Centre for Research Ethics & Bioethics (CRB)

Ethical review for biobank based research projects: Towards a risk based ethical review

What: Consensus conference
When: February 20, 2018
Where: Plateforme Maladies Rares, 96 Rue Didot, 75014 Paris

The growing complexity in the use of existing data highlights some gaps in the Ethical Review model currently in use across Europe.  Reports form scientists highlight that the typology of reviews and constrains 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 constrains for primary and secondary uses 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 conference builds on existing work. It aims at bringing together different stakeholders and experts in order to collect good practices and provide input to the Rare Diseases Research Community.

The consensus conference is organized jointly by Uppsala University, BBMRI-ERIC, EURORDIS-Rare Diseases Europe, and RD-Connect,

There is no fee, however, registration is mandatory. Lunch will be provided.

Register here

On a glance


Welcome and introduction
Mats Hansson, Professor of Biomedical Ethics, Uppsala Univeristy


Overview: Is ethical review required for secondary use of data and samples?
Deborah Mascalzoni, Senior Researcher, Uppsala University

10:30 Coffee break

History of Risk based ethical review and US model for risk based review and ethical considerations 
Berge Solberg, Professor of Medical Ethics, Norwegian University of Science and Technology (NTNU)


Patients’ perspective on Ethical review for secondary uses Virginie Bros Facer, Scientific Director, EURORDIS


Panel discussion




Group discussion: towards minimal requirements for Ethical Review


Report to the bigger group and discussion


Wrap-up session






Uppsala Univeristy