• 동의생리병리학회지
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• 제36권6호
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• pp.221-228
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• 2022

The purpose of this study is to report the research trends of Korean medicine treatment for alopecia areata. We investigated the studies on Korean medicine treatments for alopecia areata via searching 4 web databases of Korea. 13 papers were selected, and we classified them according to publication year, published journals, the types of study, research subject, the methods of treatment, confirmation of recurrence, methods of evaluation, and institutional review board(IRB). We analyzed a total of 13 clinical studies of Korean medicine on alopecia areata based on various criteria and reviewed the research trends. Based on this, we suggested points to be improved and supplemented when conducting clinical research on alopecia areata in the future. Clinical studies on alopecia areata started to be published in 2001, and acupuncture, pharmacopuncture, herbal medicines, etc. were used as treatment methods for alopecia areata. Most of the clinical studies on alopecia areata were case studies, so it is thought that various types of clinical studies are needed. In addition, it is necessary to confirm the recurrence of alopecia areata and to improve the awareness of research ethics.

• 지역사회간호학회지
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• 제28권2호
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• pp.144-155
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• 2017

Purpose: This study aims to identify the general characteristics, subjects, and methods of research on the health of North Korean refugees through a systematic literature review. Methods: A total of 140 studies on health were reviewed using the analytical framework developed by the researchers. Results: The quantitative research comprised 90.7% of the studies, whereas the qualitative research were 7.9% of them. Approximately 81.4% of those reviewed have publication dates spanning 2006 to 2015. Only 13.6% of the studies were conducted with the approval of an institutional review board. The subjects of studies were psycho-social health (151.8%), behavioral health (28.5%), cognitive health (15.0%), physical health (12.2%), integrated health (7.8%), and spiritual health (2.8%). Within the quantitative studies reviewed, the most commonly used study design was survey research (86.0%). The two sampling methods used most often were convenience sampling (53.5%) and snowball sampling (19.4%), and the most commonly used data-collection method were questionnaires (94.6%). As for the qualitative studies, the most commonly used study design was phenomenology. Conclusion: The results suggested that the reviewed studies focused on physical health more than psycho-social health, and physiological measurement more than questionnaires. Ethical considerations need to be expanded.

• Journal of Nutrition and Health
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• 제43권6호
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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.

• 의료법학
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• 제13권2호
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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.

• 생물정신의학
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• 제19권4호
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• 한국간호교육학회지
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• 제20권4호
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• pp.452-462
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• 2014

Purpose: This study explores the experience of university life in an unfamiliar department by first-year graduate students. Method: Data were collected from participants through focus group interviews between July and August 2013 using phenomenological research methods. Colsizzi's method was used for analysis after the institutional review board of the university approved the study and informed consent was obtained from the participants. All interviews were recorded on an MP3 recorder and transcribed. Results: The analysis revealed 51 meanings that were categorized by 15 key words into 6 themes: "sense of isolation," "feeling of solidarity," "limitations," "benefits," "overcoming" and "renewing." Conclusion: First-year graduate students experience both positive and negative feelings toward "university life"; however, they eventually overcome their difficulties and adapt to the conditions of their field of study and new department.

• 대한기관윤리심의기구협의회지
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• 제3권2호
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• pp.28-36
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• 2021

Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

• Journal of Korean Biological Nursing Science
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• 제21권1호
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• pp.54-61
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• 2019

Purpose: This study aimed to identify the incidence and risks for pressure ulcer among older patients with hip fracture. Methods: The subject were 215 older patients suffering from hip fracture who were admitted for surgical operation from January 1, 2012 to April 30, 2016 in a university-affiliated hospital. The incidence of pressure ulcer was collected retrospectively through medical record review and the risk factors were analyzed using Cox's proportional hazard model. Results: Out of the total, 32 patients (14.9%) developed pressure ulcer with the average occurrence period being 4.72 (${\pm}3.81$) days. Stage II pressure ulcer was the most common at 72.0%. Risk factors included ambulation status before injury (p= .039), spinal anesthesia (p= .029), and stay at intensive care unit after operation (p= .009). Conclusion: Despite pressure ulcer prevention efforts, the incidence remained relatively high. Considering the identified risk factors, more efforts is needed for early detection and prevention of pressure ulcers in such patients.

• Clinics in Shoulder and Elbow
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• 제19권3호
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• pp.176-178
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• 2016

Panner's disease, osteonecrosis of the capitellum of the elbow, was first reported by Panner in 1927. The disease occurs mainly in boys between 6 and 15 years old and shows unilateral distribution. Pain, stiffness, localized tenderness over the lateral condyle of the elbow, and decreased range of motion are the typical clinical symptoms. Conservative treatment is generally recommended for patients in the early stage of this disease. A few cases of Panner's disease have been reported and few are related to long-term follow-up results. To the best of our knowledge, all reported cases were over six years. Therefore, we report on a five-year-old boy diagnosed as Panner's disease that showed resorption and regeneration of the humeral capitellum with no limitation of motion over three years. The current study was exempted from review by the institutional review board because it was a single retrospective case report. Informed consent was obtained from the patient's guardian.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.