Berman Institute of Bioethics, School of Medicine, and Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Ropes & Gray, Boston, MA, USA; Yale Law School, New Haven, CT, USA.
Lancet HIV. 2018 Aug;5(8):e468-e472. doi: 10.1016/S2352-3018(18)30073-0. Epub 2018 Jun 24.
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.
具有高危共用行为的吸毒者具有较高的 HIV 传播率，并面临 HIV 护理障碍。需要采取干预措施来克服这些障碍；然而，对吸毒和 HIV 感染的污名化导致在规划和开展此类干预措施的研究时存在安全问题。在为解决对国际研究项目（HIV 预防试验网络 074）参与者安全和福祉的担忧做准备时，我们在每个地点制定了参与者安全计划（PSP），以补充当地研究伦理委员会监督、社区参与和常规临床试验程序。PSP 的制定依据是系统的当地法律和政策评估以及与主要利益相关者的访谈。在 PSP 细化和实施后，我们在每次研究访问时评估社会影响，以确保持续安全。在整个研究过程中，有五名参与者报告了负面的社会影响，其中三人是由于参与研究造成的。未来针对污名化人群的研究应考虑使用和评估这种方法，以增强安全性和福利。
