Standard of care for social harms in HIV prevention trials: A South African perspective

Abstract

Background: The prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports.

Methodology: This paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such reports.

Results: This review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal.

Conclusion: Social harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence-based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials.

Keywords: HIV/AIDS; clinical trials; social harm.