Abstract
BackgroundSince January 2008, the National Institutes of Health (NIH) has required that all investigators who receive NIH support submit de-identified high-throughput genomic data to the database of Genotypes and Phenotypes (dbGaP). The purpose of this study was to explore the feasibility of re-consenting participants from three inactive studies, conducted from 2000 through 2009, to submit their data to dbGaP.MethodsParticipants were those enrolled in one of three prior population-based case-control studies of lung cancer who had given a DNA sample. Consent to release de-identified data to dbGaP took place via mailed forms and follow-up phone calls. Chi-squared tests were used to examine differences in re-contact and consent proportions between groups.ResultsA total of 2,471 participants were initially eligible for re-contact. Six hundred and thirty-eight participants were found to be deceased (n = 627) or did not give permission to re-contact (n = 11). Of the 1,833 remaining participants, 42.3% provided written consent, 37.0% could not be located, 13.7% verbally agreed to have their data released but never returned written consent, 5.3% refused, and 1.6% were too ill at the time of contact. There were significant differences in ability to locate participants by age, race, gender, and case-control status; however, once located, there were no differences in re-consent rates.ConclusionThis study demonstrates that while most previous study participants agreed to release data, a small proportion are opposed to submitting their data to dbGaP. In addition, it demonstrates the difficulty studies based on existing samples may have in locating inactive participants for re-consent.
Highlights
Since January 2008, the National Institutes of Health (NIH) has required that all investigators who receive NIH support submit de-identified high-throughput genomic data to the database of Genotypes and Phenotypes
We attempted to re-consent participants who had given a blood sample in the original study to allow future genome-wide association studies (GWAS) data to be submitted to an NIH central repository, database of Genotypes and Phenotypes (dbGaP)
Of the 1,833 where recontacted was attempted, 42.3% (n = 775) consented to have their data submitted to dbGaP, 37.0% (n = 678) could not be located, 13.7% (n = 252) told interviewers that they planned to return the consent form in the future but never did, 5.3% (n = 98) refused, and 1.6% (n = 30) were too sick to respond
Summary
Since January 2008, the National Institutes of Health (NIH) has required that all investigators who receive NIH support submit de-identified high-throughput genomic data to the database of Genotypes and Phenotypes (dbGaP). Starting in January 2008, the National Institutes of Health (NIH) has required NIH-supported studies which generate high-throughput genomic data to submit their de-identified data to the database of Genotypes and Phenotypes (dbGaP) [1,2]. Many current genome-wide association studies (GWAS) include individuals who have only consented to aims of the original study, meaning that it may be necessary to re-contact participants. Similar to the ACT study, all three studies drafted their original consent forms prior to the NIH mandate that genomic research with NIH support be sent to the dbGaP. We explored re-consent feasibility and the willingness of study participants to submit their genomic data to dbGaP
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