1.Ethical Review on Science of Life.
Journal of the Korean Medical Association 2006;49(3):196-200
No abstract available.
Ethical Review*
2.Ethical Reviewers are Essential for Scholarly Journals for Timely Processing of Submissions and Avoiding Retractions
Journal of Korean Medical Science 2019;34(5):e41-
No abstract available.
Ethical Review
3.Ethic review on clinical experiments of medical devices in medical institutions.
Wanjun SHUAI ; Yong CHAO ; Ning WANG ; Shining XU
Chinese Journal of Medical Instrumentation 2011;35(4):274-276
Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.
Biomedical Research
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ethics
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Equipment and Supplies
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ethics
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Ethical Review
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Humans
4.Ethical consideration in several commonly used study design.
China Journal of Chinese Materia Medica 2011;36(20):2901-2903
Any study involving human subjects must undergo ethical review which covers scientific soundness and ethical resonance, for which, there are common elements to be considered when doing ethical review of research protocols involving human subjects. However, different study design accrue to different ethical considerations. This paper explores the main ethical considerations when reviewing study designs such as observational study, case record review; surveys, questionnaires and interviews. Ethical consideration well-targeted to study design will contribute to the human subjects protection.
Confidentiality
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Ethical Review
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Humans
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Informed Consent
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Research Design
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Surveys and Questionnaires
5.Chinese ethics review system and Chinese medicine ethical review: past, present, and future.
En-Chang LI ; Ping DU ; Ke-Zhou JI ; Zhen WANG
Chinese journal of integrative medicine 2011;17(11):867-872
The Chinese medical ethics committee and the ethical review system have made the following achievements: (1) enabled the institutionalization of medical ethics, (2) carried out the ethics review of Chinese medicine (CM) and integrative medicine extensively, (3) trained a large number of ethical professionals, (4) supported and protected the interests of patients and subjects, and (5) ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways: (1) to refine the relevant rules of ethical review, (2) to develop the relevant standards of the CM and integrative medicine ethical review, (3) to enhance the independence and authority of ethics committee, (4) to emphasize innovation and to discover and solve new problems, and (5) to increase international exchanges and improve relevant research.
Ethical Review
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Ethics, Medical
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Humans
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Integrative Medicine
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Medicine, Chinese Traditional
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trends
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Patient Rights
6.Ethical review of clinical study on intervention with traditional Chinese medicine in new public health emergencies.
Hao GU ; Zhi-Fei WANG ; Yan-Ming XIE
China Journal of Chinese Materia Medica 2020;45(10):2287-2290
High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.
Betacoronavirus
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Coronavirus Infections
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Emergencies
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Ethical Review
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Humans
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Medicine, Chinese Traditional
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Pandemics
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Pneumonia, Viral
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Public Health
7.Ethics review characteristics of clinical research of acupuncture and moxibustion.
Hui XU ; Jian-Qiao FANG ; Rui-Jie MA ; Qin CHEN ; Han LI ; Bang-Wei LI ; Jing LIU ; Hui-Juan MA ; Yuan-Yuan WU
Chinese Acupuncture & Moxibustion 2021;41(11):1273-1275
The elements of ethical review related to clinical research of acupuncture and moxibustion is discussed to provide ideas for various institutions to carry out relevant ethical review. It is believed that the ethical review of clinical research of acupuncture and moxibustion needs to focus on the specificity of acupuncture and moxibustion. Starting from the basic theory of traditional Chinese medicine, the theory of meridians and acupoints and the theory of syndrome differentiation along meridians, the key contents of ethical review such as intervention methods, grouping design and placebo control should be considered, so as to standardize the clinical research of acupuncture and moxibustion and protect the health and rights and interests of participants.
Acupuncture Points
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Acupuncture Therapy
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Biomedical Research
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Ethical Review
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Humans
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Meridians
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Moxibustion
8.A Systematic Review of Forest Therapy Programs for Elementary School Students.
