인체유래물 연구에 대한 생명윤리 = Ethics of Research Involving Human Subjects

다국어 초록 (Multilingual Abstract)

This study examined ethical issues pertaining to the handling of human tissues, including organs, based on fundamental principles that have been discussed in relation to human tissue donation.
As a result of examining the fundamental issues regarding the donation and handling of human tissues, including organs, the following five conclusions have been reached: Firstly, the principle of “autonomy” applies to organ and human tissue donation, emphasizing that donation should be voluntary and based on the individual’s free will. Respecting autonomy means not interfering with one’s actions as long as they do not clearly harm others, while placing importance on the autonomous and careful opinions and choices of individuals. However, clear criteria for protection based on decision-making capacity are required, recognizing that not all individuals can exercise autonomy.
Secondly, non-processed human tissue separated from the body, such as organs, should not be commercialized, and the principle of “non-profit” should be upheld, meaning that it should not be pursued for profit (Article 38, Paragraph 3 of the Bioethics Law). Although trading in organs and tissues is prohibited (Organ Transplantation Act, Article 7; Act on the Development of Organs and Tissues, Article5), strict responsibility must be imposed on medical practices that knowingly engage in illegal activities related to organ trafficking, brokerage, solicitation, or assistance. Particularly, commercial activities that involve processing donated bodies into dehumanizing specimens for display should be prohibited as inhumane acts of “commodifying” corpses.
Thirdly, the principles of “fairness and efficiency” are crucial in organ and human tissue donation and handling. Access to donated organs should be fair and equal for all individuals, including minorities, genders, religions, and those with disabilities, without unfair discrimination based on social or economic status or national power.
Fourthly, ownership of donated organs and other human tissue materials is a complex issue, but explicit regulations are necessary as a principle of “ethics” that considers respect for all parties involved in donation-related human tissue materials. When organs are donated, the donor is considered to relinquish ownership of the material, allowing the recipient individual or institution to exercise ownership rights in using and handling the donated human tissue, but there are no explicit legal provisions. It is necessary to clearly define the rights and obligations between donors and recipients in the Bioethics Law.
Fifthly, the principle of “anonymity protection” applies to organ donors. Even in cases of legal donation, human tissue contains sensitive information about an individual’s physical and physiological characteristics, so personal information and rights must be protected from infringement. Maintaining anonymity prevents discrimination based on race, gender, religion, economic status, etc., and fosters an environment where all donors are equally respected, thereby ensuring the reliability of research and medical activities.
These fundamental principles will serve as ethical and legal standards for organ and human tissue donation, and are expected to lay the foundation for creating an environment conducive to promoting donation activities within society.

참고문헌 (Reference)

