Clinical trials have always required informed consent, guaranteeing that participants are fully aware of the study’s goals, methods, and risks. However, conventional, lengthy consent forms often frustrate potential volunteers and delay enrollment, especially in vaccine clinical trials. A new study, funded by the NIH’s CTSA Program, points in a different direction.
This study implemented electronic consent, a concise and concise form that streamlines the process without sacrificing compliance or clarity. The Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) study tested this novel approach, which was carried out during the COVID-19 pandemic: a period when transparent, remote procedures were crucial for efficacy and safety.
The procedure was as follows:
- Participants were given the complete econsent form to review first, and if they decided to move forward, they only had to sign a brief synopsis covering the study’s main points.
- The process was carried out through a remote platform utilized at most study locations.
- eConsent empowers patients in clinical trials. Participants can remotely review econsent forms, which allows them the time and flexibility to talk with trusted friends or family members about their decision before enrolling. eConsent enables people who live far from the Hospital to include their loved ones in decision-making.
- eConsent facilitates remote participation by removing the need for patients to deal with complicated consent forms alone. This digital solution supports clearer comprehension and cooperative review.
Why eConsent was this Crucial in this Clinical Trial?
Enrollment was quicker and more effective since participants didn’t have to navigate complicated documents repeatedly. The summary was more comprehensible, less daunting, and more aligned with the participants preferences. Additionally, sites could modify the format to suit their local requirements while keeping it consistent.
What did they learn about eConsent?
Compliant electronic consent procedures don’t have to be difficult. With clever, straightforward tools, researchers can increase participation, expedite enrollment, and make the experience more user-friendly for participants, particularly in decentralized and remote trials.
A More Intelligent eConsent Process with TrialPal
Integra IT is aware that enhancing the informed consent procedure requires more than simply going digital; it also entails meeting participants where they are and making the procedure user-friendly, compliant, and completely customizable.
TrialPal is our ePRO/eCOA platform, which was created specifically for vaccine clinical trials. Subjects can report their symptoms, experiences, and outcomes directly from their devices. In addition, it has an interactive, AI-enhanced eConsent module that streamlines consent and immediately increases participant engagement.
In contrast to generic tools, TrialPal’s eConsent is:
- Easily construct informed consent flows with customized sections, interactive formats, and dynamic question/answer combinations according to the particular requirements of your study.
- Participant-Friendly: This platform is appropriate for a wide range of users, including senior citizens, thanks to its multilingual options, multimedia support, and easy navigation.
- Quick and IRB-Ready: TrialPal promises a completely customized ePRO setup in as little as two days, including the ability to generate and configure consent forms in record time.
- Increases Adherence: TrialPal's eConsent module, when used with real-time notifications, significantly attains our demonstrated +98% participant adherence rate throughout vaccine trials.
Sponsors and research sites benefit from a simplified, auditable process that satisfies regulatory requirements and lowers drop-off rates. At the same time, participants can easily comprehend what they’re getting into from the first click.
Learn more about eConsent in vaccine clinical trials
Source of Information
National Center for Advancing Translational Sciences. (2025, March 27). Electronic consent summary form creates more participant-focused process, speeds clinical trial enrollment. U.S. Department of Health and Human Services, National Institutes of Health. https://pubmed.ncbi.nlm.nih.gov/39931425/
