GDPR's Consent Rules Spark Debate in Medical Research
The General Data Protection Regulation (GDPR), set to come into effect in 2016, has sparked debate in the medical research community. Under this new EU law, data from deceased patients becomes inaccessible for research purposes, and obtaining consent for each new use of personal data can impose significant time and monetary costs on time-sensitive studies.
Research groups such as Science Europe, the League of European Research Universities, and the European Society for Medical Oncology have voiced their opposition to these burdensome regulations. They argue that the GDPR's strict consent requirements hinder medical research, which relies on the analysis of large datasets to make breakthroughs.
An ongoing EU-funded genetic study of colorectal cancer, involving 7,000 patients, would require reconsenting all participants for follow-up studies. This process is not only time-consuming but also raises ethical concerns, as some patients may no longer be able to provide consent due to their health status.
Patrick Breyer, a former Member of the European Parliament from the Pirate Party, proposed a solution. He suggested introducing a possibility for researchers to obtain a one-time consent to use patient data for multiple related purposes. This amendment would streamline the process and reduce the administrative burden on researchers.
The GDPR's impact on medical research is significant, with potential implications for future breakthroughs. As the EU spent €6.1 billion ($7.8 billion) on medical research from 2007-2013, it is crucial to strike a balance between data protection and research progress. The debate surrounding the GDPR's consent requirements continues as the final language is expected to be adopted in late 2014.
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