WORKSHOP Challenges in international Ethics Review equivalency

Co-chairs: Global Alliance for Genomics and Health - Regulation and Ethics Workshop Group, Bartha M. Knoppers and Edward Dove

The governance of biomedical research is operating sub-optimally. Research ethics committees (RECs) exercise the discretionary function of reviewing the ethical acceptability of proposals involving human participants, yet they employ remarkably uneven and inconsistent review, particularly for international multi-site studies. Many RECs fail to demonstrate effective coordination between committees and across jurisdictions. This has serious ramifications for global health research. Research that is impeded or prevented from going forward because of disharmonised ethics review may prevent significant research breakthroughs from occurring. This workshop will develop alternative models for structuring the review of multi-site international biomedical research, with a goal towards internationally harmonising ethics review – what we term Ethics Review Equivalency (ERE). Such models could allow for international mutual recognition of ethics review and importantly, better balance the interests of science, society and research participants. This workshop represents an opportunity to make a significant contribution to addressing the problems with inconsistent and disharmonised REC review. It will consist of presentations and discussions about the on-going challenges of international, multi-site ethics review, ‘big data‘ genomics and health-related data sharing and research.

Symposium: Open bridges for life-science data