• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.257-285
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• 2011

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

• The Journal of the Korea Contents Association
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• v.18 no.5
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• pp.175-190
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• 2018

This was a descriptive study aiming to verify the effects of work environment, job satisfaction, and organizational commitment on the turnover intention of Clinical Research Coordinator(CRC) nurses. In the results of this study, the organizational commitment had significant effects on the turnover intention of CRC nurses. On the other hand, the work environment and job satisfaction had no statistically significant effects on the turnover intention of CRC nurses. Based on the results of this study, the main discussions were drawn as follows. In order to increase the organizational commitment, it would be necessary to have the institutional improvement like the increase of opportunity to participate in the hospital operation, administration, and the establishment of affiliated institution for improving a sense of belonging. It would be also necessary for each hospital to establish the standard of welfare, wage system for the improvement of work environment. If the organizational commitment of CRC nurses who are the actual performers, supporters of researches is ignored, it is unavoidable that the performance and quality of clinical tests would be declined. Therefore, there should be some changes, so that CRC nurses could play a pivotal role in the whole process of clinical test, by changing the employment status from contract position to more stable employment status, to increase their commitment to organization and work continuity.

• 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.

• Proceedings of the Korean Society of Medical Physics Conference
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• 2003.09a
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• pp.33-33
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• 2003

목적 : 현재 국내에서 사용되고 있는 방사선치료계획 장비는 거의 모든 방사선종양학과에서 외국 회사의 제품을 사용하고 있는 실정이다. 본 연구는 국내 기술로 개발된 3 차원 조형 방사선치료계획 장비인 Core Plan의 선량계산 알고리즘의 정확성 및 방사선 치료계획 장비로서의 유용성에 관해 평가하고 본 장비의 특징에 대해 간략히 소개하고자 한다. 재료 및 방법 : 본 연구는 2002 년 11 월에 가톨릭대학교 성모병원 방사선종양학과와 서울씨앤제이의 연구계약에 의해 시행되었다. 본 장비에 대한 평가는 방사선분포 및 계산상의 정확성과 임상적용시의 유용성의 관점에서 시행되었다. 본 장비에서 이용된 광자선 선량계산은 Clarkson-Cunningham 모델이며 전자선 선량계산은 2.5D Hogstrom 알고리즘이다. 방사선분포 및 계산상의 정확성 평가를 위하여 방사선치료 장비는 본 병원이 보유한 Clinac 2100CD (Varian, USA)를 이용하였고 폴리스티렌 팬텀과 필름 및 이온 전리함을 이용하여 방사선분포 및 계산상의 정확성을 평가하였다. 방사선분포의 평가 방법은 필름을 이용한 방사선분포의 중심부단면 선량분포와 CorePlan 에서 재현된 방사선분포의 동일면 선량분포를 비교하였다. 임상적용은 2003 년 3 월부터 7 월까지 방사선치료를 받은 50 명의 환자를 대상으로 분석하였다. 본 시험에 적용된 환자는 본 병원이 보유한 3 차원 방사선치료계획 장비인 Prowess 3D (SSGI Inc., USA)를 이용하여 실제 치료된 환자들이며 이 환자를 대상으로 CorePlan에서 동일하게 재현하여 비교하였다. 결과 및 결론 : 방사선분포 및 계산상의 정확성 평가에서는 실제 측정된 결과와 CorePlan에서 재현된 결과가 모두 $\pm$3% 이내로 평가되었다. 50 명의 환자를 대상으로 시행한 임상시험 결과 Prowess 3D에서 나타낸 결과와 비교하여 두경부에서는 1.678%, 흉부 1.578%, 복부 1.271%의 선량값의 오차를 보였다. 본 연구를 진행하는 과정에서 많은 부분의 프로그램 수정이 있었으며 실제임상에 필요한 부분에 대한 추가 및 보완이 이루어졌다. 앞으로 진행될 과정은 실제임상의 사용에 필요한 부분의 계속적인 업그레이드와 전자선에 대한 방사선분포 및 계산정확성 평가, 임상적용에 있어서 Prowess3D 뿐만 아니라 다양한 방사선 치료계획 장비와의 비교를 할 예정이다.

• The Korean Society of Law and Medicine
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• v.17 no.1
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• pp.299-346
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• 2016

There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.