title: Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.
abstract: OBJECTIVE
  Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants.
  
  
  METHODS
  Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants.
  
  
  RESULTS
  A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment.
  
  
  CONCLUSIONS
  These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.
authors.affiliation: Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
authors.forename: E
authors.initials: E
authors.lastname: Denning
authors.forename: S
authors.initials: S
authors.lastname: Sharma
authors.forename: M
authors.initials: M
authors.lastname: Smolskis
authors.forename: G
authors.initials: G
authors.lastname: Touloumi
authors.forename: S
authors.initials: S
authors.lastname: Walker
authors.forename: A
authors.initials: A
authors.lastname: Babiker
authors.forename: M
authors.initials: M
authors.lastname: Clewett
authors.forename: E
authors.initials: E
authors.lastname: Emanuel
authors.forename: E
authors.initials: E
authors.lastname: Florence
authors.forename: A
authors.initials: A
authors.lastname: Papadopoulos
authors.forename: A
authors.initials: A
authors.lastname: Sánchez
authors.forename: J
authors.initials: J
authors.lastname: Tavel
authors.forename: C
authors.initials: C
authors.lastname: Grady
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D008297:Male; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents
keywords: START trial; informed consent