title: Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.
abstract: OBJECTIVE
  This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions.
  
  
  METHODS
  A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test.
  
  
  RESULTS
  The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001).
  
  
  CONCLUSIONS
  The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.
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, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan.
authors.forename: Nut
authors.initials: N
authors.lastname: Koonrungsesomboon
authors.affiliation: Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Thipaporn
authors.initials: T
authors.lastname: Tharavanij
authors.affiliation: Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Kittichet
authors.initials: K
authors.lastname: Phiphatpatthamaamphan
authors.affiliation: Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Ratha-Korn
authors.initials: RK
authors.lastname: Vilaichone
authors.affiliation: Department of Anesthesiology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Sudsayam
authors.initials: S
authors.lastname: Manuwong
authors.affiliation: Department of Anesthesiology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Parichat
authors.initials: P
authors.lastname: Curry
authors.affiliation: Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Sith
authors.initials: S
authors.lastname: Siramolpiwat
authors.affiliation: Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Thanachai
authors.initials: T
authors.lastname: Punchaipornpon
authors.affiliation: Department of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Supakit
authors.initials: S
authors.lastname: Kanitnate
authors.affiliation: Department of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Nattapol
authors.initials: N
authors.lastname: Tammachote
authors.affiliation: Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Rodsarin
authors.initials: R
authors.lastname: Yamprasert
authors.affiliation: Department of Otolaryngology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Waipoj
authors.initials: W
authors.lastname: Chanvimalueng
authors.affiliation: Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Ruchirat
authors.initials: R
authors.lastname: Kaewkumpai
authors.affiliation: Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Soiphet
authors.initials: S
authors.lastname: Netanong
authors.affiliation: Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Peerapong
authors.initials: P
authors.lastname: Kitipawong
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.|Center of Excellence in Applied Epidemiology, Thammasat University, Pathum Thani, 12121, Thailand.
authors.forename: Paskorn
authors.initials: P
authors.lastname: Sritipsukho
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; D000369:Aged, 80 and over; D035843:Biomedical Research; D032882:Comprehension; D032962:Consent Forms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D011795:Surveys and Questionnaires; D013785:Thailand; D055815:Young Adult
keywords: Clinical studies; Clinical trials; Comprehension; Consent forms; Informed consent; Understanding