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Moving the needle: strengthening ethical protections for people who inject drugs in clinical trials
  1. Daniel Wolfe
  1. Correspondence to Daniel Wolfe, Open Society Foundations, 224 West 57th St, New York, NY 10019; Daniel.wolfe{at}opensocietyfoundations.org

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Those researching HIV prevention measures for people who inject drugs (PWID) face a dilemma. Regions where baseline HIV prevalence and onward transmission via injecting is sufficiently high to power HIV prevention trials are also those where repressive laws, policies and practices raise concerns about the ethics of research subject protection. Dawson et al, outlining criteria to address ethical challenges in HIV prevention research among PWID, recommend that all trial participants be offered sterile injecting equipment and urge additional strategies to limit research and background risks.1 In light of ethical questions opened by recent clinical trials involving PWID, including several the authors cite favourably, these cautions are timely.

Dawson et al urge weighing of costs and benefits of PWID participation in research trials as an essential part of the ethical calculus. Overdose is a particular risk in any trial that uses abstinence from opioids as a precondition for participation or as an outcome of interest, and a risk that institutional review boards and researchers frequently ignore. Given the increased likelihood of fatal overdose for those who return to injection following a period of abstinence, provision to all trial participants of naloxone—the overdose antidote …

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