의학연구를 위한 인체유래물 기증계약의 법적성격

유지홍(Yoo, Ji Hong) 충북대학교 법학연구소 2019 과학기술과 법 Vol.10 No.1

At present, the demand and utility of human materials has increased rapidly, and the field of application has also diversified. On the other hand, the risk of illegal transactions and leakage of personal information has increased. Therefore, from the stage of contracting, systematic legal system and supervision over ‘human material donation and research’ are needed. Based on this scientific situation, this paper reviewed the legal issues related to donation of human materials and examined the legal characteristics of the donation contract. Through this study, the author confirmed that donation of human materials for medical research is a contract in which the donor grants authority to study human materials to the researcher for for public interest . This contract was the closest to the mandate of the typical contract in the civil law, and was closely related to the medical contract in particular. The legal issues and theories reviewed in this paper are as follows. The legal status of the human materials is the quasi state of human body and the dead body is the quasi state of the body when he was alive . Both 「Bioethics and Safty Law」, 「Declaration of Helsinki」, 「French Law on Respect for Human Body」, and ｢US Common Rules｣ identify donating human materials as granting authority to study human materials rather than transferring ownership . The legal characteristics of ‘the donation contract of human materials’ can be identified as a quasi-mandate contract as an atypical contract close to a medical contract. In a mandate contract, the interests of the mandator should be sought but In a the donation contract of human materials, Public interest should be sought. Therefore in the future, it is necessary to establish a unique contract system considering the characteristics of the donation of human materials .

현행 인체유래물은행 기증 동의의 문제점과 그 개선방안

구영신(Youngshin KOO),남승민(Seungmin NAM),김은애(Eunae KIM),최경석(Kyungsuk CHOI),권복규(Ivo KWON) 한국생명윤리학회 2024 생명윤리 Vol.25 No.2

The Human Material Bank is in charge of promoting the activation of research by collecting and preserving not only human materials but also related information such as genetic information, epidemiological information, and clinical information from donors. It goes without saying that prior consent must be obtained by sufficient explanation of related information in addition to human materials. However, even considering the purpose of the Human Material Bank as a research infrastructure, the current Bioethics And Safety Act on the consent to donate human materials and related information is insufficient in the consent principle. This study is to propose improvement measures by analyzing the deficiencies of the current law from the perspective of the principle of consent. First, the law only provides clear regulations on the consent to donate human materials and other related information, but does not have a clear basis for consent to donate other related information, causing confusion not only about the role category of the Human Material Bank but also the category of the target to be provided. In this regard, it is proposed to use the terms 'human resource' or 'human materials, etc.' that encompass related information. Second, the law only receives broad consent that does not specify or limit the researchers or researchers to which the donor's human materials and related information will be used, and there are no special regulations to guarantee the right to self-determination in case it is used or provided for unexpected purposes at the time of donation. In addition to the legal form, a separate explanation should be made, and the donor's choice should be given more than broad consent to ensure the right to self-determination as much as possible. Third, the law also includes consent from electronic documents in written consent, and in this case, there is controversy over whether electronic copies are allowed in the provision of copies of consent, but it is reasonable to assume that this is permitted.

인체유래물은행 관련 법적 기준의 문제점과 개선방안

유수정,구영신,최경석 이화여자대학교 생명의료법연구소 2022 Asia Pacific Journal of Health Law & Ethics Vol.15 No.3

The Bioethics and Safety Act(hereinafter referred to as the “Bioethics Act”) was fully revised in 2012, and came into effect in 2013. The Act was revised and expanded to include not only genetic and genetic information but also human materials introducing the term, ‘human material bank.’ The Bioethics Act stipulates that human material bank has the ability to collect and provide human materials to others, as well as to directly collect and use human materials to be used for research. There is no clear regulation on qualification requirements of the person to collect. There is confusion and difficulty in interpreting the relevant regulations on whether or not for the institutional review board of human material bank to pre-review when a human material bank directly collects or asks others to collect human materials. In addition, there is no clear management protocol for human material bank to prevent its over-collecting human materials. Thus, we point out the problems of the vague legal regulation regarding human material banks under the Bioethics Act. In order to secure citizens’ trust on the operation of human material biobank and improve its quality, we provide clear interpretation of the relevant current regulations in Bioethics Act and suggest concrete legal contents for the revision of the problematic regulations related to human material bank or the introduction of new regulations. 2012년 「생명윤리 및 안전에 관한 법률」이 전부개정되어, 2013년부터 시행된 생명윤리법에서의 유전자은행 관련 규정을 단지 유전자 및 유전정보만이 아니라 인체유래물까지 포함한 “인체유래물은행”으로 개정 확대하였다. 생명윤리법에서는 인체유래물은행이 수집·획득한 인체유래물을 타인에게 제공하는 기능뿐만 아니라 인체유래물연구에 쓰일 인체유래물을 직접 채취하여 이용할 수 있도록 정하고 있으나 인체유래물은행의 개설허가 및 채취자의 자격요건에 대한 명확한 규정이 없고, 인체유래물은행의 직접 채취 또는 채취 의뢰 시 기관위원회 사전 심의 여부에 대해서도 관련 법률 규정을 해석하는 데 혼란과 어려움을 겪고 있다. 그뿐만 아니라 인체유래물은행의 인체유래물 과잉 채취 방지를 위한 관리방안도 거의 마련되어 있지 않다. 따라서 본 논문에서는 생명윤리법상 인체유래물은행에 관한 법적 기준이 모호하고 불명확한 점에 대한 문제점을 지적하고, 인체유래물은행 운영의 신뢰 확보 및 질적 향상을 위해 현행 생명윤리법상 인체유래 물은행 관련 규정에 대한 명확한 해석뿐만 아니라, 현행 생명윤리법에서 인체유래물은행 관련 법 개정이 필요한 사항에 대한 개선방안을 제시하고자 한다.

