임상연구에서 피험자 서면동의의 질 평가*

This study was designed to assess the quality of the informed consent process in clinical research by measuring subjects’ understanding of informed consent. A convenience sample of 188 subjects aged 20 and above participated in bioequivalence studies at the Inje regional clinical trial center in Busan (South Korea). The study instruments were self-reported questionnaires, which were modified versions of the Quality of IC (QuIC) questionnaire developed by Joffe et al. (2001) and the Informed Consent Questionnaire-4 items (ICQ-4) developed by Guarino et al. (2006). The data were collected from February to May, 2007 and analyzed with descriptive statistics to assess the quality of the informed consent process and also with a t-test, X2 test, and paired t-test to identify correlates of increased understanding of informed consent. Prior to the subjects’ participation in these clinical trials, the mean QuIC objective knowledge score (QuIC-A) was 68.7 points (maximum: 100 points) and the perceived (subjective) understanding score (QuIC-B) was 78.7; after the clinical trials were completed, the mean scores for (QuIC-A) and (QuIC-B) were 68.7 and 80.4 respectively. The general quality of informed consent (ICQ-4) was measured after the clinical trials were completed; the score was 78.3 points (maximum: 100 points). Higher objective knowledge (QuIC-A) scores were associated with age (25 years old and above, p=0.043), and education (college and above, p=0.001). Higher QuIC-B scores were associated with previous experience with clinical trials (p=0.028) and memorization of the date of the signed consent (p=0.037). The quality of informed consent measured in this study is significantly lower than that reported in similar studies conducted in the US and Australia. Thus, this study suggests that it is there is a need to develop strategies to improve subjects’ understanding of informed consent.