Multistakeholder initiative to harmonize terminologies and processes on various aspects of eConsent, to increase insight in different stakeholder value models and to provide a consistent country-level overview of local acceptance/non-acceptance
What is eConsent about?
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.
There is no one size fits all eConsent model. Each study, each country, each site, each participant might have different needs.
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
Each stakeholder group will drive their value models and enable awareness and education within their community. A sustainable maintenance model for the database and practical guideline will be implemented.
The 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). The focus of each workstream is detailed below:
- Library workstream defines harmonized terminologies to describe various digital features and processes of eConsent.
- Study docs workstream defines a harmonized overview of which eConsent aspects should be described in which study documents and to which level of detail.
- Database workstream defines a country-level overview on acceptance/non-acceptance of various eConsent aspects and rationale of non-acceptance.
- Individual stakeholder workstream workstream provides insight into individual stakeholders' needs, challenges and value drivers, and guidance on how to measure and generate impact.
The outcome of the library, study docs and individual stakeholder workstreams will be combined in the practical guideline.
Close alignment between workstream is handled by the
Resources and Publications
Where are we?
Regular status updates will be shared via this website.
Conferences, Webinars, Interviews
- European Site Solution Summit (SCRS): EFGCP eConsent sharing insight on eConsent and Decentralized Trials at the “Exploring Practical Examples of Decentralized Elements” on 14 November 2023 in Lisbon. Click here form more information: View External Link
- Vaccelerate eConsent Webinar: EFGCP eConsent presenting “eConsent - Chances and Challenges for a Multistakeholder Community” on 5 July 2023. Recording available in case you missed it: View External Link (Youtube Video)
- Interview by Applied Clinical Trials at Global DIA Annual Conference: Click here for a glimpse of the interview by Applied Clinical Trials to learn more about EFGCP eConsent initiative at the Global DIA Annual Conference: View External Link
- Global DIA Annual Conference: EFGCP eConsent sharing multistakeholder eConsent perspectives at the Global DIA Annual Conference on 28 June 2023 in Boston, together with FDA and MHRA with Roche as chair of the panel session. Click here for more information: View External Link
- ECRIN International Clinical Trials Day (ICTD): EFGCP eConsent presenting “eConsent: not a one size fits all” at ECRIN ICDT conference on 23 May 2023 in Poland. Click here for more information: View External Link