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Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial
  1. Nut Koonrungsesomboon1,
  2. Chanchai Traivaree2,
  3. Charnunnut Tiyapsane2,
  4. Juntra Karbwang3
  1. 1 Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
  2. 2 Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand
  3. 3 Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan
  1. Correspondence to Dr Juntra Karbwang; Jkarbwang{at}


Objective This study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.

Design A prospective, randomized, controlled design.

Setting Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand.

Participants 210 parents of children with thalassemia (age=35.6 ± 13.1 years).

Interventions The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.

Primary and secondary outcome measures Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.

Results Forty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).

Conclusions The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.

  • informed consent
  • parental consent
  • pediatrics
  • consent forms
  • comprehension

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  • Contributors The study was designed by NK and JK, and conducted by CTr and CTi. Data analysis was done by NK. The manuscript was written by NK and revised by JK, with contributions from all authors. All authors approved the final version submitted.

  • Funding This study was partially supported by Phramongkutklao Hospital and Phramongkutklao College of Medicine, Chiang Mai University, and TDR, the Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank, and WHO through the Forum for Ethical Review Committees in the Asian and Western Pacific region (FERCAP). The funding sources had no role in the analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit this manuscript for publication.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study was approved by the Institutional Review Board of Royal Thai Army Medical Department (No. IRB/RTA1200/2557). Informed consent was obtained by action.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

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