceptability of COVID-19 control measures. FINDINGS: Hong Kong respondents were much less supportive of digital contact tracing and monitoring devices than those in Malaysia and Singapore. Around three-quarters of Hong Kong respondents perceived digital contact tracing as an unreasonable restriction of individual freedom; <20% trusted that there were adequate local provisions preventing these data being used for other purposes. This was the opposite in Singapore, where nearly 3/4 of respondents agreed that there were adequate data protection rules locally. In contrast, only a minority of Hong Kong respondents viewed mandatory testing and vaccination for travelers as unreasonable infringements of privacy or freedom. Less than 2/3 of respondents in all territories were willing to be vaccinated against COVID-19, with a quarter of respondents undecided. However, support for differential travel restrictions for vaccinated and unvaccinated individuals was high in all settings. INTERPRETATION: Our findings highlight the importance of sociopolitical context in public perception of public health measures and emphasize the need to continually monitor public attitudes toward such measures to inform implementation and communication strategies.

Patient Isolation during Infectious Disease Outbreaks: Arguments for Physical Family Presence.

This article argues that outbreak preparedness and response should implement a 'family presence' policy for infected patients in isolation that includes the option of physical visits and care within the isolation facility under some conditions. While such a 'physical family presence' (PFP) policy could increase infections during an outbreak and may raise moral dilemmas, we argue that it is ethically justified based on the least infringement principle and the need to minimize the harms and burdens of isolation as a restrictive measure. Categorical prohibition of PFP during the course of an outbreak or epidemic is likely to result in unnecessary harms to patients and families, and violate values such as the moral commitments of families to care for each other. Supporting the option of PFP under particular circumstances, on the other hand, will least infringe these moral considerations. An additional reason for a family presence policy is that it may facilitate voluntary cooperation with isolation and other restrictive measures. We provide an analysis of these considerations for supporting modes of family presence during an outbreak emergency, before defending the riskier option of PFP in the isolation facility from plausible objections and concerns.

Towards a balanced approach to identifying conflicts of interest faced by institutional review boards.

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.