Date Published: March 15, 2011
Publisher: Public Library of Science
Author(s): Jerome Amir Singh
Abstract: Jerome Singh discusses some ethical issues raised by a new research article by Edward Jónes-Lopez and colleagues that examined the effectiveness of the standard WHO recommended retreatment regimen (Category II) for TB in Uganda.
Partial Text: The paper by Jones-López et al. in this week’s PLoS Medicine (hereinafter “the Uganda study”) illustrates the challenge of conducting research in resource-constrained settings. At the time the study was proposed and initiated, the prevalence of multidrug resistant tuberculosis (MDR-TB) in Uganda was unknown. Further, second-line therapy for MDR-TB, available in other settings, was not available in the country. The Uganda study accordingly highlights at least two classic ethical conundrums: (1) should research be conducted in a setting if the existing standard of care for the health issue under investigation is “no treatment,” despite efficacious treatment existing elsewhere? and (2) should investigators introduce an efficacious standard of care in a setting if it would not otherwise be available?
It is worthwhile examining the ethics of the Uganda study through the lens of prominent international research ethics guidelines. Although these instruments are not binding on any setting, including Uganda, they offer helpful guidance on a range of issues that confront researchers. According to the Council for International Organizations of Medical Sciences (CIOMS) Guidelines (formally known as International Ethical Guidelines for Biomedical Research Involving Human Subjects; hereinafter “CIOMS Guideline”) :
The Uganda study holds valuable lessons for others contemplating conducting research in resource-scarce settings. While not conducting a study in a setting where no efficacious standard of care exists may, at face value and in certain instances, seem a more ethically defensible option, it could overall have more negative consequences. For instance, crucial epidemiological evidence that could demonstrate the actual state of disease prevalence in a setting, and which may be pivotal to compelling (or shaming) apathetic, obstinate, and indifferent governments to change their existing treatment policy, may end up never being yielded. Accordingly, the relevant health crisis will remain unaddressed, resulting in dire public health consequences for that setting, and in some instances, the surrounding region. The Uganda study investigators were thus justifiable in conducting the study in Uganda.
The Uganda study has undoubtedly addressed an important knowledge gap in science. It will hopefully herald revisions to Uganda’s TB treatment program and inspire similar reforms elsewhere. Equally significant, the study catalyzed the provision of second-line TB therapy in that country. In so doing, the study has undoubtedly left the local population better off compared to before its commencement. These two factors, alone, make the Uganda study ethically defensible.