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Developing a Simplified Consent Form for Biobanking
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In: ftp://ftp.ncbi.nlm.nih.gov/pub/pmc/27/1b/PLoS_One_2010_Oct_8_5(10)_e13302.tar.gz
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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.
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URL: http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.351.4499
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