IRB: Ethics & Human Research
Positive Social Impacts Related to Participation in an HIV Prevention Trial Involving People Who Inject Drugs
Although attention has focused on whether participants actually derive better medical outcomes in research, the social benefits experienced in research have not been systematically examined. At regular follow-up visits during a phase III randomized trial conducted in China and Thailand to assess the safety and efficacy of a long-term versus a short-term drug treatment intervention in decreasing HIV transmission and mortality, participants identified research-related negative and positive social impacts (PSIs). Open-ended PSI responses were coded using standard qualitative techniques. Among 1,250 participants, only 4 reported a negative social impact; however, 77% reported at least one PSI over the 104-week follow-up period. Given the high prevalence of PSIs we observed, future research should embed assessments of negative and positive social impacts experienced by participants in research not only to ensure their well-being but also to inform policy and conceptual work related to research ethics.
Jeremy Sugarman, Randy Stalter, Kevin Bokoch, Ting-Yuan Liu, and Deborah Donnell. “Positive Social Impacts Related to Participation in an HIV Prevention Trial Involving People Who Inject Drugs.” IRB: Ethics & Human Research 2015; 37(1):17-19.