What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research

TLDR

Debate over ethics of research in developing countries centers on standard of care, availability of proven interventions, and quality of informed consent, with controversies persisting due to ambiguous, contradictory, or unstated guidelines. The study aims to unify ethical guidance by applying a developed‑country clinical research framework to developing countries, clarifying the need for collaboration. The authors propose practical benchmarks for researchers and ethics committees to evaluate fulfillment of ethical principles. Excerpt provided.

Abstract

In recent years there has been substantial debate about the ethics of research in developing countries. In general the controversies have centered on 3 issues: first the standard of care that should be used in research in developing countries; second the “reasonable availability” of interventions that are proven to be useful during the course of research trials; 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. 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. 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. (excerpt)