Researchers in Europe are concerned that a regulation meant to protect cancer patients' privacy may actually inhibit future progress in cancer research. Due to its specific wording, patients' consent must be given every time a study wishes to use add their tissue samples to a database, something that scientists say would “put a halt to many public health research efforts.”
The proposed EU General Data Protection Regulation specifically states that “explicit and specific patient consent,” is needed for researchers to use their data or tissue samples. This ruling would still be apply even for “patients who have since passed and can no longer provide consent to allow for research that could save lives in the future,” explained Kathy Oliver, Chair of the International Brain Tumour Alliance, in a recent press release.
These possible restrictions of cancer information could have devastating consequences seeing that “hope for patients facing a life-threatening disease like cancer is based in research,” Oliver explained. It would make cancer research nearly impossible and put an unnecessary burden to both doctors and cancer paints. Hans Keulen, a patient suffering from a rare cancer at the Chordoma Foundation, explained they “cannot think of any reason not to allow access to my data to help other patients receive better care and contribute to advancing cancer research.”
The European Society for Medical Oncology has proposed an inclusion of a ‘one-time consent’ as a more reasonable replacement. This would allow for data already stored to be continued to be used even after the end of the trial. Patients would be fully aware of what they are consenting to and able to withdraw their consent at any time. “Our proposal achieves the correct balance between the right to privacy and the right to health," ESMO president Rolf A. Stahel said in the press release. Shahel went on to explain how the proposal would “empower patients” by “allowing them to choose whether to donate their data and tissue,” until the ultimate goal of a cure is found.
The ESMO want the EU to recognize the possible trouble that would come from the regulation’s passing. They would also like the ruling body to “assure that all forms of public health research will survive and be able to function…without adding the nearly impossible administrative burden or re-consenting each patient every time for every single project.“ Patient consent is an important aspect of clinical trials and cancer research. It is designed to protect the rights and safety of participating individuals. However it is the concern of the ESMO that the extreme measure needed to achieve the suggested level of consent may have an effect on public health that has been accidentally overlooked.