Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed.
Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV (...) prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. (shrink)
Health researchers working in low-resource settings routinely encounter serious unmet health needs for which research participants have, at best, limited treatment options through the local health system (Taylor, Merritt, and Mullany 2011). A recent case discussion features a study conducted in Bamako, Mali (Dickert and Wendler 2009). The study objective was to see whether children with severe malaria develop pulmonary hypertension in order to improve the general understanding of morbidity and mortality associated with malaria. In the study team's interactions with (...) participating children, they encountered not only malaria but also "eye infections, upper respiratory tract illnesses, rashes, pericardial effusions," .. (shrink)
Researchers conducting large community-based studies among underserved populations may collect data on health conditions that are little-acknowledged in the local setting, and for which there are few if any services for referral of participants who need follow-up diagnosis and care. In the design and planning of studies for such settings, investigators and research ethics committees may struggle to determine what constitutes effective referral and whether it is reasonably available. We offer a guiding framework for referral planning, informed by our experiences (...) of research in the field and of service on research ethics committees, to support evaluation of local referral resources and consideration of the benefits, burdens and risks of referral in the local setting. The framework addresses both the impact of referral on the well-being of the people who would be referred and the impact that referral of study participants would have on local people outside the study. We use a sustained discussion of three field-based case examples to illustrate the ethical concerns at issue and to demonstrate the use of the referral planning framework. (shrink)
This article proposes an action guide to making decisions regarding the ethical allocation of resources that affect access to healthcare services offered by community-based healthcare organizations. Using the filter of empirical data from a study of decision making in two community-based healthcare organizations, we identify potentially relevant conceptual guidance from a review of frameworks and action guides in the public health, health policy, and organizational ethics literature. We describe the development of this action guide. We used data from a prior (...) empirical study of the values that influence decision making about the allocation of resources in particular types of community-based healthcare organizations. We evaluated, organized, and specified the conceptual guidance we found in 14 frameworks for ethical decision making. The result is an action guide that includes four domains that are relevant to the context of the decision to be made, eight domains that are relevant to the process of the decision to be made, and 15 domains that are relevant to the criteria of the decision to be made. We demonstrate the potential use of this action guide by walking through an illustrative resource allocation decision. The action guide provides community-based healthcare organizations with a conceptually grounded, empirically informed framework for ethical decision making. (shrink)
Background: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. Methods: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset (...) to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? Findings: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)
We sought to assess formally the extent to which different control and elimination strategies for human African trypanosomiasis Trypanosoma brucei gambiense would exacerbate or alleviate experiences of societal disadvantage that traditional economic evaluation does not take into account. Justice-enhanced cost-effectiveness analysis is a normative approach under development to address social justice considerations in public health decision-making alongside other types of analyses. It aims to assess how public health interventions under analysis in comparative evaluation would be expected to influence the clustering (...) of disadvantage across three core dimensions of well-being: agency, association and respect. As a case study to test the approach, we applied it to five strategies for Gambiense HAT control and elimination, in combination with two different other evaluations: a cost-effectiveness analysis and a probability of elimination analysis. We have demonstrated how JE-CEA highlights the ethical importance of adverse social justice impacts of otherwise attractive options and how it indicates specific modifications to policy options to mitigate such impacts. JE-CEA holds promise as an approach to help decision makers and other stakeholders consider social justice more fully, explicitly and systematically in evaluating public health programs. (shrink)