7 J. Biosecurity, Biosafety and Biodefense Law (2016, Forthcoming)
21 Pages Posted: 17 Nov 2015 Last revised: 18 Apr 2016
Date Written: November 16, 2015
In the absence of proven therapies for persons with Ebola, efforts are underway to expedite the development of experimental drugs and other treatments. However, despite the general preference for testing new treatments in randomized controlled trials, many Ebola researchers and aid organizations have refused to participate in any studies involving a randomized controlled design. This is not the first time that randomized controlled trials in developing countries have provoked ethical controversy, but the objections to randomized clinical trials for Ebola treatments are fundamentally different from the concerns that have been raised in the past.
This Article examines the current controversies over Ebola study designs in the context of previous debates over the ethics of international clinical research. It concludes that randomized controlled trials offer the most reliable method for evaluating the safety and efficacy of novel Ebola treatments, and that their methodological rigor is itself a persuasive ethical argument in favor of using them. However, limited departures from the methodologically ideal approach may be necessary to accommodate the expectations of participants and to promote community trust. Ultimately, while decisions about study design study must be informed by scientific considerations, they also involve ethical and practical questions that should not be entrusted to scientists alone.
Keywords: Ebola, clinical trials, control groups, randomization, research ethics
JEL Classification: K32
Suggested Citation: Suggested Citation
Coleman, Carl H., Control Groups on Trial: The Ethics of Testing Experimental Ebola Treatments (November 16, 2015). 7 J. Biosecurity, Biosafety and Biodefense Law (2016, Forthcoming); Seton Hall Public Law Research Paper. Available at SSRN: https://ssrn.com/abstract=2691592