Bioethics International

Evidence-based informed consent practices-such as writing in plain language, formatting for readability, and assessing understanding using validated instruments-are underutilized in research practice. Yet the Common Rule does not specifically require the use of evidence-based informed consent practices. In this paper, we explore the wisdom of mandating evidence-based informed consent practices either at the institutional or federal level. In the first part, we share findings from a series of six focus groups with leaders of institutional review boards (IRBs) about mandating evidence-based informed consent practice. In general, IRB leaders had positive views toward plain language and optimal document formatting but were skeptical about validated assessments of participant comprehension of consent information. They generally opposed federal and institutional mandates, preferring an educational approach to promoting evidence-based informed consent practices. In the second part of the paper, we draw upon data from several of our studies and the literature to defend the conclusion that IRBs should experiment with mandates for evidence-based informed consent practices. We accept that federal regulations may be insufficiently flexible. However, educational efforts alone have not sufficed and are not likely to increase adoption of evidence-based informed consent practices. We believe institutional mandates will not actually lead to greater delays in review of research protocols or investigator burden if rolled out with sufficient guidance and resources, which are readily available.

LGBTQIA+ individuals continue to face significant health disparities globally, driven by stigma, discrimination, and culturally insensitive healthcare practices. In India, despite progress such as the decriminalization of same-sex relationships in 2018, LGBTQIA+ individuals often encounter marginalization and exclusion within healthcare systems. Nurses, as primary healthcare providers, play a pivotal role in addressing these disparities; however, nursing education frequently lacks adequate training to prepare students for the unique needs of LGBTQIA+ patients. This study aimed to assess the perceptions, confidence, and institutional training of nursing students in India regarding LGBTQIA+-inclusive care. A quantitative, descriptive survey design was employed, involving 90 nursing students who completed a 16 item structured and validated questionnaire. Results revealed that while students exhibited positive perceptions toward LGBTQIA+ individuals, their confidence in performing critical tasks, such as sexual history-taking and physical examinations, was low. Institutional training was also found to be insufficient, indicating gaps in the current curriculum. The findings highlight the urgent need for comprehensive and practical LGBTQIA+-specific training in nursing education to enhance cultural competence and confidence among future nurses. Addressing these gaps is crucial to reducing health disparities and ensuring equitable, inclusive, and compassionate care for LGBTQIA+ individuals. • This study highlights significant gaps in nursing education regarding LGBTQIA+ healthcare. • Students show positive perceptions but low confidence in clinical tasks like sexual history-taking. • Insufficient institutional training and limited practical exposure were identified as key barriers. • The findings emphasize the need for comprehensive, hands-on LGBTQIA+-specific training.

The COVID-19 pandemic was a devastating worldwide event with great consequences on medical and surgical care that has not been fully evaluated. The pandemic caused an imbalance between rapidly increasing patient needs and limited hospital resources such as staff, personal protective equipment (PPE), and open beds. As a result, surgeons in the United States were encouraged or required to postpone "non-emergent" operations, including some cancer surgeries, in March of 2020. Resource allocation during the pandemic focused on the needs of the community to accommodate potential surges, and cancer patients needing "non-emergent" operations had operations delayed. This paper is an ethical analysis based on the review of the literature covering a range of topics from known harms due to certain operation delays, to COVID-19 caseloads, to triage ethics. The key surgery types examined were cancer surgeries for a wide range of organ systems. Many mandates for suspension of surgical care came from the national level without consideration of the local COVID-19 caseload, which was variable. It could be argued that the physical and mental harm sustained by patients whose disease progressed as a result of surgery delay outweighed the benefits of preserving resources, particularly in the regions with low COVID volumes. This paper uses the principles of medical ethics within a public health framework to examine the ethical issues surrounding the cancellation of oncologic surgeries and makes recommendations for times of future resource strain.

Increasingly, new legal measures are restricting the use of gender-affirming care, raising challenges not only for the medical care of transgender/gender-nonbinary individuals, but also for medical research and research ethics. These restrictions may discourage researchers from conducting various types of research with transgender/gender-nonbinary individuals, such as asking about sexual behavior and gender identity or related issues in studies of adolescents and young adults more broadly. Researchers and institutions may also face professional risks in pursuing such research. Thus, restrictions on the use of gender-affirming care have important implications for researchers, institutional review boards (IRBs), institutional officials, policy-makers, and others. Restrictions could have an impact on the design, implementation, and management of research studies, potentially requiring consent form modifications, reconsent of participants, and asking participants about possible resulting physical/legal/social problems. Researchers and IRBs need to carefully assess these shifting legal restrictions. Input from legal experts may be needed concerning the interpretation, implementation, and enforcement of local and federal legal measures for initial and continuing IRB review of research protocols and the assessment of any changes to relevant legal measures. Researchers, IRBs, and others thus need to recognize, address, and develop "best practices" regarding these new restrictions.

Adults are not always capable of representing children's views and interests, and many ethical issues in paediatric research could be better approached if children's perspectives are taken into consideration. Children do not currently serve as institutional review board (IRB) members or provide support to IRBs who review and decide on paediatric research proposals. Based on research on moral development, however, many children are competent and could play expert roles in the IRB process with significant benefits to the latter. In this article, we argue that competent children should be permitted to assist members of IRBs in reviewing proposed paediatric research. We present three reasons in favour of involving children in IRB activities: (1) this allows children to be more adequately represented; (2) this yields a more sensitive approach to ethical complexities in paediatric research; and (3) this can improve the quality of paediatric research and enhance the well-being of research subjects. We offer a model of how competent children could play a role in the IRB process and we discuss the application of this model in the context of global paediatric research in Ghana. We address some worries about involving children in IRBs, focusing on different stakeholders involved in the research review process: the impact on children, IRB members and paediatric researchers.

Conscientious objection is a critical topic that has been sparsely discussed from a global health perspective, despite its special relevance to our inherently diverse field. In this Analysis paper, we argue that blanket prohibitions of a specific type of non-discriminatory conscientious objection are unjustified in the global health context. We begin both by introducing a nuanced account of conscience that is grounded in moral psychology and by providing an overview of discriminatory and non-discriminatory forms of objection. Next, we point to the frequently neglected but ubiquitous presence of moral uncertainty, which entails a need for epistemic humility—that is, an attitude that acknowledges the possibility one might be wrong. We build two arguments on moral uncertainty. First, if epistemic humility is necessary when dealing with values in theory (as appears to be the consensus in bioethics), then it will be even more necessary when these values are applied in the real world. Second, the emergence of global health from its colonial past requires special awareness of, and resistance to, moral imperialism. Absolutist attitudes towards disagreement are thus incompatible with global health’s dual aims of reducing inequity and emerging from colonialism. Indeed, the possibility of global bioethics (which balances respect for plurality with the goal of collective moral progress) hinges on appropriately acknowledging moral uncertainty when faced with inevitable disagreement. This is incompatible with blanket prohibitions of conscientious objection. As a brief final note, we distinguish conscientious objection from the problem of equitable access to care. We note that conflating the two may actually lead to a less equitable picture on the whole. We conclude by recommending that international consensus documents, such as the Universal Declaration on Bioethics and Human Rights, be amended to include nuanced guidelines regarding conscientious objection that can then be used as a template by regional and national policymaking bodies.