국내 한의학 관련 학술지에 게재된 전향적 임상연구의 윤리적 측면 분석
Analysis on The Status of Prospective Clinical Researches Related to Korean Oriental Medicine and their Ethical Aspects
2
조회
0
다운로드
4
인용
0
참고문헌
키워드
초록
In this research, the status of prospective clinical researches related to Korean Oriental Medicine was identified from the papers published in domestic Korean medicine journals for the past 10 years, and the ethical validity of them were evaluated. Selection of researches and assessment on the ethical validity were made from the evaluation of two independent persons and the adjustment of the third party, and the collected data was analyzed using SPSS 17.0 software. The yearly status of prospective clinical researches related to Korean oriental medicine showed that the average number of them, which was six before 2005, was decreased to only one in 2006, and it started to recover gradually after 2007. The result of ethical validity test of prospective clinical researches related to oriental medicine showed that 5 researches (12.2%) in “unbiased selection of subjects and recruitment”, 15 researches (36.6%) in “informed consent”, 10 researches (24.4%) in “ethical considerations for vulnerable subjects”, and 8 researches (19.5%) in “pre-deliberation and ethical oversight of the IRB” were appropriate to the ethical standards. The interest for clinical researches has been increased, and the ethical aspect of the clinical researches has been emphasized in oriental medicine. The results reported here are expected to provide a help to perform an ethical oriental medicine related clinical researches.
Abstract
In this research, the status of prospective clinical researches related to Korean Oriental Medicine was identified from the papers published in domestic Korean medicine journals for the past 10 years, and the ethical validity of them were evaluated. Selection of researches and assessment on the ethical validity were made from the evaluation of two independent persons and the adjustment of the third party, and the collected data was analyzed using SPSS 17.0 software. The yearly status of prospective clinical researches related to Korean oriental medicine showed that the average number of them, which was six before 2005, was decreased to only one in 2006, and it started to recover gradually after 2007. The result of ethical validity test of prospective clinical researches related to oriental medicine showed that 5 researches (12.2%) in “unbiased selection of subjects and recruitment”, 15 researches (36.6%) in “informed consent”, 10 researches (24.4%) in “ethical considerations for vulnerable subjects”, and 8 researches (19.5%) in “pre-deliberation and ethical oversight of the IRB” were appropriate to the ethical standards. The interest for clinical researches has been increased, and the ethical aspect of the clinical researches has been emphasized in oriental medicine. The results reported here are expected to provide a help to perform an ethical oriental medicine related clinical researches.
참고문헌 (19)
- Evidence-Based Medicine Working Group, "Evidence-Based Medicine. A New Approach to Teaching the Practice of Medicine", JAMA, 268(17), pp.2420~2425 (1992)
- 안형식, "근거중심의학의 개념과 발전방안", 대한직업환경의학회 제43차 추계학술대회, pp.35~44 (2009)
- 오정아, "국내 전문 학술지에 의한 위암 외과의 연구 경향에 대한 분석", 대한위암학회지, 9(4), pp.186~192 (2009), 대한위암학회
- 김윤영, "국내 한약 처방을 이용한 무작위 배정 임상연구논문의 질 평가", 동의생리병리학회지, 25(5), pp.927~933 (2011), 대한동의병리학회
- 임선미, "근거수준별 문헌의 질 평가 도구", 대한의사협회지, 54(4), pp.419~429 (2011), 대한의사협회
- 신철민, "임상연구 논문의 질 평가를 위한 도구들", 대한정신약물학회지, 22(2), pp.67~72 (2011), 대한정신약물학회
- 정인숙, "간호학 학술지에 게재된 논문의 생명윤리기준 준수", 한국의료윤리학회지, 11(2), pp.153~162 (2008), 한국의료윤리학회
- 박하영, "대한응급의학회지에 실린 전향적 임상연구 논문들의 연구윤리적 측면에 대한 고찰", 대한응급의학회지, 20(1), pp.134~137 (2009), 대한응급의학회
- 김옥주, "실험적 연구에서 생명윤리와 개인정보 보호", 한국역학회지, 29(1), pp.1~12 (2007)
- 식품의약품안전청, "의약품 임상시험 관리기준(Korea Good Clinical Practices)", 식품의약품안전청, ~ (2010)
- International Conference on Harmonization(ICH), "Good Clinical Practice: Consolidated Guideline" (2011), International Conference on Harmonization(ICH)
- The Belmont Report : Ethical Principles and Guidelines for the Protection of Human Subjects of Research, "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research", National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, ~ (1979)
- Council for International Organization of Medical Sciences(CIOMS), "International Ethical Guidelines for Biomedical Research Involving Human Subjects" (2002), Council for International Organization of Medical Sciences(CIOMS)
- 조은희, "연구윤리교육에 대한 생명과학 연구자들의 의견 및 요구", 한국의료윤리학회지, 9(2), pp.187~202 (2006), 한국의료윤리학회
- 류화신, "임상시험 법률관계에서 미성년자 동의능력의 문제", 한국의료윤리학회지, 12(2), pp.165~176 (2009), 한국의료윤리학회
- 정희정, "국내 한방병원의 IRB 및 임상시험 실태조사", 대한한의학회지, 31(1), pp.122~129 (2010), 대한한의학회
- 맹광호, "의학 연구의 윤리", 대한의사협회지, 44(1), pp.1058~1064 (2001)
- WMA(The World Medical Association), "Declaration of Helsinki : Ethical Principles for Medical Research Involving Human Subjects", International Journal of Bioethics, 15(1), pp.124~129 (2004)
