• Title/Summary/Keyword: 환자의 자기결정권

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The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)

  • Lee, Jiyoun
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.163-207
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    • 2020
  • Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

A Study on the Job Performance of Dental Coordinators and Their Perception (치과코디네이터의 업무수행 및 인식도에 관한 조사연구)

  • Kwon, Soon-Bok;Kim, Young-Nam;Moon, Hee-Jung;Shin, Myung-Suk;Han, Gyeong-Soon;Han, Su-Jin
    • Journal of dental hygiene science
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    • v.5 no.4
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    • pp.211-220
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    • 2005
  • The purpose of this study was to examine the job performance of dental coordinators and their perception of their job to lay the groundwork for utilizing dental personnels more efficiently. The subjects in this study were dental coordinators who worked at selected dental hospitals and clinics in Seoul, Gyeonggi province and Incheon. A survey was conducted to gather data from May 1 to August 8, 2005 and answer sheets from 108 respondents were analyzed. The findings of the study were as follows: 1. As for the length of service, 43.5 percent of the dental coordinators investigated had worked at dental institutes for five years or more, which was followed by less than two years(19.5%) and three years to less than five years(19.4%). Concerning the length of service as dental coordinators, 39.8 percent had served for less than two years, and 19.4 percent had worked for two years to less than three years and for five years or more respectively. Regarding the name of position, 38 percent were called team leaders, and 30.6 percent were called coordinators. As to duties, the largest group of them that stood at 30.6 percent were in charge of receiving, and in regard to department, the largest group, 57.4 percent, belonged to the treatment backup department. 2. Concerning education, the greatest number of them, 45.4 percent, had received education at private institutes, and 73.1 percent found it necessary for dental coordinators to take an authorized qualification test. 43.5 percent, the largest group, looked upon the central government as the best organization to authorize their qualifications and 70.8 percent believed that what they learned enabled them to perform their job successfully. As to the necessity of follow-up education as a means to improve job performance, 96.3 percent consented to it. As for the reason, 63.9 percent considered that necessary to enhance their own ability and 22.2 percent were in want of systematic education. Regarding educational expenses, 29.6 percent were subsidized by the dental institutes where they had worked and 25.9 percent had totally been responsible for that. Regarding a required course, medical service and marketing was most widely pointed out(66.7%), followed by theory and practice(65.7%) and introduction to dentistry(57.4%). As to what sort of education they wanted to receive more, dental service and marketing was selected the most, followed by practical health insurance(35.2%). 3. In regard to what type of job they performed as dental coordinators, 88.9 percent were in charge of appointment in the field of customer service, and 87.9 percent paid attention to having good manners as service providers in the area of self-management. In the field of hospital affairs, 81.3 percent were in charge of receiving. 4. As to their awareness of dental coordinator job, the largest group took pride in the job they performed ($3.99{\pm}0.76$), and the second largest group believed that dental coordinators made a great contribution to hospital management ($3.92{\pm}0.70$). The third largest group gave a great weight to their own job ($3.91{\pm}0.84$) in light of overall dental duties and the fourth largest group found themselves to get along with other employees regardless of position ($3.86{\pm}0.74$). The fifth largest group believed their job was of great use for promoting the oral health of patients ($3.76{\pm}0.75$), and the sixth largest group thought the future of dental coordinators was promising($3.74{\pm}0.86$). 5. In regard to their perception by age group, those who were older had a better opinion on every item of their job in general. Their age made a statistically significant difference to their view of the weight of dental coordinator job(P < 0.001) in light of overall dental duties, of being approved and trusted by managers(P < 0.01), of social awareness of dental coordinator, and of being understood and approved by other employees and dentists. Their pride in current job and their satisfaction with the name of their position were statistically significantly different according to their age as well. Besides, their age made a statistically significant difference to their opinion about whether or not there was an age limit to their occupation and about their contribution to hospital management (P < 0.05). 6. As for their perception by type of job, the dental hygienists were generally most satisfied with their job, followed by nursing aids and others. There was a statistically significant gap among their opinions about whether to make a job-related decision on their own(P < 0.001). the weight of their job in terms of overall dental duties, whether their job improved their ability, whether their job made a great contribution to enhancing the oral health of patients, whether their job was understood and approved by other employees(P < 0.01), social awareness of their job, whether they conflicted with other employees during job performance, and whether dental hospitals or clinics offered a self-development opportunity for them to take their ability to another level(P < 0.05). And their satisfaction with current pay was statistically significantly different as well.

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