The proposed European Union General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patient, leading oncologists have warned.
The planned wording of the Regulation stipulates “explicit and specific patient consent,” meaning 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, says the European Society for Medical Oncology (ESMO).
This could put a halt to many research efforts, says ESMO, which is calling instead for the Regulation to 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. It actually ‘empowers’ patients, allowing them to choose whether to donate their data and tissue for public health research, whose ultimate goal is to find cures,” said ESMO president Rolf Stahl.
“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,” adds Paolo Casali, chair of ESMO’s public policy committee.
Population-based cancer registries, for example, are intrinsically incompatible with any requirement of individual consent. “If a patient is allowed not to consent use of his/her anonymised data for the registry, the data provided by that will be unrepresentative and can lead to incorrect conclusions for public health actions,” he says.
Many other groups have expressed concern at the EU proposal, including Cancer Research UK (CRUK), which is calling for the EU to revert back to the principle of the original European Commission proposal – to make research exempt from the Regulation. Exempting researchers from the need to seek consent for personal data use would a logical step, as it reaffirms the rules that have governed research for decades, says the charity.
Commenting on ESMO’s proposal for the Regulation’s text to include a “one-time consent” for research, CRUK’s EU public affairs manager, Catherine Castledine, agrees that “consent is a crucial principle that should always be stuck to where possible.”
“However, in some cases asking study participants for consent – even just once – can cause problems. It may make a study involving lots of patients unworkable, or could even skew the results,” she says.