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한국의료윤리학회> 한국의료윤리학회지> 무작위 임상시험의 윤리적,법적 문제

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무작위 임상시험의 윤리적,법적 문제

Ethical and Legal Problems of Randomized Clinical Trials

최경석 ( Kyung Suk Choi )
  • : 한국의료윤리학회
  • : 한국의료윤리학회지 11권1호
  • : 연속간행물
  • : 2008년 06월
  • : 45-62(18pages)

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Human experimentation can be ethically justified when subjects participate on a voluntary basis. Informed consent is required for clinical trials, including randomized clinical trials. Nevertheless, ethical issues arise when subjects are randomly distributed to experimental and control groups in randomized clinical trials. I argue that equipoise as well as informed consent is a condition of randomized clinical trials. Benjamin Freedman distinguishes theoretical equipoise from clinical equipoise. I call the former the "individual physician equipoise" and the latter the "clinical community equipoise". Under clinical community equipoise, randomized clinical trials are ethically justified because physicians may still provide the best treatment to their patients. The above ethical principle should be applied to placebo-controlled randomized clinical trials. When experimental drugs and placebos are in clinical community equipoise, a trial may be ethically justified. In addition, placebo-controlled randomized clinical trials should be designed with double-blinding. The reason for this requirement is that physicians would cheat their patients without doubleblinding. Current FDA regulations in Korea and the US do not sufficiently reflect the above ethical points. Institutional review boards should review their protocols in light of these ethical points. In particular, IRB regulations should reflect the basic ideas of equipoise in randomized clinical trials and double-blinding in placebo-controlled randomized clinical trials.

ECN


UCI

I410-ECN-0102-2012-330-002269669

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  • : 의약학분야  > 기타(의약학)
  • : KCI 등재
  • : -
  • : 계간
  • : 2005-8284
  • :
  • : 학술지
  • : 연속간행물
  • : 1998-2018
  • : 405


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1미국 생명윤리의 경계들과 그 너머

저자 : 김은성 ( Eun Sung Kim )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 1-12 (12 pages)

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American bioethicists have established several conceptual boundaries in institutionalizing bioethics into hospitals, academic programs, and the government. Bioethical expertise has been shaped and maintained through such boundary-making practices. This paper examines the following three boundaries of American bioethics: the boundary between bioethics and society, between bioethics and politics, and between scientific knowledge and society. The first boundary designates the view that bioethics is de-contextualized from society, the second boundary results from the view that bioethics should be politically neutral, and the third boundary is built on the dichotomy between scientific knowledge and social values. These boundaries have been both contested and strengthened by American bioethicists. Through the analysis of such boundarymaking practices of American bioethics, this paper aims to suggest fruitful lessons concerning the institutionalization of Korean bioethics.

2죽임(Toten)과 죽게 내버려둠(Sterbenlassen) -인과성의 관점에서 바라본 부작위(Unterlassen)-

저자 : 김문정 ( Moon Jeong Kim )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 13-22 (10 pages)

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Whereas active and direct euthanasia is ethically and legally prohibited, passive or indirect euthanasia is, except for special cases, acceptable and even recommendable. The actual difference between an intentional act of killing and an act of withholding or withdrawing life-sustaining treatment can be described most clearly in terms of the causal role of the physician. Active euthanasia represents a new cause of death: the patient`s death results from the physician`s medical intervention (iatrogenic). In the case of passive euthanasia, the cause of death is the patient`s underlying disease. But a physician`s omission which allows the patient to die may be a cause of the patient`s death in the sense of an inus-condition, that is, an insufficient but non-redundant part of an unnecessary but sufficient Condition. The inus-condition is responsible for the causation of the occurrence. Both killing and letting die are inus-conditions of minimally sufficient conditions of the patient`s death. The abandonment of withholding or withdrawing of persistence-treatment is thus causally responsible for the fatal outcome.

3사전의사결정(Advance Directives, 死前意思決定)에 대한 사법연수원생들과 전공의와 수련의들의 인식도 조사

저자 : 신영태 ( Young Tae Shin ) , 이일학 ( Il Hak Lee ) , 김선현 ( Sun Hyun Kim ) , 이희일 ( Hee Il Lee )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 23-36 (14 pages)

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Background: The legal and ethical issues related to advance directives have recently become controversial in Korea. This study was designed to determine whether there are any significant differences between judicial apprentices and medical trainees (including residents and interns) with respect to their attitudes toward advance directives. Methods: A questionnaire was administered to 283 judicial apprentices from May 29 to June 9, 2006, and to 254 medical trainees (150 residents and 104 interns) from May 1 to July 31, 2006. Thus, there were a total of 537 respondents in this study. Results: More medical trainees than judicial apprentices were familiar with advance directives (P < 0.05). More medical trainees than judicial apprentices claimed that a law for advance directives was necessary (P < 0.05). After adjusting for other predisposing factors, differences between the two groups were still statistically significant (P = 0.038). After adjusting other predisposing factors, it is found that the group which knew about advance directives beforehand responded more positively to the question whether legislation for advance directives was necessary than the group which didn`t(P=0.000). Conclusion: In this study, the difference in the number of medical trainees versus judicial apprentices who were familiar with advance directives was found to be statistically significant (P < 0.05). This caused statistically significant differences between the number of judicial apprentices versus medical trainees who believed that a law covering advance directives is needed. Therefore, greater awareness of advance directives is needed in order to establish a law governing them.

