'It's almost as if stakeholder engagement is the annoying 'have-to-do…' recognizing 'tokenism' in stakeholder engagement - Perceptions of key role-players in HIV prevention

BACKGROUND: Ethics guidance encourages researchers to engage stakeholders, and REC/ IRBs to review engagement plans (CIOMS, 2016; UNAIDS-AVAC, 2011; UNAIDS 2012). This could be strengthened by understanding how 'tokenistic' engagement is perceived, and how it can be avoided. We explore characterizations of tokenistic engagement in clinical trials, as part of a study exploring how to facilitate engagement during the ethics review process.
METHODS: We conducted in-depth interviews with 23 representatives of key stakeholder groupings, between April 2019 and June 2020 (13 female; 10 male). We used purposive and snowball sampling to identify key stakeholders from countries conducting HIV prevention trials. We conducted Thematic Analysis (UKZN REC BE 38/19).
RESULTS: The following practices were linked to tokenism - when engagement is too late or infrequent ('like a speed dating thing, here today, gone tomorrow' P8); when it is poorly resourced ('engagement isn't free' P6); when it is not inclusive ('not just the gatekeepers but the quiet voices', P1); when stakeholders are co-opted ('part of the machine' P11); when it is exclusively CAB-centric ('the default position' P13); when it is not responsive to inputs ('concerns are not being heard' P9); when engagement ignores contextual conditions ('ignorant of daily lives' P6), and when engagement practices are not ethically grounded ('something you have to get done to move a project forward' P13) nor rooted in collaborative partnership (researchers 'paint themselves as saviours' P7). However, there were additional categories of worrisome engagement beyond tokenism, namely harmful engagement ('reinforces power inequalities' P7) or engagement that is poorly tailored to the study at hand ('intensity of engagement must match the risks of the study' P10). There were concerns about inadequate indicators to recognize excellent engagement, both in clinical trials and other non-interventional studies ('shortage of explicit criteria' P10).
CONCLUSIONS: RECs may be well placed to address all 3 worrisome forms of engagement (tokenistic or harmful or one size fits all) in an ethics review process that is itself non-tokenistic. We describe empirically and theoretically informed 'indicators' to assist, including for COVID-19 studies. Using a 'reflexivity-based' review model (rather than 'compliance'-based), we recommend insightful inquiries RECs could raise.