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Chunk #11 — Results

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To share or not to share: a randomized trial of consent for data sharing in genome research.
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Three hundred seventy-eight individuals were approached for recruitment into one of the six genomic studies; 42 were deemed ineligible or chose not to enroll and were removed from the randomization. A total of 349 experimental consent documents were randomized to 336 individual participants (Figure 1). Most of the participants were either consenting adult patients or parents or guardians of pediatric patients. Two of the genomic studies (autism and epilepsy) also enrolled patients’ family members to serve as matched case controls. Parents of pediatric patients who enrolled as matched case controls made two consent choices, one for their child who was the primary subject (i.e., parental consent) and one for themselves as a matched case control (i.e., adult/self consent); these cases were treated as a single participant making two distinct decisions (n=13). All participating members of the same family were randomized to the same experimental consent document (n=18 families comprised of 34 individuals making 47 distinct decisions).