title: Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study.
abstract: OBJECTIVE
  This study aimed to evaluate the applicability of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in a clinical pharmacokinetic study by comparing the volunteers' understanding of the enhanced ICF (developed based on the SIDCER methodology) and the conventional ICF (which was previously approved by local Ethics Committee and used in the clinical study).
  
  
  METHODS
  A total of 550 volunteers were randomly assigned to read either the enhanced ICF or the conventional ICF (1:1) in a mock informed consent approach and subsequently performed the post-test questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥ 80 %; the secondary endpoints were the total score of the post-test, the score of the categorized ICF elements, and time spent for participation.
  
  
  RESULTS
  The proportion of the participants in the enhanced ICF group who achieved the primary endpoint was significantly higher than the conventional ICF group (82.2 % vs. 60.4 %, p < 0.001). The participants in the enhanced ICF group obtained higher scores and spent less time in reading the given ICF and answering the post-test than those in the conventional ICF group (total score 19/21 vs. 18/21, p < 0.001; time spent 20 min vs. 25 min, p < 0.001).
  
  
  CONCLUSIONS
  The enhanced ICF improved the understanding of the participants in this study. This demonstrates the applicability of the SIDCER ICF principles and its template in the development of an enhanced ICF for improving the quality of ICFs and subjects' understanding in clinical research.
  
  
  BACKGROUND
  TCTR20140727001.
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan.|Leading Program, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
authors.forename: Nut
authors.initials: N
authors.lastname: Koonrungsesomboon
authors.affiliation: Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
authors.forename: Supanimit
authors.initials: S
authors.lastname: Teekachunhatean
authors.affiliation: Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
authors.forename: Nutthiya
authors.initials: N
authors.lastname: Hanprasertpong
authors.affiliation: Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Junjira
authors.initials: J
authors.lastname: Laothavorn
authors.affiliation: Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Kesara
authors.initials: K
authors.lastname: Na-Bangchang
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. karbwangj@nagasaki-u.ac.jp.
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D035843:Biomedical Research / Q000941:ethics; D032882:Comprehension; D032962:Consent Forms; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D012107:Research Design; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Clinical research; Clinical study; Healthy subjects; Healthy volunteers; Informed consent; Understanding