title: Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention.
abstract: To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension.
  
  
  
  We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that topic.
  
  
  
  Consistent with our first hypothesis, comprehension among those who received the simplified form was not inferior to that among those who received the traditional form. Contrary to expectations, receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group. The review/retest procedure significantly improved quiz scores in every combination of consent form and education level. Although improved, comprehension remained a challenge in the lowest-education group. Higher quiz scores were significantly associated with willingness to participate.
  
  
  
  Ensuring consent comprehension remains a challenge, but simplified forms have virtues independent of their impact on understanding. A review/retest intervention may have a significant effect, but assessing comprehension raises complex questions about setting thresholds for understanding and consequences of not meeting them.Genet Med advance online publication 13 October 2016.
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.|Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Beskow
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Lin
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Carrie B
authors.initials: CB
authors.lastname: Dombeck
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Emily
authors.identifier: 0000-0003-4269-1025
authors.initials: E
authors.lastname: Gao
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.|Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Weinfurt
mesh_terms: D000328:Adult; D017677:Age Distribution; D018070:Biological Specimen Banks; D032882:Comprehension; D032962:Consent Forms; D005260:Female; D006801:Humans; D007258:Informed Consent; D020407:Internet; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D011795:Surveys and Questionnaires; D055815:Young Adult