EUCANCan’s consortium is passionate about disseminating its knowledge about opportunities and challenges with sharing health data across countries and research institutions.
Prof Bartha M. Knoppers from the McGill University in Montreal, Canada, has been very active in recent months and co-authored two publications. One article, titled Ethical challenges of precision cancer medicine has been published in Elsevier’s journal Seminars in Cancer Biology. The other, How to fix the GDPR’s frustration of global biomedical research was published in the magazine Science.
Together with her McGill University colleague Alexander Bernier, Prof Knoppers is responsible for analyzing ethico-legal data sharing and protection issues related to Canada’s participation in EUCANCan as well as developing overarching guidance aimed at project members.
We have included Prof Knoppers’s recent article’s abstracts and information on where you can find the full-text versions below.
1. Bovenberg J, Peloquin D, Bierer B, Barnes M, Knoppers BM, How to fix the GDPR’s frustration of global biomedical research, (2020), Science Vol. 370, Issue 6512, pp. 40-42, DOI: 10.1126/science.abd2499
Summary: How to fix the GDPR’s frustration of global biomedical research
Since the advent of the European Union (EU) General Data Protection Regulation (GDPR) in 2018, the biomedical research community has struggled to share data with colleagues and consortia outside the EU, as the GDPR limits international transfers of personal data. A July 2020 ruling of the Court of Justice of the European Union (CJEU) reinforced obstacles to sharing, and even data transfer to enable essential research into coronavirus disease 2019 (COVID-19) has been restricted in a recent Guidance of the European Data Protection Board (EDPB). We acknowledge the valid concerns that gave rise to the GDPR, but we are concerned that the GDPR’s limitations on data transfers will hamper science globally in general and biomedical science in particular (see the text box) (1)—even though one stated objective of the GDPR is that processing of personal data should serve humankind, and even though the GDPR explicitly acknowledges that the right to the protection of personal data is not absolute and must be considered in relation to its function in society and be balanced against other fundamental rights. We examine whether there is room under the GDPR for EU biomedical researchers to share data from the EU with the rest of the world to facilitate biomedical research. We then propose solutions for consideration by either the EU legislature, the EU Commission, or the EDPB in its planned Guidance on the processing of health data for scientific research. Finally, we urge the EDPB to revisit its recent Guidance on COVID-19 research.
The article, which was published in the magazine Science Vol 370 on October 2, 2020, is written by Jasper Bovenberg, David Peloquin, Barbara Bierer, Mark Barnes, and Bartha Maria Knoppers.
The article can be found here: https://science.sciencemag.org/content/370/6512/40
2. Winkler EC, Knoppers BM, Ethical challenges of precision cancer medicine, Seminars in Cancer Biology (2020), doi: https://doi.org/10.1016/j.semcancer.2020.09.009
Abstract: Ethical challenges of precision cancer medicine
Amongst common diseases, cancer is often both a leader in self-regulatory policy, or the field for contentious ethical issues such as the patenting of the BRCA1/2 genes. With the advent of genomic sequencing technologies, achieving precision cancer medicine requires prospective norms due to the large and varied sources of data involved. Here, we discuss the ethical and legal aspects of the policy debate around the relevant topics in precision cancer medicine: the return of incidental findings and sequencing raw data to patients, the communication of genetic results to patients’ relatives, privacy and communication risks with concomitant oversight strategies, patient participation and consent models. We present the arguments and empirical data supporting specific policy solutions delineating still contested areas. What type of consent and oversight are required to acquire genomic data or to access it where desired, either by the participant/patient or third-party researchers? Most of the raw sequencing data is still uninterpretable and the variants revealed subject to reinterpretation over time. No doubt the ethical challenges of precision cancer medicine are a prototype of what’s to come for other diseases. They are also paradigmatic for regulatory and ethical questions of the translational endeavors since the two worlds – basic science and patient care – are governed by different ethical and legal principles that need to be reconciled in precision cancer medicine.
This article was co-written by Eva Caroline Winkler and Bartha Maria Knoppers. It was published in Seminars in Cancer Biology and made available online on October 9, 2020.
The article can be found here: DOI: https://doi.org/10.1016/j.semcancer.2020.09.009