• 한국콘텐츠학회논문지
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• 제5권4호
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• pp.54-61
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• 2005

우리 경찰이 창설 된지도 올해로 60년이 됐다. 그동안 경찰수사권 독립과 관련된 논의는 창경(創警)이래 지금까지 계속 되고 있는데, 역대 정권들에서 대선 공약의 하나로서 경찰수사권 독립 문제를 거론하였으며, 특히 참여정부의 탄생 과정에서 또 다시 수면 위로 떠올라 큰 이슈가 되고 있다. 수사권과 관련된 문제는 1954년 검찰과 경찰의 지휘관계를 규정한 형사소송법이 '수사의 주재자는 검사(현행 형소법 제195조)' 이며, '경찰은 검사의 수사 지휘를 받아야 한다(현행 형소법 제196조)'는 규정에서 비롯된 것으로 최근 노무현 대통령이 언론사와의 인터뷰를 통해 '대통령이 직접 나서서라도 수사권 문제를 매듭짓겠다'라고 발언한 이래 급물살을 타고 있다. 본 논문에서는 우리나라의 경찰수사권 독립논의의 합리적인 해결책을 모색하기 위하여 대륙법계와 영미법계의 대표적 국가들의 수사권 체제에 관해 살펴보고 인권보장과 권력분립의 원칙에 입각한 보다 비교타당한 수사권 체제에 대해 검토해본다.

• 한국임상약학회지
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• 제5권2호
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• 한국임상약학회지
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• 제32권3호
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• pp.166-177
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• 2022

Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating in clinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25, 2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before and after enforcement of the regulation. Methods: Recruitment advertisements for clinical trial subjects 3 years before and after enforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways) and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 for investigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-group comparisons. SPSS version 26 was employed for statistical analyses. Results: A total of 137 advertisements were collected comprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisements increased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expected adverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to 70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased. Conclusions: Enforcement of regulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.