EU data protection regulations could hinder cancer research

The draft EU General Data Protection Regulation could make cancer research "unworkable" by adding a significant administrative burden, according to a position paper published by the European Society for Medical Oncology (ESMO) on Friday. In March, the European Parliament published its position on the proposed regulation, which would set the rules under which personal data are to be handled in the EU, including for health and research use.

ESMO said the Parliament's proposed wording requiring "explicit and specific patient consent" could have unintended consequences because it would require researchers to continuously ask patients to re-consent each time new research is planned using available data or tissue samples. ESMO recommends that the regulation instead allow patients to "donate" their data through a one-time consent process, which could then be withdrawn at any time. The EU adopted Clinical Trial Regulations in 2014 that also include a withdrawable one-time consent, ESMO said. ...