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.

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.

西勢東漸과 東아시아 사상의 대응 논리 - 강증산의 神道사상을 중심으로 -

고남식 동아시아고대학회 2018 동아시아고대학 Vol.0 No.49

20세기 초 조선은 서양의 침탈로 개화와 보수의 내부적 분열이 일어나며 서양의 진출에 제대로 대처하지 못한 채 쇠락의 길을 가게 되었다. 강증산은 서세동점의 상황 속에서 서양에 대한 대응과 조선사회의 변혁을 주장하였다. 강증산은 서세동점의 상황을 17세기 이후 발달된 과학 물질문명의 여파로 인식하였다. 서양제국주의의 동양 침공의 배경과 힘이 되는 것은 17세기 이후의 물질문명의 발달이었다. 그런데 이 물질문명의 발달은 강증산의 지적에 따르면, 이마두가 文運을 열어 문명신에 의한 과학의 발달이 있었으나 폐단이 생겼다는 것이다. 그 폐단은 유럽에서 사람들이 정신적 측면 보다는 물질 문화적 측면을 주로 해서 문명을 발달시켜나갔다는 것이다. 물질문명에 기인한 서양 제국주의 세력이 점차 동양으로까지 그 영향을 크게 증대시키게 되어 이에 대한 동양의 대응이 절실히 요구되었다. 강증산 사상의 목적은 물질과 정신의 균형을 위한 신도의 회복이었다. 물질에 치우쳤다는 것은 문명은 발전했으나 정신이 성숙하지 못했다는 것이다. 이는 도통신에 의한 도가 세워지지 않았음을 보여준다. 강증산은 정신문명을 바탕으로 이루어지는 미래의 세계를 後天으로 정의하였다. 이 후천은 인간의 物慾이 빚어낸 17세기 이후 발달한 과학 물질문명의 폐단과 같은 것이 없는 문명으로 정신과 물질이 相 生과 調和를 이룬 문명이다. 후천이라는 유토피아를 위해 一心은 강증산이 정한 새로운 도덕적 패러다임에 따르는 인간의 자세로 조선 말기 사회를 변혁시켜 새로운 정신문화의 진작 운동을 통해 전 세계적, 우주적 차원으로 확장하여 문제된 세상의 질서를 바로 잡으려는 강륜이다. 인간의 도덕적 사고와 실천에 토대하여 강증산은 인간의 풍요로운 경제적 삶을 福祿이라는 단어로 壽命보다 강조하여 정성, 공경, 믿음을 지키는 인간의 수행에 귀착시켰다. 이에 미래의 물질적 풍요는 인간의 정신적 사고와 깊게 연계되어 있는 덕성적인 것과 밀접함을 강조하여 복록이 떨어지면 인간이 죽는다는 변혁적 인간 생활의 원리가 강증산 전승에 나타난다. In the early 20th century when the Western Powers were influencing the entire East, Joseon Dynasty went through internal divisions between the reformists and conservatives being unable to counteract to the expansion of the West. At this time of confusion, Kang Jeungsan claimed Joseon’s taking action to the inflow of Western powers and carrying out social reformation. Kang Jeungsan understood the situation as the result of scientific advancement and material civilization, which has developed since the 17th century. The advanced material civilization was the background and resource that promoted the Western imperialism to dominate over the East. According to Kang, the scientific development of the West was the work of Imadu(Matteo Ricci) who brought deities of culture and led the cultural enlightenment, but Europeans were heavily leaned to material culture and disregarded the aspect of moral and spiritual culture. As the Western powers of material civilization greatly influenced the East, it became essential for the East to prepare and counteract the effects of it. The purpose of Kang Jeungsan’s descending was to restore Divine Dao and the balance between material and mental aspects of human civilization. Kang’s saying “the civilization is heavily leaned to materialism” implies that human consciousness is not mature yet. He defined the future world with advanced human consciousness as “Later World.” In Later World, there is no such problem as those caused from materialism, but the civilization will be balanced and harmonized in both aspect of material and mental aspect of human civilization. Iisim(Devoted Heart-Mind) is a mind set of humans who follow the new moral paradigm of Kang Jeungsan, which will transform and correct not only the society of Joseon Dynasty but also the world and the whole universe. When the true law is realized in the Later World, humans become to have a truthful mind called Jeongsim(Proper Heart-Mind), which enables humans to live a truthful life. Kang Jeungsan emphasized the importance of moral cultivation of human beings because the blessings and fortune, which are earned from observing moral life with the attitude of sincerity, propriety, and faithfulness, rather than just having a long lifespan, are the sources of humans’ abundant and happy life. Therefore, material abundance in the future is closely related to human heart-mind and depend on how they practice virtuous speech and deeds. These reformative principles for new human life are described in the story of Kang Jengsan.

