eConsent

Initiative leader: EFGCP

Duration: Ongoing

eConsent refers to the use of one or more digital features (e.g. tiered content, glossary, quiz, videocalls, reports) to support the consenting process for all stakeholders involved. Of note, eConsent only augments the overall consent process, it does not change any of the traditional paper consent process steps – confirming interest, informing, discussing, signing, and providing a signed copy – as represented below along with some examples of eConsent digital features.

Enabling clinical trials access to anyone, anytime, anywhere starts with the consenting process. Any physician should be able to provide to any potential participant an easy-understandable, non-biased and consistent explanation of what the clinical trial entails so that an informed decision to participate or not can be taken.

The EFGCP eConsent initiative is a non-profit multistakeholder initiative involving pharma, vendors, academic institutes, participants, sites, ethics committees and health authorities. The main deliverables are:

• A practical guideline with harmonized terminologies for various eConsent aspects, where and to which level of detail to describe in study documents, and specific stakeholder needs to consider
• A global database providing a country-level overview on acceptance/ non-acceptance of various eConsent aspects, including exact concern in case of non-acceptance, in line with the model used

ECRIN's Role in eConsent

The EFGCP eConsent initiative is divided into multi-stakeholder workstreams (library, study docs and database) and individual stakeholder workstreams (pharma, vendors, academic institutes, participants, sites, ethics committees and health authorities). ECRIN is involved in the Academic Institutes Workstream, which aims to provide insight into the needs, challenges and values of academic stakeholders.