Unrest is stirring in Europe over a proposed amendment to the EU's draft General Data Protection Regulation that would prohibit researchers from using individual medical records for research unless explicit consent for that purpose has been given by patients. The policy, if implemented, would dramatically reduce the ability to conduct investigations involving data from disease registries and stymie cohort studies, which obtained more general consent from their participants years ago.

Given these concerns, a coalition of more than 40 medical organizations, led by the London-based Wellcome Trust, launched a campaign on 29 January to petition politicians to undo the proposed change when the draft regulation comes before the European Parliament in the coming months. As written, the amended regulation “narrows the scope of what a consent can be,” says Alison Hall, program leader for legal and ethical issues at the PHG Foundation, a UK-based genetics and health policy think tank that is part of the coalition. “It says it has to be specific, informed and explicit, whereas before a broad consent would have sufficed.”

Europe's legislative framework to unify data protection rules across the continent has been in the works for more than two years. It requires all individuals to opt in to have their personally identifiable information obtained and used by others. But the original draft regulation, published in January 2012, also included a provision that exempted scientific research studies from this mandate, the logic being that ethics committees already provide sufficient safeguards for research participants. This exemption is now under threat after a European Parliament committee introduced a proposal last October to dramatically limit the research exclusion for many types of medical data.

With that amended exemption headed for a vote, “we are all very, very concerned,” says Elio Riboli, director of the School of Public Health at Imperial College London, who describes the regulation's potential impact on medical research as a “disaster.” Riboli coordinates the European Prospective Investigation into Cancer and Nutrition (EPIC), a massive longitudinal study involving more than 500,000 participants across ten European countries that uses broad consent to allow researchers access to relevant data. He says it would be “nonsensical” if EPIC investigators had to send consent letters to each of the study's half-million-plus participants each time they wanted to study the data for a new research question. “Sixty-five million euros [$89 million] of investment to establish this project would be basically destroyed,” he says.

Even if the restriction on medical research studies gets through the European Parliament, Magnus Stenbeck, an epidemiologist and expert in database infrastructure at the Karolinska Institute in Stockholm, expects the proposed regulation to face challenges in the more research-minded Council of Ministers, the other main branch of the bicameral European legislature. “I'm really quite optimistic that we will get reasonable legislation that will take away most of the obstacles that we felt was a danger,” he says.