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. (shrink)

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards 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 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. (shrink)

There is at present, far too little empirical research into the actual decision-making process of Institutional Review Boards and it is sobering to be reminded by Robert Klitzman's article that while theoretical debates might rage and prove fertile ground for new theories and better ways of approaching research ethics; ethics committee members must try to make sense of these concepts and apply them in very practical situations.1 Klitzman provides important insights into the ….

Background Healthcare professionals face a myriad of ethical challenges during the coronavirus disease 2019 pandemic. However, there is limited literature examining the ethical challenges faced by HCPs in low- and medium-income countries. The research was designed to explore the ethical challenges experienced by HCPs in a Malaysian hospital setting during the pandemic. Methods Semistructured interviews were conducted via video calls with 10 Malaysian HCPs across different clinical disciplines involved in managing patients diagnosed with COVID-19 infections. The calls were audio-recorded, transcribed (...) verbatim and checked. Thematic analysis with constant comparison across transcripts was carried out to identify categories and themes. Results Three main themes emerged. Firstly, there was deprioritisation of care for non-COVID-19 patients resulting from resource limitations. HCPs raised concerns that there was curtailed access to various healthcare services by non-COVID-19 patients. There was also a trade-off between protecting individual patient safety and public health interests. Secondly, patients were disempowered from decision-making; the decision to segregate suspected COVID-19 patients to high-risk areas without seeking patients’ approval may result in an increased risk of infection. Lastly, HCPs expressed internal conflicts when balancing the professional duty of care against concerns about contracting COVID-19 and spreading it to their family members. Conclusion The study highlighted ethical issues faced by HCPs in Malaysia during the pandemic. It underscores the need for clinical ethics consultation services in hospitals to navigate the various ethical dilemmas. (shrink)

The 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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

Developing World Bioethics, Volume 21, Issue 4, Page 227-236, December 2021.

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’ 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. (shrink)