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eConsent Initiative

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

eConsent Initiative

Chairing Hilde Vanaken
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.

Mission

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.

Workstreams

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 governance team, comprised of all workstream leads and the chair.

Resources and Publications
Where are we?
2022 - September
+100 participants of +70 different organizations joined the kickoff meeting on 22 September where the overall design, deliverables, workstreams and roadmap were presented for their input. Excellent feedback was received and workstream nominations were initiated.
2022 - October
Follow up meetings were held in October to collect feedback and to finalize workstream assignments. A phased approach was agreed. In first instance, predominantly pharma, vendors and academic institutes will bring all their experiences together and create a first draft of the practical guideline and country-level database. Next, the input of participants, sites, ethics committees and health authorities will be collected using local/regional workshops and material tailored to their interests and needs.
2022 - November
Kickoff meetings of the different workstreams were initiated in the week of 14 November. Biweekly meetings will be initiated to prepare the first draft material.
2023 - April
The Library workstream has finalized an overview of different categories, definitions, and examples of digital features, named the glossary of digital features. This glossary has been incorporated in the overall glossary of eConsent Terms (see 2023 December update). The Study Docs Workstream has launched two surveys to get insight into what respectively Health Authorities and Ethics Committees should be informed about (or not), and in which study documents should be described.
2023 - August
The database workstream has launched two surveys to get a better insight into experiences, perceptions and expectations of ethics committees and sponsors/vendors on the use of eConsent, as part of their deliverable to provide a global country-level overview of specific eConsent aspects.
2023 - November
The results of the eConsent Ethics Committees (ECs) and Health Authorities (HAs) Submission Documents have been published in Applied Clinical Trials on 13 November. Both surveys addressed various eConsent Platform and Operational Aspects. 62 organizations gave their perspective on what ECs should be informed about (or not) and why, where it should be reported, and whether it should be approved by ECs. 58 organizations gave a similar perspective but for HAs. Highlights have been covered in the article “Navigating eConsent Submission: Who, What, Where and Why” published by Applied Clinical Trials (External Link).
2023 - December
The library workstream has finalized a first of its kind Glossary of eConsent Terms, which incorporates the former glossary of eConsent Digital Features. Having harmonized terminologies to describe the platform and operational aspects of eConsent is critical to eliminate misconceptions and to enable transparency and a common understanding between all stakeholders. In addition, the glossary can also serve as a general knowledge base of key aspects to consider when deploying eConsent. Highlights of the glossary has been covered in the article “eConsent – Why Language Matters” published by Applied Clinical Trials (External Link)

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
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