Ethical implications of economic compensation for voluntary medical male circumcision for HIV prevention and epidemic control.

Despite tremendous efforts in fighting HIV over the last decades, the estimated annual number of new infections is still a staggering 1.5 million. There is evidence that voluntary medical male circumcision (VMMC) provides protection against men's heterosexual acquisition of HIV-1 infection. Despite good progress, most countries implementing VMMC for HIV prevention programmes are challenged to reach VMMC coverage rates of 90%. Particularly for men older than 25 years, a low uptake has been reported. Consequently, there is a need to identify, study and implement interventions that could increase the uptake of VMMC. Loss of income and incurred transportation costs have been reported as major barriers to uptake of VMMC. In response, it has been suggested to use economic compensation in order to increase VMMC uptake. In this discussion paper, we present and review relevant arguments and concerns to inform decision-makers about the ethical implications of using economic compensation, and to provide a comprehensive basis for policy and project-related discussions and decisions.

Artificial Intelligence and global health: opportunities and challenges.

Artificial Intelligence (AI) offers unprecedented opportunities and challenges for humanity. If AI can be positioned and leveraged correctly, it can rapidly accelerate progress on achieving the United Nations' Sustainable Development Goals (SDGs), including SDG #3: 'Ensure healthy lives and promote wellbeing for all at all ages'. Achieving this goal could have a transformative impact on global health. An ethical, transparent and responsible approach to AI development will result in AI translating data into contextually relevant knowledge, conclusions, and impactful actions.

Challenges with participant reimbursement: experiences from a post-trial access study.

Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits.

How Bioethics is Complementing Human Rights in Realizing Health Access for Clinical Trial Participants: The Case of Formative PrEP Access in South Africa.

Following the demise of apartheid, human rights in South Africa are now constitutionally enshrined.The right to health in South Africa's Constitution has been credited with transforming the lives of millions of people by triggering programmatic reforms in HIV treatment and the prevention of mother to child transmission (MTCT) of HIV.However, a constitutionally enshrined right to health offers no guarantee that clinical trial participants will enjoy post-trial access to beneficial interventions. Using access to HIV pre-exposure prophylaxis (PrEP) in South Africa as an example, this paper argues that adherence to bioethics norms could realize the right to health for trial participants following the end of a clinical trial.

Balancing efficiency, equity and feasibility of HIV treatment in South Africa - development of programmatic guidance.

South Africa, the country with the largest HIV epidemic worldwide, has been scaling up treatment since 2003 and is rapidly expanding its eligibility criteria. The HIV treatment programme has achieved significant results, and had 1.8 million people on treatment per 2011. Despite these achievements, it is now facing major concerns regarding (i) efficiency: alternative treatment policies may save more lives for the same budget; (ii) equity: there are large inequalities in who receives treatment; (iii) feasibility: still only 52% of the eligible population receives treatment.Hence, decisions on the design of the present HIV treatment programme in South Africa can be considered suboptimal. We argue there are two fundamental reasons to this. First, while there is a rapidly growing evidence-base to guide priority setting decisions on HIV treatment, its included studies typically consider only one criterion at a time and thus fail to capture the broad range of values that stakeholders have. Second, priority setting on HIV treatment is a highly political process but it seems no adequate participatory processes are in place to incorporate stakeholders' views and evidences of all sorts.We propose an alternative approach that provides a better evidence base and outlines a fair policy process to improve priority setting in HIV treatment. The approach integrates two increasingly important frameworks on health care priority setting: accountability for reasonableness (A4R) to foster procedural fairness, and multi-criteria decision analysis (MCDA) to construct an evidence-base on the feasibility, efficiency, and equity of programme options including trade-offs. The approach provides programmatic guidance on the choice of treatment strategies at various decisions levels based on a sound conceptual framework, and holds large potential to improve HIV priority setting in South Africa.

Shared principles of ethics for infant and young child nutrition in the developing world.

BACKGROUND: The defining event in the area of infant feeding is the aggressive marketing of infant formula in the developing world by transnational companies in the 1970s. This practice shattered the trust of the global health community in the private sector, culminated in a global boycott of Nestle products and has extended to distrust of all commercial efforts to improve infant and young child nutrition. The lack of trust is a key barrier along the critical path to optimal infant and young child nutrition in the developing world. DISCUSSION: To begin to bridge this gap in trust, we developed a set of shared principles based on the following ideals: Integrity; Solidarity; Justice; Equality; Partnership, cooperation, coordination, and communication; Responsible Activity; Sustainability; Transparency; Private enterprise and scale-up; and Fair trading and consumer choice. We hope these principles can serve as a platform on which various parties in the in the infant and young child nutrition arena, can begin a process of authentic trust-building that will ultimately result in coordinated efforts amongst parties. SUMMARY: A set of shared principles of ethics for infant and young child nutrition in the developing world could catalyze the scale-up of low cost, high quality, complementary foods for infants and young children, and eventually contribute to the eradication of infant and child malnutrition in the developing world.

In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?

BACKGROUND TO THE DEBATE: After the failure of three large clinical trials of vaginal microbicides, a Nature editorial stated that the microbicide field "requires a mechanism to help it make rational choices about the best candidates to move through trials" [1]. In this month's debate, James Lavery and colleagues propose a new mechanism, based on stopping trials early for "opportunity costs." They argue that microbicide trial sites could have been saturated with trials of scientifically less advanced products, while newer, and potentially more promising, products were being developed. They propose a mechanism to reallocate resources invested in existing trials of older products that might be better invested in more scientifically advanced products that are awaiting clinical testing. But David Buchanan argues that the early stopping of trials for such opportunity costs would face insurmountable practical barriers, and would risk causing harm to the participants in the trial that was stopped.

Do human rights matter to health?

Legal instruments and litigation as a way to enforce the rights to life and to health is a relatively new strategy that is increasingly common. We show how legal measures have been used to attain health and human rights with case examples from India and South Africa that resulted in large public-health benefits.