Activities & Operations

Remote consent

Remote consent is a key decentralised element in DCTs that enables participants to give their consent to participate in a trial without a visit to the trial centre. In a DCT, the process usually take place online (eConsent) through identification online (eIdentification) and digitally signing documents (eIdentification). Yet implementation of eConsent faces challenges due to regulations and questions around the levels of digital literacy needed to complete and support the procedures.

Recommendations

We advocate for clearer, harmonised regulatory guidance on eConsent implementation to streamline multi-country DCTs and avoid fragmented processes. All variations in country-specific requirements in consent forms or signatures adds complexity, which need to be implemented and tested. Harmonisation will simplify the technical implementation process and ensure consistency. This includes standardisation of legal interpretations and requirements regarding signatures, such as the necessity of multiple signatures for GDPR and other purposes.

Ensure that all PDFs requiring digital signatures are saved as PDF/A for long-term preservation. Additionally, implement the highest level of long-term validity checking (PAdES-B-LTA level) for all ICFs signed after a specified date. This will ensure that the signatures remain verifiable over time.

Establish backup procedures for scenarios where eConsent is blocked or signatures cannot be obtained. This includes having alternative methods remote methods such as via post. Back-up procedures may also be used for participants who do not have the digital literacy to navigate the eConsent process.

Improve the accessibility of remote eConsent by addressing barriers such as the requirement for specific types of identification. For example, work with service providers to accept a broader range of identification documents, especially in regions where certain IDs are less common. This will help include a wider demographic. One can even consider if eIdentification is necessary according to local guidance; a qualified e-signature (QES) might not always be required.

Equip clinical trial sites with the knowledge and resources they need to confidently guide participants through remote consent procedures. Ensure that staff receive thorough initial training and have access to continuous support, enabling them to address participant questions, navigate technical challenges, and deliver a smooth, participant-friendly consent experience.

How Trials@Home reached these recommendations

According to EU EMA guidance, while remote methods for obtaining informed consent are permissible, they require careful consideration and planning to ensure compliance with ethical standards, legal requirements, and the protection of trial participants’ rights and data. In RADIAL, we evaluated the use of remote eConsent with eIdentification. This experience brought insight on how best to adhere to these standards, maintain equitable access, and technical implementation.

Further reading

Publications

Recruiting and Consenting Decentralized Clinical Trial Participants – Learnings from the Trials@Home RADIAL Proof-of-Concept Trial.

Lagerwaard, et al
Clinical Pharmacology & Therapeutics
2025
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Video

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