Enabling data sharing: two publications highlight ethical and legal questions to be addressed

18 June 2013


The rare disease community is currently debating the ongoing reform of the EU Data Protection Regulation and other topical questions relating to consent and privacy safeguards in medical research. In light of this, two short articles by RD-Connect partners have been published. These discuss the importance of maintaining the exception for research data in the data protection regulation, and propose a simplified, risk-based ethical review procedure. These recommendations would enable the continuation of data sharing and make the ethical process for information-based research more straightforward.

EU  Data Protection Regulation: maintaining the exception for research data

Recent discussions at the European parliament about the use of genetic data have sparked concern amongst the rare disease community. The declared focus of the reform of the Data Protection Regulation is to strengthen privacy protection and personal control over data in general, but according to researchers, using the same rules for health research could have serious consequences for rare diseases.

Current EU privacy rules for the use of genetic data give individuals the right to manage their own personal information and consent to each specific use. But the requirements are flexible when data is used for health research, and in cases where there are safety measures to ensure confidentiality, researchers can share “codified” data. The new draft of the Data Protection Regulation foresees measures to ensure confidentiality but grants an exception to the explicit consent rule when data is used for research purposes. An amendment currently under consideration proposes to cancel this exception, which would seriously hinder effective data sharing. Research based on biobanks and registries is effective only if access to sufficient data is granted and if the use of data is maximized through data sharing. This is particularly important for rare disease research, which requires participation across national borders to gain sufficient statistical significance and cannot cope with the loss of collected data. Rare disease researchers (and the patient community led by EURORDIS – see this news item) therefore strongly believe that the exception for scientific research should be maintained in the upcoming legislation.

Simplified and risk-based ethical review

Ethics committee reviews of research protocols are a cornerstone of the safeguards in place to ensure the protection of research participants. However, ethics researchers have suggested that in some cases, patients suffer when research is hindered by an extended ethical review and overly strict procedures for informed consent. In the belief that survey and interview-based studies that carry minimal risks to participants might not need the same degree of oversight as interventional research, Hansson et al. propose the adoption of a risk-based model that simplifies the ethical review process for information-based research. The risks associated with research that uses genetic information, stored biospecimens or information from databases, medical registries, patient records and questionnaires  are not physical, but informational, e.g. related to unauthorised release of information about the participants. The proposal from the US Department of Health and Human Services for a change towards a risk-based review system for the protection of research participants is of great interest, and may pave the way to a simplified procedure for “data sharing” research.


Read more: 

Mascalzoni D, Knoppers BM, Aymé S, Macilotti M, Dawkins H, Woods S, Hansson MG, Rare Diseases and Now Rare Data?, Nature Reviews Genetics 14, June 2013

Hansson MG, van Ommen GJ, Chadwick R, Dillner J, Patients would benefit from simplified ethical review and consent procedure, Lancet Oncology 14, May 2013