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IRBs in Developing Countries

BayBiotech.NET
Conducting clinical trials in developing countries usually are faced with several local challenges and one of them is lack of local Institutional Review Board (IRBs) to review the informed consents and study protocols as well as monitor the study. Mostly, if a clinical trial is initiated outside US, the IRB within United States guides the trial. Mostly, in developing countries maintaining an efficient IRB is considered an extra financial burden on the system. Thus, a US sponsor in a developing country may face the challenges as the views on the judgment about risks and benefits of a trial may differ between the countries. In addition, developing informed consents become a main barrier due to a low literacy rate.
Thus, the best solution to this could be that two IRB committees oversee the work, one based in United States as well as one in the developing country. The US sponsor must ensure the existence of such an IRB in the country of interest. The IRB in the country of interest may have a US member who must have either loved or worked in the country and understand the local issues around specific disease or population. This will help in developing appropriate level of informed consents as well as study protocols.
Sufficient efforts must be in place to improve the competency of IRB committees in developing countries as well as the advice of the IRB committees in developing countries should be respected. Follow the link http://johnmm.bol.ucla.edu/irbReview.htm# to read more on this.

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