title: Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process.
abstract: The US Department of Health and Human Services addresses clear communication in the informed consent process as part of the Notice of Proposed Rulemaking for revisions to the Common Rule. However, prior research has shown that participants may not fully comprehend research studies despite completion of an informed consent process. Our main goal was to provide plain language information about donation processes to a cancer biobank to supplement an informed consent form. We developed and conducted cognitive testing with supplemental brochures that clearly communicated information about three different models for consent (notice, broad and study-specific) to future use of biospecimens. During the brochure development process, we conducted qualitative, semi-structured, individual, in-person cognitive interviews among 14 women to examine participants' perceptions of the brochures. Each participant provided feedback regarding the understandability, graphics and layout, and cultural appropriateness of the brochures. Our findings demonstrate that these methods may be used to tailor consent form brochures, such as the ones developed here, to other populations. This study therefore adds to our understanding of how best to present content to help women from two different racial groups make informed decisions about participation in a cancer biobank.
authors.affiliation: Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA. drakeb@wudosis.wustl.edu.|Alvin J. Siteman Cancer Center, St. Louis, MO, 63110, USA. drakeb@wudosis.wustl.edu.
authors.forename: Bettina F
authors.initials: BF
authors.lastname: Drake
authors.affiliation: Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA.
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Brown
authors.affiliation: Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA.|Alvin J. Siteman Cancer Center, St. Louis, MO, 63110, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Gehlert
authors.affiliation: Center for Law Health and Society, Georgia State University College of Law, 85 Park Place NE, Atlanta, GA, 30303, USA.
authors.forename: Leslie E
authors.initials: LE
authors.lastname: Wolf
authors.affiliation: Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA.
authors.forename: Joann
authors.initials: J
authors.lastname: Seo
authors.affiliation: Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA.
authors.forename: Hannah
authors.initials: H
authors.lastname: Perkins
authors.affiliation: Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA.|Alvin J. Siteman Cancer Center, St. Louis, MO, 63110, USA.
authors.forename: Melody S
authors.initials: MS
authors.lastname: Goodman
authors.affiliation: Department of Communication, University of Utah, 255 S. Central Campus Dr., Salt Lake City, UT, 84112-0491, USA.|Huntsman Cancer Institute, 2000 Circle of Hope Drive, Salt Lake City, UT, 84112, USA.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Kaphingst
mesh_terms: D000328:Adult; D001741:Black or African American; D018070:Biological Specimen Banks / Q000706:statistics & numerical data*; D032882:Comprehension; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D007802:Language; D008875:Middle Aged; D010174:Pamphlets; D014481:United States; D044465:White People
keywords: Biorepository; Cancer; Consent models; Minority; Plain language