• 1 丸山英二, "２．＜オピニオン＞ （１）医学系研究と生命倫理" HAB 研究機構 28 (28): 2021
• 2 송윤진, "한국의 장기기증 의사결정상의 문제점과 그 대안" 한국의료윤리학회 20 (20): 2017
• 3 김명희, "한국의 생체장기 기증제도에 대한 윤리적 고찰" 연세대학교 대학원 2004
• 4 강현구, "한국공공조직은행 강청희 은행장" 의약뉴스
• 5 양민철, "충격! 인체불가사의전 표본에 '중국 사형수 사체' 쓰여" 더 코리아
• 6 권복규, "줄기세포 연구의 윤리적 문제점" 세포응용연구사업단 윤리위원회
• 7 김동엽, "장기기증 활성화, 더 많은 노력 필요하다" 복지타임즈
• 8 송수연, "인체조직 할인 판매'가 드러낸 현실…‘성장통’ 겪는 공공조직은행" 청년의사
• 9 유지홍, "인체유래물의 법적 지위에 대한 인격적 측면에서의 고찰" 서울대학교 법학연구소 56 (56): 2015
• 10 최용전, "인체유래물연구에 있어서의 자기결정권과 동의면제 연구" 한국국가법학회 18 (18): 2022
• 11 유호종 ; 김소윤, "인체유래물과 유전정보에 대한 권리 및 분배 기준" 한국의료법학회 23 (23): 2015
• 12 최희 ; 손영화, "인간대상연구에서 서면동의 면제에 관한 고찰" 한국법정책학회 24 (24): 2024
• 13 박정규 ; 김정식 ; 김용희, "이종장기이식 및 줄기세포를 이용한 이식 연구의 현재와 미래" 대한의사협회 51 (51): 2008
• 14 박석건, "의사윤리강령 및 지침 해설과 활용방안 연구" 대한의사협회 의료정책연구소 2020
• 15 강진원, "의료윤리에도 원칙이 있을까?" 의학신문
• 16 이주갑 ; 윤운 ; 안준호 ; 주연호 ; 김창윤, "유엔장애인권리협약과 강제입원 : 강제입원 금지에 대한 비평" 대한신경정신의학회 56 (56): 2017
• 17 최용전 ; 한준섭, "영국의 인체유래물 연구에 있어서의 동의 및 면제제도" 유럽헌법학회 33 : 2020
• 18 강준호, "연구윤리 지침에 대한 윤리학적 고찰" 서울대학교 철학사상연구소 24 : 2006
• 19 PR Newswire, "생명의 선물 기증자 프로그램, 15년간 미국 내 장기기증을 선도" 메디포뉴스
• 20 손영화, "생명윤리와 연구대상자 보호" 한국법정책학회 23 (23): 2023
• 21 진교훈, "생명복제기술의 윤리적 문제와 대안" 한국정책지식센터
• 22 한국조직기증원, "비전 및 목표"
• 23 존 스튜어트 밀, "더클래식 서양고전 2 자유론" 더클래식 2021
• 24 한영자, "뇌사자 장기기증 활성화 방안" 한국보건사회연구원 2004
• 25 "기관생명윤리위원 정보포털"
• 26 KODA, "검사실 (KODA LAB)"
• 27 松村外志張, "直接本人の治療に関わらない人体臓器·組織·細胞の取扱い ─ その現代的課題解決の道を探る" 28 (28): 2021
• 28 村岡潔, "医師の裁量権と患者の自己決定権(2) 医師の作法と真実告知あるいはパレー シアの倫理をめぐって" (12) : 2018
• 29 丸山英二, "医事法学と生命倫理" 2004
• 30 松村外志張, "前揭論文(“直接本人の治療に関わらない人体臓器·組織·細胞の取扱い ─ その現代的課題解決の道を探る”)"
• 31 田村祐子, "前揭資料(“【イギリス】臓器提供に関する法律の改正”)"
• 32 丸山英二, "今知っておくべき研究における倫理 - 生命倫理 4原則と医学研究 －" 27 (27): 2011
• 33 津⾕喜⼀郎, "ベルモント·レポート"
• 34 松村外志張, "ヒト組織の創薬研究利用を進めるためにはなにが必要か" 28 (28): 2021
• 35 田村祐子, "【イギリス】臓器提供に関する法律の改正" 国立国会図書館 調査及び立法考査局 287 (287): 2021
• 36 김태화, "[윤리법제위원회] 장기 이식과 관련한 의료 이슈" 대한중환자위학회
• 37 International Military Tribunal, "Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law" Government Printing Office 1950
• 38 Tomuschat, Christian, "The legacy of Nuremberg" 4 (4): 2006
• 39 Bloom, David E., "The Global Economic Burden of Noncommunicable Diseases" 2011
• 40 Cohen, Carl, "The Case for Presumed Consent to Transplant Human Organs After Death" 24 (24): 1992
• 41 Department of Health, Education, and Welfare, "The Belmont Report"
• 42 Varkey, Basil, "Principles of Clinical Ethics and Their Application to Practice" 30 (30): 2021
• 43 Skene, Loane, "Ownership of human tissue and the law" 3 (3): 2002
• 44 Amy Lewis, "Organ donation in the US and Europe: The supply vs demand imbalance" 35 (35): 2021
• 45 Thaler, Richard H, "Opting in vs. opting out"
• 46 Jacobs, Miriam N., "OECD test guidelines" Frontiers in Toxicology 5-, 2023
• 47 "Medical Times"
• 48 Petrini, Carlo, "Is my blood mine? Some comments on the Convention on Human Rights and Biomedicine" 11 : 2013
• 49 Liverpool University, "Human material"
• 50 ABC News, "Hawaii Shuts Down Real Human Bodies Show" ABC News
• 51 Burns, Lawrence, "Gunther von Hagens' BODY WORLDS: Selling Beautiful Education" 7 (7): 2007
• 52 OPTN, "Guidance for Donor and Recipient Information Sharing"
• 53 "Experience of Murses in the Process of Donation of Organs and Tissues for Transplant" 22 (22): 2014
• 54 Cristina Ruiz, "Executed Chinese Prisoners Likely Used in UK Exhibition" The Art Newspaper
• 55 Iserson, Kenneth V., "Ethical principles-emergency medicine" 24 (24): 2006
• 56 Lo, Bernard, "Ethical issues in stem cell research" 30 (30): 2009
• 57 Lewis, Jennifer, "Ethical and legal issues associated with organ donation and transplantation" 41 (41): 2023
• 58 "Elsa Tsioumani and Asterios Tsioumanis, Biological Diversity: Protecting the variety of life on Earth"
• 59 "ETHICAL PRINCIPLES OF THE BELMONT REPORT"
• 60 Johnson, Eric J., "Do defaults save lives?" 302 : 2003
• 61 Cronin, Antonia J., "Directed and Conditional Deceased Donor Organ Donations: Laws and Misconceptions" 18 : 2010
• 62 Singer, Peter A, "Clinical ethics revisited" 2 (2): 2001
• 63 Terzic, Andre, "Chronic diseases : the emerging pandemic" 4 : 2011
• 64 Rhamil Taguba, ""Bodies: The Exhibition" IS MORALLY WRONG, Southwest Shadow"