The growing complexity of the use of existing data highlights some gaps in the ethical review model currently in use across Europe. Reports from scientists highlight that the typology of reviews and constraints applied throughout Europe are highly uneven.
Research using human data and samples should occur under ethical scrutiny. The general rule is applied unevenly across borders and even across institutions. While some review ethical committees (REC) apply strict constraints for primary and secondary use of data and samples by binding possible projects to strict and specific consent, others do not apply the same rules to primary and secondary studies. In certain instances, if data and samples are used for secondary studies, no ethical review is performed at all. There is a compelling need to push the conversation towards agreed standards and minimal requirements.
In light of the new GDPR and the upcoming new legislation in the US replacing the Common Rule, this consensus conference organised jointly by Uppsala University, BBMRI ERIC, EURORDIS-Rare Diseases Europe, and RD-Connect, building on existing work, aims at bringing together different stakeholders and experts in order to collect good practices and provide input to the rare diseases research community.