체질의학임상연구자들의 임상연구 윤리에 대한 인식 및 태도 조사
A Study on Constitutional Medicine Researchers’ View and Attitude Concerning Human Research Ethics
0
조회
0
다운로드
3
인용
0
참고문헌
키워드
초록
1. Objectives This study aims to find out identify the recognition and attitude about the research ethic among Constitutional medicine researchers. 2. Methods This survey was conducted to the 37 researchers who were currently participating in Korea Constitution Multicenter Study guided by Korea institute of Oriental medicine(KIOM). The survey consist of 4 parts that level of acknowledgment about the systems and laws on clinical research ethic, clinical research experiences and education, the level of acknowledgment about Institutional Review Board(IRB) and the recognition about overall research ethic. 3. Results Thirty one questionnaires were collected. Most researchers had low level of acknowledgment about the guidelines of basic research ethic. It was proved that more than 65% of the respondents have never received education for clinical research ethic. Moreover, 70% of them felt the need for education of clinical research ethic. In addition,most of the respondents recognized the fact that IRB is responsible for ethically implementing clinical research. 39% of the researchers thought that they themselves have a firm ethical viewpoint, while the rest of the group showed somewhat difficulty on their own ethical implementation of clinical research. 4. Conclusions Most of researcher had partial awareness of regulations and laws on clinical research ethic. And Educational needs of research ethic was high. Therefore education and Public Relations need to be done to extend research ethic. Moreover,standardized course of education on research ethic should be developed and activated.
Abstract
1. Objectives This study aims to find out identify the recognition and attitude about the research ethic among Constitutional medicine researchers. 2. Methods This survey was conducted to the 37 researchers who were currently participating in Korea Constitution Multicenter Study guided by Korea institute of Oriental medicine(KIOM). The survey consist of 4 parts that level of acknowledgment about the systems and laws on clinical research ethic, clinical research experiences and education, the level of acknowledgment about Institutional Review Board(IRB) and the recognition about overall research ethic. 3. Results Thirty one questionnaires were collected. Most researchers had low level of acknowledgment about the guidelines of basic research ethic. It was proved that more than 65% of the respondents have never received education for clinical research ethic. Moreover, 70% of them felt the need for education of clinical research ethic. In addition,most of the respondents recognized the fact that IRB is responsible for ethically implementing clinical research. 39% of the researchers thought that they themselves have a firm ethical viewpoint, while the rest of the group showed somewhat difficulty on their own ethical implementation of clinical research. 4. Conclusions Most of researcher had partial awareness of regulations and laws on clinical research ethic. And Educational needs of research ethic was high. Therefore education and Public Relations need to be done to extend research ethic. Moreover,standardized course of education on research ethic should be developed and activated.
참고문헌 (22)
- 정인숙, "임상연구에서 피험자 서면동의의 질 평가", 한국의료윤리학회지, 13(1), pp.43~58 (2010), 한국의료윤리학회
- The Nuremberg Code, "Nuremberg Military Tribunal", ~ (1947)
- "Ethical Principles for Medical Research Involving Human Subjects" (2000)[URL]
- "Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behaviral Research" (1979)[URL]
- ICH-GCP, "Guidelines for Goodl Clinical Practice for Trials on Pharmaceutical Products", World Health Organization, ~ (1995)
- 약사법 시행규칙 별표 3의 2, "의약품 임상시험 관리기준(제32조 관련)", ~ (2011)
- 생명윤리 및 안전에 관한 법률, "생명윤리 및 안전에 관한 법률", ~ (2011)
- 식품의약품안전청, "임상시험 윤리기준의 이해" (2005)
- "임상시험 정책방향" (2011), 식품의약품안전청[URL]
- 한승훈, "한국의 임상시험 현황", 대한의사협회지, 53(9), pp.745~752 (2010), 대한의사협회
- 임인애, "임상시험과 윤리", 대한의사협회지, 53(9), pp.774~779 (2010), 대한의사협회
- 정인숙, "간호연구자의 연구윤리 교육요구도 조사", Journal of Korean Academy of Nursing, 40(4), pp.515~523 (2010), 한국간호과학회
- Kim JS, "An investigation into the IRB members' and investigators' perceptions of institutions of review boards" (2006), Yonsei University: Graduate school of public health
- 안성희, "생명과학 연구자의 연구윤리 교육과정 개발을 위한 기초연구 - 연구윤리 경험, 교육현황 및 요구 -", 한국의료윤리학회지, 10(1), pp.83~98 (2007), 한국의료윤리학회
- 조은희, "연구윤리교육에 대한 생명과학 연구자들의 의견 및 요구", 한국의료윤리학회지, 9(2), pp.187~202 (2006), 한국의료윤리학회
- Son SY, "A study of researcher's view and attitudes concerning human research ethics" (2010), Korea university: Graduate school of public health
- Kim HC, "Laws and ethics of Clinical Trial" (2007), Seoul:Ewha Institute for Biomedical Law & Ethics
- Choi KS, "bioethics and Research ethics", Kor J Thinking and Expression, 2(1), pp.173~201 (2009)
- 박병주, "우리나라 연구윤리심의위원회의 운영실태와 개선방안에 관한 연구", 임상약리학회지, 12(2), pp.137~146 (2004), 대한임상약리학회
- 손화철, "한국 대학의 연구윤리교육 실태 분석", 철학사상, (24), pp.143~183 (2007), 철학사상연구소
- Shin HY, "The Characteristics of the Western Institutional Review Board", J Korea Bioethics Assoc, 8(1), pp.61~66 (2007)
- 백수진, "임상시험심사위원회와 기관생명윤리심의위원회의 개선방향에 관한 고찰", 생명윤리정책연구, 1(2), pp.141~156 (2007), 생명의료법연구소