Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies Article Swipe
Bethany Y. Norton
,
James Liu
,
Sara A. Lewis
,
Helen Magee
,
Tyler N. Kruer
,
Rachael Dinh
,
Somayeh Bakhtiari
,
Sandra H. Nordlie
,
Sheetal Shetty
,
Jennifer Heim
,
Yumi Nishiyama
,
Jorge Arango
,
Darcy Johnson
,
Lee Seabrooke
,
Mitchell Shub
,
Robert B. Rosenberg
,
Michele Shusterman
,
Stephen R. Wisniewski
,
Blair Cooper
,
Erin Rothwell
,
Michael Fahey
,
M. Wade Shrader
,
Nancy Lennon
,
Joyce Oleszek
,
Wendy Pierce
,
Hannah Fleming
,
Mohan V. Belthur
,
Jennifer Tinto
,
Garey Noritz
,
Laurie Glader
,
Kelsey Steffan
,
W. Walker
,
Deborah Grenard
,
Bhooma R. Aravamuthan
,
Kristie Bjornson
,
Malin Joseph
,
Paul Gross
,
Michael C. Kruer
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1101/2024.05.01.24306461
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1101/2024.05.01.24306461
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.
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Metadata
- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.1101/2024.05.01.24306461
- https://www.medrxiv.org/content/medrxiv/early/2024/05/03/2024.05.01.24306461.full.pdf
- OA Status
- green
- Cited By
- 1
- References
- 41
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4396642400
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4396642400Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1101/2024.05.01.24306461Digital Object Identifier
- Title
-
Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studiesWork title
- Type
-
preprintOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-05-03Full publication date if available
- Authors
-
Bethany Y. Norton, James Liu, Sara A. Lewis, Helen Magee, Tyler N. Kruer, Rachael Dinh, Somayeh Bakhtiari, Sandra H. Nordlie, Sheetal Shetty, Jennifer Heim, Yumi Nishiyama, Jorge Arango, Darcy Johnson, Lee Seabrooke, Mitchell Shub, Robert B. Rosenberg, Michele Shusterman, Stephen R. Wisniewski, Blair Cooper, Erin Rothwell, Michael Fahey, M. Wade Shrader, Nancy Lennon, Joyce Oleszek, Wendy Pierce, Hannah Fleming, Mohan V. Belthur, Jennifer Tinto, Garey Noritz, Laurie Glader, Kelsey Steffan, W. Walker, Deborah Grenard, Bhooma R. Aravamuthan, Kristie Bjornson, Malin Joseph, Paul Gross, Michael C. KruerList of authors in order
- Landing page
-
https://doi.org/10.1101/2024.05.01.24306461Publisher landing page
- PDF URL
-
https://www.medrxiv.org/content/medrxiv/early/2024/05/03/2024.05.01.24306461.full.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
-
https://www.medrxiv.org/content/medrxiv/early/2024/05/03/2024.05.01.24306461.full.pdfDirect OA link when available
- Concepts
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Informed consent, Stakeholder, Psychology, Data science, Engineering ethics, Computer science, Political science, Engineering, Medicine, Public relations, Alternative medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1Per-year citation counts (last 5 years)
- References (count)
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41Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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