Ethical Considerations in HIV Prevention and Vaccine Research in Resource-Limited Settings

Abstract

HIV prevention research has been facing increasing ethical and operational challenges. Factors influencing the design and conduct of HIV prevention trials include a rapidly changing evidence base, new biomedical prevention methods and modalities being tested, a large diversity of countries, sites and populations affected by HIV and participating in trials, and challenges of developing and making available products that will be feasible and affordable for at-risk populations. To discuss these challenges, a meeting, Ethical considerations around novel combination prevention modalities in HIV prevention and vaccine trials in resource-limited settings, was convened by NIH/NIAID/Division of AIDS on April 22-23, 2013. Several themes emerged from the meeting: (1) because of both trial design and ethical complexities, choosing prevention packages and designing combination prevention research trials will need to be evaluated on a case by case basis in different clinical trials, countries, and health systems; (2) multilevel stakeholder engagement from the beginning is vital to a fair and transparent process and also to designing ethical and relevant trials; (3) research should generally be responsive to a host country's needs, and sponsors and stakeholders should work together to address potential barriers to future access; and finally, (4) another meeting including a broader group of stakeholders is needed to address many of the outstanding ethical issues raised by this meeting. We offer an overview of the meeting and the key discussion points and recommendations to help guide the design and conduct of future HIV prevention and vaccine research in resource-limited settings.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…Of the 108 studies, 48 studies (44.4%) conducted stakeholder engagement in high‐income countries 5, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70. In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93,...…”

“…In contrast to this targeted approach in defining stakeholders, members of the general public were engaged in just 12 studies (11.1%). Thirteen studies (12%) described engagement conducted with community stakeholders or community representatives without specifying further as to what aspect of the community these stakeholders represent [29,30,56,59,70,92,98,108,112,120,122,125,128].…”

“…The second and third most frequent purpose for conducting stakeholder engagement was to inform the ethical conduct of the trial (16 studies) and to develop trial tools (15 studies) respectively. In informing the ethical conduct of trials, stakeholders were engaged for providing input on ethicsrelated concerns, either in terms of the overall trial process [70,76,88,99] or in relation to particular aspects of the trial; for example, trial stopping rules [78], trial communication strategies [123] and concepts of fairness in the research relationship [94].…”

Clinical Ethics in HIV/AIDS Prevention, Care, and Research

“…There is ongoing debate among international ethicists about whether a "double standard" in the calculation of risks and benefits in research improves health care in low-income countries or perpetuates injustice (Macklin 2008). The National Institutes of Health's (NIH) ethical priorities for prevention trials call for researchers to engage multilevel stakeholders in ethical study design, including provisions to ensure that the research is responsive to the host country's needs and that potential barriers to future access to the study intervention are minimized (Garner et al 2014).…”