임상시험 피험자에게 발생하는 이상반응 관리 절차의 문제점과 개선방안 = Problems in the Adverse Event Report Procedure and Its Management

다국어 초록 (Multilingual Abstract)

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.

목차 (Table of Contents)

• Ⅰ. 머리말
• Ⅱ. 이상반응 관리 현황
• 1. A병원 임상시험심사위원회의 이상반응 관리 절차
• 2. B병원 임상시험심사위원회의 이상반응 관리 절차
• 3. C병원 임상시험심사위원회의 이상반응 관리 절차
• 4. D병원 임상시험심사위원회의 이상반응 관리 절차
• 5. E병원 임상시험심사위원회의 이상반응 관리 절차
• Ⅲ. 이상반응 관리 절차의 문제점
• 1. 이해갈등의 가능성
• 2. 부정확한 진단의 가능성
• 3. 미흡한 심의절차
• Ⅳ. 의미 있는 이상반응 관리방안을 위한 제언
• 1. 연구자의 이해갈등과 관련된 국내 규정 확충
• 2. 이차자문(Second opinion)의 활용
• 3. 이상반응 소위원회의 활용
• Ⅴ. 맺음말
• Abstract

참고문헌 (Reference)

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