• The Journal of Korean Medicine
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• v.31 no.1
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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.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.37-55
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• 2021

On March 19, 2021, the Korean Bioethics Association and related academic circles published a joint statement criticizing the partial revision of Infectious Disease Control And Prevention Act. However, according to the Bioethics And Safety Act of Korea, research conducted by the state or local governments for public welfare is excluded from human subjects research project. In addition, since the Korean legal system is not based on the dichotomy between research and surveillance, the discussion of the US Common Rule cannot be directly applied to Korea. For the harmonious operation of the state's duty to manage infectious diseases and the Institutional Review Boards, institutional alternatives should be prepared in consideration of the following issues. First, the related academic community should first pay attention to the problems of the current laws in Korea. Second, it should be understood that the state is carrying out many tasks without the consent of the parties in order to fulfill its duty to manage infectious diseases. Third, when presenting institutional alternatives, it is necessary to consider the feasibility of implementation in Korea. An in-depth discussion of the institutional alternatives by the Medical Law Society and other related academic circles is necessary.

• Journal of Korean Society of Archives and Records Management
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• v.17 no.3
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• pp.1-21
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• 2017

Oral history research is carried out through collecting information about a living person. The data collected from an oral history project is not a mere fact or a mass of information but accounts of persons who reveal their own personalities. For this reason, oral history research and data collection and the use of such data must be based on rigorous ethical standards. The Bioethics and Safety Law shares a similar view on human subject research, and the Institutional Review Boards includes human subject research as a subject of review and management. However, the Bioethics and Safety Law's protection of personalities and human rights focuses on life sciences methodologies, which are not suitable for qualitative research, such as an oral history of a value oriented and critical approach to human beings. This study examines the details of the Bioethics and Safety Law related to human subject research and the problems that may arise when this law is applied to subjects in humanities and social sciences such as oral history. Through this study, alternative methodologies, which can be used for oral history research, while maintaining academic autonomy, are suggested.

• The Journal of KAIRB
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• v.4 no.2
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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.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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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.

• Korean Journal of Oriental Medicine
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• v.13 no.2 s.20
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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.

• Korean Journal of Health Education and Promotion
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• v.30 no.2
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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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• v.22 no.2
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• pp.49-66
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• 2019

Along with the advances in medical technology and the economic development, more terminally ill patients are receiving hospice and palliative care services. Moreover, hospice and palliative care clinicians have been showing considerable interest in studies that aim to improve the quality of said care for patients and their families. Meanwhile, after the government has strengthened its policy to protect research participants, the institutional review boards (IRBs) are more closely examining various ethical issues related to patients' vulnerability when reviewing protocols for hospice and palliative care research. However, terminally ill patients should be provided with guaranteed qualities of hospice and palliative care to improve and maintain their quality of life. To that end, support should be provided for efforts to conduct ethical and safe studies with hospice and palliative care patients. Thus, this review paper proposes ethical guidelines for hospice and palliative care research. The guidelines could be appropriately used as a reference for researchers who should prepare for ethically safe and scientifically valued research protocols and the IRBs that will review the protocols.

• The Korean Journal of Emergency Medical Services
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• v.23 no.1
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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.

• The Journal of KAIRB
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• v.6 no.1
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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.