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Conduct of clinical trials in developing countries
1Orthopaedic Hospital, Los Angeles, California 90007, USA. ckasper@laoh.ucla.edu
Abstract:
Research subjects in developing countries may be especially vulnerable to exploitation. Scrupulous care should be taken to maintain the basic principles of ethical trial conduct: the right of participants to make their own informed decisions, a favorable balance of benefit to risk, good trial design, candour about results, and, above all, use of honourable investigators. Involvement of local participants in planning a trial helps ensure both culturally-sensitive protocols and consents and also maximum benefit to patients and to local research infrastructure.
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