• 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.

• 의료법학
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• 제22권4호
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• pp.37-55
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• 2021

2021년 3월 19일 한국생명윤리학회, 한국의료법학회, 한국의료윤리학회, 대한기관 윤리심의기구협의회는 감염병예방법 일부개정안과 병원체자원법일부개정안을 비판하는 공동성명서를 발표하였다. 이들은 공중보건상 긴급조치가 필요한 상황에서도 기관생명윤리위원회 심의는 필수적이며 생략할 수 없다고 선언하였다. 하지만 우리나라 생명윤리법은 국가나 지방자치단체가 공공복리를 위하여 수행하는 연구는 인간대상연구에서 제외하고 있다. 또한 우리나라 법제는 연구와 감시를 구분하는 이분법에 기초하고 있지 않기 때문에 미국 커먼룰의 논의를 그대로 우리나라에 적용할 수 없다. 국가의 감염병 관리 의무와 기관생명윤리위원회의 조화로운 운영을 위해서는 다음 사안들을 고려하여 제도적 대안을 마련해야 한다. 첫째, 관련 학계는 가장 먼저 우리나라 현행 법률의 문제점에 관심을 기울여야 한다. 둘째, 국가는 감염병 관리 의무를 이행하기 위하여 당사자의 동의 없이 많은 업무를 수행하고 있다는 점을 이해하여야 한다. 셋째, 제도적 대안을 제시할 때 우리나라에서의 집행가능성을 고려해야 한다. 제도적 대안에 대하여 의료법학회 등 관련 학계의 심도 있는 논의가 필요하다.

• 한국기록관리학회지
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• 제17권3호
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• pp.1-21
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• 2017

구술사는 살아있는 사람의 이야기를 통해서 이루어진다. 구술사를 통해서 수집된 자료는 단순한 사실이나 정보의 덩어리가 아니라, 구술자의 인격을 온전하게 드러내는 사람 그 자체이다. 이런 까닭에 구술사연구와 자료 수집 및 활용은 엄격한 윤리적인 기준에 입각해서 이루어질 필요가 있다. "생명윤리법"은 인간대상연구에 대해서 비슷한 관점을 공유하면서, 기관생명윤리위원회의 심의와 관리 대상으로 구술사를 포함하고 있다. 그렇지만 "생명윤리법"의 인격과 권리 보호는 생명과학연구를 중심으로 작성된 것으로, 사람을 상대로 가치 지향적이고, 비판적인 접근이 이루어지는 구술사를 비롯한 질적 연구에 합당하지 않다. 이 연구에서는 "생명윤리법"의 인간대상연구와 관련된 규정의 상세한 내용을 알아보고, 그것이 구술사와 같은 인문사회과학연구에 적용될 때에 나타날 수 있는 문제점을 점검하였다. 이러한 과정들을 통하여 구술사 연구가 학문적 독자성과 자율성을 유지하면서 지속가능할 수 있는 방법적인 대안들을 제시하였다.

• 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.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1997년도 추계학술대회
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• pp.35-39
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• 1997

Recent development of human genetics and techniques of gene transfer and expression have opened the way for investigating novel approaches based on the genetic modification of cells to treat both inherited and acquired diseases. This approach is referred to as gene therapy. Over the past few years, gene therapy has moved from the laboratory to phase I clinical trials. Although the clinical performance of gene transfer experiments is still in an early phase of development, the NIH of Health Recombinant DNA Advisory Comittee (RAC) has approved more than 150 protocols that involve gene transfer or putative gene therapy procedures in clinical settings. Many sectors of society in United States have participated in the design and formulation of these clinical trials through local Institutional Review Boards, the National Institutes of Health (NIH) RAC, the Chemotherapy Evaluation Program of the National Cancer institute, and the FDA. Currently, clinical trials involving gene modification are under way at many medical centers throughout the United Slates. The goals of these trials are as follows. (1) The design should be directed to short-term achievable goals. (2) Each clinical trial is best considered as an intermediate step in a multistep process. (3) The design should identify evaluable proximate endpoints for toxicity and for efficacy, (4) The potential benefits and possible risks for patients participating in these trial should be defined.

