By allowing patients to review materials remotely and interact with content more flexibly, electronic informed consent changes how clinical trials connect with participants. In hybrid and decentralized models, these tools can allow remote consent workflows, although eConsent can also take place on a device with in-person interaction from research staff.
eConsent expands options for ensuring participant comprehension, but that flexibility comes with nuances. Confirming participant identity, supporting comprehension, and protecting data all require planning. As eConsent becomes more central to modern trial design, the essentials below can help research teams approach it with a focus on clarity, compliance, and participant understanding.
Essential #1: The Basics of Informed Consent
Informed consent in research is grounded in three core elements:
- Information: Do participants receive the details they need?
- Comprehension: Do participants understand what the provided information means?
- Voluntariness: Can patients make a voluntary decision about whether or not to take part in the study, and can they discontinue participation at any time?
These principles apply for any method of establishing consent, whether the documents are stored on paper or electronically and if the process occurs in-person or remotely. eConsent does not change these requirements. However, it does affect how research teams support them.
In decentralized and hybrid trials, participants may review materials on their own time, revisit content through digital platforms, and receive updates as protocols change. One benefit is that this creates more opportunities to treat consent as an ongoing process. For example, teams can use electronic systems to share amendments, prompt re-consent if needed, and maintain continuous access to study information. At the same time, these workflows require thoughtful design so that flexibility does not come at the expense of understanding or active engagement from researchers.
Essential #2: Confirming Identity
Electronic consent in FDA-regulated research must align with 21 CFR Part 11. This establishes requirements for electronic records and signatures. Broadly speaking, systems must be secure, access must be controlled, and there must be confidence that the person providing consent is who they say they are.
In fully remote trials, research teams often cannot rely on the traditional identity checks that support 21 CFR Part 11 compliance. Even in hybrid trials, consent initiated through links, apps, or email introduces difficulties.
Data privacy is also a factor. Digital transmission or storage must be handled in a way that protects the sensitive information that is often present in electronic consent documents.
To address these challenges, research teams must include identity verification and security in the consent process from day one. Common approaches include:
- Using secure platforms with unique logins or multi-factor authentication
- Verifying identity through third-party tools or knowledge-based questions
- Incorporating live touchpoints (e.g., video calls or chat features) to confirm identity and discuss trial information with the participant
- Ensuring all systems meet Part 11 audit trail and electronic signature requirements
IRBs are key in evaluating whether these processes are appropriate and sufficient. They identify gaps, recommend safeguards, and help ensure that consent workflows meet all necessary regulatory expectations and respect patients’ rights.
Identify Verification for Pediatric Studies
Pediatric studies introduce additional considerations, as consent often involves both parental permission and child assent. Specific requirements will depend on the participant’s age and ability to understand the study. Electronic processes can support both permission and assent, but they must be designed carefully. Identity verification methods used for adults may not apply to children, and the way assent is presented should match the child’s level of comprehension. In some cases, a parent may provide initial documentation of assent, which the research team can confirm later.
Essential #3: Using Technology to Improve Comprehension
One of the main advantages of eConsent is the ability to present information so patients can more easily understand it. Instead of relying on written documents only, research teams mix formats to support varying learning styles and reinforce key concepts.
This may include:
- Embedding short videos to explain study procedures or expectations
- Using diagrams or graphics to illustrate timelines, visits, or treatment steps
- Incorporating brief quizzes or knowledge checks to confirm understanding
- Providing interactive elements, such as expandable sections or pop-ups
Approaches like these create opportunities for participants to engage with the material, revisit sections later, and confirm understanding before each new step. This is especially important in remote settings since there are fewer natural opportunities for back-and-forth discussion between the participants and research team.
eConsent platforms can give researchers a closer view of how participants interact with consent materials. For example, sponsors may be able to see where participants spend more review time or which questions they miss most in comprehension checks. These insights can help refine consent processes, making them more effective and participant-centered with each iteration.
IRB Expertise to Guide eConsent
As eConsent becomes more widely used in hybrid and decentralized trials, having the right oversight in place is essential. An experienced IRB can help research teams align technology with regulatory expectations, strengthen identity verification processes, and identify opportunities to improve participant comprehension.
At Sterling IRB, our team brings comprehensive experience in evaluating eConsent across a range of trial models. We work closely with sponsors, CROs, and institutions to help design consent processes that are clear, compliant, and participant-centered.
To explore these considerations in more detail, download our white paper on informed consent in modern clinical trials.