• 디지털융복합연구
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• 제18권2호
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• pp.121-126
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• 2020

본 논문은 학교폭력의 실태를 고찰하고, 2019년 개정된 학교폭력대책 및 예방에 관한 법률(학폭법) 내용을 소개하여 학폭법의 더 나은 개선책을 모색하는 데 연구 목적이 있다. 학교폭력에 대한 적극적인 개입의 성과로 2004년 학폭법이 도입되었지만 학교폭력자치위원회의 비전문성 문제, 학폭 관련 업무 가중 문제, 학교의 재심 기관 이원화로 인한 심의 일관성 문제 등이 제기되었다. 2019년 개정된 학폭법은 이런 부분을 대폭 개선하여 경미한 학교폭력에 대한 학교장 재량권을 도입하는 등 교육현장의 피로도를 해결하고, 학교폭력심의기구를 일선 학교단위에서 교육청 전문심의위원회로 상향 조정하는 등 그동안 간과되었던 학교폭력에 대한 교육적 접근을 확대하였다는 점에서 함의하는 바가 크다. 향후 학폭법의 과제는 기존의 사법적 접근 중심에서 교육적 접근을 더 확대하는 과제가 남았다고 할 수 있다.

• 한국항해항만학회:학술대회논문집
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• 한국항해항만학회 2018년도 춘계학술대회
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• pp.89-91
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• 2018

연안에서 12해리 밖의 배타적 경제수역을 포함하는 공해에서의 해저지명은 기구나 국가에서 지명 심의 제안을 IHO 산하 해저지명소위원회(SCUFN)에 요청하여 채택이 되면 정식 국제해저지명으로 인정받게 되고 해도 및 각종 지명자료에도 활용된다. 해저지명은 종종 영유권 주장의 근거로 활용되기 때문에 공해를 탐사하고 해저지명을 제안하여 채택하는 것은 국가적 차원에서도 중요한 일이다. 국가간 갈등 및 지역간 갈등을 유발할 수 있는 지명에 대한 제안 양식이 존재하지만, 제안자의 자유 기입 측면이 강해서 지명의 제안과 승인 및 적용을 위한 데이터베이스 관리의 어려움이 존재한다. 또한 지명 제안의 근거가 되는 각종 과학적 자료의 보존과 활용에도 제약이 크다. 본 연구에서는 해저지명에 대한 표준 마련의 일환으로 현재의 해저지명 관리 현황을 분석하고 S-100 기반의 해저지명 데이터 모델을 구축하였으며 그 결과 지명 분류를 고려한 데이터 모델의 초안을 완성하였다.

• 한국정보통신학회:학술대회논문집
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• 한국정보통신학회 2014년도 춘계학술대회
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• pp.525-526
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• 2014

최근 게임물관리위원회(이하 게임위) 출범과 함께 청소년이용불가에 해당하는 성인용 아케이드 게임에 대한 관심이 높아지고 있다. 2006년 사회적 물의를 일으킨 바다이야기와 같은 릴게임을 모사하고 더 나아가 주게임과 부게임 형태까지 모사한 게임물이 '게임위'의 심의를 기다리고 있다. 과거 2013년5월23일 대법원 판결에서는 게임시스템은 포커방식인데 반하여 게임그래픽은 사행성유기기구인 릴 게임을 모사하였다 하더라도 포커 게임으로 볼 수 밖에 없으며 더욱이 재산상의 큰 손실을 보이지 않고 환전이 이루어 지지 않을 것으로 판단하였기 때문에 사행성게임물로 보기는 어렵다는 판결이 났다. 본 연구는 객관성과 신뢰성을 확보 할 수 있는 청소년이용불가 아케이드 게임물 심의 방향을 모색하고자 한다.

• 대한기관윤리심의기구협의회지
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• 제1권1호
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• pp.5-21
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• 2019

