Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant comprehension and satisfaction with traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy. iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant comprehension was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research. Overall, participants demonstrated high comprehension and retention of key human subjects considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant comprehension, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction. Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and comprehension while increasing study reach.

Paul Gross is President and CEO of the CP Research Network, which contributed to the funding of this project. Mr. Gross personally made financial contributions (donations) to CPRN to support this work, but receives no financial compensation related to either. Dr. Noritz has consulted for Abbott Nutrition, unrelated to this project. Dr. Shrader receives research funding from NIH and serves on the National Advisory Board for Medical Rehabilitative Research for NIH/NICHD. The remaining authors declare no conflict of interest.

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Funding Statement MCK was supported by the National Institute of Neurological Disorders and Stroke (NINDS) (1R01 NS106298 and NS127108).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Phoenix Children's IRB reviewed and approved this study as the single IRB. Informed consent was obtained from all participants. Although participant level phenotypic data were not included in our analysis, these de-identified data were obtained for the trio-based genomic study through collaboration with the CPRN registry.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Participant informed consent authorizes sharing of de-identified data with researchers for research purposes only. Anonymized survey data will be made available upon reasonable request to the corresponding author.

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