On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup...

Area of Science:

• Clinical Research Informatics
• Pediatric Biobanking
• Informed Consent Technology

Background:

• Informed consent is essential for clinical trials and biobanking, especially in pediatric studies requiring assent from minors and consent from guardians.
• Electronic consent systems offer potential benefits like error reduction and streamlined documentation of multiple consents.
• Integrating electronic consent into existing research infrastructure presents challenges.

Purpose of the Study:

• To evaluate the usability of the generic Informed Consent Service (gICS) for electronic consent in pediatric studies.
• To assess the integration capabilities of gICS within a multi-user, multi-study research environment.
• To compare the error rates of electronic versus paper-based consent processes.

Main Methods:

• A 54-week study involving 1061 children and adolescents (ages 3-17) at a pediatric research setting.
• Utilized the gICS for electronic consent and assent, with separate paper-based consent for biobanking.
• Analyzed 2066 total consents/assents (945 paper-based, 1121 electronic).

Main Results:

• Electronic consent significantly reduced error susceptibility by 94.7% compared to paper-based methods.
• The gICS system was successfully implemented and integrated into the existing research infrastructure.
• 1121 electronic consents and 945 paper-based consents were collected, including 348 participants for biobanking.

Conclusions:

• The gICS is a viable and effective tool for electronic consent in pediatric research, including complex scenarios like biobanking.
• Electronic consent systems demonstrably improve data integrity and reduce errors in pediatric clinical trials.
• Successful implementation highlights the potential of gICS for broader application in various research studies.