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 using digital components (e.g. tiered consent, glossary, quiz, videocalls, system integrations, reports) to support and improve the overall consenting process for all stakeholders involved. Digital components can be used in one or more of the consenting process steps.
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, patients, 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 in multi-stakeholder workstreams (library, study docs and database) and individual stakeholder workstreams (pharma, vendors, academic institutes, patients, sites, ethics committees and health authorities). The focus of each workstream is detailed below:
- Library workstream defines harmonized terminologies to describe various aspects of eConsent, such as digital components, identity verification/ authentication, electronic storage of personal data, remote data access to sponsors, archiving, etc
- Study docs workstream defines which aspects of eConsent need to be described where and to which level of detail in study documents such as protocol, EC & HA docs, patient & site manuals, monitoring guidelines, etc.
- Database workstream provides 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
- Individual stakeholder workstream provides insight in what is needed, missing, hampering uptake and the overall value model for a specific stakeholder group
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 governance team, comprised of all workstream leads and the chair.
Where are we?
Regular status updates will be shared via this website.