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  • Ethics review procedures for research in developing countries: a basic presumption of guilt

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Based on their experience of 18 years of collaborative research in Peru, Robert Gilman and Hector Garcia argue that efforts to provide ethical review of research in developing countries are often duplicated unnecessarily and frequently hampered by trivial, unnecessary or invalid concerns.

Some simple studies may require as many as 40 separate institutional review board approvals or renewals of approval, suggest the authors. In such a system - in which there is no hierarchy and every committee wants the last word - any requirement requested by one committee needs to be reviewed by all the others prior to final review, creating large piles of paperwork. In addition, many members of committees in developed countries may lack knowledge of the local culture and, trusting neither the local institution nor the investigator, may inappropriately amend the consent form or recommend procedures that are not culturally suitable.

The authors conclude that thorough and stringent review by one developed and one developing country institution is sufficient to adequately protect research participants and that the review committee in the country hosting the research should be responsible for approving the consent document.

Link to full CMAJ article

Reference: CMAJ 2004; 171, 248-249. 
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