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DO-IT project under the aegis of the IMI: TMF brings together data protection experts, researchers and the pharmaceuticals industry

European consent form template for medical studies

29 October 2018. The big Data for better Outcomes, policy Innovation and healthcare system Transformation (DO-IT) project is part of the European Union and EFPIA’s Innovative Medicines Initiative (IMI). Within the scope of DO-IT, representatives of national data protection agencies and ethics commissions within Europe met with pharmaceuticals industry professionals and scientific community delegates at TMF in Berlin on 11 and 12 October to exchange opinions and insights.

As part of the project, a working group coordinated by TMF that comprises members of the European university research community and the European Federation of Pharmaceutical Industries and Associations (EFPIA) has proposed modified wording for a European consent form template for medical studies in line with the recently introduced EU Data Protection Regulation. The template wording was presented to government agency representatives from Germany, France, the UK and Spain.

The goal is to strengthen legal certainty for research activities within Europe, and to reduce the effort and expense associated with medical studies. A further aim is to guarantee a level playing field for research activities in all countries by standardising data protection mechanisms. The template was discussed in detail during the two-day meeting of government agencies, ethics commissions, researchers and industry. It became clear that there are still considerable differences between the various EU member states when it comes to interpreting European data protection law. Against this background, the attendees felt the workshop generated positive and highly practical insights that will be incorporated into the next version of the template.

The DO-IT project is coordinated by the London School of Economics (LSE), and is co-funded the European Union’s Innovative Medicines Initiative 2 and the EFPIA. Development of the consent form template is the remit of work package 4, which is jointly overseen by TMF and Bayer AG.


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