CONTRACT - Unravelling informed consent!

The CONTRACT project (CONsent in a TRial And Care EnvironmenT) is a two-year support action (2010-2012) funded under the Health theme of the EU’s Framework Programme 7.

Project background and aims

Since the introduction of the EU Clinical Trials Directive in 2001 (2001/20/EC), a significant drop in the number of new clinical trials initiated in the EU has been witnessed. The complex legal environment and related formal requirements resulting from the implementation of EU legislation in this area cause delays in setting up trials which can be seen as a major contributing factor to this negative trend.

When starting up a new trial, researchers need to consider the requirements of the Clinical Trials Directive, legislative requirements for treatment and care and, as they work with sensitive patient information, also the obligations arising from the EU Data Protection Directive (1995/46/EC). The result is extensive paperwork, a maze of bureaucratic hurdles and a pervasive sense of legal uncertainty for clinical and research staff.

The problems become more serious when the trial is set up on a trans - European level as the different national implementations of the Directive can have a tremendous impact on the legal situation covering the trial.

The question of informed consent is at the nexus of this complex framework; on one hand as the essential basis of a successful patient – researcher relationship, on the other, a serious impediment resulting from uncertainty surrounding legal requirements.It is at this juncture that the CONTRACT seeks to find solutions to support researchers in both today’s and future clinical practice.

The idea

The CONTRACT consortium will investigate the impact of EU legislation on informed consent (Clinical Trials Directive, Data Protection Directive) on translational research with a view to informing future policy-making in this area. In order to comprehensively assess the spectrum of issues related to informed consent, the consortium, coordinated by Professor Nikolaus Forgó, Leibniz Universität Hannover, brings together multidisciplinary specialists from the fields of law (Leibniz Universität and Katholieke Universiteit Leuven), informatics (Custodix and Technological Education Institution of Crete) and clinical practice (Universität des Saarlands). Together they will analyse how informed consent issues are handled in clinical research and care environments in close cooperation with the relevant stakeholders. A particular focus will be placed on research and clinical trials involving vulnerable patient groups, with a particular focus on the paediatric population, due to the complex requirements involved for these cohorts.

The CONTRACT consortium will conduct a survey among stakeholders (clinical trials coordinators, ethics committees, patient organisations, data protection authorities and data managers) to obtain a multi-facetted and comprehensive overview of the main issues, difficulties and best practice solutions surrounding informed consent in clinical trials. This, together with an analysis of pertinent EU and national legislation, will form the basis for concrete policy recommendations on how the European Union can jointly protect patient’s rights and support translational research by a better structured approach towards consent issues.

In addition, CONTRACT will establish a helpdesk to offer advice to clinical research projects on all issues of informed consent. The helpdesk will offer a ready-to-run data protection framework and will provide a help forum for legal, ethical, IT-related and clinical questions on informed consent and data protection in translational research.

Finally the project results will be disseminated at two stakeholder workshops to be held in month 12 and 24 of the project (September 2011 and September 2012). These will provide an ideal forum for European policy makers and researchers to exchange views on the project’s results and possible options for future policies in this area.