Significant European investments in genetics, biobanks and disease registries - and the promise they hold of progress in medical research and innovation – are under threat as a result of proposed amendments to the EU data protection regulation that is currently winding its way through the legislative mill, according to leading medical and scientific research funding bodies across the continent.
The original draft of the regulation set out a mechanism for protecting privacy without constricting research, by including a requirement that specific and explicit consent must be given for the use and storage of personal data, but providing an exemption for research.
This exemption was based on the understanding that an individual’s interests would be protected through ethical and governance safeguards applying to research projects, such as approval by a research ethics committee.
However, in October the Civil Liberties, Justice and Home Affairs (LIBE) Committee of the European Parliament proposed amendments to significantly reduce the scope of this research exemption. Responding to the revelations by the whistleblower Edward Snowden of mass surveillance, MEPs on the LIBE Committee inserted stronger safeguards for data transfers to non-EU countries. They also added an explicit consent requirement, a right to erasure, and bigger fines for organisations that break the rules.
If voted through, the use of personal data in research without specific consent would be prohibited, or become impossible in practice. This would be despite the fact that research requires ethical approval, confidentiality is safeguarded, and the identity of individuals is often masked.
Leading the charge against the amendments is the UK’s Wellcome Trust, the largest charitable funder of research in Europe. “The proposed amendments are disproportionate and put at risk future medical research and improvements in health,” claims Jeremy Farrar, Director of the Wellcome Trust.
Concerns about patient confidentiality are legitimate and it is essential that people’s privacy is protected. “But when the safeguards become disproportionate, they benefit no one. The original regulation was measured and sensible, and struck the right balance between protecting the individual and making possible huge benefits for all of our health,” Farrar said.
Research at risk
According to R&D funding bodies, the amendments will put at risk significant European investments in genetics, cohort studies and the use of routinely collected data, such as:
- The European Prospective Investigation into Cancer and Nutrition (EPIC), the largest study of diet and health ever undertaken, involving over half a million European citizens, which uses broad consent from participants to allow researchers to access relevant data;
- The European Medical Information Framework, a €56 million project to link together existing health data from sources across Europe and make it available to researchers for studies in obesity and Alzheimer’s disease;
- The Human Brain Project, - a flagship EU research programme that requires medical data to build a computer model of the brain, and so catalyse a global collaborative effort to understand the human brain and its diseases.
Undermining social science
The amendments would not only affect medical research projects that relies on patient data, they would also undermine social sciences and economic research, which in many cases relies on data from a range of sources collected over a number of years. On example is the European Social Survey, which measures opinions and behaviours across more than thirty European countries, to inform policy in areas such as health inequalities and economic development.
In many of the projects that will be hampered by the amendments, individuals have voluntarily given broad consent for their data to be used in research. These valuable contributions could be wasted if the amendments become law..
Led by the Wellcome Trust, a coalition of research organisations, is now busy lobbying MEPs and the Council of Ministers, urging them to reject the proposed amendments. The European Parliament is due to vote on the amendments in the Spring, while discussions are in train in the Council. It is intended that the legislation is in place before the European elections in May.
Personal data, including individual patient records, provide a vital resource for research. For example, personal data allow researchers to compare different factors, such as lifestyle, and the incidence of disease at an individual level. These observational studies have led to breakthroughs such as identifying the association between smoking and lung cancer, preventing defects such as spina bifida in newborns, and informing treatment of infection in unborn babies.
Research using personal data follows a robust ethical and governance framework to ensure that an individual’s personal data are only used in research when this is proportionate to the potential benefits for society as a whole. Researchers are given access to personal data only under strict confidentiality controls, which have been effective at preventing misuse and harm to data subjects.
The LIBE Committee amendments would make it very difficult, if not impossible in practice, to use pseudonymised data concerning health – where an individual’s identity is masked to protect privacy – without specific consent.
The amendments would also prohibit the use of identifiable personal data in scientific research without specific consent. Sometimes researchers need details such as age, postcode and information on a health condition that together could disclose the identity of an individual, but the study would not be possible without it, say the research bodies.