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Electronic Consent Summary Form Creates More Participant-Focused Process, Speeds Clinical Trial Enrollment

March 27, 2025

Informed consent processes ensure that people joining clinical trials fully understand the goals and risks. Electronic consent (eConsent) systems often make the process clearer and faster for those enrolling than traditional in-person consent. A recent study supported by NIH’s CTSA Program used a new and more efficient approach known as a concise summary to improve the eConsent process as it becomes more common.

The Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) study began during the first two years of the COVID-19 pandemic. A clear, remote informed consent process was needed to keep participants and staff safe. First, participants received the full consent form, which listed common features across all study sites and features unique to the site where they would enroll. If they decided to join the study, they only needed to sign a streamlined summary of the study’s key features and confirm they read the full form. This process was done through a remote platform used by most of the study sites.

Because the short summary was less likely to change than the full consent form, participants only needed to sign once. The study also noted that users preferred the shorter process, and sites were able to adapt the process to their own needs. Through the use of innovative eConsent approaches, like the concise summary method, people can join studies in ways that work best for them. These findings will help future studies enroll participants efficiently and in ways that are preferred by all.

Learn more about the study in the Journal of Pain Research.


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Last updated on March 27, 2025