CONTRACT

Consent in a Trial and Care environment

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 Obiettivo del progetto (Objective)

'CONTRACT is about consent. The project focuses on analysing how the legal (and underlying ethical) concepts of informed consent in the European Data Protection Directive and in the Clinical Trials Directive have had and continue to have an impact on the success of translational research. The project predominantly deals with vulnerable patients as their consent is of utmost complexity. The concept of informed consent in the two mentioned Directives will be analysed from a legal, ethical, IT-related and clinical point of view. The European approach on the matter will be compared with national concepts of informed consent for care purposes in the Member States. CONTRACT will support the European Commission and other policymakers in achieving a clear Community framework by providing clarity on different concepts of informed consent on European and national level. CONTRACT’s approach will be based on facts and figures by delivering an empirical survey about the handling of consent in European and national translational trials. CONTRACT will identify good practices in obtaining and administering informed consent in translational research and will give recommendations on possible harmonization of and common approaches to the legal framework. CONTRACT has already built a target community for its services, the “partner projects”, which will be significantly enlarged after the project’s start. CONTRACT will offer a help desk for its target audience on consent issues and will constantly support partner projects and other relevant stakeholders in balancing patient’s and research interests by a proper management of consent. In achieving these objectives the project has put together an internationally recognised interdisciplinary team of individuals and organisations with significant expertise and know-how on all areas of relevance to the project, it has drawn-up a ambitious – yet achievable - workplan, and has made every effort to identify and minimize potential risks.'

Introduzione (Teaser)

An EU-funded initiative has paved the way for achieving a clear Community framework with regard to informed consent, particularly for vulnerable patients. The varying conceptualisation of the term at European and national levels was the focus of the work.

Descrizione progetto (Article)

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.