Zusammenfassung

Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site ethics review, international research projects are subjected to multiple ethics reviews of the same research protocol. Consequently, the reviews may be redundant and resource-consuming, whilst the opinions delivered by ethics committees may be inconsistent both within and across jurisdictions. In this article, we present findings based on interviews conducted with international experts in research ethics on the topic of ethics review mutual recognition. We explore the issues associated with ethics committee review of multi-jurisdictional data-intensive research projects, identifying current problems, real-life experiences, and potential solutions that are both bottom-up (via researchers, participants and publics) and top-down (via statutory regulation), as well as challenges in achieving both. On the whole, participants recommended multiple changes to the current ethics review regime for data-intensive international research with the aim of reducing inefficiency and inconsistency. But, the changes recommended differ in terms of degree and scope. In general, participants stressed that key drivers of success in a reformed system should be strong leadership (on the ground and in government) and demonstration of value.

https://doi.org/10.1177/1747016117711972