The European scientific community is sounding the alarm about possible changes in the forthcoming European data-protection regulation, which originally included exceptions to allow academics to continue to work with personal information for research purposes.
But the European Parliament's lead rapporteur on the measure, Jan Philipp Albrecht of the German Green Party, has proposed changing these exceptions or removing them altogether, arguing that they water down the regulation and leave the public exposed.
As the Parliament's committee on civil liberties, justice and home affairs contemplates a slew of amendments to the proposed regulation, the scientific community has come forward with examples of work that it believes could be put at risk. In addition to medical research, flagged up as a problem early in the process, the academics highlight areas of social, economic and humanities research, many of which feed into European policy-making.
“As it is drafted now, there is not enough clarity in the regulation to allow researchers to plan for the future,” says Stephan Kuster, head of policy affairs at Science Europe, which represents 51 national research councils in 26 countries. “There is a chance that these kinds of studies will be severely hampered in the
Researchers are particularly concerned that the draft regulation does not recognise the protection given to personal information in scientific studies. These are usually overseen by ethics committees, which may insist that personal data be provided on a basis of anonymity, or with identities hidden behind pseudonyms. Similarly, the suggestion that specific and explicit informed consent would be needed for any use of personal data presents a problem for academics revisiting existing collections of data with new research questions.
For the medical community, re-analysing patient data plays an important part in revealing disease mechanisms and then developing targeted treatments. Seeking consent from each patient for each new study would either be impossible or represent a significant administrative burden.
Similar concerns appear in the social sciences, where different kinds of personal data are analysed. For example, researchers in the UK were able to assess the impact of minimum alcohol-pricing by combining data from two broad surveys, one with information about purchasing decisions, the other exploring consumption across different population sub-groups.
In addition to the broad problem of consent, one of the surveys included data about under-age drinkers, and the regulation is particularly strict about information about children. Yet it was the study's conclusions on under-age drinking that made it particularly useful to policy-makers. “That's a very clear example of research that uses personal data with potentially high impact and societal benefits,” says Kuster.
Analysing personal data of this kind has also produced insights into socio-economic variations in access to higher education, and the effect of parental separation on children's educational attainment. Meanwhile, economics researchers have used personal data to analyse the behaviour of stockmarket investors and the impact of proposed banking reforms on small and medium-sized companies.
Personal information also feeds humanities research, such as the study of language diversity based on speech recordings and work on cultural innovation that studies individuals and groups. In one unusual example collected by Science Europe, academics practising interactive design in collaboration with people on-line may have problems getting explicit informed consent because it is hard to identify their interlocutors with sufficient precision.
The confounding effect of the regulation may even extend to researchers working with archives of old letters, diaries and photographs. “Common sense would say that, for those cases, it does not apply,” says Kuster.
“They have been donated to an archive, therefore they are public and no longer personal data. But as long as that is not clarified in the regulation, there is a risk that you end up with a huge administrative burden just to be on the safe side.”
Removing the scientific exception from a list of others in the draft regulation, Albrecht wrote that the "processing of sensitive data for historical, statistical and scientific research purposes is not as urgent or compelling as public health or social protection. Consequently, there is no need to introduce an exception which would put them on the same level as the other listed justifications."
He also argued that the research exception weakened protection in cases where consent to use data had not been given, or for sensitive data and data about children. “Otherwise, any ‘research', no matter if academic or corporate and including, for example, market research, could be used as an excuse to override all protections provided for in the other parts of this regulation.” Such an exception should be allowed only for research “serving exceptionally high public interest” and with legal backing, he added.
Ian Mundell is a freelance journalist based in Brussels.