Skip to main content
Duke University Libraries
DukeSpace Scholarship by Duke Authors
  • Login
  • Ask
  • Menu
  • Login
  • Ask a Librarian
  • Search & Find
  • Using the Library
  • Research Support
  • Course Support
  • Libraries
  • About
View Item 
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Developing a simplified consent form for biobanking.

Thumbnail
View / Download
96.1 Kb
Date
2010-10-08
Authors
Beskow, Laura M
Friedman, Joëlle Y
Hardy, N Chantelle
Lin, Li
Weinfurt, Kevin P
Repository Usage Stats
246
views
183
downloads
Abstract
BACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.
Type
Journal article
Subject
Confidentiality
Cost-Benefit Analysis
Diabetes Mellitus
Humans
Informed Consent
Tissue Banks
Permalink
https://hdl.handle.net/10161/4577
Published Version (Please cite this version)
10.1371/journal.pone.0013302
Publication Info
Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; & Weinfurt, Kevin P (2010). Developing a simplified consent form for biobanking. PLoS One, 5(10). pp. e13302. 10.1371/journal.pone.0013302. Retrieved from https://hdl.handle.net/10161/4577.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
  • Scholarly Articles
More Info
Show full item record

Scholars@Duke

Laura Mari Beskow

Professor in Medicine
Weinfurt

Kevin Phillip Weinfurt

James B. Duke Distinguished Professor of Population Health Sciences
Kevin P. Weinfurt, PhD, is Professor and Vice Chair of Research in the Department of Population Health Sciences at Duke University Medical Center and a faculty member of the Duke Clinical Research Institute. He holds secondary appointment as a Professor of Psychology and Neuroscience, Professor of  Psychiatry and Behavioral Sciences, Professor of Biostatistics and Bioinformatics, and a Faculty Associate of the Trent Center for the Study of Medical Humanities and Bioethics. Dr. Weinf
Alphabetical list of authors with Scholars@Duke profiles.
Open Access

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

Rights for Collection: Scholarly Articles


Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info

Make Your Work Available Here

How to Deposit

Browse

All of DukeSpaceCommunities & CollectionsAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit DateThis CollectionAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit Date

My Account

LoginRegister

Statistics

View Usage Statistics
Duke University Libraries

Contact Us

411 Chapel Drive
Durham, NC 27708
(919) 660-5870
Perkins Library Service Desk

Digital Repositories at Duke

  • Report a problem with the repositories
  • About digital repositories at Duke
  • Accessibility Policy
  • Deaccession and DMCA Takedown Policy

TwitterFacebookYouTubeFlickrInstagramBlogs

Sign Up for Our Newsletter
  • Re-use & Attribution / Privacy
  • Harmful Language Statement
  • Support the Libraries
Duke University