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In late November 2012, ethics committees and representatives from countries that are home to over half the world’s population met for three days at the FERCAP conference in Colombo, Sri Lanka. An interesting and comprehensive programme covered issues ranging from regulatory review and harmonisation - to the role of culture and diversity in ethical review. Issues relating building capacity and the review of various forms of research ranging from traditional medicine to genomic restudies were also discussed. A compilation of the presentations during the meeting is available online.
One interesting topic of the meeting was efforts to harmonise review processes globally, to facilitate the conduct of clinical research in multiple settings. The challenges researchers face with negotiating multiple review committees with differing submission requirements have been well documented in the literature and a number of initiatives such as ACRES and the US FDA's Office of International Programs work towards harmonisation in clinical research were discussed at the conference.
Contrasting with this drive for harmonisation is the need for the review of research to be specific to local contexts. One issue eloquently discussed by Professor Robert Simpson in the opening plenary, was the role of culture in ethical review. He commented:
"It is my contention that ethical review committees (ERCs) occupy a critical position in relation to ... culture. First they are charged with responsibility for protecting the 'human' in biomedical research; that sameness that resides beneath all our differences. Second, they are charged with taking manifest cultural difference into cognisance in the conduct of biomedical research - to ensure that one culture doesn't speak for or otherwise obscure or erase another. Third, the form that ethical review itself takes is a cultural form. Culture is not external to the work of ERCs but is expressed in the work that they do and how they do it. Considering each of these readings of culture illuminates a different set of tensions and challenges for ERCs to engage with in their practice."
He has been kind enough to share full report of his presentation on this site.
The tension between reconciling the need for review of protocols to be appropriate to context and culture with a drive to standardise review processes remains unresolved and raises a number of questions. Examples include whether distinctions can be made between aspects of protocols that could and should be standardised across sites and those that will require local adaption to be appropriate. Are there certain aspects of protocols that can be reviewed by a single committee and other aspects that require local review by multiple committees? Is it possible to standardise aspects of the review process, such as application forms for review, while still providing individual committees with the information and flexibility to make decisions appropriate for their research context? Are attempts at harmonisation appropriate for the scientific aspects of protocol design but inappropriate for ethical and regulatory review processes? Should we seek to harmonise ethical and regulatory review in specific research contexts?
We welcome your comments on these topics.