인체유래물 연구에 대한 생명윤리 (Ethics of Research Involving Human Subjects)

서지정보

· 발행기관 : 인하대학교 법학연구소
· 수록지 정보 : 법학연구 / 27권 / 2호 / 173 ~ 214페이지
· 저자명 : 손영화, 최희

초록

이 연구는 인체유래물 기증과 관련하여 논의되어왔던 기본적인 원칙을 중심으로 장기등 인체유래물 취급에 있어서 필요한 윤리적인 문제(벨몬트 보고서의 윤리 3원칙을 포함한 DNA와 소유권 이전 등)들을 검토하였다. 그 결과, 첫째, 장기 등 인체유래물 기증은원칙적으로 개인의 자유로운 의사에 따른 자발적인 기증이어야 하는 ‘자율성’의 원칙이적용되어야 한다. 둘쨰, 인체에서 분리된 비가공 장기 등 인체유래물질은 상품화 대상이아니므로 이윤을 목적으로 하지 않아야 하는 ‘비이득성’의 원칙이 적용되어야 한다. 셋째, 소수 인종, 성별, 종교, 시설수용인 등을 포함한 모든 사람에게 공평하고 동등하게 기증된 장기에 접근이 가능해야 하고 사회적·경제적 지위나 국가 권력에 의해 불공정하게차별되어서는 아니 되는 ‘공정성과 효율성’의 원칙이 적용되어야 한다. 넷째, 기증한 장기 등 인체유래물에 대한 소유권은 복잡한 문제이지만 기증과 관련된 모든 당사자의 인체유래물질에 대한 존중의 원칙을 고려해야 하는 ‘윤리성’ 원칙으로서 명시적인 규정이필요하다. 다섯째, 장기 등 인체유래물이 합법적인 기증자라 하더라도 개인의 신체적, 생리학적 특성에 관련된 정보이므로 ‘익명성 보호’의 원칙이 적용되어야 한다.
이러한 기본적인 원칙은 장기 등 인체유래물 기증의 윤리적, 법적 기준이 될 것이며, 또한, 사회적으로 기증 활동 활성화가 이루어질 수 있는 환경을 구축하는데 초석이 될것으로 기대한다.

영어초록

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.

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