Wanda Montalvo|Elaine Larson
Participant Comprehension of Research for Which They Volunteer: A Systematic Review
Columbia University|Columbia University
abstract purpose evidence indicates research participants often fully understand studies volunteered aim systematic review examine relationship process obtaining informed consent research participant comprehension satisfaction research design systematic review published research informed consent participant comprehension research volunteer using preferred reporting items systematic review metaanalysis prisma statement guide methods pubmed cumulative index nursing allied health literature cochrane central register controlled trails cochrane database systematic reviews used search literature studies meeting following inclusion criteria published january 1 2006 december 31 2013 b interventional descriptive quantitative design c published peerreviewed journal written english e assessed participant comprehension satisfaction research process studies assessed quality using seven indicators sampling method use controls comparison groups response rate description intervention description outcome statistical method health literacy assessment findings 176 studies identified 27 met inclusion criteria 13 48 randomized interventional designs 14 52 descriptive three categories studies included projects assessing enhanced consent process form b multimedia methods c education improve participant understanding 78 used investigatordeveloped tools assess participant comprehension assess participant health literacy 74 assess readability level consent form 89 researchers found participants lacked basic understanding research elements randomization placebo risks therapeutic misconception conclusions findings indicate inconsistent assessment participant reading health literacy level b measurement variation associated use nonstandardized tools c continued therapeutic misconception lack understanding among research participants randomization placebo benefit risk agency healthcare quality national quality forum published informed consent authorization toolkits previously published validated tools underutilized clinical relevance informed consent requires assessment health literacy reading level comprehension research participants using validated assessment tools methods