Abstract
IntroductionClinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for HIV prevention researchers to implement “stakeholder engagement” are increasingly common. Such engagement is held to benefit inter‐stakeholder relations, stakeholders themselves and the research itself. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in HIV prevention trials. However, this is not necessarily straightforward. In this article, we consider several complexities. First, is stakeholder engagement a legitimate component of what Research Ethics Committees (RECs) should review for HIV prevention trials? Second, what are the core features of engagement that should be under ethics review? Third, what are the key practices that should be highlighted in ethics review?MethodsTo address these questions, we examined the international ethics guidelines specialized for such trials (UNAIDS 2012, UNAIDS‐AVAC GPP 2011) and directly applicable to such trials (CIOMS 2016; WHO 2011). Thematic analysis was used to code and analyse these guidelines.Results and discussionEthics guidelines support REC review of engagement. Guidance recommends that engagement be broad and inclusive; early and sustained; and dynamic and responsive. Broad engagement practices include evaluating the context, planning in writing, and resourcing. RECs should assess engagement as part of a comprehensive review, and recommend revisions where necessary. Researchers should profile key elements of engagement valued in ethics guidance, when they draft ethics submissions. Importantly, the ethics review process should not undermine the ‘dynamic responsiveness’ required for excellent engagement in this field.ConclusionsAs evidence‐informed engagement strategies emerge, these should inform the ethics submission and review process. Both parties in the review process should strive to avoid a superficial, check‐list type approach that caricatures what should be a thorough, nuanced ethics review of a rich, responsive engagement process.
Highlights
Clinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders
Is stakeholder engagement really a legitimate component of what Research Ethics Committees (RECs) should review?; second, what core engagement features should be under ethics review?; and third, what core engagement practices should be under ethics review? Given that ethics guidance is central to determining the acceptability of researchers’ practices and of RECs’ practices, we looked to ethics guidance to address these questions
We aimed to find ethics guidelines that would be relevant to any researcher or REC involved in HIV prevention trials anywhere in the world, regardless of host country, institutional affiliation or network membership
Summary
Clinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in HIV prevention trials. Is stakeholder engagement a legitimate component of what Research Ethics Committees (RECs) should review for HIV prevention trials? There is the vulnerability of key stakeholders, such as participants and community stakeholders, who are at increased risk of potential harm because of marginalization or HIV stigma and discrimination [1] They might be exploited because of disparities in wealth, scientific experience, power, and technical capacity relative to researchers [1]. Ethics guidelines recognize that when sponsors and researchers engage relevant stakeholders, potential risks and harms can be mitigated
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
