• The Journal of KAIRB
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• v.4 no.2
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• pp.30-35
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• 2022

The Human Research Protection Program (HRPP) includes all subject protection activities and entities involved in the process of planning, reviewing, and conducting clinical research and it ultimately aims that research can be conducted ethically and scientifically while protecting the rights and welfare of research subjects. At the beginning of its introduction in Korea, it was settled down by adopting the United States HRPP, especially the form of AAHRPP element and regulations. However, regulations and operating forms of HRPP have been changed according to the Korean domestic research environment. Actually, all the Korean institutions are adopted the Korean HRPP guidelines that have been officially announced by the Ministry of Food and Drug Safety in Korea. Recently, Korean domestic laws such as the "Advanced Regenerative Biology Act" or "In Vitro Diagnostic Medical Device Act" have been dramatically innovated and our research environment becomes to be more complicated. Therefore, the development of a suitable Korean HRPP model considering the Korean research environment is strongly demanded. For the early settle down of the Korean HRPP model, the positive incentive method should be applied, when the HRPP is operated and/ or properly operated. These improvements in the Korean HRPP environment will eventually lead to the appropriate protection of subjects who are participating in human clinical research and the quality improvement of clinical research.

• Korea Trade Review
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• v.47 no.5
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• pp.201-221
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• 2022

This study aims to analyze a harmonious approach between trade norms for the protection of human rights and the WTO agreements is increasingly necessary and important. conflicts and harmonization that may occur between major human rights protection trade norms and WTO agreements were comprehensively reviewed. The hard legalization of corporate social responsibility for sustainable development, such as human rights protection, was in conflict with the WTO Agreement, which was based on the principle of non-discrimination. As the currently expanding human rights protection trade norms reflect differences in the positions of developed and developing countries, it was also pointed out that there may be disputes over WTO compatibility and distorted protectionism measures. Accordingly, the applicability of the general exceptions to Article 20 of the GATT were reviewed together, and Article 20(a) of GATT, "necessary to protect public morals" may differ between developed and developing countries, and thus limitations were also considered. At the same time, When it is necessary to take regulatory measures such as prohibition of imports from a specific country for human rights protection, it was reviewed and proposed domestic trade norms revision.

• The Journal of KAIRB
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• v.5 no.2
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• pp.51-58
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• 2023

Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ²-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

• The Journal of KAIRB
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• v.3 no.2
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• pp.28-36
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• 2021

Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

• The Journal of KAIRB
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• v.5 no.1
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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.

• 중국학논총
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• no.72
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• pp.101-122
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• 2021

Over the past 20 years, labor standards have been widely used in free trade agreements. The U.S., the European Union and China have all aggressively signed free trade agreements with their trading partners, developing different styles on labor standards. According to the study, the implementation of the KOREa-EU FREE trade agreement has been hampered by ongoing disputes over the terms of the FREE trade agreement and the ILO since the korea-EU free trade agreement was signed. Because in order to break this deadlock, relevant scholars have done a lot of research, but mainly focused on the economic and trade field. Therefore, this paper for the first time systematically studies the substantive focus of disputes over FTA and ILO clauses, and carefully analyzes the domestic law amended by South Korea, and provides suggestions and inspirations for China by drawing lessons from the revision model of South Korea's domestic law. This is from a newperspective: the essence of the korea-EU FTA and ILO disputes is the conflict between international law and domestic law, and the conflict between free trade agreements and human rights protection. It holds that the essence of disputes should be sorted out from the perspective of legal principles and human rights protection, and the free trade and human rights protection should be actively coordinated. In order to make China more actively integrate into the international economy, China should adopt a positive attitude to revise and perfect its own laws, so as to realize the purpose of common development of international trade and human rights protection.

• Nuclear Engineering and Technology
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• v.41 no.5
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• pp.747-752
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• 2009

A vulnerability assessment is essential for the efficient operation of a physical protection system (PPS). Previous assessment codes have used a simple model called an adversary sequence diagram. In this study, the use of a two-dimensional (2D) map of a facility as a model for a PPS is suggested as an alternative approach. The analysis of a 2D model, however, consumes a lot of time. Accordingly, a generalized heuristic algorithm has been applied to address this issue. The proposed assessment method was implemented to a computer code; Systematic Analysis of physical Protection Effectiveness (SAPE). This code was applied to a variety of facilities and evaluated for feasibility by applying it to various facilities. To help upgrade a PPS, a sensitivity analysis of all protection elements along a chosen path is proposed. SAPE will help to accurately and intuitively assess a PPS.

• The Korean Society of Law and Medicine
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• v.12 no.1
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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.

• The Journal of KAIRB
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• v.4 no.1
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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.

• Korean Journal of Ecology and Environment
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• v.41 no.1
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• pp.34-42
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• 2008

Water quality standards (WQS) are mandatory to guarantee the human health and protection of aquatic ecosystems, and maintain the condition of suitable water quality. The present WQS for the protection of human health in Korea contain nine substances (As, Cd, $Cr^{6+}$, CN, Pb, Hg, ABS, organophosphorus compounds and PCBs), but it is insufficient to preserve the human and aquatic ecosystem from a variety of chemicals. Therefore, it is necessary to expand the substance of WQS for the protection of human health. In this study, we chose the 20 chemicals from 43 chemicals of the project entitled 'Development of Integrated Methodology for Evaluation of Water Environment'. The methodology for calculating water quality criteria was amended from the US Environmental Protection Agency (US EPA)'s equation for deriving ambient water quality criteria for the protection of human health. The factors including fish intake, drinking water intake, and human body weight used in the equation reflected Korean situations. The monitoring values were derived from the water quality monitoring data in Korean four main rivers. The orders of priorities of chemicals were evaluated by human health risk assessment, and the proposed WQS was derived by technical and economic analyses. These results were reflected to expand the WQS for the protection of human health.