title: Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa.
abstract: OBJECTIVE
  Informed consent and understanding are essential ethical requirements for clinical trial participation. Traditional binary measures of understanding may be limited and not be the best measures of level of understanding. This study designed and compared 4 measures of understanding for potential participants being prepared for enrollment in South African HIV vaccine trials, using detailed operational scoring criteria.
  
  
  METHODS
  Assessment of understanding of 7 key trial components was compared via self-report, checklist, vignettes, and narrative measures. Fifty-nine participants, including members of vaccine preparedness groups and 1 HIV vaccine trial, took part.
  
  
  RESULTS
  There were significant differences across the measures for understanding of 5 components and for overall understanding. Highest scores were obtained on self-report and checklist measures, and lowest scores were obtained for vignettes and narrative descriptions.
  
  
  CONCLUSIONS
  The findings suggest that levels of measured understanding are dependent on the tools used. Forced-choice measures like checklists tend to yield higher scores than open-ended measures like narratives or vignettes. Consideration should be given to complementing checklists and self-reports with open-ended measures, particularly for critical trial concepts, where the consequences of misunderstanding are potentially severe.
authors.affiliation: HIV AIDS Vaccines Ethics Group, School of Psychology, University of KwaZulu-Natal, Pietermaritzburg, Private Bag X01, Scottsville 3209, South Africa. lindegger@ukzn.ac.za
authors.forename: Graham
authors.initials: G
authors.lastname: Lindegger
authors.forename: Cecilia
authors.initials: C
authors.lastname: Milford
authors.forename: Catherine
authors.initials: C
authors.lastname: Slack
authors.forename: Michael
authors.initials: M
authors.lastname: Quayle
authors.forename: Xolani
authors.initials: X
authors.lastname: Xaba
authors.forename: Eftyhia
authors.initials: E
authors.lastname: Vardas
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology*; D032882:Comprehension; D003625:Data Collection / Q000379:methods / Q000592:standards; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007258:Informed Consent / Q000523:psychology* / Q000592:standards; D010865:Pilot Projects; D012309:Risk-Taking; D013019:South Africa; D011795:Surveys and Questionnaires / Q000592:standards*
chemical_list: D016915:AIDS Vaccines