title: A cognitive approach for design of a multimedia informed consent video and website in pediatric research.
abstract: Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents.
  
  
  
  A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial.
  
  
  
  A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization).
  
  
  
  Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives.
  
  
  
  New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials.
authors.affiliation: Division of Psychiatry and Psychology, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: holly.antal@nemours.org.
authors.forename: Holly
authors.initials: H
authors.lastname: Antal
authors.affiliation: Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: tim.bunnell@nemours.org.
authors.forename: H Timothy
authors.initials: HT
authors.lastname: Bunnell
authors.affiliation: Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: Suzanne.mccahan@nemours.org.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: McCahan
authors.affiliation: Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: chris.pennington@nemours.org.
authors.forename: Chris
authors.initials: C
authors.lastname: Pennington
authors.affiliation: Center for Health Care Delivery Science, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: tim.wysocki@nemours.org.
authors.forename: Tim
authors.initials: T
authors.lastname: Wysocki
authors.affiliation: Center for Pharmacogenomics and Translational Research, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: kathryn.blake@nemours.org.
authors.forename: Kathryn V
authors.initials: KV
authors.lastname: Blake
mesh_terms: D000293:Adolescent; D001249:Asthma; D035843:Biomedical Research; D002648:Child; D002986:Clinical Trials as Topic; D032882:Comprehension; D006801:Humans; D007258:Informed Consent; D020407:Internet; D019212:Multimedia; D012107:Research Design; D014584:User-Computer Interface; D014741:Video Recording
keywords: Electronic; Informed consent; Learning theory; Multimedia; Video; Website