Among the proposals suggested by Glasziou et al. 1 to reduce waste in research oversight, one deserves a further reflection. To reduce the review turnaround time, it was proposed that multiple applications should be ‘prohibited’: a single research ethics committee should be responsible for reviewing multi-site clinical trials. 1 Thanks to having a single research ethics committee approval process, Glasziou et al argued, RECOVERY was able to rapidly start recruiting participants in many UK hospitals. Conversely, recruitment in the WHO-sponsored SOLIDARITY trial ‘was slowed or even thwarted by the multiple ethics committee requirements within and between the 30 countries involved’. 1 Although the purpose of the proposal is adequate (the ‘one country, one research ethics committee involved’ approach), it was wrongly formulated.
Having a single research ethics committee reviewing a multi-centre trial protocol is, in principle, correct provided all sites are in one country, as it happened with RECOVERY. When sites are in more than one country, this is difficult to accept. Even acknowledging that all scientific aspects of a protocol could be acceptable for all countries involved – something that should not be taken for granted–. Ethics requires a local approach. That is why a research ethics committee from each participating country should review the trial protocol, which is the approach taken in the European Union regulation. 2 SOLIDARITY was conducted in four continents: it seems appropriate that research ethics committees from, for example, Egypt, Honduras, India or Norway, could have their say on the trial protocol, even though it was approved by the World Health Organization. Furthermore, following Glasziou et al proposal, who will decide the country of the single research ethics committee responsible for reviewing the trial protocol? Are (and will) all stakeholders involved in a multinational trial run in the European Union willing to accept that only one research ethics committee across the European Union will review the trial protocol? Are (and will) western research ethics committees and regulatory agencies eager to admit that a low-income-country research ethics committee should be the only one conducting the review? Considering that most multinational trials involving several continents are funded/sponsored by western institutions/organisations, choosing a research ethics committee from a western participating country could be reasonable, but if this becomes the norm, it could correctly be labelled a new form of research imperialism.
Finally, the ‘one country, one research ethics committee involved’ approach for the review of multi-centre randomised controlled trials should have a limit. In multi-centre randomised controlled trials conducted in large countries like Brazil, China, India, Indonesia or South Africa with huge cultural, educational, social and healthcare disparities between population groups, trial protocol review should be conducted by more than one research ethics committee to ensure that the values and interests of potential participants and communities are taken into account. 3
Acknowledgements
None
Declarations
Competing Interests
none declared
Funding
none
Ethics approval
not required
Guarantor
the author
Contributorship
conceived and written by the author
Provenance
Not commissioned; editorial review.
ORCID iD
Rafael Dal-Ré. https://orcid.org/0000-0002-0980-2486
References
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