Up to 2014, within the scope of the European project "Electronic Health Records for Clinical Research" (EHR4CR), partners from academic research and industry will be jointly establishing a Europe-wide technology platform that aims to allow secondary use of data from electronic health records for the purpose of clinical research.
Today, lawyers, ethics specialists, and data protection experts from various EU member states are discussing in Berlin what legal and ethical issues will have to be addressed. The workshop is being organized by TMF, which – due to its extensive preliminary work on data protection and ethical issues of networked medical research – in this project is leading a work package dealing with the topic of data protection and data security.
Secondary use of data from electronic health records for the purpose of medical research could cut costs, speed up clinical research projects and make them more efficient. In particular, researchers could better identify suitable study patients – hitherto one of the major difficulties in planning and conducting clinical studies. Now a technological platform is to be created which will seamlessly integrate electronic health records into existing research platforms and networks in the health sector.
Legal Regulations in the EU Countries Vary Considerably
However, many legal and ethical issues still have to be clarified on the way. In particular, one of the reasons why the legal framework to which physicians, researchers and patients are exposed in the cross-border use of patient data for clinical research is uncertain is that the legal regulations and implemented legal practice concerning data protection and protection of the private domain vary substantially throughout the individual EU member states. For this reason, one work package in the EHR4CR project has the task of analyzing the current legal situations in the various member states of the EU and comparing them with one another. The aim is to provide recommendations as to how legal certainty can be created for clinical research when using the EU-wide technology platform.
At the workshop in Berlin on January 12 and 13, 2012, the legal situation in selected pilot countries is being presented: France, Great Britain, Scotland, and Germany. European researchers, lawyers and data protectionists will be jointly examining what points on the pathway of data from clinics to research are critical in legal terms.
One of the Largest Public-Private Partnership Projects in Europe
The EHR4CR project is being funded with a total of 17 million euros within the scope of the Innovative Medicines Initiative (IMI) over the period from 2011 to 2014. IMI is one of the largest public-private partnership projects in Europe with the aim of speeding up the development of better and safer medicinal drugs. The initiative is being jointly funded by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
10. Workshop Magnetlagertechnik Zittau-Chemnitz
31.08.2015 | Hochschule Zittau/Görlitz
Bio-based films suitable for industrial use
08.06.2015 | Fraunhofer-Institut für Angewandte Polymerforschung IAP
Longer, more severe, and hotter droughts and a myriad of other threats, including diseases and more extensive and severe wildfires, are threatening to transform some of the world's temperate forests, a new study published in Science has found. Without informed management, some forests could convert to shrublands or grasslands within the coming decades.
"While we have been trying to manage for resilience of 20th century conditions, we realize now that we must prepare for transformations and attempt to ease...
A University of Oklahoma astrophysicist and his Chinese collaborator have found two supermassive black holes in Markarian 231, the nearest quasar to Earth, using observations from NASA's Hubble Space Telescope.
The discovery of two supermassive black holes--one larger one and a second, smaller one--are evidence of a binary black hole and suggests that supermassive...
A team of European researchers have developed a model to simulate the impact of tsunamis generated by earthquakes and applied it to the Eastern Mediterranean. The results show how tsunami waves could hit and inundate coastal areas in southern Italy and Greece. The study is published today (27 August) in Ocean Science, an open access journal of the European Geosciences Union (EGU).
Though not as frequent as in the Pacific and Indian oceans, tsunamis also occur in the Mediterranean, mainly due to earthquakes generated when the African...
In mountainous regions earthquakes often cause strong landslides, which can be exacerbated by heavy rain. However, after an initial increase, the frequency of these mass wasting events, often enormous and dangerous, declines, in fact independently of meteorological events and aftershocks.
These new findings are presented by a German-Franco-Japanese team of geoscientists in the current issue of the journal Geology, under the lead of the GFZ...
Bacteria do not cease to amaze us with their survival strategies. A research team from the University of Basel's Biozentrum has now discovered how bacteria enter a sleep mode using a so-called FIC toxin. In the current issue of “Cell Reports”, the scientists describe the mechanism of action and also explain why their discovery provides new insights into the evolution of pathogens.
For many poisons there are antidotes which neutralize their toxic effect. Toxin-antitoxin systems in bacteria work in a similar manner: As long as a cell...
20.08.2015 | Event News
20.08.2015 | Event News
19.08.2015 | Event News
31.08.2015 | Awards Funding
31.08.2015 | Materials Sciences
31.08.2015 | Materials Sciences