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Abstract
Objective This study aimed to test 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 neonatal research requiring maternal consent.
Design A single-centre open-label randomised controlled study.
Setting Antenatal care clinics at Phramongkutklao Hospital, Thailand.
Patients 234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study.
Interventions The participants were randomly assigned to read either the SIDCER ICF or the conventional ICF.
Main outcome measures The participants’ understanding of essential trial-related information was assessed using 25 closed-ended questions. The primary endpoint was the proportion of the participants who obtained the satisfactory level of understanding at 80% (score of ≥20/25).
Results 72.5% (87/120) of the participants in the SIDCER ICF group and 59.8% (67/112) of the conventional ICF group achieved the primary endpoint (relative risk (RR)=1.212, 95% CI 1.005 to 1.462, p=0.041). The superiority of the SIDCER ICF over the conventional ICF was significant, particularly among the participants whose education was at the high school level or below (63.5% vs 44.1%, RR=1.441, 95% CI 1.022 to 2.030, p=0.031).
Conclusions The SIDCER ICF methodology is applicable to neonatal research requiring maternal consent. The SIDCER ICF significantly improved the understanding of pregnant women, particularly among those with lower levels of education. The present study confirms the value of the SIDCER ICF methodology in research involving individuals with a limited academic background.
- parental consent
- consent forms
- newborn
- neonatal research
- pregnant women
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Footnotes
Contributor The studywas designed by NK, CT, SC and JK and conducted by CT, SC, PR and YT. Dataanalysis was done by NK and JK. The manuscript was written by NK and JK withcontributions from all authors. All authors approved the final versionsubmitted.
Contributors The study was designed by NK, CT, SC and JK and conducted by CT, SC, PR and YT. Data analysis was done by NK and JK. The manuscript was written by NK and 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 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
Ethics approval Institutional Review Board of Royal Thai Army Medical Department.
Provenance and peer review Not commissioned; externally peer reviewed.