인체유래물 연구에 대한 생명윤리

손영화,최희 인하대학교 법학연구소 2024 법학연구 Vol.27 No.2

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.

의료기관에 의한 잔여검체 제공 관련 피채취자 권리 보호 : 거부의사표시방식(일명 ‘opt-out방식’)의 절차적 내용적 문제점을 중심으로

박수경,김은애 이화여자대학교 생명의료법연구소 2019 Asia Pacific Journal of Health Law & Ethics Vol.13 No.1

This paper intended to address the issue of the protection of the donor’s rights in the collection of residual human materials by medical institutions and the provision of them to the biobank under the ˹Bioethics & Safety Act˼ as amended in October 2019. In particular, we examined the procedural content issues regarding the adoption of the optout system, and also argued that the opt-in system was more appropriate. Of course, we agree that the medical institutions, which are intended to be amended by the law, will use the residual human materials for treatment and diagnosis purposes to lay the foundation for more efficient and active disease research for research purposes. In addition, the CIOMS guidelines stipulate that residual human materials can be stored and used in research, unless explicitly stated by the person who is the source of the residual human materials, and the conditions are set forth. That is opt-out system. However, the relevant details of the revised legislation suggest that the opt-out system, in which the residual human materials is donated to the biobank, unless the objector rejects it, will make it difficult for the informed consent to make integrated autonomous decisions. Because it is necessary to express the objection of rejection through the information received in writing, it is difficult for the patient to acknowledge that he has obtained enough information and understood and agreed to it. And, due to the subordinate hierarchical difficulties arising from the doctor-patient relationship, it is difficult to guarantee voluntary rejection of the donor. In addition, within three days after the human materials is collected, it is necessary to clarify the rejection of the offer, which is cumbersome and inconvenient to express the objection. Finally, privacy issues related to residual human materials may arise. Therefore, it is appropriate to adopt an opt-in system for protecting the donor’s rights, which is more important than the effective progress of disease research and the result of excellent scientific results. First of all, we argued that sufficient training and information were required for the Institutional Review Board Member under consideration according to the revised law to work in consideration of this problems. 본 논문은 2019년 10월 개정된 「생명윤리 및 안전에 관한 법률」상의 의료기관에 의한 잔여검체 수집 및 인체유래물은행으로의 제공에 있어 피채취자의 권리 보호 문제를 다루고자 하였다. 특히 잔여검체의 기증 여부 동의 절차 방식에 있어 거부의사표시방식인 옵트아웃방식(opt-out방식)을 채택함에 관하여 절차적 내용적 문제점을 살펴보고 궁극적으로 동의의사표시방식인 옵트인방식(opt-in방식)이 더 적절함을 주장하였다. 물론 법의 개정 취지인 의료기관이 치료 및 진단을 목적으로 사용하고남은 잔여검체를 연구목적을 위하여 인체유래물은행에 제공할 때에는 일련의 절차 등을 거쳐 제공할수 있도록 함으로써 보다 효율적이고 적극적으로 질병을 연구할 수 있는 기반을 마련하려는 것에는동의한다. 그리고 CIOMS 가이드라인에서도 잔여검체의 출처가 되는 사람이 명시적으로 반대하지 않는 한 잔여검체가 저장되어 연구에 사용될 수 있음을 규정하고 있고 이에 대한 조건들이 제시되어 있다. 하지만 개정 법률의 관련 세부 내용을 살펴보면, 피채취자가 거부하지 않으면 잔여검체를 인체유래물은행에 기증하게 되는 방식(opt-out방식)에 있어, 서면으로 수령한 내용을 통해 거부의사를 표명해야 하므로 피채취자가 이를 충분한 정보를 습득하여 이해하고 동의하였다고 인정하기 어려운 점, 거절의사를 표현함에 있어 의사-환자 관계에서 발생하는 종속적인 위계상 어려움으로 인해 피채취자의 자발적인 거부의사가 보장되기 어려운 점, 인체유래물이 채취되고 3일 내에 제공거부의사를 밝혀야 하는데 현실적으로 거부의사를 표명하기 번거롭고 불편한 점, 연구를 위해 인체유래물뿐 아니라개인정보까지 필요할 수 있으나 이에 관한 규정이 미비하다는 점에 있어 이러한 사항이 피채취자로하여금 진정성 있는 자율적 의사 결정을 어렵게 할 것으로 생각한다. 이에 질병 연구의 효율적인 진행과 이로 인해 과학적 성과를 탁월하게 하기 위한 목적이 중요한 것 이상으로 피채취자의 권리보호가중요하므로, 동의의사표시방식(opt-in방식)을 적용하는 것이 더 적절하다고 판단된다. 그리고 우선적으로 개정된 법률에 따라 심의하는 기관위원회가 이러한 문제점들을 고려하여 업무할 수 있도록 충분한 교육과 정보를 제공해야 한다.

