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Observational research and informed consent


Lessons learned from the legal protection of data In Europe

In June 2013 the European parliament will start the postponed voting on the New Regulation on Data Protection. More than 4000 amendments have been proposed and the Regulation is one of the most lobbied texts in the EU history. Not because of the problems it […]

New Developments: Data Protection in the EU


The new developments in the saga on data protection in the EU have rightly generated lots of concern. Many years of investments in infrastructure to help improving our knowledge on how to improve treatment and prevention for diseases and ill health may all be wasted. Here is the latest report on the topic from […]

New legislation on data protection in the EU / a follow up


Evert Ben van Veen has written a summary of the LIBE views and makes comparisons to the proposed data protection regulation. The LIBE proposal will set back epidemiologic research in many European countries if used in the new law. It will threaten free and critical research and the principles of democracy and open societies. […]

EpiBlog: EU and Data Protection


The rapid response committee has kept IEA members up to date on important legal issues related to use of data in epidemiologic research, especially data collected for monitoring or administrative use. The proposed Regulation provided a legal framework that would not add new restrictions to our use of health data in research. That may unfortunately have changed. Albrecht’s revisions to the proposed text will have serious consequences for epidemiology if they are all accepted. Please note Welcome Trust’s concern below and have a look at the changes yourself – pay special attention to amendments 15,17,19,22 and 31. […]

Data protection in the EU, an update


The text on data protection for the EU is being debated and it is clear that several changes will be made. It is currently unclear whether we end up with a directive or a regulation. A directive will provide more flexibility for individual countries in how they practice the law. A regulation imposes a common law for all member states. By November 2012 6 countries support a ‘directive mode’. Not quite enough to avoid that a regulation will be implemented by parliament but many countries have not yet made their position clear. There are other part of the text being debated so the battle is far from over and we still run a risk of having less options for doing research after new legislation has been agreed upon next year. […]

Rapid Response Committee: EU Data Protection Regulation at the EURO Epi 2012, Porto, Portugal


At the IEA European Congress in Porto the new EU regulation was debated on Friday September 7th, 2012. At the session the Italian Judge Giovanni Buttarelli was present and took part in a panel debate with epidemiologists from Germany, Italy, Portugal and Denmark. He has worked as the supervisor and advisor (EDPS) for the […]

Missing data and New England Journal of Medicine (NEJM)


NEJM recently (2012; 367: 1355-1360) requested better analyses of missing data in randomized trial. This recommendation may be expanded to other study designs, especially since the problem with missing responders and missing responses is increasing. This suggestion will not only provide work for statisticians and epidemiologists in the time to come, it will also provide better justified conclusions and most importantly will open up for other types of sensitivity analyses. […]

New Regulation on Data Protection, Europe; an update


Since our last report, several groups have been active in suggesting modification of the text to facilitate epidemiologic research in Europe.

Epidemiologists have contacted members of the European Parliament from their home countries. Ministers of Research have been contacted, and newspaper articles have been published on the topic.

Not only epidemiologists have been active. Large […]

General Data Protection Regulation


Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data Comments and follow-up of “EpiBlog: Informed consent” and “EpiBlog: A New EU Directive for Data Protection in Europe”[1]

I have […]

Four deadly sins that will not go away


Understanding case-control studies as involving sampling the necessary information from an underlying, often unknown, cohort to learn about the relative increase in disease occurrence among exposed compared to not-exposed goes back to the 1980s. But comparing cases and controls in a table (often table 1) is still what we see. “You should stop this business of comparing cases and controls” was what Miettinen’s students were told more than 30 years ago. Apparently, not many listened… […]