Conduct of clinical trials in developing countries

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...

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Bibliographic Details
Published in:Haemophilia : the official journal of the World Federation of Hemophilia 2002-05, Vol.8 (3), p.166-169
Main Author: KASPER, C. K.
Format: Article
Language:English
Subjects:
Bioethics
clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - standards
concentrate
Developing Countries
Ethics, Clinical
Hemophilia A - therapy
Humans
informed consent
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Summary: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.
ISSN:1351-8216
1365-2516
DOI:10.1046/j.1365-2516.2002.00594.x