How to collect informed consent with eConsent

eConsent replaces the paper informed consent form with a digital one that the participant reads, discusses and signs on a phone, tablet or computer. The rules stay the same as on paper: the participant must understand the study, sign of their own free will, and receive a copy. What changes is the evidence you keep: a date and time on every version and every signature.

What regulators expect

ICH E6 requires informed consent before any study procedure, with a copy for the participant. In the United States, the FDA and OHRP guidance on electronic informed consent covers content, identity verification and 21 CFR Part 11 signatures. In the European Union, rules differ by country: some accept remote eConsent, others ask for a wet signature or an in-person discussion. Check each country before you plan remote consent.

How to set up eConsent in 7 steps

1. Start from the approved consent text. Convert the ethics-approved document first, then add structure: sections, a table of contents, a glossary.
2. Add media where it helps understanding. A short video or a diagram of the visit schedule explains more than a page of text. Submit the media to the ethics committee with the text.
3. Check comprehension. Add a few questions on the key points: risks, the right to withdraw, what happens to the data. Route wrong answers to a discussion with the investigator.
4. Verify identity. Decide how you confirm the signer is the participant: in person at the site, a code sent by SMS, or an identity check for remote consent.
5. Collect the signatures. Capture the participant's signature, then the investigator's countersignature, each with date and time.
6. Give the participant a copy. Send the signed document by email or make it available in their account.
7. Manage versions and re-consent. When an amendment changes the information, publish the new version per country or site and ask current participants to sign it again.

Mistakes to avoid

• Treating the tool as the process. The investigator still answers questions. Keep a step for that discussion.
• Remote consent where the country requires a site visit. Confirm the national rules first.
• Losing track of versions. A participant who signed version 2 after version 3 went live is a finding at inspection.

eConsent in Datacapt

Datacapt eConsent works in a web browser on any device, with videos and diagrams in the consent, step-by-step logic that checks understanding before the signature, and investigator countersignatures. You send the form by email, SMS or QR code, manage versions per country and site, and follow consent status on a live dashboard. Signatures support the eIDAS Advanced Electronic Signature level, and the televisit module lets the investigator discuss the form with the participant in real time.

Keep reading

• The eConsent guide
• Can an electronic signature be used for informed consent?
• Five misconceptions about eConsent
• Datacapt eConsent