Leading US medical researchers have warned that a new European Union law on data protection is posing major hurdles to work that involves international collaborations.

The EU General Data Protection Regulation, which was implemented in May, is causing ¡°significant difficulties¡± at US and European labs, said Francis Collins, director of the US National Institutes of Health, the nation¡¯s leading funder of basic medical research.

Although the GDPR might not overtly forbid existing arrangements for sharing data about participants in medical trials, Dr Collins said, its language was ¡°sufficiently vague¡± that lawyers often cannot find a clear consensus. And with the GDPR carrying heavy penalties for violations, medical science was being slowed as a result, Dr Collins claimed.

Furthermore, the regulation requires agencies such as the NIH to be indemnified against legal risks and also ¡°to?tolerate audits of our internal workings ¨C which happen to be things we cannot do for a foreign country¡±, Dr Collins said.

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The GDPR established a tight framework for handling personal data, including the transfer of such information to countries outside the EU. It requires researchers to obtain explicit consent from individuals before sharing their personal data. It also adds various new limits on data transfers, including requirements that a transfer is ¡°not repetitive¡± and ¡°concerns only a limited number of data subjects¡±.

Dr Collins described the problems with GDPR implementation during a semi-annual meeting of his chief advisory board. One member of the board, Jose Florez, professor of medicine at Harvard University, said that he was seeing the same thing.

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Dr Florez, head of the Diabetes Unit and the Center for Genomic Medicine at Massachusetts General Hospital, said that research was also being hindered by the inability of lawyers at different US institutions collaborating on an international project to agree on what the GDPR requires.

¡°It is not only disagreement with the European attorneys, but even internally there¡¯s disagreement,¡± Dr Florez said. ¡°It¡¯s a quagmire.¡±

That same confusion exists abroad, said Dr Collins, who has his own lab at the NIH studying genetics-related diseases. ¡°We have collaborations in Helsinki where nothing has happened ¨C everybody¡¯s in a total snarl,¡± he said. ¡°We have other collaborations in Kuopio [also in Finland] where the lawyers think that we can work this out, and we have pretty much been able to go forward.¡±

¡°Same country, same regulations ¨C totally different interpretation by the legal experts,¡± Dr Collins said.

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paul.basken@timeshighereducation.com