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. 2018 Aug;5(8):e468-e472.
doi: 10.1016/S2352-3018(18)30073-0. Epub 2018 Jun 24.

Development and implementation of participant safety plans for international research with stigmatised populations

Jeremy Sugarman  1 , Mark Barnes  2 , Scott Rose  3 , Kostyantyn Dumchev  4 , Riza Sarasvita  5 , Ha Tran Viet  6 , Oleksandr Zeziulin  4 , Hepa Susami  7 , Vivian Go  8 , Irving Hoffman  9 , William C Miller  10
Affiliations

Development and implementation of participant safety plans for international research with stigmatised populations

Jeremy Sugarman et al. Lancet HIV. 2018 Aug.

Abstract

People who inject drugs with high-risk sharing practices have high rates of HIV transmission and face barriers to HIV care. Interventions to overcome these barriers are needed; however, stigmatisation of drug use and HIV infection leads to safety concerns during the planning and conduct of research on such interventions. In preparing to address concerns about safety and wellbeing of participants in an international research study, HIV Prevention Trials Network 074, we developed participant safety plans (PSPs) at each site to supplement local research ethics committee oversight, community engagement, and usual clinical trial procedures. The PSPs were informed by systematic local legal and policy assessments, and interviews with key stakeholders. After PSP refinement and implementation, we assessed social impacts at each study visit to ensure continued safety. Throughout the study, five participants reported a negative social impact, with three resulting from study participation. Future research with stigmatised populations should consider using and assessing this approach to enhance safety and welfare.

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Conflict of interest statement

DECLARATION OF INTERESTS

Unrelated to the work described in this paper, Dr. Sugarman serves on the Merck KGaA Bioethics Advisory Panel and Stem Cell Research Oversight Committee; and the IQVIA Ethics Advisory Panel. He receives consulting income for this work and support for travel to meetings of these committees. Mr. Barnes is a partner in an international law firm that represents universities, academic medical centers and industry entities in matters related to clinical trials.

Figures

Figure.
Figure.
Participant Safety Plan Development, Implementation and Assessment
See this image and copyright information in PMC

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