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Handb Clin Neurol. 2013;118:301-13. doi: 10.1016/B978-0-444-53501-6.00025-1.

The ethics of clinical research in low- and middle-income countries.

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  • 1Department of Microbiology & Immunology, Geisel School of Medicine at Dartmouth, Hanover; Section of Infectious Diseases and International Health, Department of Medicine, Lebanon and Bioethics Committee, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. Electronic address: timothy.lahey@dartmouth.edu.

Abstract

The increasing conduct of clinical research in low- and middle-income countries (LMIC) is motivated by the desire to promote host country access to biomedical research, to enhance LMIC access to modern clinical care, and opportunities to conduct research with simpler regulatory requirements and at lower cost. Yet clinical research in LMIC is associated with ethical risks beyond those of clinical research conducted in high-income countries (HIC). Ethical challenges particular to clinical research in LMIC include the conduct of placebo-controlled clinical trials in LMIC despite HIC availability of effective comparator interventions, obtaining informed consent despite power inequities, and the obligation of HIC researchers to redress health disparities in LMIC. This chapter covers these and additional ethical challenges of clinical research in LMIC, and proposes ways to navigate these challenges through awareness, regulatory oversight, consultation, and collaboration with LMIC investigators and community representatives. With its ethical challenges properly managed, clinical research in LMIC provides historic opportunities to bring biomedical research and better healthcare infrastructure to countries previously left behind in the modern rush to biomedical innovation.

© 2013 Elsevier B.V. All rights reserved.

KEYWORDS:

cultural competency; developing countries; healthcare disparities; informed consent; placebos; research ethics; research ethics committees; scientific misconduct; vulnerable populations

PMID:
24182387
[PubMed - indexed for MEDLINE]
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