Improved pregnant women’s understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research

Abstract

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.

Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial

“…The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of several elements of the ICF content. The overall results of this study are consistent with three previous informed consent studies that exhibited the improvement of participants’ understanding by the SIDCER ICF 17 19 20. In line with a recent integrative review on informed consent, it is reasonable to assume that the evidence of improved participants’ understanding by the SIDCER ICF is largely attributable to its simplicity and concise format with increased processability (using summary boxes, highlights and illustrations, when appropriate) 23…”

“…Deficiencies in understanding were still prevalent even among those who read the SIDCER ICF. Moreover, we have noticed that the level of parental understanding in this study is apparently lower than our observations in the previous ICF studies involving other groups of populations 17 19 20. Continued consideration of the normative and practical aspects of informed consent is needed in an attempt to facilitate understanding among parents who act as proxies for their child’s participation in research 28 29.…”

“…Parental understanding of essential research-related information was measured using the questionnaire (in Thai), which was modified from our previous studies 17 19 20. It consisted of 24 scenario-based questions which assessed parental understanding of relevant ICF content in the following categories: general items (five questions), patient’s rights (four questions), scientific aspects (eight questions) and ethics aspects (seven questions).…”

Can we make informed consent forms more informative?

“…In this issue of Archives of Disease in Childhood, Fetal Neonatal Edition, Koonrungsesomboon et al present results of their randomized clinical trial of a novel informed consent form based on the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). [4] The SIDCER outlines three basic principles for an informed consent form: it contains all required elements for relevant ethical regulations and guidelines; it provides only the relevant information for a subject’s decision making on study participation; it presents information in a simple format to convey the relevant information to the target population. [5]…”