Year: 2017
Type: article
Abstract: IntroductionProtecting participants from exploitation is one of the primary ethical challenges posed by clinical research.1 This challenge is especially pressing for clinical trials that are conducted in lower-income countries by sponsors and investigators from higher-income countries.2 For many commentators, the paradigmatic example of a problematic trial in this regard is one that evaluates in lower-income countries an intervention which will be marketed in higher-income countries only.3 To address the potential for exploitation, it is widely agreed that the host communities and the individuals who participate in these trials should receive sufficient benefits.4 The Fair Benefits framework describes one possible way to realize this goal.5 It argues that host communities and research participants should receive a fair level of benefits given the extent to which they contribute to the study in question and the extent to which they are thereby exposed to risks and burdens.6 Since it was first described in 2002, the Fair Benefits framework has been subject to a number of criticisms, leading some commentators to conclude that it should be rejected in favor of alternative approaches.7 To assess whether this conclusion is warranted, the present manuscript describes the eight most prominent criticisms and evaluates their implications for how best to address the potential for exploitation in multinational research.This analysis reveals that the prominent criticisms fall into three groups.First, several do not pertain to the Fair Benefits framework itself, but concern related issues that merit assessment in their own right.8 Second, a number of the most prominent criticisms are mistaken.9 Third, a few of the criticisms point to aspects of the Fair Benefits framework that require refinement and elaboration.10 This third group of criticisms would support the conclusion that the Fair Benefits framework should be rejected if it is unlikely that the needed refinements can be realized, or there exists an alternative approach that does better in this regard.We argue that the nature of the needed refinements suggests future research will be able to address them.In addition, there does not exist an alternative approach which needs significantly fewer or even no refinements and addresses the potential for exploitation
Source: PubMed
Authors: David Wendler, Seema K Shah
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2810115469