In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of (...) socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. (shrink)

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes of (...) all patients within an institution or region independent of their individual participation in trials. We further contend that this “infrastructure effect” can yield particular benefits for patients in low- and middle-income countries. The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. (shrink)

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not (...) being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. (shrink)