Oversight of Clinical Trials

What are the obstacles involved with instituting institutional oversight in developing countries?

The biggest challenges with instituting institutional oversight in developing countries are: culture and the lack of regulations / enforcement. In the case of culture, many countries will have different ethical attitudes about various clinical trials. This is because most businesses do not have to meet as stringent guidelines and subjects are not provided with full disclosure. These issues are problematic, as many nations may have existing regulations in place. Yet, there is a lack of will to address these causes, based upon the traditions embraced by the medical community. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)

The lack of regulations and enforcement; is from many developing nations not conducting clinical trials. In these kinds of situations, medical research is something that is relatively new. This means that there is a lack of resources, regulations...
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