Effective eConsent Strategies for Every Study: Utilising the eConsent Fit-for-Purpose Study Framework

This feature article explains how the European Forum for Good Clinical Practice eConsent Initiative, a group of more than 50 organisations, developed the eConsent Fit‑for‑Purpose Study Framework to move study teams beyond a “one size fits all” view of electronic informed consent. It is aimed at research teams considering electronic informed consent and needing a clear method to decide whether to use it, which digital features to prioritise, and how to measure its impact on participants, sites and sponsors, helping investigator‑initiated trials move from ad hoc choices to a structured, transparent approach with shared objectives and terminology. The authors define electronic informed consent as the usual informed consent process supported by one or more digital features and clarify that remote consent, when participant and investigator are in different locations, is a separate concept that can still be conducted on paper.

The five‑step framework is described as follows:

1. Define potential e-consent benefits and challenges for sponsors, sites and participants, recognising that challenges should be identified and mitigated rather than used as reasons to avoid electronic informed consent.
2. Choose the best platform features and operational set‑up using a standardised list of more than 60 terms covering digital features, data types, devices and locations of participants and investigators, while taking into account budget, countries involved and cultural or language diversity.
3. Check e-consent objectives and assumptions with selected stakeholders by discussing planned objectives, features and operational choices with investigators, site staff and, where possible, participants, using interviews or group meetings to inform a Go/No‑Go decision or adjustments to the design.
4. Define how success will be measured by selecting from nine key performance indicators that together reflect the main benefits and challenges, and by deciding which qualitative and quantitative data can realistically be collected.
5. Plan analysis and reporting, for example by comparing sites that use electronic informed consent with those that do not and by timing assessments to capture both early and later inspection findings.

Overall, the article encourages teams to integrate electronic informed consent planning, measurement and reporting early in study design, and to generate study‑level evidence that can be shared with the wider clinical research community.