본문 바로가기
KERD
논문KCI 등재

새로운 의료시술의 도입과 임상적용 시의 윤리적 절차

Ethical Process for Development and Clinical Application of an Innovative Medical Procedure

이선희|이동수|이상무|박재현|박지용|이일학|고윤석|구영모|강명신|이윤성|최보문
한국의료윤리학회 (The Korean Society For Medical Ethics)|2013.04|한국의료윤리학회지 (Korean Journal of Medical Ethics)|제16권 제1호|pp. 92-116|DOI 10.35301/ksme.2013.16.1.92

1

조회

0

다운로드

1

인용

0

참고문헌

키워드

medical ethicshealth technology assessment윤리적 규제외과적 시술새로운 시술의학 연구윤리근거중심의학의료기술평가surgical proceduresoperativeethical reviewhuman experimentationinnovative procedures
주제분류의학일반

초록

Medical care largely depends on developments of medical sciences and technologies. Development of innovative medical procedure have to be based on medical evidence. And ethical climate among individual physicians, academic societies, specialists' organization, and healthcare institution which applies the procedure is as much critical as the ethical stance of the developer. Therefore, it is necessary to make decisions on clinical application and evaluation, social costs and benefits, reimbursement through rational procedure and standards taking into account issues like medical evidence and conflict of interests. Especially, in the case of innovative surgical and surgico-medical procedure, the adoption has almost been up to non-formal studies until recently. Formal review process based on basic principles of biomedical research ethics and evidence-based medicine, is to be proposed for development of innovative surgical and medical procedures. And this process is to be an integral part of biomedical technology assessment and ethical regulation. This paper suggests an ethical guideline for ethical review and evaluation of a new medical procedure from its initial attempt to clinical application. Though focused on innovations, this suggested guideline is also applicable to a new medical procedure. The paper consists of four parts. Firstly, it outlines the general discussion about surgical innovations from the ethical viewpoint. Secondly, prior researches about the need of guideline are reviewed. Thirdly, under this background, basic principles for process of review and evaluation, and fourthly, the very process is proposed. Lastly, the further suggestions in connection with health care policy are given.

Abstract

Medical care largely depends on developments of medical sciences and technologies. Development of innovative medical procedure have to be based on medical evidence. And ethical climate among individual physicians, academic societies, specialists' organization, and healthcare institution which applies the procedure is as much critical as the ethical stance of the developer. Therefore, it is necessary to make decisions on clinical application and evaluation, social costs and benefits, reimbursement through rational procedure and standards taking into account issues like medical evidence and conflict of interests. Especially, in the case of innovative surgical and surgico-medical procedure, the adoption has almost been up to non-formal studies until recently. Formal review process based on basic principles of biomedical research ethics and evidence-based medicine, is to be proposed for development of innovative surgical and medical procedures. And this process is to be an integral part of biomedical technology assessment and ethical regulation. This paper suggests an ethical guideline for ethical review and evaluation of a new medical procedure from its initial attempt to clinical application. Though focused on innovations, this suggested guideline is also applicable to a new medical procedure. The paper consists of four parts. Firstly, it outlines the general discussion about surgical innovations from the ethical viewpoint. Secondly, prior researches about the need of guideline are reviewed. Thirdly, under this background, basic principles for process of review and evaluation, and fourthly, the very process is proposed. Lastly, the further suggestions in connection with health care policy are given.

참고문헌 (35)

