Standards en investigación en países pobres

The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings

Singh JA (2011) The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings. PLoS Med 8(3): e1000421. doi:10.1371/journal.pmed.1000421

“Lessons for Others

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.

Further, as was the case in the Uganda study, the investigators’ role should not be limited to merely highlighting a problem. The duty of beneficence requires investigators to assume an advocacy role. This includes making reasonable attempts to change the prevailing state of affairs (i.e., the absence of efficacious treatment in the country). To this end, investigators could follow the example of the Uganda study and provide the efficacious standard of care to study participants as soon as practically possible for the duration of the study (and, if necessary, a limited period thereafter). Moreover, they could attempt to secure an undertaking from the authorities that the state will assume the responsibility of continuing that standard of care in the study setting, post-trial, and eventually expanding its access throughout its territorial jurisdiction. Admittedly, investigators do not have the power to compel authorities to approve their study, to assume post-trial responsibilities, or to implement an efficacious standard of care beyond the study site. However, this should not stop investigators from trying to do so.”

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