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The rapidly evolving situation raises three fundamental questions: how much emphasis should the international community place on experimental interventions in response to the Ebola epidemic; what are the ethical considerations if experimental treatments or vaccines are deployed; and if any interventions prove safe and effective, how can they be made more widely available?

Following endorsement by WHO,1,2 the World Bank,3 and the UN's Sustainable Development Goals,4 the drive towards universal health coverage (UHC) is now one of the most prominent global health policies. As countries progress towards UHC, they are forced to make difficult choices about how to prioritise health issues and expenditure: which services to expand first, whom to include first, and how to shift from out-of-pocket payment towards prepayment.

In a Policy Forum, Marc Lipsitch and colleagues discuss trial design issues in infectious disease outbreaks.In a Policy Forum, Marc Lipsitch and colleagues discuss trial design issues in infectious disease outbreaks.

Amid ongoing efforts to reduce the risk of Covid-19 infection in correctional facilities, researchers are considering whether incarcerated people should be included in efficacy trials of vaccine candidates after there is some evidence that such vaccines are safe.

After decades of setbacks, gene therapy (GT) is experiencing major breakthroughs. Five GTs have received US regulatory approval since 2017, and over 900 others are currently in development. Many of these GTs target rare pediatric diseases that are severely life-limiting, given a lack of effective treatments. As these GTs enter early-phase clinical trials, specific ethical challenges remain unresolved in three domains: evaluating risks and potential benefits, selecting participants fairly, and engaging with patient communities. Drawing on our experience as clinical investigators, basic scientists, and bioethicists involved in a first-in-human GT trial for an ultrarare pediatric disease, we analyze these ethical challenges and offer points to consider for future GT trials.

Background This paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds. Methods The consensus process used a modified Delphi approach. Results Consensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise). Conclusions Through articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of practice of empirical bioethics research can develop and evolve further.

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries. However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct their research elsewhere, potentially depriving the local population of the opportunity to benefit from international clinical research. In this paper, we propose a three-step ethical framework that helps policy-makers to navigate this trade-off. We use a recent set of regulatory protections in Chile to illustrate the practical value of our proposed framework, providing original ethical analysis and previously unpublished data from Chile obtained through freedom of information requests.

Global health reciprocal innovation (GHRI) is a recent and more formalised approach to conducting research that recognises and develops innovations (eg, medicines, devices, methodologies) from low- and middle-income countries (LMICs). At present, studies using GHRI most commonly adapt innovations from LMICs for use in high-income countries (HICs), although some develop innovations in LMICs and HICs. In this paper, we propose that GHRI implicitly makes two ethical commitments: (1) to promote health innovations from LMICs, especially in HICs, and (2) to conduct studies on health innovations from LMICs in equitable partnerships between investigators in LMICs and HICs. We argue that these commitments take a significant step towards a more equal global health research enterprise while helping to ensure that populations and investigators in LMICs receive equitable benefits from studies using GHRI. However, studies using GHRI can raise potential ethical concerns and face legal and regulatory barriers. We propose ethical, legal and regulatory considerations to help address these concerns and barriers. We hope our recommendations will allow GHRI to move the global health research enterprise forward into an era where all people are treated equally as knowers and learners, while populations in both LMICs and HICs benefit equitably from studies using GHRI.

IntroductionA data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data. The objective of this study was to explore the extent to which the structure, membership and deliberations of DMCs enable them to address ethical issues.MethodsWe conducted qualitative individual interviews (n=22) with DMC members from countries across Africa, the Americas, South Asia and the UK. We selected interview respondents through purposive sampling, managed data using NVivo (Release V.1.7) and analysed data thematically.ResultsAll respondents were highly experienced professionals; many (18/22) had received training in medicine and/or statistics. One respondent had academic qualifications in ethics, and four indicated that they served on DMCs as ethicists. While respondents generally felt DMCs should be required for studies that were high-risk or enrolled vulnerable populations, some were concerned about the overuse of DMCs. There were divergent views on the necessity of geographical and disciplinary representation in DMC membership, including about whether ethicists were helpful. Many respondents described a DMC member recruitment process that they felt was somewhat exclusive. While one respondent received DMC-specific training, most described learning on the job. Respondents generally agreed that study protocols and DMC charters were key guiding documents for addressing ethical issues and described DMC deliberations that often, but not always, involved consensus-building.ConclusionThis study is one of the first to consider the ethical implications of DMC structure, membership and deliberations. The potential overuse of DMCs, DMC member recruitment processes that seem somewhat insular, limited training for DMC members, and divergent approaches to deliberation may limit the capacity of DMCs for addressing ethical issues. Further research on DMC structure and processes could help enhance the ethical preparedness of DMCs.