What makes clinical research in developing countries ethical? The benchmarks of ethical research

Eamnuel E. J., Wendler D., Killen J., Grady C. | The Journal of Infectious Diseases | Vol. 189, Issue 5 | Oxford Journals | 1 March 2004

In recent years, there has been substantial debate about the ethics of research in developing countries [15]. In general, the controversies have centered on 3 issues: first, the standard of care that should be used in research in developing countries[613]; second, the “reasonable availability” of interventions that are proven to be useful during the course of research trials [1419]; and third, the quality of informed consent. The persistence of controversies on such issues reflects, in part, the fact that existing ethical guidelines can be interpreted in multiple ways, are sometimes contradictory, or rely on unstated, yet controversial, ethical principles [6, 7, 911, 13, 2024].

To provide unified and consistent ethical guidance, we apply a previously proposed ethical framework for clinical research within developed countries to developing countries, explicating a previously implicit requirement for collaboration [25]. More importantly, we propose specific and practical benchmarks to guide researchers and research-ethics committees in assessing how well the enumerated ethical principles have been fulfilled in particular cases.

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