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  • Ethical review and the globalisation of clinical trials

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Last year the United States released a report entitled 'The globalisation of clinical trials: a growing challenge in protecting human subjects'. The report called for the highest level of protection for clinical trial participants abroad, and pointed towards the responsibility of sponsors of foreign clinical trials to educate local institutional review boards (IRBs).

The authors of this opinion article highlight the difficulties faced by trying to harmonise the operation and quality of ethical review in countries that have enormous political, social and economic differences.

They say that while international guidance and national legislation are essential to developing well-functioning ethical review systems, such measures alone will not suffice. They call for a systematic approach to information gathering and capacity building that utilises local knowledge. Only through a concerted, international commitment can the challenges of protecting human subjects be met.

Link to full opinion article (pdf file)
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