How to See eConsent as More Than Just a Digital Signature

Redefining eConsent necessitates debunking the prevalent myth that it is simply about digital signatures. At its core, eConsent is not just an electronic version of a paper process, nor is it solely about capturing a digital acknowledgment. While the signature is a component, eConsent represents a nuanced and layered system, addressing complexities inherent in the consent process.?

To successfully adopt eConsent, here are three approaches sites and sponsors need to rethink:

eSignature vs. eConsent vs. digital signature: Not the same but connected

Sites and sponsors' misconceptions like "eConsent is only the eSignature" are at odds with how eConsent works . eConsent is more than a signature. It is an ecosystem of information participants can access at any time—before, during, and after site visits—to stay informed. It allows participants to ask questions and test their knowledge before consenting to a trial.??

eConsent advocacy is the first step to adoption. The research community must understand that it is not a signature but an entire ecosystem with possibilities for better-informed participants, which is what regulatory bodies want in the first place.

Electronic signatures (eSignatures) are an important part of eConsent, especially for fully remote trials. However, trial sites don't have to take an all-or-nothing approach to eSignature. Castor tracks eSignature use by country, and we've seen a variety of adaptations on eSignature:

• Participants print forms, sign them during a video call, and mail them back to researchers.
• Researchers help participants sign forms on their devices during an onsite visit.
• Researchers print forms onsite for participants to sign
• During a video call, participants complete the eConsent process and sign on their devices.

Types of digital signatures accepted for eSignatures vary across local IRBs and national regulatory bodies. For example, some accept checked boxes or marks on a digital scratch pad, whereas others have complicated, multi-step verification processes for digital signatures. eConsent tools can be adapted to whatever digital or paper signature sites and regulatory bodies require.

Digital vs. analog systems: eConsent enhances data retrieval over traditional paper processes

Picture the traditional paper-based consenting process: manilla folders, stacks of paper, and the risk of misplacing a crucial document. This familiar analog approach presents challenges. As the volume of participants grows, so does the paperwork, leading to an increased risk of data loss.

The wait-and-see approach to adopting new technology is often rooted in the misbelief that digital systems are more complicated than analog ones. But let's debunk a myth: digital systems, especially in the consenting process, are designed to secure data storage and be user-friendly. With everything stored electronically, data accessibility becomes seamless. If the study team needs to pull up a specific patient's consent form, it is only a click away.

A "digital first" mindset helps everyone move toward eConsent adoption

Transitioning from paper is about more than mere digitization - it's about revolutionizing the informed consent process. eConsent's tenfold benefits over paper include streamlined processes, reduced errors, and an intuitive user experience. To reap these rewards, early adoption is crucial.

The “digital first” perspective not only underscores the safety advantages of eConsent over traditional paper but also exposes the expansive capabilities of the eConsent ecosystem. By visualizing these capabilities, clinical staff and study designers can optimize the delivery of vital information, custom-tailored to participant requirements.

Still unsure whether eConsent can benefit your studies? Watch our on-demand recording of eConsent from Sponsor to Site: Navigating Successful eConsent Adoption webinar to hear about the impact of eConsent, real-world examples of eConsent evaluation, readiness, and implementation.