4의료 전문직 윤리교육과 합리적인 의료오류보고 체계 마련을 통한 의료분쟁의 예방 -일개 지역응급의료센터 의료오류보고 체계를 통한 민원 분석-

저자 : 황순영 ( Soon Young Hwang ) , 배현아 ( Bae Hyun A )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 37-44 (8 pages)

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Purpose: Claims of malpractice and medical error are on the rise in South Korea. In this paper we argue that, in order to prevent or reduce such medical disputes, ethical education must be strengthened and an effective system for reporting medical errors must be established. Method: The research subjects for this study were patients who complained of inadequate treatment at the emergency center of one Korean hospital between January 2006 and December 2007. The complaints of these subjects were examined in order to determine the nature and cause of the complaints, including any human factors that led to the complaints. Result: A total 54 complaints were reported. Among these, "unkindness" was the most frequently reported complaint. In 27 (49%) of the cases, the cause of the complaint was traced to a human factor, with "lack of explanation" and "bad attitude" totally 69% of the cases. Such complaints were resolved by a variety of methods, including further explanations, apologies, reduction or exemption from the cost of treatment or asking for assistance from related departments. Conclusion: Patients that experience medical errors tend to lose trust in the doctor-patient relationship, which hinders the resolution of such medical errors. This study emphasizes the need to strengthen ethical education and establish a proper procedure for reporting medical errors in order to prevent and resolve medical error and the disputes to which they give rise.

5무작위 임상시험의 윤리적,법적 문제

저자 : 최경석 ( Kyung Suk Choi )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 45-62 (18 pages)

다운로드

(기관인증 필요)

초록보기

Human experimentation can be ethically justified when subjects participate on a voluntary basis. Informed consent is required for clinical trials, including randomized clinical trials. Nevertheless, ethical issues arise when subjects are randomly distributed to experimental and control groups in randomized clinical trials. I argue that equipoise as well as informed consent is a condition of randomized clinical trials. Benjamin Freedman distinguishes theoretical equipoise from clinical equipoise. I call the former the "individual physician equipoise" and the latter the "clinical community equipoise". Under clinical community equipoise, randomized clinical trials are ethically justified because physicians may still provide the best treatment to their patients. The above ethical principle should be applied to placebo-controlled randomized clinical trials. When experimental drugs and placebos are in clinical community equipoise, a trial may be ethically justified. In addition, placebo-controlled randomized clinical trials should be designed with double-blinding. The reason for this requirement is that physicians would cheat their patients without doubleblinding. Current FDA regulations in Korea and the US do not sufficiently reflect the above ethical points. Institutional review boards should review their protocols in light of these ethical points. In particular, IRB regulations should reflect the basic ideas of equipoise in randomized clinical trials and double-blinding in placebo-controlled randomized clinical trials.

6국내 간호학 학술지 투고규정의 연구윤리 기준 분석

저자 : 정인숙 ( Ihn Sook Jeong ) , 엄영란 ( Young Rhan Um ) , 김금순 ( Keum Soon Kim )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 63-71 (9 pages)

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Background: All research involving human subjects, including research done in the field of nursing, should satisfy appropriate scientific and ethical requirements. Medical journals that publish the results of such research can help to ensure that researchers do satisfy these requirements by explicitly listing them as preconditions of publication in the publication guidelines ("Instructions for Authors"). Purpose: This study was designed to examine the explicit ethical requirements for the protection of human subjects in the publication guidelines of nursing journals. Methods: The guidelines of 19 nursing journals were reviewed to determine whether or not they required authors to a) comply with the Helsinki Declaration, b) have their projects approved by an institutional review board (RB), c) obtain informed consent, d) protect subjects` privacy and confidentiality, and e) explicitly state any conflicts of interest. Results: Twelve of the 19 (63.2%) journals included at least one of these ethical requirements in their publication guidelines. The most common requirement was the need to obtain informed consent, followed by the need to comply with the Helsinki Declaration. None of journals mentioned the need to have research projects approved by an IRB. Conclusion: While the publication guidelines of nursing journals have improved in recent years, there is a need for further explicit instructions to ensure that authors satisfy all ethical requirements in conducting research on human subjects. Further studies are recommended to determine if IRB approval should be a requirement for publication in nursing journals.

7성산 장기려 선생의 의학전문직업성

저자 : 박재현 ( Jae Hyun Park )

발행기관 : 한국의료윤리학회 간행물 : 한국의료윤리학회지 11권 1호 발행 연도 : 2008 페이지 : pp. 72-83 (12 pages)

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There is widespread agreement among medical professionals that it is essential to teach medical professionalism to medical students and residents. While role modeling is regarded as an important way of teaching medical professionalism, it is not always easy to find positive role models. Dr. Chang Kee-Ryo provides an admirable example of a physician who practices medicine with professionalism; the values of medical professionalism can be acquired through attention to his deeds and words. Dr. Chang demonstrated the most fundamental principles and professional responsibilities described in "Medical Professionalism in the New Millenium: A Physician Charter". Exposure to his life and work enables students to understand the concept of medical professionalism concretely and comprehensively rather than abstractly.

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