Print“If a patient is allowed not to consent use of his/her anonymized data for the registry, the data provided by that registry will be unrepresentative and can lead to incorrect conclusions for public health actions, says Paolo Casali.”
The proposed EU General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients, according to a position paper just published by the European Society for Medical Oncology, or ESMO. The regulation will set the rules for how personal data will be handled in the European Union, including for healthcare and research use. The European Commission published its position on the proposed regulation in March.
The European trade association representing cancer doctors and researchers is concerned that the European Parliament has proposed wording that stipulates “explicit and specific patient consent” could have the unintended consequence that researchers would have to approach patients every single time research is planned in order to consult their data or use tissue samples stored for research purposes.
“We understand the need for the EU to address data privacy concerns in many sectors, with the surge of risks brought about by the use of digital information, but its effect on public health research may have been unintentionally overlooked,” says Paolo Casali, chair of the ESMO Public Policy Committee Chair and author of the position paper on the risks of the proposed regulation.
Access to a wide pool of patient data is crucial for advancing cancer research, which could be severely hampered if researchers must get patient consent every time they need to use the data. Population-based cancer registries, for example, that store information to monitor disease trends, are intrinsically incompatible with any requirement of individual consent.
“If a patient is allowed not to consent use of his/her anonymized data for the registry, the data provided by that registry will be unrepresentative and can lead to incorrect conclusions for public health actions,” says Casali.
ESMO says the wording as it stands could stop many public health research efforts. As an alternative ESMO proposes that the text of the EU General Data Protection Regulation include a one-time consent for research, ensuring patients are aware of what they are consenting to—with the appropriate safeguards in place, and that they can withdraw their consent at any time.
“Our proposal achieves the correct balance between the right to privacy and the right to health,” says ESMO President Rolf Stahel. It lets patients choose whether to donate their data and tissue for public health research, most of which is directed at finding cures.
The Clinical Trials Regulation, adopted by the European Union in 2014, includes the withdrawable one-time consent concept, says ESMO. It allows the use of data already stored beyond the end and the specific scope of a trial, with the typical strict safeguards.
“We are calling upon the European Union to assure that all forms of public health research will survive and be able to function within the safeguards that are in place, without adding the nearly impossible administrative burden of re-consenting each patient, every time, for every single project, which could irreversibly slow down the accelerated pace that cancer research has gained over the past decades”, says Casali.
July 27, 2014
http://www.burrillreport.com/article-proposed_eu_data_protection_rules_could_impede_cancer_research.html