투명성 소재에 의한 인체 표현의 조형성 연구

이인영 한국의류산업학회 2018 한국의류산업학회지 Vol.20 No.1

This study has its purpose in classifying the ways in which transparent materials appear in clothes creating a sample garment on this basis, and studying the formative characteristics of human body expression through materials. The study methods for this study are: first, related documents and precedent theses were researched. Second, the expression methods of transparent materials shown in the clothes collection were classified through objective research. Transparent refers to the lexical definition of being see-through, and the transparency of materials arises from the chemical components and physical characteristics of its raw materials. Transparent materials have been applied to clothes and expressed in diverse ways, revealing the beauty of the human body. Such expression methods of transparent materials are classified by the ‘degree of transparency’, ‘presence of patterns’, and ‘range of use’. In clothes, transparent materials are depicted through ‘revealing’ which exposes the body, ‘making seemingly lighter’ which makes the body livelier, and ‘overlapping’ which overlaps the body with the structure and patterns of the material. Furthermore, transparent materials express the human body through having the beholder ‘peep’ into other parts of the body, ‘imagine’ areas which are covered by looking at the areas which are exposed, and through ‘blurring’ the boundaries or the shape of the human body, depending on the degree of transparency. As such, the study of the expression methods of transparent materials and human expression has its importance in that it explores the expression methods of materials and formative characteristics of human body expression through these methods.

인체유래물의 법적 지위에 대한 인격적 측면에서의 고찰 -인격성의 본체로서 DNA의 성격을 중심으로-

유지홍 ( Ji Hong Yoo ) 서울대학교 법학연구소 2015 서울대학교 법학 Vol.56 No.2

The juridical issues relating to gene are in two parts. Firstly, is the cell separated from body a thing or a part of a human body still? Secondly, is it the invention of a thing or the invention of medical procedure to identify human disease DNA? There are various kinds of theories from a viewpoint of civil law. The human materials are excluded from the attribute of a thing according to the first paragraph of the Declaration of Helsinki and the Article 16-1(3) of the French Civil Code. Presently, the somatic cell cloning of human embryo has became a common biotechnology all over the world. It is anticipated that the essence of personal rights can be infringedby just one cell such as the leaking of genetic information, the cloning of human. If all these points are examined, it is reasonable that the legal status of the human materials separated from a body is still a part of human body in civil law. The author examines the protection methods for the research result of human materials. It is reasonable that the research result of human material should be treated as medical procedure in the patent practice because the research result for human material is applicable to the treatment of diseases. In the medical procedure, we can ensure the securing of a license for the purpose of humanism through the compulsory licensing effectively.

