eConsent (Electronic Informed Consent)

eConsent (electronic informed consent, sometimes written eIC) is the use of an electronic system — typically a tablet, computer, or web application, often incorporating multimedia such as narrated videos, animations, or embedded comprehension checks — to present the informed consent process for a clinical trial or other human subjects research and to capture the participant’s electronic signature, in place of a printed paper form signed with pen and ink. eConsent replaces the delivery and signing mechanism for informed consent; it does not change what informed consent legally requires. The consent document itself must still contain every element required under the applicable regulation — the Common Rule (45 CFR 46) for HHS-funded human subjects research, or FDA’s own informed consent regulation (21 CFR Part 50) for FDA-regulated clinical investigations — and must still be reviewed and approved by an IRB before use, exactly as a paper form would be.

What Makes a Process eConsent (Operational Definition)

A process counts as eConsent when all of the following are true:

• Electronic delivery of consent content. The participant reviews the IRB-approved consent information on a screen rather than (or in addition to) paper — often using layered or interactive presentation (short video segments, plain-language summaries, embedded quiz-style comprehension checks) rather than a single static document.
• A genuine opportunity for questions. The electronic process still has to provide a real opportunity for the participant to ask questions and discuss the study with an investigator or study staff member — live, by phone/video, or in person — before signing, not just a click-through screen.
• An electronic signature that is attributable and durable. The signature is captured, time-stamped, and non-detachably linked to the specific, version-controlled document the participant actually reviewed, with a retrievable audit trail of who signed what version and when.
• A copy provided to the participant. The participant receives (or can readily obtain) a copy of the signed consent, electronic or printed.

Regulatory Basis

Two distinct regulatory layers apply to eConsent, and it’s worth keeping them separate:

• 21 CFR Part 11 — FDA’s general rule (in force since 1997) governing when an electronic record or electronic signature is trustworthy enough to substitute for a paper record or handwritten signature for any record an FDA “predicate rule” already requires. See CASRAI’s 21 CFR Part 11 entry for the full mechanics (audit trails, validation, access controls). For FDA-regulated clinical investigations, an eConsent signature has to meet Part 11’s criteria to serve as the record of consent.
• The FDA/OHRP joint eConsent guidance. In December 2016, FDA (jointly with HHS’s Office for Human Research Protections, OHRP) issued “Use of Electronic Informed Consent in Clinical Investigations — Questions and Answers,” aimed at IRBs, investigators, and sponsors, covering both FDA-regulated clinical investigations and HHS-regulated human subjects research more broadly. It recommends that IRBs review not just the consent document’s language but the electronic process and interface itself — how information is presented, whether interactive elements genuinely aid comprehension, how the participant’s identity is verified before signing, and how the electronic signature is captured and secured — and it encourages (without mandating) the use of multimedia to improve participant understanding relative to a static paper form.

FDA’s later guidance on decentralized clinical trials also addresses obtaining informed consent remotely, reflecting how eConsent has become a practical enabler of remote and hybrid trial designs rather than a purely on-site convenience.

Benefits Over Paper-Based Consent

• Comprehension support. Video, graphics, and embedded quiz-style checks can clarify complex risk/benefit information in ways a dense paper document cannot, and can flag when a participant answers a comprehension question incorrectly so staff can follow up before signing.
• Built-in audit trail. Every view, edit, and signature event is time-stamped and logged automatically, rather than relying on a site’s manual version-control discipline for paper forms.
• Version control at scale. Multi-site trials that amend a consent form mid-study can push the current IRB-approved version to every site simultaneously and prevent an out-of-date paper form from being used or signed.
• Remote and decentralized trial enablement. A participant who cannot travel to a site can still complete a compliant consent process from home, with real-time discussion by video or phone, which is part of why eConsent adoption accelerated alongside decentralized and hybrid trial designs.
• Re-consent efficiency. When a protocol amendment or new safety information requires re-consenting an active participant population, an eConsent platform can track who has and hasn’t re-consented and route the updated document automatically.

IRB Considerations

Because eConsent changes the process, not just the document, IRBs typically review it as its own submission element, separate from approving the consent language itself:

• Platform and interface review. IRBs generally expect to see (or test) the actual participant-facing interface, not just a paper mock-up, to confirm the electronic presentation doesn’t obscure or minimize required information.
• Identity verification and signer authentication. How the platform confirms the person signing is the actual participant (or their legally authorized representative) is a standard IRB question, particularly for fully remote consent.
• Access for participants without reliable technology. IRBs commonly require a paper-based alternative remain available so eConsent doesn’t functionally exclude participants without a suitable device, connectivity, or comfort with the interface — an equity and access consideration alongside the regulatory one.
• Data security and privacy. Because the signed consent is now an electronic record containing identifiable information, IRBs and institutional privacy/security offices typically review how it’s stored, transmitted, and access-controlled, often alongside HIPAA considerations for U.S. sites.
• Withdrawal and re-consent workflows. The IRB will typically want the platform to support — not complicate — a participant’s ability to withdraw consent and to be re-consented cleanly when the protocol changes.

eConsent vs. Related Concepts

eConsent is a delivery mechanism, and it’s easy to conflate with adjacent but distinct ideas. Dynamic consent is an ongoing, typically digital consent relationship that lets a participant revisit and adjust their preferences over time — eConsent can be used to implement a dynamic-consent model, but a one-time electronic signature captured at enrollment is eConsent without being dynamic consent. Broad consent is about the scope of what’s being consented to (future secondary use of biospecimens/data under the 2018 Common Rule revisions) rather than the medium used to capture it — broad consent can be obtained on paper or electronically. See CASRAI’s guide on informed consent in research for the underlying requirements eConsent has to satisfy regardless of medium.

Frequently Asked Questions

Is an electronic signature on an eConsent form legally valid?

Yes, provided it meets the applicable standard — 21 CFR Part 11 for FDA-regulated clinical investigations, and generally applicable e-signature law (such as the U.S. federal E-SIGN Act) for records governed only by the Common Rule. The signature has to be attributable to the specific signer and non-detachably linked to the exact document version reviewed.

Does an eConsent process still need IRB approval?

Yes — both the consent document’s content and, typically as a distinct review element, the electronic process and interface itself. FDA/OHRP’s 2016 guidance is explicit that IRBs should review how information is presented electronically, not only what it says.

Can eConsent be used for fully remote or decentralized trials?

Yes. eConsent is one of the practical building blocks of decentralized and hybrid trial designs, allowing a participant to complete a compliant consent process, including real-time discussion with study staff, without traveling to a physical site — though a site still needs a verified identity-confirmation process and an accessible alternative for participants without adequate technology.

Is eConsent required, or can sites still use paper consent?

Paper consent remains fully acceptable. eConsent is optional and adopted where it fits the trial design and participant population — IRBs generally expect a paper alternative to stay available regardless.