Respecting informed consent, protecting patient rights
The 'Consent in a trial and care environment' (Contract) project analysed how legal concepts of informed consent in two European directives have had and continue to have an impact on the success of translational research. The European Data Protection Directive (Directive 95/46/EC) and the Clinical Trials Directive (2001/20/EC) were the focus of these analyses, which were conducted from a legal, ethical, clinical and information technology (IT)-related point of view. Focusing on vulnerable patients, the internationally recognised and interdisciplinary Contract team compared the European approach with the approaches of individual EU Member States. An examination of research projects with vulnerable patient groups or particularly sensitive issues of consent highlighted issues and concerns surrounding the proper handling of informed consent in European and transnational research trials. Partners then developed a questionnaire for stakeholders to explore related legal, technical and clinical issues. An analysis of the responses was complemented by a study of the legal framework of informed consent in national legislation for four Member States. Based on the outcomes of the questionnaire activity and a drafted set of guidelines on preparing informed consent forms as well as for identifying best practice examples, a policy-oriented study was produced. This offers recommendations on how to achieve better coordination and harmonisation across different concepts of informed consent in Europe. It also includes concrete recommendations for the European Commission relative to future legislative action and the strengthening of patients' rights, without compromising the usability of their personal data. Another Contract success was the setting up of a helpdesk: among other functions, it provides an informed consent generator for informed consent forms for end users. The helpdesk will continue to operate after the Contract project ends. The outcomes of the Contract project support translational research projects through a better structured approach towards issues of consent. Their application, in trials as well as by policymakers, will serve to protect patient rights for enhanced overall care of vulnerable patient groups across Europe.
