• 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.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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• pp.23-29
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• 2019

"Conflict of Interest(COI)" is defined as a situation where a person or an institution is involved in multiple interests, and an interest is against the others. COI in medical researches should well addressed and managed in order not to breach the integrity of the research. Numbers of methods have been introduced to manage the COI. In this article, the concept of COI and its application to medical researches is reviewed and the methods evading COI are introduced.

• Clinical and Experimental Reproductive Medicine
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• 제39권4호
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• pp.138-143
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• 2012

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

• 문화기술의 융합
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• 제1권2호
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• pp.53-64
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• 2015

본 연구는 초등학교 고학년 학생들의 흡연 경험 실태, 흡연에 대한 태도, 흡연 유무에 영향을 미치는 요인을 분석한 서술적 조사연구이다. 본 연구는 횡단면 기술적 연구 방법을 통하여 충청도와 강원도 소재 초등학교의 4,5,6학년 학생들 중 총 810명을 편의표본추출방법으로 선정하였으며, 흡연 유무에 따른 특성과 흡연에 대한 태도를 일반화 선형 방법을 이용하여 흡연에 영향을 미치는 영향요인을 분석하였다. 본 연구를 위하여 사전에 Y 대학교의 연구윤리심의위원회(IRB)의 승인을 받았다. 본 연구를 위하여 810명의 학생들이 조사에 포함되었는데, 이들 중 7.3%의 초등학교 고학년 학생들이 흡연 경험이 있다고 보고하였다. 흡연에 영향을 미치는 분석 결과, 흡연 경험이 있는 친구를 가진 학생들, 친구의 담배 권유를 거부가 어려운 학생, 그리고 남학생들이 유의하게 흡연 경험이 높은 것으로 나타났다. 본 연구를 통해 초등학교 학생들을 위한 금연교육은 친구의 담배 권유를 거부할 수 있는 인지 프로그램을 포함한 남학생들을 대상으로 같은 또래들의 정서에 맞는 맞춤 금연 교육 프로그램이 실시되어야 하며, 원하지 않는 흡연 경험으로 인한 피해로부터 초등학생들을 보호하기 위해서는 적극적인 학교의 금연교육을 강화해야 한다.

• 한국임상약학회지
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• 제25권3호
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• pp.166-170
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• 2015

Background: Primary warm autoimmune hemolytic anemia (AIHA) is a relatively rare hematologic disorder resulting from autoantibody production against red blood cells. There has been very few studies about primary warm AIHA in South Korea because of its low incidence. We retrospectively analyzed the treatment outcome of primary warm AIHA. Method: We reviewed retrospectively the medical records of 9 primary warm AIHA patients from December 2002 to January 2015. We analyzed the causes and clinical characteristics of primary warm AIHA patients. We retrospectively analyzed the clinical data in electronic medical records for 9 Korean patients with AIHA patients who were diagnosed during the period from December 2002 to January 2015 at the Regional University Hospital in Korea. The study protocol was approved by the Institutional Review Board (IRB #2015-08-007, Chosun University Hospital IRB). Results: The mean age was 52 years (range 27~78), the mean hemoglobin level was 5.0 g/dL (range 2.5~6.4 g/dL). All patients received steroids at therapeutic dosages (corticosteroid 1 mg/Kg) as first line treatment. Eight of them showed complete response (5/8, 62.5%) and partial response (3/8, 37.5%), one patient required second-line treatment with rituximab. Two patients who responded first line treatment were relapsed at 86 weeks and 24 weeks after response, respectively. Only one patient of them was retreated with corticosteroid because of anemic symptoms. Conclusion: This study indicates that oral corticosteroid is an effective therapy for primary warm AIHA.

• 동의생리병리학회지
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• 제26권3호
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• pp.392-398
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• 2012

This research aims to analyze the ethical requirements and to find the problems for the publication guidelines of oriental medicine journals. A total of 13 domestic journals, related to oriental medicine and registered in 'National Research Foundation of Korea' list, were selected for the analysis of ethical requirements. We inquired the revised year of the publication guideline and the status of ethics committee of selected journals. The ethical requirements of publication guidelines were evaluated by categorizing them into Institutional Review Board(IRB), Helsinki Declaration, Informed Consent, confidentiality and anonymity of subjects, and conflict of interest. In the case of revised year of the publication guidelines, the year of the most recently revised journal was 2011. However, the revised year of publication guidelines were not announced for three journals and a few journals haven't revised the publication guidelines since 2002. In the case of ethics committee status, four journals out of 13 journals maintained the ethics committee. In the result of ethical requirement analysis, nine journals included the information for confidentiality and anonymity of subjects, and four journals included the information for Helsinki Declaration and Informed Consent. However, only one journal included the information for IRB and conflict of interest. Recently, the importance of clinical researches has been increased to prove the effect of oriental medicine scientifically and objectively. The clinical researches should be considered in scientific side and ethical side as well, because they have potential risks to human subjects. In this sense, announcing the ethical requirements in the publication guidelines can be one way to secure the morality of researches. Thus, it is required to prepare correct publication guidelines and ethical requirements in oriental medicine journals.

