• 한국기록관리학회지
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• 제23권1호
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• pp.127-132
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• 2023

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.

• Journal of Acupuncture Research
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• 제32권2호
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• pp.11-21
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• 2015

Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

• Clinical and Experimental Reproductive Medicine
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• 제39권4호
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• pp.138-143
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• 2012

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

• 한국보육지원학회지
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• 제14권2호
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• pp.1-17
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• 2018

Objective: The purpose of this paper is to understand the bioethics and the Institutional Review Board (IRB) in the social and behavioral research area through "The Bioethics and Safety Act" and to examine the IRB's present situation, roles, responsibilities, and tasks. Methods: This paper reviewed articles, materials for education, and "The Bioethics and Safety Act" related with the IRB. Results: Bioethics included all the research in the social and behavioral area, and "The Bioethics and Safety Act" has been enforced in every research projects targeting human subjects since February 2, 2013. Accoding to the law, the IRB must review the research proposals for human subjects and was introduced in social and behavioral research as a self-regulating system. At present, all the related institutions including universities must establish and run the IRB. This paper introduced the definition of bioethics, the IRB's roles and review types, the total number of registered IRB, and "The Bioethics and Safety Act". Conclusion/Implications: Both the central government and the local government have to make an effort for the establishment and settlement of the IRB system. This paper also presented some of the problems of the IRB.

• 한국임상약학회지
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• 제26권1호
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• Journal of Yeungnam Medical Science
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• 제35권1호
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• pp.36-39
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• 2018

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 2001년도 제53차 추계 학술대회 연제집
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• pp.359-360
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• 2001

• 의료법학
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• 제12권1호
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• pp.99-131
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• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

• Clinical and Experimental Pediatrics
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• 제52권1호
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• pp.1-5
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• 2009

Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Finally, criteria for the protection of children in clinical trials therefore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.