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Is the IRB process for international research “overly-legalistic”?

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Is the IRB process for international research “overly-legalistic”?

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Gilman and Garcia (2004) argue that “overly-legalistic” IRBs are reducing the amoung of research done in developing countries: • 18 years of collaborative research experience in Peru. • They have found the IRB procedure to be “duplicated unecessarily and frequently based in… invalid concerns.” • They cite an example of a village survey study over a 5 year period that required 40 separate IRB approvals. • They complain about: • Bureaucratic delays. • Contradictory demands of different IRB committees. • Interruption of multi-year projects due to conflicting demands. Suggest a balance between: • Ensuring the ethical protection of human subjects in developing countries. • Encouraging research to benefit people in developing countries. Complaint that IRB members in developed countries have little understanding of the local issues in developing coutries: • Lack of knowledge of the local culture. • Lack of trust in the local IRB committee and investigators. • This can lead to the developed

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