Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies.

Autor:	Norton BY; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Liu J; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Lewis SA; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Magee H; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Kruer TN; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Dinh R; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Bakhtiari S; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Nordlie SH; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Shetty S; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA.; Programs in Behavioral Health, Biomedical Informatics, Molecular & Cellular Biology, and Neuroscience, Arizona State University, Tempe, AZ, USA., Heim J; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA., Nishiyama Y; Programs in Behavioral Health, Biomedical Informatics, Molecular & Cellular Biology, and Neuroscience, Arizona State University, Tempe, AZ, USA., Arango J; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Johnson D; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Seabrooke L; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Shub M; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Rosenberg R; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Shusterman M; Cerebral Palsy Research Network, Greenville, SC, USA., Wisniewski S; Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA., Cooper B; Cerebral Palsy Research Network, Greenville, SC, USA., Rothwell E; Department of Obstetrics & Gynecology, University of Utah, Salt Lake City, UT, USA., Fahey MC; Department of Paediatrics, Monash University, Clayton, VIC, Australia., Shrader MW; Department of Orthopaedics, AI DuPont Children's Hospital, Wilmington, DE, USA., Lennon N; Department of Orthopaedics, AI DuPont Children's Hospital, Wilmington, DE, USA., Oleszek J; Department of Physical Medicine & Rehabilitation, Colorado Children's Hospital, Aurora, CO, USA., Pierce W; Department of Physical Medicine & Rehabilitation, Colorado Children's Hospital, Aurora, CO, USA., Fleming H; Department of Physical Medicine & Rehabilitation, Colorado Children's Hospital, Aurora, CO, USA., Belthur M; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Tinto J; Division of Complex Care, Department of Pediatrics, Nationwide Children's, Colombus, OH, USA., Noritz G; Division of Complex Care, Department of Pediatrics, Nationwide Children's, Colombus, OH, USA., Glader L; Division of Complex Care, Department of Pediatrics, Nationwide Children's, Colombus, OH, USA., Steffan K; Department of Neurology, Washington University, St. Louis, MO, USA., Walker W; Department of Pediatrics, Division of Developmental Medicine, Seattle Children's, Seattle, WA, USA., Grenard D; Department of Pediatrics, Division of Developmental Medicine, Seattle Children's, Seattle, WA, USA., Aravamuthan B; Department of Neurology, Washington University, St. Louis, MO, USA., Bjornson K; Department of Pediatrics, Division of Developmental Medicine, Seattle Children's, Seattle, WA, USA., Joseph M; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA., Gross P; Cerebral Palsy Research Network, Greenville, SC, USA., Kruer MC; Barrow Neurological Institute, Phoenix Children's, Phoenix, AZ USA.; Departments of Child Health, Cellular & Molecular Medicine, Neurology and Program in Genetics, University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA.; Programs in Behavioral Health, Biomedical Informatics, Molecular & Cellular Biology, and Neuroscience, Arizona State University, Tempe, AZ, USA.
Jazyk:	angličtina
Zdroj:	MedRxiv : the preprint server for health sciences [medRxiv] 2024 May 03. Date of Electronic Publication: 2024 May 03.
DOI:	10.1101/2024.05.01.24306461
Abstrakt:	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. Competing Interests: Conflicts of Interest 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.
Databáze:	MEDLINE
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