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Project

electronic Personalised Informed Consent (ePIC)

The principle of informed consent (IC) is a cornerstone of clinical research. However, current IC practices often use long, legalized, incomprehensible paper documents in a 'take it or leave it' approach that fail to fulfil their purpose, i.e. truly inform a trial participant about the trial procedures, risks and benefits. Electronic IC (eIC) can solve these issues. However, adoption of eIC by stakeholders has been slow due to several drawbacks. In particular, secure systems that allow personalisation and long-term interaction with participants are lacking. In the ePIC project, research in legal, ethical, social, technical, and clinical sciences is combined to develop a patient-centric, science-driven regulatory framework, software architecture and user guidance for eIC tools that allow long-term interaction with research participants at various levels of engagement and interactivity. The project will serve as leverage to trigger additional external funding to further develop and integrate patient-centricity in eIC tools.
Date:1 Oct 2019 →  30 Sep 2023
Keywords:e-consent, personalised, patient-centric, longitudinal, interactive
Disciplines:Pharmacology not elsewhere classified