Journal of Physiology & Pathology in Korean Medicine (동의생리병리학회지)

The Physiological Society of Korean Medicine and The Society of Pathology in Korean Medicine (대한동의생리학회·한의병리학회)
권호 표지

Analysis on The Status of Prospective Clinical Researches Related to Korean Oriental Medicine and their Ethical Aspects

국내 한의학 관련 학술지에 게재된 전향적 임상연구의 윤리적 측면 분석

  • Received : 2012.09.17
  • Accepted : 2012.11.25
  • Published : 2012.12.25
Download PDF
⟨ Previous Next ⟩

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.

Keywords

Acknowledgement

Grant : 사상체질의학 연구의 국제적 활성화를 위한 베트남 협력 임상연구

Supported by : 한국한의학연구원

References

  1. Evidence-Based Medicine Working Group. Evidence-Based Medicine. A New Approach to Teaching the Practice of Medicine. JAMA. 268(17):2420-2425, 1992. https://doi.org/10.1001/jama.1992.03490170092032
  2. 안형식. 근거중심의학의 개념과 발전방안. 대한직업환경의학회 제43차 추계학술대회. pp 35-44, 2009.
  3. Pubmed Database. www.pubmed.com.
  4. 오정아, 김대훈, 오승종, 조현진, 최민규, 노재형, 손태성, 배재문, 김성. 국내 전문 학술지에 의한 위암 외과의 연구 경향에 대한 분석. 9(4):186-192, 2009.
  5. 김윤영, 유종향, 이수경, 이시우. 국내 한약 처방을 이용한 무작위 배정 임상연구논문의 질 평가. 동의생리병리학회지 25(5):927-933, 2011.
  6. 임선미, 신인순, 이선희, 서경화, 정유민, 장지은. 근거수준별 문헌의 질 평가 도구. 대한의사협회지 54(4):419-429, 2011.
  7. 신철민, 한창수, 배치운, Ashwin AP. 임상연구 논문의 질 평가를 위한 도구들. 대한정신약물학회지 22(2):67-72, 2011.
  8. 정인숙, 엄영란, 김금순. 간호학 학술지에 게재된 논문의 생명윤리기준 준수. 한국의료윤리교육학회지 11(2):153-162, 2008.
  9. 이성수, 박하영, 조익준, 정연권, 신병섭, 최병인, 송형곤. 대한응급의학회지에 실린 전향적 임상연구 논문의 연구윤리적 측면에 대한 고찰. 대한응급의학회지 20(1):134-137, 2009.
  10. 김옥주. 실험적 연구에서 생명윤리와 개인정보 보호. 한국역학회지 29(1):1-12, 2007.
  11. 의약품 임상시험 관리기준(Korea Good Clinical Practices). 식품의약품안전청. 2010.
  12. International Conference on Harmonization(ICH). Good Clinical Practice: Consolidated Guideline. 2011.
  13. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report : Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979.
  14. Council for International Organization of Medical Sciences(CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002.
  15. 강은희, 김은애, 권복규, 조은희. 연구윤리교육에 대한 생명과학 연구자들의 의견 및 요구. 한국의료윤리학회지 9(2):187-202, 2006.
  16. 류화신. 임상시험 법률관계에서 미성년자 동의능력의 문제. 한국의료윤리학회지 12(2):165-176, 2009.
  17. 정희정, 최선미, 박지은. 국내 한방병원의 IRB 및 임상시험 실태조사. 대한한의학회지 31(1):122-129, 2010.
  18. 맹광호. 의학 연구의 윤리. 대한의사협회지 44(1):1058-1064, 2001.
  19. WMA(The World Medical Association) Declaration of Helsinki : Ethical Principles for Medical Research Involving Human Subjects. International Journal of Bioethics. 15(1):124-129, 2004. https://doi.org/10.3917/jib.151.0124