title: A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.
abstract: Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants' understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, including those for trials involving treatment of genetic disorders. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time.
authors.affiliation: Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, Wisconsin.
authors.forename: Andrea N
authors.initials: AN
authors.lastname: Mahnke
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Plasek
authors.forename: David G
authors.initials: DG
authors.lastname: Hoffman
authors.forename: Nathan S
authors.initials: NS
authors.lastname: Partridge
authors.forename: Wendy S
authors.initials: WS
authors.lastname: Foth
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Waudby
authors.forename: Luke V
authors.initials: LV
authors.lastname: Rasmussen
authors.forename: Valerie D
authors.initials: VD
authors.lastname: McManus
authors.forename: Catherine A
authors.initials: CA
authors.lastname: McCarty
mesh_terms: D000368:Aged; D032882:Comprehension; D032962:Consent Forms; D005260:Female; D017144:Focus Groups; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D057285:Precision Medicine; D035842:Research Subjects; D011795:Surveys and Questionnaires; D014584:User-Computer Interface
keywords: computer-based informed consent; decision making; focus groups; genetic research; usability