title: Improving the Proficiency of Research Consent Administrators.
abstract: OBJECTIVE
  To describe the development and testing of a module to improve consent administrators' skills when obtaining research consent from culturally and linguistically diverse and low literacy populations.
  
  
  METHODS
  Development and psychometric testing of video module including community vignettes.
  
  
  METHODS
  Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre- and postknowledge tests and satisfaction surveys completed by 112 consent administrators.
  
  
  RESULTS
  Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t-test 95% confidence interval of difference: -0.18 to -0.88; two-tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0-35), but years of experience was not significantly associated with either pre- or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made.
  
  
  CONCLUSIONS
  Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training.
authors: School of Nursing, Mailman School of Public Health, Columbia University, New York, New York, USA.
authors: Elaine L
authors: EL
authors: Larson
authors: Human Research Protection Office, Columbia University, New York, New York, USA.
authors: Rachel
authors: R
authors: Lally
authors: School of Continuing Studies, Columbia University, New York, New York, USA.
authors: Gabriella
authors: G
authors: Foe
authors: The City College of New York, New York, New York, USA.
authors: Gabriela
authors: G
authors: Joaquin
authors: Community Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York, USA.
authors: Dodi D
authors: DD
authors: Meyer
authors: Center for Health Innovation, Adelphi University, Garden City, New York, USA.|School of Nursing, Columbia University, New York, New York, USA.
authors: Elizabeth G
authors: EG
authors: Cohn
mesh_terms: D035843:Biomedical Research; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent
keywords: biomedical ethics; clinical research; health literacy; informed consent