title: Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.
abstract: BACKGROUND
  Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial.
  
  
  METHODS
  In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh.
  
  
  RESULTS
  Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care.
  
  
  CONCLUSIONS
  There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.
authors.forename: Debashish
authors.initials: D
authors.lastname: Das
authors.forename: Phaik Yeong
authors.initials: PY
authors.lastname: Cheah
authors.forename: Fateha
authors.initials: F
authors.lastname: Akter
authors.forename: Dulal
authors.initials: D
authors.lastname: Paul
authors.forename: Akhterul
authors.initials: A
authors.lastname: Islam
authors.forename: Abdullah A
authors.initials: AA
authors.lastname: Sayeed
authors.forename: Rasheda
authors.initials: R
authors.lastname: Samad
authors.forename: Ridwanur
authors.initials: R
authors.lastname: Rahman
authors.forename: Amir
authors.initials: A
authors.lastname: Hossain
authors.forename: Arjen
authors.initials: A
authors.lastname: Dondorp
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Day
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: White
authors.forename: Mahtabuddin
authors.initials: M
authors.lastname: Hasan
authors.forename: Aniruddha
authors.initials: A
authors.lastname: Ghose
authors.affiliation: Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd,, Bangkok 10400, Thailand. liz@tropmedres.ac.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Ashley
authors.forename: Abul
authors.initials: A
authors.lastname: Faiz
mesh_terms: D000293:Adolescent; D000328:Adult; D001459:Bangladesh; D002986:Clinical Trials as Topic; D032882:Comprehension; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D007407:Interviews as Topic; D008288:Malaria / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010465:Perception; D055815:Young Adult