• 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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• 제6권2호
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• pp.33-37
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• 2024

Recently, with the development of biotechnology and molecular genetics, research using human biological materials has been receiving attention, and the demand for the use of human- biological materials has also increased significantly. In particular, human biological materials contain the personal information of the person providing them, so special care must be taken to protect personal information throughout the entire process from drafting the human biological materials research plan, Institutional Review Board (IRB) review, and research progress. In addition, it is important to appropriately utilize residual human biological materials obtained during medical diagnosis and treatment at medical institutions to achieve scientific results, while protecting the rights of human biological materials providers and improving the method of expressing consent so as not to damage the trust of human biological materials providers in researchers. To this end, it is necessary to provide sufficient information and education so that researchers and IRB members can understand and apply related laws such as the Bioethics Act and the Personal Information Protection Act.

• 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.

• 대한한의학회지
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• 제31권1호
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

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

• Journal of Yeungnam Medical Science
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• 제30권2호
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• pp.73-78
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• 2013

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

• 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.

• 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.

• 대한기관윤리심의기구협의회지
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• 제5권2호
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• pp.43-50
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• 2023

Purpose: Due to the stringency of regulations related to clinical research, researchers face various requirements in the Institutional Review Board (IRB) review process. Specifically, they encounter time constraints and administrative burdens. In order to cultivate a more favorable review culture and establish a robust research environment, it is necessary to analyze researchers' perceptions of the IRB review. Therefore, this study aims to assess researchers' overall experiences with the IRB and identify researchers' educational needs and demands for research-related policies. Methods: A semistructured questionnaire with 34 items was developed and refined in consultation with advisors from IRB and Human Research Protection Program (HRPP). The questionnaire was distributed via an online survey to researchers with experience in IRB review. The survey covered general characteristics, satisfaction with the IRB review process (rated on a 10-point scale), experiences with IRB review, HRPP policy demands. Results: The study's descriptive statistics revealed a moderate satisfaction level (average rating, 6.75 out of 10) with the IRB review. Researchers from clinical medicine and other disciplines showed similar satisfaction scores of 6.65 and 6.87, respectively. However, respondents with over 5 years of research experience expressed higher satisfaction (mean score, 7.03) compared to those with less experience (mean score, 6.57). Institutional support was emphasized for improving the IRB review process. Certain training topics generated higher demands for addressing frequently raised IRB issues among minor discipline researchers compared to clinical medicine (p=0.017). Conclusion: We conducted an analysis of researchers' perceptions regarding the IRB as well as their demands concerning educational and HRPP policies. It is imperative to address the pinpointed areas for enhancement and integrate a range of perspectives in order to effectively cultivate a robust research ethics culture and ensure comprehensive participant protection.

• 보건행정학회지
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• 제32권1호
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• pp.1-2
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• 2022

With the rising attention dedicated to research ethics, the responsibility of researchers to comply with research ethics is also highlighted. Among a number of research ethics obligations that researchers should abide by, an institutional review board (IRB) review is the most essential step to be taken before launching research. As the health service research field grapples with human subjects, it closely aligns with IRB deliberation. However, it seems that researchers still do not fully understand their obligations of IRB reviews. Due to the nature of health services research, there are many cases that are exempt from IRB reviews, which often elicits confusion in the research field. On that note, we aim to explore the issues regarding IRB reviews that health service researchers need to know.