Healthy Volunteers in Clinical Studies

In Doris Schroeder, Julie Cook, François Hirsch, Solveig Fenet & Vasantha Muthuswamy (eds.), Ethics Dumping: Case Studies From North-South Research Collaborations. Springer. pp. 67-70 (2018)
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Abstract

Patients participate in clinical trials for a variety of reasons, the first of which is often the prospect of direct health Benefit for themselves. Healthy volunteers, by definition, cannot expect such benefits. In resource-limited settings, healthy volunteers are most often poor people with low literacy levels who might not understand the Risks they may be taking and are in no position to refuse Financial incentives. For many of them, participation in clinical trials is a critical source of income. An added complication is that some participants covertly enrol in several studies simultaneously, in order to increase their income. This exposes the volunteers to medical risks, and also potentially biases study Data. Our recommendations are that specific efforts are made to ensure proper informed Consent of this Vulnerable population and that compulsory national databases be established to ensure that healthy volunteers do not participate simultaneously in several studies.

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