Research on intimate partner violence prevention - complex ethical issues

Ethical challenges of randomized violence intervention trials: examining the SHARE intervention in Rakai, Uganda.

Wagman JA, Paul A, Namatovu F, Ssekubugu R, Nalugoda F. Psychol Violence. 2016 Jul;6(3):442-451.

Objective: We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.

Methods: Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.

Results: Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.

Conclusion: Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

Abstract access [1]

Editor’s notes: Data from 81 countries indicate that 30% of women aged 15 and above have experienced physical and/or sexual intimate partner violence in their lifetime. Settings with the highest intimate partner violence prevalence were found to be in sub-Saharan Africa, the region most affected by HIV.  Intimate partner violence is now widely accepted to be both a precursor to and sequelae of HIV infection. In response, a growing number of combination intimate partner violence and HIV prevention programmes have been implemented and systematically evaluated through randomised trials. The authors of this paper discuss some of the practical, ethical and safety challenges introduced by randomised trials on violence prevention, drawing on experience from a project in rural Uganda.

International guidelines have been established for the ethical conduct of biomedical research involving human subjects. The subject of violence against women and the method of randomised controlled trials are not easily resolved with these standard guidelines. In response, specialised recommendations for conducting safe and ethical population-based survey research on violence against women have been developed. These guidelines are an important development, but randomised trials to evaluate intimate partner violence prevention programmes face practical challenges in responding to common research ethics and safety considerations. These include: what to offer control communities in a trial investigating the optimal delivery approach for an activity likely to be effective in a setting with no standard of care. This needs to be done while maintaining the integrity of the study.

Drawing from their experience of the SHARE trial in the Rakai District in Uganda, the authors offer three reflections from lessons learned. (1) Ongoing need to formally update programmes that address multiple and overlapping vulnerabilities of individuals experiencing intimate partner violence and at risk of, or living with, HIV. (2) Cluster-randomised trials are a promising approach for programme evaluation but introduce numerous challenges with practical and ethical implications. (3) Given widespread underreporting of intimate partner violence, evaluation of violence programmes may have particularly high levels of unanticipated demand. The authors advocate for a framework of relevant considerations to be developed to guide researchers working on activities to reduce intimate partner violence. These guidelines should address potentially common challenges. They also encourage researchers to share field lessons arising from their studies in order to a) contribute to the development of this framework b) for revising and improving guidelines for the ethical conduct of intimate partner violence programmes in low resource settings.

Africa [7]
Uganda [8]
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