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eConsent Initiative

A multistakeholder initiative to harmonize terminologies and study documents needs on various aspects of eConsent, to increase insight in different stakeholders’ value models and country needs, and to provide a fit for purpose eConsent study framework.

eConsent Initiative

Chairing Hilde Vanaken
What is eConsent?

The informed consent is a process between participant and site personnel – the two key players – but the sponsor and other parties also have important roles to drive, support, and verify the accuracy of the process.

The term ‘eConsent’ is the overarching terminology for the traditional informed consent process supported by one or more digital features (e.g. tiered content, glossary, quiz). There are many different eConsent models, and it is important to understand that the consent process does not change, the same consent process steps are still applicable, as shown in Figure 1.

Figure 1: eConsent Definition and Some Examples of eConsent Digital Features

There are many disconnects regarding eConsent with some misconceptions as outlined in Figure 2. For example, eConsent is often confused with remote consent but they are two different concepts. Remote consent refers to the location of the participant and investigator during the consent process and that they are not in the same physical location. A remote consent process could be conducted entirely on paper (not eConsent) or by using digital features (eConsent).

Figure 2: Some Common eConsent Misunderstandings

Enabling clinical trials access to anyone, anytime, anywhere starts with the consenting process. Using digital features to support the consenting process can benefit all stakeholders involved but eConsent deployment needs to be driven from a stakeholders’ value, not technology perspective, and challenges need to be addressed proactively.

There is no one size fits all eConsent: each indication, each study, each study population, each site and each participant might have different needs.

Our Mission

The EFGCP eConsent initiative is a non-profit multistakeholder initiative involving Pharmaceutical companies, Vendors, Academic Institutes, Participants, Sites, Ethics Committees and Health Authorities.

The main deliverable is the creation of practical tools and recommendations aimed at harmonizing eConsent terminologies, study document requirements, and implementation methods. This will enable the development of the right eConsent strategy for a particular study.

Each stakeholder group will drive their value models and enable awareness and education within their community.

Our Workstreams

The initiative is divided into multistakeholder workstreams (Library, Study Documents and Database Workstreams) and individual stakeholder workstreams (Pharma, Vendors and Academic Institutes Workstreams). Over 50 leading organizations, featuring several world-renowned eConsent leaders, joined one or more workstreams.

The focus of each workstream is detailed below:

  • Library Workstream: to define harmonized terminologies to describe various eConsent digital features, platform and operational aspects.
  • Study Documents Workstream: to define a harmonized overview of which eConsent aspects should be described in specific study documents and to what level of detail.
  • Database Workstream: to provide insight into local needs of specific eConsent aspects.
  • Pharma, Vendor and Academic Institutes Workstreams: to provide insight into individual stakeholders’ needs, challenges and value drivers, and guidance on how to measure and generate impact.

Other stakeholders (Participants, Sites, Ethics Committees and Health Authorities) are involved on an ad hoc basis for input and when appropriate.

Close alignment between workstream is handled by the governance team, comprised of the different workstream leads and the chair.

Resources and Publications

Tools

Articles

Where are we?
2024 – October
The Database Workstream has published the results of the eConsent Ethics Committees (ECs) and sponsors/vendors perspectives and experiences in Applied Clinical Trials on 11 October. 49 Ethics Committee Respondents of 15 different countries completed the eConsent ECs survey, and 42 respondents the sponsor/supplier survey with 67% sponsor and 33% vendor respondents. The survey results reveal some interesting insights into Ethics Committees’ perspectives and expectations on topics such as 1) minimal signature requirements for on-site, remote with video call, or remote with phone call interactions between investigator and participants, 2) personal data hosting requirements, 3) important factors for approval, among many other items. Interestingly, the regional difference between ECs may not be as significant as often assumed. On the sponsor (commercial, non-commercial) and vendors (technology, CRO) side, the surveys examined drivers, barriers, usability of digital features, and other aspects. While common viewpoints were shared, there were also notable differences between both organizational types. Highlights have been covered in the article “Understanding Acceptability of eConsent from a Global, Ethical and Industry Perspective” published by Applied Clinical Trials and the detailed survey results can be accessed through the supplemental information section of the article.
2024 – August
The Pharma Workstream, in close collaboration with other workstreams, has finalized the eConsent Fit-for-Purpose Study Framework. This tool provides sponsors (and any stakeholder interested in eConsent) a guide on how to define and design the right eConsent for a particular study and how to generate effective and comparable study data on eConsent. Potential eConsent benefits and challenges of participants, sites and sponsors; or impact of various eConsent platform and operational aspects on targeted benefits, or potential eConsent Key Performance Indicators with qualitative and quantitative measurement approaches, are just some of the items detailed in this 5-process step framework. Highlights have been covered in the article “Effective eConsent Strategies for Every Study: Utilizing the eConsent Fit-for-Purpose Framework” published by Applied Clinical Trials and the entire framework is available in the Resources.
2024 - July
The Library Workstream has made updates to the glossary to be consistent with the Fit for Purpose eConsent Study Framework.
2024 - July
The Study Documents Workstream has released its recommendations on which eConsent Platform and Operational Aspects should be described in nine different study documents: Protocol, Health Authority and Ethics Committee Submission Cover Letter, Participant-related eConsent Documents, Informed Consent Document, Site eConsent Documents, Monitoring Plan, Data Management Plan and Platform/Vendor Due Diligence Documents.
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 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 and the entire Glossary of eConsent Terms is available in the resources.
2023 - November
The Study Documents Workstream has published the results of the eConsent Ethics Committees (ECs) and Health Authorities (HAs) Submission Documents in Applied Clinical Trials on 13 November. 62 organizations completed the ECs submission documents Survey, 58 organizations the HAs submission documents survey. Both surveys contained 28 questions, addressing various eConsent Platform and Operational Aspects. Objective was to get industry’s perspective whether EC (or HA) should be informed about (or not) and why, where it should be reported, and whether EC (or HA) should approve. Highlights have been covered in the article “Navigating eConsent Submission: Who, What, Where and Why” published by Applied Clinical Trials and the detailed survey results can be accessed through the supplemental information section of the article.
2023 - August
The Database Workstream launched two surveys to get a better insight into experiences, perceptions and expectations of Ethics Committees and sponsors/vendors on the use of eConsent and specific eConsent aspects.
2023 - April
The Study Documents Workstream launched two surveys to get industry’s perspective into what Health Authorities and Ethics Committees should be informed about (or not), their rationale, in which study documents it should be described, and whether they should approve or not.
2022 - November
Kickoff meetings of the individual workstreams took place in the week of 14 November. Biweekly meetings were initiated to prepare the first draft material.
2022 - October
Follow-up meetings were held in October to collect feedback and to finalize workstream members and co-leads assignments for the 6 different workstreams: Library, Study Documents, Database, Pharma, Vendor and Academic Institutes workstreams. Over 20 leading Pharmaceutical companies, 20 leading vendors and 10 Academic Institutions signed up from one or more workstreams.
2022 - September
+100 participants of +70 different organizations joined the kick-off meeting on 22 September where the overall design, deliverables, workstreams and roadmap were presented for their input. Representatives were from Pharmaceutical companies, Vendors, Academic Institutes, Patients, Sites, Ethics Committees and Health Authorities. Excellent feedback was received and workstream nominations were initiated.
Conferences, Webinars, Interviews
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