• The Journal of KAIRB
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• v.1 no.2
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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.

• Journal of Physiology & Pathology in Korean Medicine
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• v.27 no.1
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• pp.26-33
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• 2013

The present study explored studies directed at elucidating the effectiveness of Korean medicine in the treatment of sterility and systematically analyzed the trends of studies on sterility. The standardization and objectification based on results for this study may contribute to the development of effective Korean medicine in reducing sterility. In the annual tendency of sterility-related clinical studies, the number of papers began to increase rapidly from 2000, and 15 papers were published from 2000 till 2011. Then, in the technical journals publishing them, The Journal of Oriental Obstetrics & Gynecology published 13 the most papers. In the institutions to which the first authors belonged, Dongguk University Hospital had 5 the most papers. In the number of test subjects was also analyzed and as the result the studies with 1~9 were the most as 10. In the study design analysis, there were 10 case reports, 5 case series and 4 before and after studies. In the analysis of intervention methods, there were 10 papers where only the Korean medicines were given, next 6 papers where the acupuncture and moxibustion were added, and 3 papers where the Korean medical therapies and other subsidiary therapies were used. In the analysis on the existence of pattern identification, there were 12 papers with the pattern identification, 6 without the pattern identification and 1 with the four constitution identification. In the IRB approval, 18 or most papers had not received the IRB approval and just 1 paper got the IRB approval. When the sterility-related clinical studies published in the Korean medical journals were surveyed, it turned out that there are no RCT studies and there is just one study with the IRB approval. And there were 6 papers without the pattern identification of Korean medicine. So, it seems necessary in the future to improve the papers in these respects for the development of Korean medicine sterility treatment with a good basis through the more systematic and accurate study method.

• Journal of Nutrition and Health
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• v.43 no.6
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• pp.653-660
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• 2010

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.

• The Korean Society of Law and Medicine
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• v.13 no.2
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.359-360
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• 2001

• Microbiology and Biotechnology Letters
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• v.25 no.6
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• pp.552-559
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• 1997

Fe (III) impurities in clay could be microbially removed by inhabitant dissimilatory Fe (III) reducing microorganisms. Insoluble Fe (III) in clay particles was leached out as soluble reductive form, Fe (II). The microorganisms removed from 10 to 45% of the initial Fe (III) when each sugar was supplemented to be in ranges of 1 - 5 % (w/w; sugar/clay). The microorganisms reduced 2.1 - 12.8 mol of Fe (III) per 100 mol of carbon in sugars metabolized when sugars such as glucose, maltose, and sucrose were used as sole carbon source. Bacillus sp. IRB-W and Pseudomonas sp. IRB-Y were isolated from the enrichment culture of the clay. The isolates were considered to participate in metabolizing organic compounds to fermentative intermediates with relatively little Fe (III) reduction at initial Fe (III) reduction process. By the microbial treatment, the whiteness of the clay was increased form 63.20 to 79.64, whereas the redness was obviously decreased form 13.47 to 3.55. This treatment did not cause any unfavorable modifications in mineralogical compositions of the clay.

• Journal of Korean Clinical Nursing Research
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• v.14 no.3
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• pp.153-163
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• 2008

Purpose: The purpose of this research, using descriptive correlation design was to identify the extent to which the mothers having children with rare genetic metabolic diseases(MPS, PWS) have parenting stress and guilt feeling. Method: This study used PSI /SF(Abidin, 1995) and Guilt Index as devised herein. From 156 mothers, data were collected from February to July 2006, using self-administered questionnaires. This study received the approval from IRB at S Hospital (IRB File No: 2006-02-014). Data were analyzed with descriptive statistics, t-test, ANOVA, and correlation. Results: Mothers felt very high level of parenting stress and sense of guilt. Parenting stress was related positively to guilt feeling. Conclusion: These findings could help understand the families of children with rare genetic metabolic diseases and those provide basic information in developing effective counseling and education programs for relief of parenting stress and guilt feeling. This study would be significant in the fact that it is the first research, targeting on the families of children with rare genetic metabolic diseases in Korea.

• The Korean Society of Law and Medicine
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• v.19 no.1
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• pp.165-206
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• 2018

Researchers, Institutional Bioethics Committee(IBC)/Institutional Review Board (IRB) members, Research Institutions that have multiple interests in relation to research should ensure that conflicts of interest(COI) do not arise in making professional judgments. In other words, according to the role that must be performed or the obligation to fulfill it, the primary interest, which must be considered or should be prioritized, should not be affected by the secondary interest. Therefore, standards and methods should be prepared so as to prevent and solve the problems of COI that have arisen, and the basic matters on standards and methods should be clearly defined in terms of the law and policy so that all parties such as Researchers can understand and follow them. In order to establish a more realistic legal policy, it is necessary to grasp the current situation. Therefore, I have reviewed results of the questionnaire survey and interview conducted for the administrative staff of IBC/IRB to confirm their opinions on legal policy problems related to COI and countermeasures for resolving them. Also, I have reviewed the main contents of issued by the US Department of Health and Human Services in order to assist in the preparation of domestic legal policy about conflicts of interest. Finally, I have analyzed the present state of domestic legal policy in relation to the Researcher's COI, the IBC/IRB member's COI, and Institutional COI and suggested way to improve it.

• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.1
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• pp.73-84
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• 2019

Objectives: The purpose of this study is to collect and analyze the KCD codes applied to the treatment of 27 postpartum women who had been treated with Korean traditional medicine in a Korean medicine hospital, so that this study may be used as a basic data for setting the direction of postpartum Korean medical treatment research. Methods: It was approved by the Institutional Review Board (IRB) of ${\bigcirc}{\bigcirc}$ University medical center (IRB approval number : WSOH IRB H1708-02-01). Twenty-seven postpartum women who had been treated at ${\bigcirc}{\bigcirc}$ University medical center were received outpatient treatment for two weeks (from September 27, 2017 to January 5, 2018), and the KCD codes applied to the mothers were collected after obtaining the consent. On the day of registration of the study, the fertility, obstetric history and high-risk pregnancies were identified through an interview. Results: 1. The mean age of the 27 subjects was $33.33{\pm}3.99\;years$ old. Among the subjects, 17 mothers (63.0%) were high-risk pregnancy and 10 mothers (37.0%) were normal. 2. Among the 22 major disease categories, 8 categories were used. M code (musculoskeletal system) was used 243 times (70.85%), followed by R code (unclassified symptom) of 51 times (14.87%) and U code (special purpose code) of 23 times (6.71%). 3. The most commonly used code among the ten frequently used codes was M25.57 (joint pain, ankle and foot), a total of 47 times. Of the remaining nine codes, except for R60.1 (systemic edema) and U68.4 (The deficiency of yang in Bi), all codes were M codes (musculoskeletal system). 4. The M code (musculoskeletal system) was the most used major disease category in high-risk group, a total of 159 times. But in specific categories, the most commonly used code was R60.1 (systemic edema), a total of 28 times. 5. In normal group, the M code (musculoskeletal system) was the most used major disease category, a total of 84 times. Also, in specific categories, the most commonly used code was M25.57 (joint pain, ankle and foot), total 29 times. 6. The U code, corresponding to 'the diagnosis of childbirth and other obstetrical medical use', was used 23 times (6.71%), O code three times (0.87%) and Z code two times (0.58%), which was less than 10% of the total number of codes used. Conclusion: When analyzing KCD codes related to Korean medicine treatment for postpartum diseases, it is important to select the KCD codes that reflect the actual clinical state.

• The Journal of KAIRB
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• v.5 no.1
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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.