Improved participants’ understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study

Abstract

PurposeThis 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).MethodsA 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.ResultsThe 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).ConclusionThe 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.Trial registration: TCTR20140727001

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…”

“…This ICF study planned to enrol 210 parents (with 105 parents in each arm), based on an a priori estimate to detect the hypothesised effect size of 20% difference between two independent proportions of the primary endpoint ( p 1 =0.8 and p 2 =0.6), with the precision and confidence level of 95%, 80% power and allocation ratio of 1, with a continuity correction. This hypothesised effect size was based on the findings in our previous study 19…”

“…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).…”

Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam

“…Developing a consent process with the right amount of information for sufficient understanding continues to be a challenge for researchers, especially with complex study designs. Several methods have been designed to adapt the consent process to specific contexts using, for example, an enhanced consent process that reduces the amount of information presented while maintaining international regulations [3] or rapid ethical assessments prior to development of specific consent processes [4,5]. In a recent review, Gillies (2018) synthesized papers that focused on patient reported measures of consent in clinical trials and found that the majority of measures focused on understanding, not the myriad factors that influence participation, such as decision-making mechanisms [6].…”

Informed Consent: A Complex Process in Iran's Nursing Practice

“…Clients should give their consent voluntarily and should not be impelled to do so. Patients should have a real understanding of the risks that would be involved in their treatment process [16].…”