Developing a simplified consent form for biobanking.

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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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Beskow, Laura M, Joëlle Y Friedman, N Chantelle Hardy, Li Lin and Kevin P Weinfurt (2010). Developing a simplified consent form for biobanking. PLoS One, 5(10). p. e13302. 10.1371/journal.pone.0013302 Retrieved from

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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 Bioethics, Humanities & History of Medicine. Dr. Weinfurt also co-directs the Center for Health Measurement at Duke and is co-director of the Clinical Research Training Program (Masters degree offered through the School of Medicine). Dr. Weinfurt worked as a Special Governmental Employee for the U.S. Food and Drug Administration for four years, helping to create the Patient-Focused Drug Development guidance series. He is also a member of the Secretary's Advisory Committee for Human Research Protections. 

Dr. Weinfurt conducts research on measuring patient-reported outcomes, medical decision making, and bioethics. In addition to conducting research, Dr. Weinfurt has taught undergraduate courses in introductory psychology, judgment and decision making, and the psychology of medical decision making; and graduate courses in multivariate statistics, patient-reported outcomes, and research ethics.

Areas of Expertise: Bioethics, Health Measurement, Health Services Research, and Health Behavior

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