The Journal of KAIRB (대한기관윤리심의기구협의회지)

Korean Association of Institutional Review Boartds (대한기관윤리심의기구협의회)
권호 표지

Validation of the Effectiveness of Education for Obtaining Consent in Clinical Study

임상연구 동의서 교육 시행의 효용성 검증

  • Ji Eun Kim (Human Research Protection Center, Asan Medical Center) ;
  • Mi Sung Lee (Human Research Protection Center, Asan Medical Center) ;
  • Sul Hwa Kim (Human Research Protection Center, Asan Medical Center) ;
  • Ji Hye Yang (Human Research Protection Center, Asan Medical Center) ;
  • Seung Ah Go (Human Research Protection Center, Asan Medical Center) ;
  • Cho Long Lee (Human Research Protection Center, Asan Medical Center) ;
  • Soo Yeon Yang (Human Research Protection Center, Asan Medical Center) ;
  • Hae Joo Shin (Human Research Protection Center, Asan Medical Center) ;
  • Bo Ah Kim (Human Research Protection Center, Asan Medical Center) ;
  • Jong Woo Chung (Human Research Protection Center, Asan Medical Center)
  • 김지은 (서울아산병원 임상연구보호센터) ;
  • 이미성 (서울아산병원 임상연구보호센터) ;
  • 김설화 (서울아산병원 임상연구보호센터) ;
  • 양지혜 (서울아산병원 임상연구보호센터) ;
  • 고승아 (서울아산병원 임상연구보호센터) ;
  • 이초롱 (서울아산병원 임상연구보호센터) ;
  • 양수연 (서울아산병원 임상연구보호센터) ;
  • 신혜주 (서울아산병원 임상연구보호센터) ;
  • 김보아 (서울아산병원 임상연구보호센터) ;
  • 정종우 (서울아산병원 임상연구보호센터)
  • Received : 2023.08.09
  • Accepted : 2023.09.13
  • Published : 2023.09.27
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Abstract

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.

Keywords

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