임상시험 연구윤리에 대한 임상연구자들의 인식 및 태도 조사 = A study of a researcher's views and attitudes concerning human research ethics
http://www.riss.kr/link?id=T12292037
초록 (Abstract)
- Abstract A study of a researcher's views and attitudes concerning human research ethics Department of Health Policy and Hospital Management Graduate School of Public Health, Korea University (Supervising Professor : Hyeong-sik Ahn M.D, Ph.D) Objec...
- Abstract A study of a researcher's views and attitudes concerning human research ethics Department of Health Policy and Hospital Management Graduate School of Public Health, Korea University (Supervising Professor : Hyeong-sik Ahn M.D, Ph.D) Objectives : This study aimed to step up clinical research ethics and figure out the needs of its education by reviewing domestic and foreign laws and systems of clinical research ethics and examining researchers' notions about it. Methods : The results of the survey were analysed with SPSS.12.0 of which frequency analysis, ANOVA, Two sample t-test and chi-squared test were carried out. Results : The study's major findings were as below. As for the general information of the respondents, women outnumbered men and most of them were in their 30s making their livings as researchers. Their major was mostly biotechnology. Specifically, many specialized in indirect clinical research such as studying human tissues and cells and had master's degrees. As asked their awareness of clinical research ethics related laws and systems, 34% of respondents said they were well aware. Also, those who received related education proved to be more aware of laws and systems than those who didn't. Among the respondents, those whose research plans were reviewed by IRB outnumbered those whose plans had never been. The main reason for IRB review was to 'publish papers in foreign journals' Asked how they found IRB review, most of them stated that there were too complicated procedures for documentation and too many formal documents required and called for the simplification of the procedures. As for questions asking what was the most important to raise levels of clinical research ethics, enactment and enforcement of more strict laws topped the list. Those who received ethics education emphasized the importance of the education more than those who didn't. The analysis showed statistically significant difference. Conclusion : Most of researchers generally made positive assessments on IRB review but they complained of the complicated procedures and requirements. In this regard, IRB review needed to be simplified. Most of them had only partial awareness of laws and systems which would serve as basic standards when they carried out clinical research. Therefore, to raise the levels of research ethics, more systematic and regular education programs need to be developed and implemented to get substantial results. Key words : Clinical research, Researcher, clinical research ethics, awareness and attitudes
목차 (Table of Contents)
- 목 차
- Abstract i
- Ⅰ. 서 론 1
- 1. 연구의 배경 1
- 2. 연구의 목적 3
- 3. 용어의 정의 4
- 4. 연구윤리 관련 국제지침 및 법률 6
- II. 연구대상 및 방법 8
- 1. 연구의 설계 8
- 2. 연구 대상 및 자료수집 9
- 3. 연구 도구 10
- 4. 자료분석 방법 11
- III. 연구결과 12
- 1. 연구 대상자의 일반적 특성 12
- 2. 임상시험 연구윤리에 대한 인식 15
- 1) 임상시험 연구윤리 관련 법률 및 제도에 대한 인식 15
- 2) 임상시험심사위원회(IRB)에 대한 인식 19
- 3) 우리나라 임상시험 연구윤리 수준에 대한 주관적인 인식 27
- 3. 임상시험 연구윤리 교육형태 및 인식 30
- 1) 임상시험 연구윤리 교육형태 30
- 2) 임상시험 연구윤리 교육에 대한 인식 34
- IV. 고 찰 36
- V. 결 론 40
- 참고문헌 41
- 부 록 43
- 국문요약