Purpose: Institutional review board (IRB) classifies risks of clinical trials into less than minimal risk, minor increase over minimal risk, and more than minimal risk. Based on classification and evaluation for risk, IRB decides whether permitting consent exemption or asking additional protection for clinical research subject or not. The purpose of this study is to analyze how IRB members evaluate minimal risk by sending questionnaire survey with 12 predetermined scenarios. Methods: IRB members and researchers (pediatrician, gastroenterologist, neurologist, and neurosurgeon) in 11 different hospitals were asked to answer survey questions via email or online. We analyzed the differences of answers among several subgroups in each predetermined scenarios. Result: Responders were 212 personnel(110 researchers and 102 IRB members) from 11 centers. There were significant differences between IRB members and researchers in response such as blood sampling, skin prick test, one time catheterization in a girl, spinal tapping in child, non-enhance MRI in child, non-enhance MRI with chrolal hydrate in a child, spinal tapping without anesthesia in adult, bioequivalence test, gastric endoscopy, and non-enhance CT. significant differences between medical IRB members and non-medical members were also revealed in one time catheterization in a girl, spinal tapping in a child, non-enhance MRI in a child, bioequivalence test. Depending on researchers' department, they responded differently in several questionnaires as well. Conclusions: We have found that IRB members and researchers evaluate the risks differently. Researchers compared to IRB members, medical IRB members compared to non-medical members answered less than minimal risk in many cases. In assessing and evaluating the risks associated with the study, medical IRB members answered predetermined scenarios as less dangerous compared to non-medical IRB members. Difference among researchers where also revealed significantly. Researchers answered predetermined scenarios as less dangerous compare to other department researchers, especially in predetermined scenarios containing procedures they are familiar with.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• 대한기관윤리심의기구협의회지
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• 제3권1호
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• pp.11-18
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• 2021

Purpose: The purpose of this study is to investigate a satisfaction survey of untact education and platforms that can be used for untact education to provide recommendations on future development of Education of Persons Conducting Clinical Trials. Methods: Online survey was distributed among students who have taken Untact Education of Persons Conducting Clinical Trials. The result was separated according to topic and descriptive statistics was used for analysis. The satisfaction survey used 10-point scale. Results: Of the 1,720 students who received the survey, 1,347 (78.3%) responded to the lecture satisfaction survey. The satisfaction level for broadcasting program (Kakao TV), an untact educational platform for the education of clinical trial workers at Kyung Hee University Medical Center, was relatively high with 8.09±1.99 points. Average score respondents recommending Kyung Hee University Untact Education of Persons Conducting Clinical Trials was 8.03±1.83 and customer recommendation score (Net Promotor Score) was 27.1%. Satisfaction level of the preferred training time was divided into weekday-morning (8-11 AM) (8.16±1.75), weekday-afternoon (12-4 PM) (7.73±2.07), weekday-evening (5-9 PM) (7.78±2.22), and weekend-morning (9-11 AM) real-time untact education (8.48±1.76) and analyzed. There was a noticeable difference between weekend-morning and weekday-afternoon (p<0.0001) and weekend-morning and weekday-evening (p=0.0001) real-time untact education. When asked about conducting education after COVID-19 pandemic ends, 79.2% (1,012 of 1,279) of the respondents answered that they prefer real-time untact education while 20.8 % (266 of 1,279) preferred face-to-face education. Conclusion: Online education, without time and space constraint, is expected to be the mainstream market in Korea for Education of Persons Conducting Clinical. Kyung Hee University Untact Education of Persons Conducting Clinical has achieved above average satisfaction using Kakao TV. Kyung Hee University Real-time Untact Education of Persons Conducting Clinical Net Promotor Score is 27.1%, which is above industry average, communication with trainees should be considered to improve Net Promotor Score.

• 대한기관윤리심의기구협의회지
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• 제4권1호
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• pp.16-22
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• 2022

Purpose: The traditional ethical study only suggests a blurred insight on the research using medical big data, especially in this rapid-changing and demanding environment which is called "4th Industry Revolution." Current institutional/ethical issues in big data research need to approach with the thoughtful insight of past ethical study reflecting the understanding of present conditions of this study. This study aims to examine the ethical issues that are emerging in recent health care big data research. So, this study aims to survey the public perceptions on of health care big data as part of the process of public discourse and the acceptance of the utility and provision of big data research as a subject of health care information. In addition, the emerging ethical challenges and how to comply with ethical principles in accordance with principles of the Belmont report will be discussed. Methods: Survey was conducted from June 3th August to 6th September 2020. The online survey was conducted through voluntary participation through Internet users. A total of 319 people who completed the survey (±5.49%P [95% confidence level] were analyzed. Results: In the area of the public's perspective, the survey showed that the medical information is useful for new medical development, but it is also necessary to obtain consents from subjects in order to use that medical information for various research purposes. In addition, many people were more concerned about the possibility of re-identifying personal information in medical big data. Therefore, they mentioned the necessity of transparency and privacy protection in the use of medical information. Conclusion: Big data on medical care is a core resource for the development of medicine directly related to human life, and it is necessary to open up medical data in order to realize the public good. But the ethical principles should not be overlooked. The right to self-determination must be guaranteed by means of clear, diverse consent or withdrawal of subjects, and processed in a lawful, fair and transparent manner in the processing of personal information. In addition, scientific and ethical validity of medical big data research is indispensable. Such ethical healthcare data is the only key that will lead to innovation in the future.

• 대한기관윤리심의기구협의회지
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• 제4권2호
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• 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.