• 제목/요약/키워드: human trial

검색결과 432건 처리시간 0.019초

소아승낙 현황조사와 소아청소년과/소아신경과 전문의를 대상으로 면담조사를 통한 소아승낙서 공통기준 수립 연구 (Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist)

  • 이윤진;이선주;강수진;이대호;배균섭;정종우;김병수;김진석;이명아
    • 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.

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한국농촌보건(韓國農村保健)의 문제점(問題點)과 개선방안(改善方案) (Innovative approaches to the health problems of rural Korea)

  • 노인규
    • 농촌의학ㆍ지역보건
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    • 제1권1호
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    • pp.5-9
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    • 1976
  • The categories of national health problems may be mainly divided into health promotion, problems of diseases, and population-economic problems which are indirectly related to health. Of them, the problems of diseases will be exclusively dealt with this speech. Rurality and Disease Problems There are many differences between rural and urban areas. In general, indicators of rurality are small size of towns, dispersion of the population, remoteness from urban centers, inadequacy of public transportation, poor communication, inadequate sanitation, poor housing, poverty, little education lack of health personnels and facilities, and in-accessibility to health services. The influence of such conditions creates, directly or indirectly, many problems of diseases in the rural areas. Those art the occurrence of preventable diseases, deterioration and prolongation of illness due to loss of chance to get early treatment, decreased or prolonged labour force loss, unnecessary death, doubling of medical cost, and economic loss. Some Considerations of Innovative Approach The followings art some considerations of innovative approaches to the problems of diseases in the rural Korea. 1. It would be essential goal of the innovative approaches that the damage and economic loss due to diseases will be maintained to minimum level by minimizing the absolute amount of the diseases, and by moderating the fee for medical cares. The goal of the minimization of the disease amount may be achieved by preventive services and early treatment, and the goal of moderating the medical fee may be achieved by lowering the prime cost and by adjusting the medical fees to reasonable level. 2. Community health service or community medicine will be adopted as a innovative means to disease problems. In this case, a community is defined as an unit area where supply and utilization of primary service activities can be accomplished within a day. The essential nature o the community health service should be such activities as health promotion, preventive measures, medical care, and rehabilitation performing efficiently through the organized efforts of the residents in a community. Each service activity should cover all members of the residents in a community in its plan and performance. The cooperation of the community peoples in one of the essential elements for success of the service program, The motivations of their cooperative mood may be activated through several ways: when the participation of the residents in service program of especially the direct participation of organized cooperation of the area leaders art achieved through a means of health education: when the residents get actual experience of having received the benefit of good quality services; and when the health personnels being armed with an idealism that they art working in the areas to help health problems of the residents, maintain good human relationships with them. For the success of a community health service program, a personnel who is in charge of leadership and has an able, a sincere and a steady characters seems to be required in a community. The government should lead and support the community health service programs of the nation under the basis of results appeared in the demonstrative programs so as to be carried out the programs efficiently. Moss of the health problems may be treated properly in the community levels through suitable community health service programs but there might be some problems which art beyond their abilities to be dealt with. To solve such problems each community health service program should be under the referral systems which are connected with health centers, hospitals, and so forth. 3. An approach should be intensively groped to have a physician in each community. The shortage of physicians in rural areas is world-wide problem and so is the Korean situation. In the past the government has initiated a system of area-limited physician, coercion, and a small scale of scholarship program with unsatisfactory results. But there might be ways of achieving the goal by intervice, broadened, and continuous approaches. There will be several ways of approach to motivate the physicians to be settled in a rural community. They are, for examples, to expos the students to the community health service programs during training, to be run community health service programs by every health or medical schools and other main medical facilities, communication activities and advertisement, desire of community peoples to invite a physician, scholarship program, payment of satisfactory level, fulfilment of military obligation in case of a future draft, economic growth and development of rural communities, sufficiency of health and medical facilities, provision of proper medical care system, coercion, and so forth. And, hopefully, more useful reference data on the motivations may be available when a survey be conducted to the physicians who are presently engaging in the rural community levels. 4. In communities where the availability of a physician is difficult, a trial to use physician extenders, under certain conditions, may be considered. The reason is that it would be beneficial for the health of the residents to give them the remedies of primary medical care through the extenders rather than to leave their medical problems out of management. The followings are the conditions to be considered when the physician extenders are used: their positions will be prescribed as a temporary one instead of permanent one so as to allow easy replacement of the position with a physician applicant; the extender will be under periodic direction and supervision of a physician, and also referral channel will be provided: legal constraints will be placed upon the extenders primary care practice, and the physician extenders will used only under the public medical care system. 5. For the balanced health care delivery, a greater investment to the rural areas is needed to compensate weak points of a rurality. The characteristics of a rurality has been already mentioned. The objective of balanced service for rural communities to level up that of urban areas will be hard to achieve without greater efforts and supports. For example, rural communities need mobile powers more than urban areas, communication network is extremely necessary at health delivery facilities in rural areas as well as the need of urban areas, health and medical facilities in rural areas should be provided more substantially than those of urban areas to minimize, in a sense, the amount of patient consultation and request of laboratory specimens through referral system of which procedures are more troublesome in rural areas, and more intensive control measures against communicable diseases are needed in rural areas where greater numbers of cases are occurred under the poor sanitary conditions.

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