JMIR Publications

ABSTRACT

Background:

The i-CONSENT project aims to improve the comprehensibility of informed consent materials tailored to specific populations, ensuring clear communication with clinical research participants. The study focuses on the evaluation of electronic informed consent materials created following the guidelines developed in the i-CONSENT project for minors, pregnant women and adults.

Objective:

This study aims to assess understanding and satisfaction with electronic informed consent materials adapted for three different populations: minors, pregnant women and adults, in Spain, the UK and Romania. The materials were developed in accordance with the "Guidelines for adapting the informed consent process in clinical trials".

Methods:

A total of 1757 participants were recruited and exposed to digital informed consent materials, including websites, videos and infographics, tailored for their specific population. Comprehension was measured using customised versions of the Quality of Informed Consent (QuIC) questionnaire for each group. Statistical analyses were conducted to assess differences in comprehension as a function of demographic variables, such as age, gender and prior clinical trial participation.

Results:

Comprehension scores, as measured by the adapted QuIC Part A, were adequate for all domains, with mean scores above 70%, and most scores exceeding 80%. The distribution of participants with high levels of comprehension (>=90%) varied, and specific demographic factors such as age (except for pregnant women), gender and previous clinical trial experience significantly influenced the results (p<.05). Subjective understanding, measured by a 5-point Likert scale, yielded mean scores over 4 points out of 5 and a final score above 85 points out of 100 in all three studies. Satisfaction levels were also high: less than 3% of participants were dissatisfied and over 90% found the materials easy or very easy to understand.

Conclusions:

The study demonstrates that electronic informed consent materials tailored to specific populations significantly improve comprehension among diverse groups of clinical research participants. However, demographic factors such as age, gender and prior clinical trial experience affect comprehension. These results highlight, on the one hand, the usefulness of the recommendations included in the "Guidelines for tailoring the informed consent process in clinical trials" and, on the other hand, the need for further refinement of tailored consent processes to ensure equitable understanding in clinical trials.