• 대한기관윤리심의기구협의회지
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• 제5권2호
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• pp.59-59
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• 2023

• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.1-13
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• 2023

In the United States (US), due to the Common Rule, completely revised in 2017, single Institutional Review Board (IRB) review has become mandatory for government-sponsored multi-institutional research since 2020 regardless of the number of participating institutions. The goal of these changes is to reduce redundant reviews by the IRB at each institution and better protect research participants. In this paper, single IRB and Human Research Protection Program (HRPP) in the US and Korea were compared and considered, and their implications were discussed. A comparison of the HRPP evaluation and certification systems of the US and Korea includes that of SMART IRB in the US and Korea Central IRB, aiming at single IRB review for efficient review with support from the country and building a more efficient national human subject research network in the future. Its comparison and analysis will be helpful in deriving future tasks and development directions of single IRB and HRPP in Korea.

• 대한기관윤리심의기구협의회지
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• 제5권2호
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• pp.33-42
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• 2023

In the conduct of multicenter clinical trials, multiple reviews by multiple Institutional Review Board (IRB) result in unnecessary duplication of efforts, delays and increased expenses of the trials, placing unavoidable burdens on not only investigators and sponsors but also IRBs. During the coronavirus disease 2019 pandemic periods, as the need of multicenter clinical trials for its therapeutics and vaccines increased, a centralized IRB became more important than before in order to efficiently conduct the multicenter trials without unnecessary multiple reviews. Accordingly, government-supported central IBR as a new centralized IRB has launched to foster multicenter clinical trials while to avoid unnecessary reviews and delays and to reduce burdens of all stakeholders. However, there are still barriers to be overcome and problems to be solved in the central IRB. In this review, we introduce background and history of the central IRB and try to propose some strategies or solutions against the barriers and problems.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• KSLA Bulletin
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• 통권4호
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• pp.58-64
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• 2012

• 대한기관윤리심의기구협의회지
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• 제4권1호
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• pp.5-15
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• 2022

To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.

• 대한치과의사협회지
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• 제24권7호통권206호
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• pp.583-591
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• 1986

근년에 이르러 암환자의 증가, 암치료성적의 호전, 그리고 암환자의 통원치료 증가등으로 암전문변원이나 암연구소의 치과의사(institutional dentist)뿐만 아니라, 일반 치과의사(non-institutional dentist)들도 암과 관련된 환자들을 접하는 기회가 늘고 있다. 일반적으로 구강함환자는 구강암 자체, 혹 그 처치를 통하여 전신적으로, 혹은 국소적으로 위약된 조건을 갖게되므로 치과치료시에는 특별한 지식과 세심한 주의가 필요하다. 이러한 필요에 이해 선진국에서는 이미 치과종양학(Dental Oncology)의 임상이 활발하다. 이제 이러한 치과종양학적 입장에서 외과적 수술, 방사선요법, 그리고 화학요법을 통한 구강암 (혹은 두경부암)의 처치시에 치과의사의 역할과 치과치료의 문제점 및 그 해결책에 대하여 기술하고자 한다.

• 대한기관윤리심의기구협의회지
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• 제4권2호
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• pp.23-29
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• 2022

The goal of the military medicine is not as same as that of the civil medical practice, and consequently the characteristics of military biomedical researches have their own uniqueness. In front of the prerogative of national defense, some of the human rights ordinarily ensured in normal researches with human subjects are not to be fully guaranteed. The hierarchic system of the military would complicate the issue when the soldiers are enrolled as human subject for the research. Some researches could be classified as a military secret, therefore, the confidentiality issues need to be well addressed. Institutional Review Board and review procedure should be modified for the military purposes. So, it is necessary to establish the appropriate regulatory system for the military biomedical researches with human subject to manage the complicated issues involved in them.

• 좋은식품
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• 통권10호
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• pp.62-65
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• 1972

• 대한간호
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• 제20권1호통권109호
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• pp.14-17
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• 1981