Developing a simplified consent form for biobanking.
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.
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https://hdl.handle.net/10161/4577Published Version (Please cite this version)
10.1371/journal.pone.0013302Publication 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.
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Show full item recordScholars@Duke
Laura Mari Beskow
Professor in Medicine
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
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