Min Kyung SONG ; Kyung Sook BANG
Child Health Nursing Research 2017;23(3):300-311
PURPOSE: There are many forest and outdoor programs being offered but systematic reviews of effects are lacking. This study was done to identify content, format, and strategies of forest therapy programs for elementary school students. METHODS: Literature search using keywords in English and Korean was performed using 6 electronic databases in December 2016. Search participants were elementary school students and interventions conducted in the forest. Seventeen forest therapy studies were selected for evaluation. Risk of Bias Assessment tool for non-randomized study was used for quality assessment. RESULTS: All studies were quasi-experimental designs. Forest therapy programs included various activities in forests such as experience of five senses, meditation in the forest, walking in the forest, ecological play, observation of animals and insects. All studies used psychosocial health variables and forest healing programs had positive effects on sociality, depression, anxiety, self-esteem, stress, aggression, anger, and school adjustment. Limitations of these studies were vague reporting of the study, lack of ethical review and rigorous research designs. CONCLUSION: Forest therapy for elementary school child can be an effective way to improve psychosocial health. Future studies with rigorous study designs are needed to assess long-term effects of forest therapy on physical and psychosocial health.
Aggression
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Anger
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Animals
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Anxiety
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Bias (Epidemiology)
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Child
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Depression
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Ethical Review
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Forests*
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Humans
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Insects
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Meditation
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Research Design
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Walking
9.Consensus on collaborative ethical review of multi-center clinical trials of new drugs of traditional Chinese medicine (version 1.0).
Chong ZOU ; Hong DING ; Rui GAO ; Si-Yuan HU ; Jian-Zhong LIU ; Bo LI ; Xiao-Hui LI ; Ding-Ju PAN ; Jian-Yuan TANG ; Xiao-Yun TONG ; Ju-Yong WANG ; Wei-An YUAN ; Xun ZHANG ; Miao ZHANG ; Yan-Ling ZHAO ; Zhong-Qi YANG
China Journal of Chinese Materia Medica 2021;46(7):1696-1700
At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
Biomedical Research
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Clinical Trials as Topic
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Consensus
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Drugs, Chinese Herbal
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Ethical Review
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Humans
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Medicine, Chinese Traditional
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Multicenter Studies as Topic
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Pharmaceutical Preparations
10.A Study on Bioethical Consideration to Prospective Clinical Research Papers published in Journal of Korean Society of Emergency Medicine.
Sung Su LEE ; Ha Young PARK ; Ik Joon JO ; Yeon Kwon JEONG ; Byung Seop SHIN ; Byung In CHOE ; Hyoung Gon SONG
Journal of the Korean Society of Emergency Medicine 2009;20(1):134-137
PURPOSE: There is increasing concern about ethical conduct of human research in the field of medicine. The purpose of this study was to assess the ethical review process by institutional review boards for human research articles published in the journal of Korean Society of Emergency Medicine. METHODS: We reviewed human research papers published in the journal of Korean Society of Emergency Medicine from the 1st edition, 1990 to the 6th edition, 2006. A checklist was used to review the articles. RESULTS: The total number of prospective clinical research paper was 250. Among them, there were 63 papers (25.2%) in which the obtaining of informed consent was described in the article. Only two studies (0.8%) published in the journal were noted to have IRB approval. Invasive techniques were employed in 134 studies (53.6%). Among the 134, only 22 (16.4%) mentioned that informed consent taken was given during the study. Studies which may have involved discrimination totaled 21 (8.4%), and the number of studies that may have violated the patients' right to privacy was 20 (8%). The number of studies that may have a conflict of interest but was not declared was 12 (4.8%). CONCLUSION: There should be greater concern about the ethical conduct of research in studies with human research subjects in the journal of the Korean Society of Emergency Medicine.
Bioethics
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Checklist
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Conflict of Interest
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Discrimination (Psychology)
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Emergencies
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Emergency Medicine
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Ethical Review
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Ethics Committees, Research
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Helsinki Declaration
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Humans
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Informed Consent
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Patient Rights
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Privacy
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Research Subjects