P11.05
Background: Informed consent (IC) is a dialogical process between researchers and potential participants, which should be founded upon a reciprocal research rapport. A bilateral, dialogical process should be rooted in an ethos of credibility and trust. This paper will explore enablers and inhibitors of trust within the IC process in HIV vaccine trials (HVTs) in South Africa.
Methods: The study employed an open qualitative, process-oriented exploratory design, using Focus Group Discussions (FGDs) to elicit mental models or key representations of critical research-related concepts from key constituencies, including CAB representatives, educators, and site staff involved in consent processes at an HIV prevention trial research site. Four FGDs were conducted - each constituency was interviewed separately - with approximately eight participants per group. Transcribed FGDs were subjected to thematic analysis by three qualitative researchers.
Results: Findings showed several barriers to credibility and trust around research, researchers, and key research-related concepts indicated by community members, which may complicate how concepts are understood, interpreted or believed. Study respondents reported and engaged in several strategies to build trust and develop research rapport - likely to be foundational to research participation. We found socio-economic, political, gender, race and culture-based mental models that may compete with or, alternatively, complement explanations of concepts offered by site-staff (e.g. vaccine-induced seropositivity [VISP]).
Conclusions: Authentic IC should involve a systematic exploration of these barriers and enablers to trust as part of the on-going IC process, to complement efforts to promote and assess understanding. We make a series of recommendations for stakeholders who wish to incorporate trust-building into their engagement and consent work to enhance partnering and decision-making for HIV prevention trials.
