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Research Records Management in Regional Public Hospital: Focusing on the Cases of Institutional Review Board (IRB) of Incheon Medical Center

지방의료원의 연구기록관리: 인천광역시의료원 임상연구윤리위원회(IRB) 사례

  • Received : 2023.02.09
  • Accepted : 2023.02.14
  • Published : 2023.02.28

Abstract

The Incheon Medical Center Institutional Review Board (IRB), a department that reflects the characteristics of Incheon Medical Center, a medical and public institution, was established in 2013. IRB contributes to performing its role as a local accountable care hospital and protecting researchers and subjects by proving the ethics of research conducted at the medical center. So far, IRB has reviewed a total of 80 research proposals for human subject research and human-derived material research, and it currently exists as an independent department directly under the president of the medical center. This paper aims to explain the registration and preservation of IRB-related records, the maintenance of the Records Management Standard Table and related regulations, and archives, as well as to present limitations and improvements in the disclosure, utilization, and classification of records.

공공기관이자 의료기관인 인천광역시의료원의 특성을 반영하는 부서인 인천광역시의료원 임상연구윤리심의위원회(이하 IRB)는 2013년 설치되었으며, 의료원에서 시행된 연구의 윤리성을 심의·검증함으로써 연구자와 연구대상자를 보호하고 지역책임의료기관 역할 수행에 기여하고 있다. IRB는 지금까지 총 80여 건의 인간대상연구 및 인체유래물연구 계획을 검토하였으며, 현재 의료원장 직속의 독립된 처리과로 존재하고 있다. 본 고에서는 IRB 관련 기록물의 등록 및 보존, 기록관리기준표 및 관련 규정, 문서고의 정비에 관하여 설명하고, 기록물 공개와 활용, 분류에 있어 한계 및 개선 사항을 제시하고자 한다.

Keywords

References

  1. BIOETHICS AND SAFETY ACT. Act No. 17783.
  2. Enforcement Rule of Bioethics and Safety Act. Ordinance of the Ministry of Health and Welfare No. 931.
  3. ENFORCEMENT DECREE OF THE PUBLIC RECORDS MANAGEMENT ACT. Presidential Decree No. 32772.
  4. National Archives of Korea (2016). Guidelines for Medical Institution with Records Management Standard Table Management.
  5. Ministry of Food and Drug Safety (2020). ICH E6 GCP Guideline.