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eConsent vs. Traditional Consent Among Prospective Biobank Participants: A Randomized Trial.

Randi L Vogt-Yerem¹, Patrick R Heck^1,2, Tamara Gjorgjieva^1,3

¹Department of Bioethics and Decision Sciences, Geisinger College of Health Sciences, Danville, PA, USA.

Medrxiv : the Preprint Server for Health Sciences

|November 24, 2025

Summary

This summary is machine-generated.

Electronic consent (eConsent) offers cost-effective research recruitment and improved equity. A study found eConsent achieved comparable, and potentially better, participant informedness than traditional consent methods.

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Area of Science:

Clinical Research
Informed Consent Process
Health Equity

Background:

Electronic consent (eConsent) presents opportunities for cost-effective scaling of research recruitment and enhanced equity in accessing research benefits.
However, the extent to which eConsent ensures comparable levels of participant informedness relative to traditional consent methods remains an open question.

Purpose of the Study:

To compare the informedness of participants undergoing an electronic consent (eConsent) process versus a traditional, human conversation-based consent process.
To determine if eConsent is non-inferior to traditional consent in terms of participant comprehension.

Main Methods:

A randomized, controlled, non-inferiority trial involving 604 participants (ClinicalTrials.gov ID NCT04131062).
Comparison of a human conversation-based consent process against an eConsent platform, similar to those used in large-scale initiatives like the NIH's All of Us Research Program and Apple ResearchKit studies.

Main Results:

Average comprehension scores for the eConsent group (M = 85.8, SD = 14.7) were non-inferior to those in the traditional consent group (M = 76.5, SD = 22.3).
Statistical analysis indicated a significant difference in comprehension scores (t(600.6) = 9.51, p < .001), favoring the eConsent group.

Conclusions:

The findings suggest that eConsent is a viable and effective alternative or supplement to traditional consent processes.
The study indicates that eConsent may lead to more informed decisions during research enrollment, supporting its broader adoption in clinical research.