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KMID : 1161620230050020051
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Journal of KAIRB
2023 Volume.5 No. 2 p.51 ~ p.58
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Validation of the Effectiveness of Education for Obtaining Consent in Clinical Study
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Kim Ji-Eun
Lee Mi-Sung
Kim Sul-Hwa
Yang Ji-Hye
Go Seung-Ah
Lee Cho-Long
Yang Soo-Yeon
Shin Hae-Joo
Kim Bo-Ah
Chung Jong-Woo
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Abstract
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Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the
education program for researchers.
Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ2
-test were utilized to verify the difference in errors between the experimental and control groups.
Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant’s legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001).
Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.
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KEYWORD
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Education for obtaining consent in clinical study, Informed consent audit tool, Informed consent education program
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