Clinical trial · Interventional
Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants
Randomized Trial to Determine Whether eConsent is Non-Inferior to Standard Consent Among Prospective Biobank Participants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this trial is to determine whether the Sage eConsent framework (presented using an electronic application) is non-inferior to traditional, paper-based, human-mediated consent-and therefore could be part of an acceptable population screening approach to identifying patients and others with actionable hereditary syndromes-and to increase basic knowledge about patients' informational needs about different aspects of genetic/omic screening. After receiving either 1) the traditional consenting approach, or 2) a consenting approach presented on an electronic tablet, the investigators will test for differences between these two arms in a variety of outcome measures including objective and perceived comprehension, time spent and informational needs, and enrollment decision, among others.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Consent (iPad) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control (no intervention)
- description
- Consented using the traditional, human-mediated consent process already in use for MyCode consenting.
- type
- EXPERIMENTAL
- label
- Electronic Consent (iPad)
- description
- Consented using the Sage eConsent framework, which presents participants with an iPad that describes MyCode and allows participants to choose to learn more information at various steps along the process.
- interventionNames
- Behavioral: Electronic Consent (iPad)
Primary outcomes (11)
- measure
- Mean objective comprehension: eConsent vs. control
- timeFrame
- Immediately after consent decision
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * None Exclusion Criteria: * None
References
Publications (2)
- DERIVEDVogt-Yerem RL, Heck PR, Gjorgjieva T, Mestechkin R, Rosica D, Huynh A, Chabris CF, Kirchner HL, Wilbanks J, Doerr M, Wagner JK, Meyer MN. eConsent vs traditional consent among prospective biobank participants: a randomized study within a study trial. NPJ Digit Public Health. 2026;1(1):9. doi: 10.1038/s44482-026-00013-x. Epub 2026 Apr 29. PMID 42078573
- DERIVEDVogt-Yerem RL, Heck PR, Gjorgjieva T, Mestechkin R, Rosica D, Huynh A, Chabris CF, Kirchner HL, Wilbanks J, Doerr M, Wagner JK, Meyer MN. eConsent vs. Traditional Consent Among Prospective Biobank Participants: A Randomized Trial. medRxiv [Preprint]. 2025 Nov 2:2025.10.30.25339179. doi: 10.1101/2025.10.30.25339179. PMID 41282898