Developing a simplified consent form for biobanking.
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.


RESULTS
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.
Center for Genome Ethics, Law and Policy, Duke Institute for Genome Sciences and Policy, Duke University, Durham, North Carolina, United States of America. laura.beskow@duke.edu
Laura M
LM
Beskow
Joëlle Y
JY
Friedman
N Chantelle
NC
Hardy
Li
L
Lin
Kevin P
KP
Weinfurt
D003219:Confidentiality; D003362:Cost-Benefit Analysis; D003920:Diabetes Mellitus / Q000503:physiopathology; D006801:Humans; D007258:Informed Consent; D014015:Tissue Banks