• 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.6 no.1
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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.

• 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.

• 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.

• Journal of Korean society of Dental Hygiene
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• v.14 no.2
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

• Korean Journal of Occupational Health Nursing
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• v.12 no.1
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• pp.71-79
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• 2003

Purpose: The purpose of this study was to describe the status of maternity protection in the industries for the development of educational database used by occupational health nurses (OHNs). Method: 100 OHNs were purposively sampled and they were charged in the occupational health manager of their own industries. Data were collected by the postal mail, the response rate was 53.0%, and analysis rate was 43.0%. Result: The results were as follows; 1. Most of subjects responded there was the institutionalization of a special holiday for woman workers (97.7%) and 90 days maternity leave (95.4%). Otherwise, the numbers of industry were smaller in the case of providing the breast-feeding time, temporary rest from office for child raring, restriction of hazard job, night job, and over time. The application rates were lower than the rate of institutionalization of all maternity protection items. 2. There were significant differences in institutionalization of maternity protection by the activity of the trade union. And the numbers of the industry applying the maternity protection were significantly different by the area and the types of industry. 3. Most OHNs responded 17 subjects were needed to the maternity protection education for women workers. Conclusion: It would be needed to develop the maternity protection education database in base of the status of maternity protection in the industries and the need of maternity protection education. The role of OHNs for maternity protection was expected to activate.

• Journal of the Korean Society of Safety
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• v.37 no.1
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• pp.55-63
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• 2022

The correlation between the Military Service Adaptation Test and the Biometric Index is studied herein with the aim of preventing military safety accidents. The subjects were 36 soldiers under the age of 25 years. Based on the results of the service adaptation test, the soldiers who did not adapt to the service were distinguished. First, there was a significant difference in brain stress among the brain wave indicators of the general group and the group of interest. Second, the higher the left and right brain imbalance index among the brain wave indicators, the higher was the level of empathy shown by the subjects. Third, among the pulse indicators, the subjects with high cumulative fatigue levels were found to have high levels of emotion (anxiety, depression, physicalization) and relationship isolation (indifference, sensitivity). Based on these results, the implications of this study and suggestions for future research are discussed.

• Journal of the Korean Society of Clothing and Textiles
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• v.45 no.2
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• pp.253-270
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• 2021

This survey provides research into developing knee braces to protect the knee against damage, reduce knee pain, and strengthen the knee. A total of 235 surveys were conducted from December 2019 to January 2020. The subjects were adults in their 20s and over who lived in the Seoul metropolitan area and had experience of using knee braces. In terms of age differences, subjects over 60 years of age purchased knee braces mostly to secure a reduction of pain (ROP), whereas subjects in their 20s and 30s purchased knee braces for physical shock protection (PSP). Subjects in their 40s and 50s purchased knee braces for improvement of muscle movement (IMM). There was no significant difference in shape, material, and locking method based on the reason for wearing the knee brace. These results show that it is conceivable and maybe preferable to produce different knee braces-with a variety of shapes, materials, and locking materials-according to the reason behind wearing a knee brace. Knee braces are worn currently without any differentiation despite the findings of this study. In particular, we argue the need for functional and differentiated development of knee braces specifically for PSP, ROP, and IMM.

• Journal of Korean Clinical Nursing Research
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• v.29 no.3
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• pp.261-270
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• 2023

Purpose: This study aimed to identify the influence of knowledge of personal information protection law and nursing patient advocacy on practice of personal information protection among nurses. Methods: The subjects were 130 nurses who have worked for six months or more in the ward of the tertiary or general hospitals. Data were collected from February 20 to March 3, 2023. Results: Factors influencing practice of personal information protection were acting as an advocate (β=.32, p=.004), environmental and educational influences (β=.21, p=.040), knowledge of personal information protection law (β=.19, p=.013) and clinical experience for five years or more but less than ten years (β=.17, p=.036). The regression model showed an explanatory power of 34.0%. Conclusion: Acting as an advocate has the most effect on practice of personal information protection. To promote practice of personal information protection for nurses, it is necessary to provide education related to privacy protection and encourage nursing patient advocacy.

• The Journal of KAIRB
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• v.5 no.1
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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.