• 사상체질의학회지
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• 제23권4호
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• pp.514-525
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• 2011

1. Objectives This study aims to find out identify the recognition and attitude about the research ethic among Constitutional medicine researchers. 2. Methods This survey was conducted to the 37 researchers who were currently participating in Korea Constitution Multicenter Study guided by Korea institute of Oriental medicine(KIOM). The survey consist of 4 parts that level of acknowledgment about the systems and laws on clinical research ethic, clinical research experiences and education, the level of acknowledgment about Institutional Review Board(IRB) and the recognition about overall research ethic. 3. Results Thirty one questionnaires were collected. Most researchers had low level of acknowledgment about the guidelines of basic research ethic. It was proved that more than 65% of the respondents have never received education for clinical research ethic. Moreover, 70% of them felt the need for education of clinical research ethic. In addition, most of the respondents recognized the fact that IRB is responsible for ethically implementing clinical research. 39% of the researchers thought that they themselves have a firm ethical viewpoint, while the rest of the group showed somewhat difficulty on their own ethical implementation of clinical research. 4. Conclusions Most of researcher had partial awareness of regulations and laws on clinical research ethic. And Educational needs of research ethic was high. Therefore education and Public Relations need to be done to extend research ethic. Moreover, standardized course of education on research ethic should be developed and activated.

• 중환자간호학회지
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• 제6권2호
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• pp.78-88
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• 2013

Purpose: The purpose of this study was to identify the trends in studies published in Journal of Korean Critical Care Nursing (JKCCN) from 2008 to 2013. Methods: A total of 65 studies published between 2008 to 2013 were reviewed using criteria developed by researchers. Results: Approximately 36% of studies were conducted with patients. Intensive care unit (ICU) was the most popular site as the study setting. Among 59 research papers, 42.4% were approved by institutional review board (IRB). Quantitative studies were 78.6%, while qualitative studies were 4.6%. The research designs for the quantitative studies were survey (52.3%), quasi-experimental (16.9%), and so on. There was no randomized controlled trial. The most frequently used methods to provide nursing intervention was education. In addition, "nurse" and "ICU" were most commonly used keyword. Conclusion: Considering the low rate of IRB approval, more stringent application of research ethics is necessary to improve the quality of JKCCN. In addition, more randomized controlled trials should be encouraged to support evidence-based practice in critical care.

• Journal of Acupuncture Research
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• 제32권2호
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• pp.11-21
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• 2015

Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

• 문화기술의 융합
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• 제1권1호
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• pp.15-26
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• 2015

본 연구는 국내 여대생들의 성경험 실태를 파악하고 성경험 예측 요인을 규명하기 위한 서술적 조사연구이다. 본 연구는 횡단면 기술적 연구 방법을 통하여 서울, 충청도, 강원도 소재의 총 6개의 4년제 대학교에 재학 중인 여대생들 중 320명을 편의표본추출방법으로 선정하였으며 Y 대학교의 연구윤리심의위원회(IRB)의 승인을 받았다. 최종적으로 299명의 학생들을 조사에 포함시켰으며, 로지스틱 회귀분석 방법을 이용하여 분석하였다. 본 연구를 위하여 299명의 학생들이 조사에 포함되었는데, 이들 중 60.2%의 여대생들이 성경험이 있다고 보고하였다. 성경험 예측 분석 결과, 성경험이 있는 친구를 가진 학생들, 흡연 학생들, 학년이 올라갈수록 유의하게 성경험이 높은 것으로 나타났다. 본 연구를 통해 여대생들을 위한 성교육은 금연 프로그램을 포함한 흡연 학생들과 저학년 학생들을 대상으로 여대생들의 정서에 맞는 맞춤 성교육 프로그램이 실시되어야 하며, 원하지 않는 성경험으로 인한 위기 상황으로부터 여대생들을 보호하기 위해서는 대학의 모든 교직원들의 협력을 강화해야 한다.