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
Highlights
The subjects’ limited understanding of trial information has been a continuing source of concern especially in nontherapeutic studies involving healthy volunteers
The proportion of the participants in the enhanced informed consent form (ICF) group who correctly answered each item in the post-test questionnaire was compared to that in the conventional ICF group: significant differences were seen in 13 out of 21 items (Fig. 4)
The present study demonstrates the applicability of the SIDCER ICF and its template in the development of an enhanced ICF for the clinical PK trial and its effectiveness in improving the participants’ understanding of information related to the trial
Summary
The subjects’ limited understanding of trial information has been a continuing source of concern especially in nontherapeutic studies involving healthy volunteers. After the incident of the TGN1412 study, there has been an increasing concern regarding the validity of informed consent in healthy volunteers in phase I studies. All healthy volunteers who received an intervention in the TGN1412 study ended up in the intensive care unit [1]. Investigations of how much the volunteers understood the risks involved in the study show that the informed consent form (ICF) was extensively long (13 pages), lacked many essential elements, and made liberal use of complex language [2]. This study highlights concerns about the safety of healthy volunteers in clinical trials. Comprehension of research subjects, concerning their rights and the risks involved in
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