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임상시험 피험자에게 발생하는 이상반응 관리 절차의 문제점과 개선방안
이미성 이화여자대학교 생명의료법연구소 2010 생명윤리정책연구 Vol.4 No.2
Institutional Review Board (IRB) is a committee to protect clinical research subjects’ human rights and health and to guarantee the ethicality and scientificity of research. However, the adverse event report system of domestic IRBs is not playing its role adequately as a subject protection against adverse events in clinical trials. According to the SOPs of the IRBs of five hospitals surveyed, convened IRB review is judged relying on reports submitted by the investigator, and adverse events not included in the convened IRB review are reviewed in the Expedite Review or not reviewed. This report system can be a problem in three aspects. First, the investigator may submit a wrong report because of financial or non-financial conflict of interest. Second, the investigator may misdiagnose adverse events occurring in the subjects. Third, there is no system for detecting errors even if the investigator has made an incorrect report on adverse events. In order to solve these problems, this study made a number of suggestions. First, in order to manage investigators’ conflict of interest, the IRB needs to establish SOPs related to conflict of interest and KGCP should also introduce provisions on conflict of interest. Second, in consideration of the investigator’s misdiagnosis, it is proposed to use the peer review system. It is introducing ‘second opinions on adverse events’ from medical specialists in the same major. Lastly, in order to detect errors in the investigator’s report, it is suggested to utilize a committee specializing in the review of adverse events (adverse event committee). The Special Committee on Adverse Events is a subcommittee mainly on adverse events. Such a committee may provide a more professional and intensive review for adverse events. Subject protection in the true sense cannot be attained by simple documentary works or by following a procedure. Thus, it is now necessary to see adverse event reviews are made meaningfully to individual subjects.
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지역사회 정신보건 서비스에 정신건강의학과 전문의의 역할 : 광주광역시 마음건강주치의 사업 분석
전민(Min Jhon),왕수연(Soo-Yeon Wang),김선영(Sun-Young Kim),이주연(Ju-Yeon Lee),김재민(Jae-Min Kim),신일선(ll-Seon Shin),김성완(Sung-Wan Kim) 대한신경정신의학회 2021 신경정신의학 Vol.60 No.1
Objectives The treatment rate for mental illness is low in Korea (22%) compared to Western countries (40-50%). Thus, Gwangju city commenced a mental health project termed “Mind Doctor” in 2016. Psychiatrists regularly visit mental health centers to provide services, including counseling. This paper summarizes the achievements and significance of the project. Methods The project has been in progress for four years. This study evaluated 7,483 clients assisted by 322 center staff and 55 participating psychiatrists. The characteristics of the mental health center and addiction management center clients were identified. The center staff opinions and satisfaction were analyzed. Results Psychiatrists placed in community mental health services played a variety of roles as counselors, supervisors, lecturers, and program organizers. During the time since the project commenced, referral rates to mental health clinics after in-center counseling increased from 9.4% to 41.6%. Half of the psychiatrists worked in psychiatric hospitals (45.5%), and were in their 30s (43.6%). Of those seen by psychiatrists in mental health centers, 42% were aged under 30 years, and almost half were male (46%). Most clients were satisfied with their consultations (90%) and were willing to recommend the project to others (88%). More than 85% of center staff responded positively to the project, particularly in 2019. Conclusion “Mind Doctor” readily identified the mental problems of community residents and provided smooth referrals to mental health clinics. Collaboration between the psychiatrists and mental health workers in mental health centers contributed to mental health promotion and early intervention to treat mental problems.
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