  1. Robert G, "'Early warning systems for identifying new healthcare technologies", Health Technol Assess, 3(13), pp.1~118 (1999)
  2. Robert, "This figure is quoted in their article from Liaropoulus L", ~ (1997)
  3. Ashrafian H, "Evidence-Based Surgery, In Key Topics in Surgical Research and Methodology", pp.9~26 (2010), Springer
  4. Wilson CB, "Adoption of new surgical technology", BMJ, 332(7533), pp.332~7533 (2006)
  5. Wall J, "From Idea to Bedside: The Process of Surgical Invention and Innovation. Key Topics in Surgical Research and Methodology", pp.647~655 (2010)
  6. 이일학, "의료인-제약산업 관계의 이해상충과 윤리적 원칙", 한국의료윤리학회지, 14(2), pp.193~201 (2011), 한국의료윤리학회
  7. 홍진표, "의사-제약회사 상호작용이 처방에 미치는 영향", 한국의료윤리학회지, 14(2), pp.203~213 (2011), 한국의료윤리학회
  8. 정유석, "의대생", 전공의와 제약회사의 윤리적 관계, 2011, pp.14(2), 215~223[DOI]
  9. 배종면, "임상진료지침 개발 및 확산에 있어 이해상충문제", 한국의료윤리학회지, 14(2), pp.225~232 (2011), 한국의료윤리학회
  10. 박재현, "평생의학교육의 의사-제약회사 관계", 한국의료윤리학회지, 14(3), pp.335~342 (2011), 한국의료윤리학회
  11. 김승후, "의사-제약회사 상호관계가 연구에 미치는 영향", 한국의료윤리학회지, 14(3), pp.343~360 (2011), 한국의료윤리학회
  12. 강명신, "의사-제약산업체 상호작용에서의 이해상충 관리", 한국의료윤리학회지, 14(3), pp.361~371 (2011), 한국의료윤리학회
  13. 신은희, "의료법 쌍벌죄 규정에 대한 의료법리학적 문제제기", 한국의료윤리학회지, 14(3), pp.372~379 (2011), 한국의료윤리학회
  14. McCullough LB, "Standard of care, innovation and research in surgery: a problem in research ethics of professional ethics? Ethical Guidelines for Innovative Surgery, Reitsma and Moreno. 2006. Human Subjects Protection Program Guidance Document ver.1.0 Sept. 15, 2009", ~ (2009)
  15. McCullough LB, "Standard of care, innovation, and research in surgery: a problem in research ethics or in professional medical ethics?, In Ethical Guidelines for Innovative Surgery", pp.53~ (2006), University Publishing Group
  16. London AJ, "Cutting surgical practices at the joints: individuating and assessing surgical procedures, In The emperor's new scar: the ethics of placebo surgery" (2006), University of Wollongong
  17. Spodik D, "Numerators without denominators: there is no FDA for the surgeon", JAMA, 232(1), pp.1~32 (1975)
  18. Reitsma AM, "Ethical regulations for innovative surgery: the last frontier?", J Am Coll Surg, 194(6), pp.792~801 (2002)
  19. Moore FD, "Therapeutic innovation: ethical boundaries in the initial clinical trials of new drugs and surgical procedures", CA Cancer J Clin, 20(4), pp.212~227 (1970)
  20. Biff WL, "Responsible development and application of surgical innovations: a position statement of the university surgeons", J Am Coll Surg, 206(6), pp.1204~1209 (2008)
  21. Sharpe VA, "Promoting patient safety: an ethical basis for policy deliberation", Hastings Center Report Special Supplement, 33(5), pp.S1~S20 (2003)
  22. Eddy TM, "Clinical Decision Making: From Theory to Practice", pp.245~ (1996), Jones and Bartlett Publishers
  23. Reitsma AM, "Ethical Guidelines for Innovative Surgery" (2006), University Publishing Group
  24. Biffl WL, "Responsible development and application of surgical innovations: a position statement of the university surgeons", J Am Coll Surg, 206(6), pp.1204~1209 (2008)
  25. Shinebourne EA, "Ethics of innovative cardiac surgery", Br Heart J, 52(6), pp.597~601 (1984)
  26. Margo CE, "When is surgery research? Towards an operational definition of human research", J Med Ethics, 27(1), pp.40~43 (2001)
  27. Reitsma AM, "Ethical regulations for innovative surgery: the last frontier?", J Am Coll Surg, 194, pp.792~801 (2002)
  28. Gillett G, "Ethics of surgical innovation", Br J Surg, 88(7), pp.897~898 (2001)
  29. Spilker B, "Creating an IRB checklist to protect human subjects in clinical trials", Applied Clinical Trials, pp.34~36 (2002)
  30. McKneally MF, "Ethical problems in surgery: innovation leading to unforseen complications", World J Surg, 23(8), pp.786~788 (1999)
  31. Brown IT, "Medical technology horizon scanning", Australas Phys Eng Sci Med, 28(3), pp.200~203 (2005)
  32. , 2008
  34. 이상무, "근거중심 보건의료: 끊어진 선순환의 고리를 찾아서", 대한의사협회지, 52(6), pp.532~535 (2009), 대한의사협회
  35. 노먼 대니얼스, "분배정의와 의료보장" (2009), 나눔의집

관련 논문AI추천

외과적 혁신의 윤리 쟁점과 윤리적 규제의 필요성강명신, 박재현한국의료윤리학회 · 한국의료윤리학회지2011 · 제14권 제2호국가 R&D 과제의 생명윤리 관리체계 구축에 대한 고찰김보연, 김영남, 김은영, 장성미, 정경혜, 조현인, 허우성한국임상약학회 · 한국임상약학회지2016 · 제26권 제1호병원윤리위원회 표준운영지침 개발: 해외 사례를 중심으로박인경, 박지용, 손명세, 이일학생명의료법연구소 · 생명윤리정책연구2011 · 제5권 제2호환자에 대한 설명의무와 임상윤리박재훈생명의료법연구소 · 생명윤리정책연구2013 · 제7권 제2호연구윤리위반행위에 대한 법적 규율정규원법학연구원 · 법학논총2010 · 제27권 제4호국가연구개발과제 생명의학윤리 감독체계에 대한 인식조사 및 제언강영희, 권광일, 김은영, 이상미, 허우성한국임상약학회 · 한국임상약학회지2014 · 제24권 제2호

이 간행물의 다른 논문 (8건)

설명동의의 신경윤리(Neuroethics)김양태, 이상목pp. 1-10보건의료자원 분배에 있어서 세대간 정의:N. Daniels의 프루던셜한 평생이론박상혁pp. 11-26부분-인간화 동물(Part-human Animal)의 개념과 윤리적 쟁점들모효정pp. 27-40인체 부분들의 존재론적 특성에 대한 철학적 고찰조선우pp. 41-58의학적 의사결정의 실천 모델: 환자, 의사, 사회, 세 가지 주된 힘의 상호작용을 중심으로이효진pp. 59-76
원문 보기