• 대한본초학회지
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• 제27권2호
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• pp.25-29
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• 2012

Objectives : This article reviews a solution preventing the illegal distribution of herbal medicine in common use for food and medicine and risks on public health by conducting safety management of food and medicine. Also, this article would like to contribute to improvement of public health treating diseases in compliance with accurate diagnosis and prescription of Oriental Medicine Doctor("OMD")'s. Methods : An approach in this research can be categorized into two : first, to examine the current administrative situation and problems of herbal medicine in common use for food and medicine based on policy documents of Ministry of Health and Welfare and Korea Food and Drug Adminstration("KFDA") and academic articles of the herbal medicine;second, to find reasonable administrative solutions to solve the problems. Solutions : A solution is to strengthen the management level of herbal medicine in common use for food and medicine by selecting 117 items as target items requiring concentrated management. In case herbal medicine is imported for food, KFDA strengthens the quality management level of herbal medicine by making use of inspection frequency at random, collecting and verifying herbal medicine on the market. However, KFDA decides to maintain current different quality specification system of food and medicine reflecting a civil complaint that quality specification of food and medicine should separately managed according to the purpose of use. Herbal medicine as medicine that is functioned as treating diseases and alleviating symptoms, unlike herbal medicine for food, can cure all kinds of diseases by recovering inner balance of human body, making use of other properties of herbal medicine. Medicine has its own properties. If a doctor uses properties of medicine appropriately, he cures diseases. If a doctor uses herbal medicine inappropriately. he may damage human body. Thus, whether side effects of medicine depend on a doctor who uses herbal medicine. Conclusions : All herbal medicine will be supplied into the market after strict safety control of manufacturers of herbal medicine according to the revised Pharmaceutical Affairs Act, beginning in April, 2012. Thus, people can take safer and more reliable herbal medicine through strengthening safety management of herbal medicine and improving quality and transparency in the distribution system. Herbal medicine should appropriately be prescribed by licensed OMD because herbal medicine is used to treat diseases and alleviate symptoms, unlike herbal medicine for food.

• 의료법학
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• 제21권2호
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• pp.163-207
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• 2020

우리나라의 임상시험은 최근 10년간 그 규모가 성장하여 임상시험 산업의 주요 국가로 자리매김 하였다. 임상시험은 의료수준의 발전 및 치료 가능성의 확대를 위해 중요한 의미를 지니고 있다. 그러나 임상시험은 의약품 등의 안전성과 유효성을 증명하기 위한 것으로서 본질적으로 위험성을 내포하고 있으므로, 적절히 통제되어야만 임상시험대상자의 건강과 자기결정권이라는 법익을 보호할 수 있다. 이를 위해 임상시험을 수행하는 의사의 선관주의의무 이행이 특히 중요하다. 약사법과 그 하위법령은 시험자인 의사가 준수하여야 할 여러 의무를 규정하고 있다. 이 중 대상자 보호의무와 설명의무는 의사의 임상시험대상자에 대한 주된 선관주의의무를 구성한다. 이는 통상적인 의사의 진료행위에 있어서의 주의의무 및 설명의무와도 본질적으로 그 보호법익과 내용이 유사하다. 임상시험의 경우 통상적인 진료행위의 경우보다 가중된 설명의무가 요구된다. 임상시험에서의 구체적인 주의의무 기준 설정은 향후 판결과 연구를 통해 이루어져야 할 것이나. 주의의무의 기준을 막연히 높이거나 입증책임을 전환하는 등으로 임상시험을 수행하는 의사의 책임을 가중시킬 경우, 자칫 임상시험의 발전 및 환자의 새로운 치료법에 대한 접근성을 저해하고 손해의 공평·타당한 분담이라는 원칙에 위배될 우려가 있다. 이러한 의무들 외에도 임상시험에 대한 법령은 의사에 대해 여러 의무를 규정하고 있는바, 이러한 법령의 위반이 선관주의의무 위반에 해당함으로써 손해배상책임이 인정되는지의 문제는 해당 법령이 부수적으로라도 임상시험대상자의 안전과 이익을 보호하기 위한 것인지 여부, 대상자의 법익 침해의 유무와 정도, 법령위배행위의 태양 등을 종합적으로 고려하여 판단하여야 한다. 이와 같은 여러 의무의 충실한 준수가 이루어지도록 담보하고, 구체적 사안에서 임상시험대상자의 법익이 적절히 보호되었는지에 대해 사법(司法)적, 행정적 통제를 함으로써 법익 보호를 효과적으로 담보할 수 있을 것이다.

• 대한기관윤리심의기구협의회지
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• 제3권2호
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• pp.19-27
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• 2021

Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

• 마케팅과학연구
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• 제17권4호
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• pp.23-49
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• 2007

본 연구는 영업사원의 통제유형(긍정적/부정적 결과통제, 긍정적/부정적 행동통제)과 직무만족 간의 관계에서 결과/행동관련 역할명확성과 자기효능감을 매개변수로 도입하여 이들 연구단위들 간의 구조적 관계를 조사하는 것이다. 제약업계 영업사원들로부터 수집된 자료를 통한 실증분석 결과는 다음과 같다. 첫째, 영업사원에 대한 통제유형이 역할명확성에 미치는 영향을 조사한 결과, 긍정적/부정적 결과통제는 모두 결과관련 역할명확성에 정(正)(+)의 영향을 미치는 것으로 나타났으며, 긍정적 행동통제도 행동관련 역할명확성에 정(正)(+)의 영향을 미치는 것으로 나타났다. 그러나 부정적 행동통제는 행동관련 역할명확성에 영향을 미치지 않는 것으로 나타났다. 둘째, 영업사원에 대한 통제유형이 자기효능감에 미치는 영향을 조사한 결과, 긍정적 결과통제는 자기효능감에 정(正)(+)의 영향을 미치는 것으로 나타났지만, 긍정적 행동통제는 자기효능감에 영향을 미치지 않는 것으로 나타났다. 또한 부정적 결과통제와 부정적 행동통제는 각각 결과관련 역할명확성과 행동관련 역할명확성의 매개를 통해 자기효능감에 영향을 미치는 것으로 나타났다. 셋째, 역할명확성이 자기효능감과 직무만족에 미치는 영향을 조사한 결과, 결과관련 역할명확성과 행동관련 역할명확성은 모두 자기효능감에 정(正)(+)의 영향을 미치는 것으로 나타났다. 또한 행동관련 역할명확성은 직무만족에 정(正)(+)의 영향을 미치는 것으로 나타났으나 결과관련 역할명확성은 영향을 미치지 않는 것으로 나타났다. 끝으로, 자기효능감이 직무만족에 미치는 영향을 조사한 결과, 자기효능감은 직무만족에 영향을 미치지 않는 것으로 나타났다. 본 연구의 결론에서는 결과의 요약, 시사점, 한계점, 그리고 미래연구를 위한 제언을 제시하였다.