Asian Bioethics Review最新文献

Given ICH-GCP’s role in shaping IRB standards in most jurisdictions, clarifying the function and definition of nonscientific members is crucial. ICH-GCP 3.2.1 requires a nonscientific member but its definition focuses on who they are not rather than who they are, creating ambiguity and varied interpretations. This paper reviews the idea of nonscientific members of the IRB to understand their definitions and roles based on current literature. This is because, despite the ICH-GCP’s mandate, recent research is scarce. Our review identifies that in the current literature, various definitions and roles are ascribed to nonscientific members, resulting in a lack of clarity. Following our thematic analysis, we highlight two main interpretations of the nonscientific member’s definition: one as a distinct perspective from scientific members and another as an embodiment of “ordinariness” to minimize bias. In addition, we also highlight three primary roles: reviewing consent forms, representing public and participant interests, and providing oversight. Some findings may not align with current IRB practices, and without clear definitions, adherence to ICH-GCP guidelines may be inconsistent.

The utilization of in-vitro fertilization (IVF) in assisted reproduction has undergone a notable surge since its inception in 1979. Consequently, the demand for well-trained IVF personnel has become crucial to address the expanding technical requirements of this field. However, acquiring specialized technical expertise remains a challenge in various regions and countries, particularly in the Arab Islamic region, frequently playing a pivotal role in the successful implementation of medical technology. Ensuring a proficient workforce of IVF experts requires the provision of practical and comprehensive training opportunities. This work reveals the ethical considerations surrounding the utilization of actual human eggs in IVF training courses and examines potential alternative approaches to meet the training needs in a manner deemed ethically acceptable. We analyzed the bioethical issues of using human eggs in IVF training, considering ethical principles, benefits, and concerns to determine permissibility and contribute to discussions on reproductive technology ethics and the responsible use of human reproductive material. In addition, we shed light on perspectives from Islamic scholarship. In conclusion, utilizing immature eggs in practical IVF training, while ensuring informed consent, is widely deemed acceptable within the ethical framework. However, the crucial necessity of robust oversight, especially in the private sector, cannot be overstated. To address these critical considerations, the initial and fundamental step entails conducting a comprehensive regional survey. Using immature eggs in IVF training seems acceptable, but it is crucial to establish an oversight practice. Organizing a collaborative workshop with stakeholders from both the public and private sectors is a crucial first step in developing this controlled practice.

A significant and important ethical tension in resource allocation and public health ethics is between utility and equity. We explore this tension between utility and equity in the context of health AI through an examination of a diagnostic AI screening tool for diabetic retinopathy developed by a team of researchers at Duke-NUS in Singapore. While this tool was found to be effective, it was not equally effective across every ethnic group in Singapore, being less effective for the minority Malay population than for the Chinese majority. We discuss the problematic normative nature of bias in health AI and explore the ways in which bias can interact with various forms of social inequalities. From there, we examine the specifics of the diabetic retinopathy case and weigh up specific trade-offs between utility and equity. Ultimately, we conclude that it is ethically permissible to prioritise utility over equity where certain criteria hold. Given that any medical AI is more likely than not to have lingering bias due to bias in the training data that may reflect other social inequalities, we argue that it is permissible to implement an AI tool with residual bias where: (1) its introduction reduces the influence of biases (even if overall inequality is worsened), and/or (2) where the utility gained is significant enough and shared across groups (even if unevenly).

Deception in research is contentious, as ethical codes stress informed consent, yet complete disclosure may jeopardise validity. Indian Council for Medical Research (ICMR) guidelines classify deception into active, incomplete, and authorised forms. This study explores the ethical justification for incomplete (partial disclosure), permissible instances, and the dilemma faced by ethics committees in balancing scientific rigour and participant protection. The qualitative, non-experimental cross-sectional research, using in-depth interviews, identifies themes through thematic analysis. Findings reveal challenges for ethics committees, as incomplete information hampers understanding, amongst others. The paper proposes an ethics committee framework, urging researchers to minimise or avoid partial deception and recommending institutional awareness campaigns and standard operating procedures for minimal-harm studies using partial disclosure. Therefore, it proposes that partial disclosure should be justified by the 3Vs—value, validity, and veracity to preserve research integrity.

Japan has been reported as a country with high levels of vaccine hesitancy. However, a lack of comprehensive reviews studying factors for vaccine hesitancy for the COVID-19 vaccines in the Japanese context from the perspective of ethical controversy exists. Using a narrative review method, we reviewed factors associated with vaccine hesitancy to the COVID-19 vaccines and examined issues related to ethical controversy among the Japanese population. Factors associated with vaccine hesitancy include concerns about vaccine safety, suspicion of vaccine inefficacy, mistrust of the government, and low perceived threat. Factors associated with vaccine acceptance include environmental factors, factors related to Japanese cultural values, including collectivism and social norms, and positive attitudes toward information provided by authorities. Unique backgrounds in Japan are historical events such as the anti-HPV vaccine campaigns, the accessible medical system fostering high expectations of zero risk, and cultural factors of caring social norms influencing vaccine acceptance. Ethical controversies arise from preferences and practices at the individual or national level around individual rights versus public health benefits. Healthcare professionals and public health experts should continue dialoguing with the critical mass, practitioners, and policymakers, considering the ethical dilemmas surrounding individual rights and public health benefits. Insights obtained from this study indicate the need to develop tailored strategies to enhance vaccine acceptance while respecting individual autonomy within the Japanese context.

Hospitalized patients lacking the mental capacity to consent to treatment may demand to be discharged from the hospital against medical advice. Forced custody of these patients, including the use of restraints, may be required if the plan is to proceed with treatment. This raises ethical concerns with regard to depriving people of their liberty. The determination of the wishes and values of the patient and her best interests may sometimes vary, depending on the assessor or the clinical team entrusted to perform the evaluation. We therefore propose the following triad for clinicians when determining the best interests for this group of patients to ensure ethical and legal soundness as well as in providing consistency in approach. Firstly, the treatment should serve as a rescue response. Secondly, any restraint deployed must be proportionate with a foreseeable end. Her liberty and autonomy interests should be enhanced by the treatment. Thirdly, the patient’s family must be supportive. This paper analyzes the use of the triad approach on two clinical cases, both assessed as lacking in mental capacity to decide on treatment and insisting to be discharged. Using this approach, we could justify how the contrasting outcomes, one in which the voluntary discharge was acquiesced versus the other, which was not acquiesced, were reached. We also examine the compatibility of the triad approach with the obligations under the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD).

The dilemmas and uncertainties related to determining mental capacity and surrogate decision-making are universally recognised as one of the most important concepts in the field of clinical ethics. In Malaysia, healthcare practitioners often find both determining decision-making capacity of patients, and identifying surrogate decision makers for incapacitated patients confusing. This paper explores the concepts of decision-making capacity and surrogate decision-making, identifying key components and associated principles such as substituted judgement and best interests. It reviews current provisions and guidances available in Malaysia that are related to these issues, including the Power of Attorney Act 1949 (revised 1990), Mental Health Act 2001, and various guidelines. It then highlights the challenges encountered in the local clinical setting due to the lack of specific legislation and clear guidance. Finally, this paper provides recommendations for improvements to address these issues in order to safeguard both the clinical practice of healthcare professionals and the rights of patients. These recommendations include the establishment of a regulatory framework with four main domains: clear and objective criteria for mental capacity assessment, provisions for advance decision-making while patients still possess mental capacity, a ladder or hierarchy of surrogate decision-makers, and provisions for appropriate surrogate decision-making standards, as well as the need for advocacy and awareness education among both the general public and healthcare professionals.