The European General Data Protection Regulation: ESMO reinforces harmonious uptake of health research provisions
ESMO welcomes the coming into effect of the EU General Data Protection Regulation in its final form which protects the privacy of patients without jeopardising clinical, translational and epidemiological research. However, for scientific research, including oncology research, to benefit from the Regulation, it needs to be interpreted and applied appropriately and in a harmonised manner across the EU.
ESMO's objective has been to achieve a balance between citizen data security and protecting the much-needed work of researchers by ensuring access to data, acknowledging the strict safeguards protecting medical data that are already in place.
Read the ESMO position paper:
See the ESMO GDPR position paper endorsements
ESMO’s key messages
- Public health research heavily relies on medical research (clinical trials), biomedical research (biobanks and tissue banks), and epidemiological research (patient registries).
- Without access to this data, health research would be seriously affected, if not impeded.
- Broad consent gives patients the right to ‘donate’ their data for public health research purposes. Subject to the usual strict safeguards, the patient would give a ‘one-time’ consent to have their data processed within the framework of health.
- The patient should have the right to withdraw this consent at any time.
- An exemption of population-based disease registries from consent permits the collection of the complete, accurate and high-quality data needed for effective evidence-based policy decisions.
In particular, ESMO has relentlessly supported and advocated for:
- The inclusion of a withdrawable ‘one-time consent’ from patients allowing their data and tissues to be used, subject to strict ethical standards, for future retrospective clinical research, which will also ensure the viability of biobanking (recital 33)
- The inclusion of a ‘no-consent’ principle to allow research based on data from population-based disease registries in line with strict ethical standards (recital 157)
ESMO continues to stress the need for a harmonised implementation of the EU Data Protection Regulation and is committed to helping EU institutions and individual Member States protect the future of health research by understanding the importance of these two crucial provisions and ensuring their uptake in practice.
The ‘one-time consent’ is equally recognized by the EU Clinical Trials Regulation for the use of patient data and biological samples for future research.