인체 유래 물질의 재산권성에 대한 의료법학적 고찰

이웅희 대한의료법학회 2009 의료법학 Vol.10 No.2

(Background) Recent biotechnological breakthroughs are shedding new lights on various ethical and legal issues about human biological material. Since Rudolph Virchow, a German pathologist, had founded the medical discipline of cellular pathology, issues centering around human biological materials began to draw attention. The issues involving human biological materials were revisited with more attention along with series concerns when the human genome map was finally completed. Recently, with researches on human genes and bioengineering reaping enormous commercial values in the form of material patent, such changes require a society to reassess the present and future status of human tissue within the legal system. This in turn gave rise to a heated debate over how to protect the rights of material donors: property rule vs. no property rule. (Debate and Cases) Property rule recognizes the donors' property rights on human biological materials. Thus, donors can claim real action if there were any bleach of informed consent or a donation contract. Donors can also claim damages to the responsible party when there is an infringement of property rights. Some even uphold the concept of material patents overtaking. From the viewpoint of no property rule, human biological materials are objects separated from donors. Thus, a recipient or a third party will be held liable if there were any infringement of donor's human rights. Human biological materials should not be commercially traded and a patent based on a human biological materials research does not belong to the donor of the tissues used during the course of research. In the US, two courts, Moore v. Regents of the University of California, and Greenberg v. Miami Children’s Hospital Research Institute, Inc., have already decided that research participants retain no ownership of the biological specimens they contribute to medical research. Significantly, both Moore and Greenberg cases found that the researcher had parted with all ownership rights in the tissue samples when they donated them to the institutions, even though there was no provision in the informed consent forms stating either that the participants donated their tissue or waived their rights to ownership of the tissue. These rulings were led to huge controversy over property rights on human tissues. This research supports no property rule on the ground that it can protect the human dignity and prevent humans from objectification and commercialization. Human biological materials are already parted from human bodies and should be treated differently from the engineering and researches of those materials. Donors do not retain any ownership. (Suggestions) No property rule requires a legal breakthrough in the US in terms of donors' rights protection due to the absence of punitive damages provisions. The Donor rights issue on human biological material can be addressed through prospective legislation or tax policies, price control over patent products, and wider coverage of medical insurance. (Conclusions) Amid growing awareness over commercial values of human biological materials, no property rule should be adopted in order to protect human dignity but not without revamping legal provisions. The donors' rights issue in material patents requires prospective legislation based on current uncertainties. Also should be sought are solutions in the social context and all these discussions should be based on sound medical ethics of both medical staffs and researchers.

Standard based Deposit Guideline for Distribution of Human Biological Materials in Cancer Patients

Seo, Hwa Jeong,Kim, Hye Hyeon,Im, Jeong Soo,Kim, Ju Han Asian Pacific Journal of Cancer Prevention 2014 Asian Pacific journal of cancer prevention Vol.15 No.14

Background: Human biological materials from cancer patients are linked directly with public health issues in medical science research as foundational resources so securing "human biological material" is truly important in bio-industry. However, because South Korea's national R and D project lacks a proper managing system for establishing a national standard for the outputs of certain processes, high-value added human biological material produced by the national R and D project could be lost or neglected. As a result, it is necessary to develop a managing process, which can be started by establishing operating guidelines to handle the output of human biological materials. Materials and Methods: The current law and regulations related to submitting research outcome resources was reviewed, and the process of data 'acquisition' and data 'distribution' from the point of view of big data and health 2.0 was examined in order to arrive at a method for switching paradigms to better utilize human biological materials. Results: For the deposit of biological research resources, the original process was modified and a standard process with relative forms was developed. With deposit forms, research information, researchers, and deposit type are submitted. The checklist's 26 items are provided for publishing. This is a checklist of items that should be addressed in deposit reports. Lastly, XML-based deposit procedure forms were designed and developed to collect data in a structured form, to help researchers distribute their data in an electronic way. Conclusions: Through guidelines included with the plan for profit sharing between depositor and user it is possible to manage the material effectively and safely, so high-quality human biological material can be supplied and utilized by researchers from universities, industry and institutes. Furthermore, this will improve national competitiveness by leading to development in the national bio-science industry.

Green composite friction materials: A review of a new generation of eco-friendly brake materials for sustainability

Amira Sellami,Riadh Elleuch 대한환경공학회 2023 Environmental Engineering Research Vol.29 No.3

Particulate matter (PM) still poses a significant threat leading to air pollution which is responsible for continued damage to human health and the environment. Particulate matter resulting from non-exhaust emissions are considered as viable a source comes mostly from brake pad wear concept. The scientific challenge of this work is to stimulate a new generation of green friction materials to reduce particle emissions having low-environmental impact. The specificity of braking materials, their effects on the environment and human health are studied. To minimize the levels of air pollution, the use of green friction composites collected from natural elements reducing human diseases is discussed. For this purpose, the novel and high-performance friction composite materials synthesized from vegetable and animal waste used as a raw material are reported. The natural powder and fiber treatments, the optimum formulation and the binder materials related to the green friction composites are reviewed. An overview of environmentally ecofriendly green friction materials embedded by reinforcing phases of natural elements exhibiting excellent mechanical and tribological properties are mentioned. Therefore, scientific and industrial efforts should concentrate on the development of green friction materials to minimize the effect of transport related air pollution.