ESMO (the European Society of Medical Oncology) has expressed concern the proposed E.U. General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients.
The proposed wording of the regulation stipulates “explicit and specific patient consent,” meaning researchers would have to approach patients each time research is planned in order to consult their data or use tissue samples stored for research purposes.
“Hope for patients facing a life-threatening disease like cancer is based on advances in research,” said Kathy Oliver, chair of the International Brain Tumor Alliance. “And research progress requires access to a wide pool of patient data, even from patients who have since passed away and can no longer provide consent to allow for research that could save lives in the future.”
“This could put a halt to many public health research efforts,” said Rolf A. Stahel, ESMO president. ESMO proposes the text of the regulation include a “one-time consent” for research, ensuring patients know to what they are consenting, 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,” said Stahel. “It actually ‘empowers’ patients, allowing them to choose whether to donate their data and tissue for public health research, which has the ultimate goal of finding cures.”
Paolo G. Casali, ESMO public policy committee chair, said, “We understand the need for the E.U. 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.”
Population-based cancer registries, for example, storing 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,” said Casali.
ESMO is in favor of inclusion in the E.U. General Data Protection Regulation of the withdrawable “one-time consent” concept—already foreseen in the Clinical Trials Regulation adopted by the E.U. in 2014, which allows use of data already stored beyond the end and the specific scope of a trial, with the usual strict safeguards.
Casali said, “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.”