In light of recent developments in technologies such as whole genome sequencing and the increasing practice of exchanging samples and data between centres and across borders, the Council of Europe’s Committee on Bioethics is updating its 2006 Recommendation on ‘The use of biological materials of human origins in research’. In March 2014, the Council issued a consultation document and asked for views on the proposed amendments. The Recommendation aims to protect the rights and privacy of individuals who give biological samples (like blood or skin) for research and gives guidance to researchers on storing and using the samples.
A collaborative response to the charter was coordinated by the Rare Disease Patient and Ethics Council (RD-PEC) with input from partners across RD-Connect, NeurOmics and EURenOmics projects, IRDiRC and Eurobiobank.
The response emphasised the importance of balancing individual citizens’ right to privacy and their right to receive medical treatment and benefit from prevention of disorders through the advancement of research. We emphasised the scarcity of biological materials within rare disease research and therefore the importance of being able to re-use samples for more than one research project, including making samples available across different countries and different disease groups.
The Council of Europe is a human rights organisation which works directly with the European Parliament.
The response and the original consultation document can be found below:
The New European General Data Protection Regulation (GDPR)
Petra Wilson and Deborah Mascalzoni explain the new data protection regulation in the EU and how it will influence rare disease research. The webinar was realised by EURORDIS, the RD-Connect partner for patient engagement.