Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory Board (CAB) members’ experiences of trust/mistrust among community members and potential participants. We analyzed 10 focus group discussions with site staff and CAB members at two active South African HIV vaccine trial sites. We report on key characteristics perceived to contribute to the trustworthiness of communicators, as well as factors associated with mistrust. Attributes associated with trustworthy communicators included shared racial identity, competence, and independence (not being “captured”). Key foci for mistrust included explanations about site selection, stored samples, vaccination, and Vaccine Induced Sero-Positivity (VISP). Our findings suggest that community members’ trust is not necessarily global, in which trials are trusted or not; rather, it appears fairly nuanced and is impacted by various perceived attributes of communicators and the information they provide. We make recommendations for clinical trial site stakeholders invested in building trust and for future research into trust at these sites.
Ethics guidance recommends that researchers engage stakeholders and that RECs review research for such engagement. The ethics review process may present a unique opportunity to support stakeholder engagement practices for HIV prevention studies. We conducted 28 interviews with experts from 12 countries to explore this issue, and analyzed the data using Thematic Analysis. We found that the value of engagement and review processes was strongly endorsed. However, we identified 3 major thematic complexities, namely: “Tokenism” where processes risk being “tick-box”; “Toxicity”, where practices may inadvertently have negative consequences; and “Tailoring”, where processes need careful variation in intensity. We make recommendations for how these “Ts” can be addressed during the review process to help contribute to thoughtful review of meaningful stakeholder engagement in research.
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.
The burgeoning increase in Internet access and use in South Africa and globally has opened a new doorway for provision of mental health services online. This descriptive study focuses specifically on psychotherapeutic services provided by South African psychologists. Draft guidelines for online therapy were developed and a sample of South African registered psychologists was asked to review, rate, and comment on the draft guidelines via an online survey. The sample also identified key ethical dilemmas arising from the novel use of this modality in South Africa. The draft guidelines were positively appraised by the majority of participants supporting the value of such guidelines in South Africa. Key ethical dilemmas identified included confidentiality, competence, boundaries, technological limitations, emergency situations, nature of therapeutic process, security of records, payment, and verification of identity.
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