• 한국한의학연구원논문집
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• 제13권2호통권20호
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• pp.127-133
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• 2007

Objectives : This study were aimed to estimate the needs for clinical research educational program development focused on oriental medicine. Methods : Department Medical Research of Korea Institute of Oriental Medicine surveyed 204 certified subjects in total by using web-based questionnaires through e-mail from Jan. 17th to Jan. 31th, 2007. Reply from 62 on-line correspondents were collected and statistically analyzed. Results : The number of clinical trial involving oriental medicine continues to increase. According to the survey, many Issues were raised as problems such as difficulty of recruitment, lack of fund and lack of stepped program. Emphasized issues were clinical research methodologies, development of protocols and case report form (CRF), and Regulations including Institutional Review Boards (IRBs) in these three consecutive education training program. Conclusion : The results of this study may contribute to the development of an educational program for oriental medicine, a program that should be taken into consideration for developing practical items, such as, problem-based learnings which reflects participants' actual needs in their works. Also this report be used for future strategy plans and execution of training program for oriental medical clinical trial.

• 보건교육건강증진학회지
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• 제30권2호
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• pp.83-92
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• 2013

Objectives: The purpose of this study was to investigate factors affecting the drinking behavior in high school students. Methods: There were 620 subjects who were first and second graders of seven high schools in Daegu. This study used Sinhaengwoo (1998)'s drinking behavior scale, Rowlison and Felner (1988)'s stress scale, Kovacs (1981)'s children's depression inventory, Rosenberg (1965)'s self-esteem scale. The data were analyzed by descriptive statistics, Pearson's correlation coefficient, and stepwise multiple regression using SPSS/win 18.0 program. This study was approved by the Institutional Review Boards (IRB) of the Keimyung university hospital(No. 12-112). Results: The mean score for drinking behavior in high school students was 23.1points. Factors influencing drinking behavior in high school students were identified as self-esteem(t=-3.67, p<.001), stress(t=6.79, p<.001), school types(t=4.02, p<.001), sex(t=-3.67, p<.001). These factors explained 27% of drinking behavior reported by high school students. Conclusion: The results indicate which factors are majors influencing drinking behavior in high school students. Therefore, self-esteem enhancement could be considered as an effective strategy to reduce the drinking behavior in high school students.

• Journal of Hospice and Palliative Care
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• 제22권2호
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• pp.49-66
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• 2019

의료기술 발달 및 경제개발 수준 상승 등으로 호스피스 완화의료(hospice & palliative care) 서비스를 받는 말기 환자들이 점점 늘어나고 있다. 이와 더불어 최근 호스피스 완화의료 분야 임상전문가들은 환자나 가족 대상 호스피스 완화의료 서비스의 질을 향상시킬 목적으로 하는 연구에도 많은 관심을 보이고 있다. 한편 정부의 연구대상자 보호 정책이 강화되면서 IRB(생명윤리심의위원회)에서도 호스피스 완화의료 연구의 연구계획서를 심의할 때 환자의 취약성과 관련된 다양한 윤리적 사안들을 더 엄밀하게 점검하고 있다. 그러나 말기 환자들의 삶의 질 향상 및 유지를 위해서는 질적으로 보장된 호스피스 완화의료 서비스가 제공되어야 한다. 이를 위해서 윤리적으로 안전한 호스피스 완화의료 연구의 시도가 지지되어야 한다. 이에 필자는 호스피스 완화의료 연구의 윤리지침을 종설 논문 형식으로 제안했다. 이는 윤리적으로 안전하고 과학적으로 가치가 있는 연구계획서를 준비해야 하는 연구자 및 그 연구계획서를 심의하는 IRB가 적절하게 참조할 수 있도록 해주기 위함이다.

• 한국응급구조학회지
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• 제23권1호
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• pp.147-155
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• 2019

Purpose: This study aimed to analyze the research trends of the articles published in the Korean Journal of Emergency Medical Services in the past 10 years. Methods: A total of 236 articles published between 2009 and 2018 were analyzed. For analysis of the collected data, frequencies and percentages were calculated using SPSS 23 (IBM, Armonk, NY, USA). Results: Most of the articles (47.9%, 113) were authored by 2 researchers, and most first authors were affiliated with university (81.4%, 192). Most of the articles were presented with 3 key words (34.3%, 81), and the most studied subjects of emergency medical technology was clinical researches (26.7%, 63). The majority of the research was performed quantitatively (99.6%, 235) and retrospectively (72.5%, 171), and research design was the most surveyed (68.2%, 161). For the majority of articles, the size of the sample was less than 100 (35.6%, 84), and the study participants were students (38.1%, 91). Only 12.7% (40) of the articles were reviewed by institutional review boards. Conclusion: In future studies on emergency medical technology, active participation of field emergency workers is needed. In addition, qualitative and prospective studies should be conducted on various types of research subjects.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.5-16
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• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.