Features | Partner Sites | Information | LinkXpress
Sign In
GLOBETECH PUBLISHING LLC
GLOBETECH PUBLISHING LLC
GLOBETECH MEDIA

EU Data Protection Regulation May Put European Cancer Research at Risk

By BiotechDaily International staff writers
Posted on 05 Aug 2014
A European oncologic society’s members are worried that a proposed European Union (EU) data protection regulation could make cancer research unfeasible and add a substantial burden to both physicians and cancer patients.

The European Society of Medical Oncology (ESMO; Lugano, Switzerland) has expressed concern that the proposed EU General Data Protection Regulation, published in the August 2014 issue of the journal Annals of Oncology, could make cancer research impossible. The planned wording of the regulation stipulates “explicit and specific patient consent,” meaning that researchers would have to approach patients every time research is arranged to refer to 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 ESMO president Rolf A. Stahel. ESMO proposes that the text of the EU General Data Protection Regulation includes a “one-time consent” for research, ensuring patients are aware of what they are consenting to—with the suitable 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, which has the ultimate goal of finding cures.”

“As a cancer patient, I 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,” noted Hans Keulen, a Dutch rare cancer patient from the Chordoma Foundation (Durham, NC, USA).

Dr. Paolo G. Casali, ESMO Public Policy committee chair, author of the official ESMO position paper on the risks of the new EU Data Protection Regulation, said, “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.”

Population-based cancer registries, for example, storing information to track disease trends, are inherently 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,” noted Dr. Casali.

ESMO is in favor of inclusion in the EU General Data Protection Regulation of the withdrawable “one-time consent” strategy—already forecast in the Clinical Trials Regulation adopted by the European Union in 2014, which allows to use data already stored beyond the end and the specific scope of a trial, with the usual strict safeguards. ESMO spokespersons stated, “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.”

Related Links:

European Society of Medical Oncology



Channels

Drug Discovery

view channel
Image: Star-like glial cells in red surround alpha-beta plaques in the cortex of a mouse with a model of Alzheimer\'s disease (Photo courtesy of Strittmatter laboratory/Yale University).

Experimental Cancer Drug Reverses Symptoms in Mouse Model of Alzheimer's Disease

An experimental, but clinically disappointing drug for treatment of cancer has been found to be extremely effective in reversing the symptoms of Alzheimer's disease (AD) in a mouse model.... Read more

Biochemistry

view channel
Image:  Model depiction of a novel cellular mechanism by which regulation of cryptochromes Cry1 and Cry2 enables coordination of a protective transcriptional response to DNA damage caused by genotoxic stress (Photo courtesy of the journal eLife, March 2015, Papp SJ, Huber AL, et al.).

Two Proteins Critical for Circadian Cycles Protect Cells from Mutations

Scientists have discovered that two proteins critical for maintaining healthy day-night cycles also have an unexpected role in DNA repair and protecting cells against genetic mutations that could lead... Read more

Business

view channel

NanoString and MD Anderson Collaborate on Development of Novel Multi-Omic Expression Profiling Assays for Cancer

The University of Texas MD Anderson Cancer Center (Houston, TX, USA) and NanoString Technologies, Inc. (Seattle, WA, USA) will partner on development of a revolutionary new type of assay—simultaneously profiling gene and protein expression, initially aiming to discover and validate biomarker signatures for immuno-oncology... Read more
 
Copyright © 2000-2015 Globetech Media. All rights reserved.