Data protection and epidemiological research: a new EU regulation is in the pipeline

International Journal of Epidemiology
Volume 43 Issue 5 October 2014

Data protection and epidemiological research: a new EU regulation is in the pipeline
Jørn Olsen
Author Affiliations
Department of Public Health-Epidemiology, University of Aarhus, Bartholins Alle 2 – Building 1260, DK-8000 Aarhus C, Denmark.
Since the days of the Helsinki Declaration (, informed consent has been a cornerstone in all medical research. That is probably how it should be if you do experimental research on humans that carries a risk for the participants or collect new data, but in non-experimental research based on existing data it is not so clear cut. The Helsinki Declaration states that ‘the health of my patient will be my first consideration’ and ‘while the goal of the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects’. Most will agree on these general principles. However, if the principle of informed consent is required when using existing data, where the only risk is related to unwanted disclosure of personal data, they go too far and the term ‘research subject’ is misleading. If we are using data that already exist and the research can be done with no risk for the people under study, there may well more ethical problems in not doing the research than in doing it. We lack an ethics committee for important missed research opportunities!
Using the Helsinki Declaration uncritically to fit all types of research has not been without problems, including ethical problems. Important data collections have been destroyed because no informed consent had been given at the time of data collection. Useful information has not been used to benefit the public, sometimes because the data could have revealed unpleasant facts for those in charge of health service and medical treatment…