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 .

정체성의 섬뜩한 계곡과 혐오의 전유법 :무라타 사야카(村田沙耶香) 편의점 인간(コンビニ人間)의 윤리

이지형 고려대학교 글로벌일본연구원 2022 일본연구 Vol.37 No.-

Convenience Store Human is a novel that explores the reality of ‘convenience store-human’, an inseparable existence from convenience stores, the signature space of modern society. It is the story of Keiko Furukura, who was alienated and disgusted from the community because it was impossible to empathize and communicate with others. The novel represents in a surprising way the new identity that her life, which fluctuates after a man’s intervention, has struggled to achieve. The new identity reproduced through the physical, material, and ontological entanglement of convenience stores and Furukura is also read as preempting a post-human identity in the near future. Therefore, Convenience Store Human is also a narrative of self-approval and struggle for recognition that Furukura constructs a convenience store-human identity. This paper first analyzed the disgust patterns that Furukura faced in two aspects: class/gender and inability to empathize. Next, the problem of ‘uncanny feeling’ closely related to disgust affect and new identity was investigated using the theory of ‘uncanny valley’ of robotics engineer Masahiro Mori. Finally, the possibility of thinking about the problem of minority disgust through the new identity of ‘robot-human’ was sought based on Karen Barad’s argument for new materialism. The disgust pattern surrounding the novel is not unilinear. For Furukura, the paradox that convenience store labor, which is the basis of identity, is a subject of discriminatory myths and self-disgust against non-regular workers reveals that the magnetic field of disgust is very layered. The ‘uncanny valley’ theory, which states that subtle differences that are similar to each other rather than just differences, that is, an ambiguous identity, can cause more uncanny feeling and act as a disgusting affect, is also very suggestive for thinking about disgust for Furukura. By reflecting on the meaning of the unexpected influence of the human observer in the quantum mechanics experiment, Karen Barad argued that all beings, including humans and objects, do not exist independently and that objects and subjects are intricately intertwined. It inspires us to identify new identities, ‘convenience store-human’. Barad’s position that even if she aims for post-anthropocentrism, she cannot be completely free from the existence condition of “human” is ethical in that she acknowledges the ontological limitations of human subjects. For Furukura, who cannot be identified with social norms and common sense due to his inability to empathize by birth, convenience stores are inseparable, but she knows that this is not self-evident or eternal. This would be the ethics-existence-epistemology of the new identity ‘convenience store-human’, in which existence and knowledge, ethics and knowledge become one. Furukura’s ethics, which can only find meaning when connected to a convenience store, are those that divide and penetrate human and non-human existence. 편의점 인간 은 현대 사회의 시그니처 공간 편의점과 분리 불가능한 존재, ‘편의점-인간’의 실체를 탐구하는 소설이다. 타인과의 공감, 소통이 불가능해 공동체로부터 소외, 혐오된 후루쿠라 게이코의 이야기이다. 소설은 한 남성의 개입 이후 요동치는 그녀의 삶이 어렵사리 성취한 새로운 정체성을 놀라운 방식으로 재현한다. 편의점과 후루쿠라의 신체적, 물질적, 존재론적 얽힘을 통해 재현되는 새로운 정체성은 근미래의 탈인간적 정체성을 선취하는 것으로도 읽힌다. 그래서 편의점 인간 은 후루쿠라가 편의점-인간의 정체성을 구성해 가는 자기 승인의 서사이자 인정 투쟁의 서사이기도 하다. 본 논문은 후루쿠라가 직면한 혐오 양상을 계급/젠더와 공감 불가능성의 두 가지 측면에서 우선 분석하였다. 이어 혐오 정동 및 새로운 정체성과 긴밀히 관련된 ‘섬뜩함’의 문제를 로봇 공학자 모리 마사히로의 ‘섬뜩한 계곡’ 이론을 원용해 살폈다. 끝으로 ‘로봇-인간’이라는 새로운 정체성을 통한 마이너리티 혐오 문제 사유 가능성을 캐런 버라드의 신유물론 주장에 토대해 모색하였다. 소설을 둘러싼 혐오 양상은 단선적이지 않다. 후루쿠라에겐 정체성의 근간인 편의점 노동이 비정규직에 대한 차별적 통념과 자기혐오의 대상이 된다는 역설은 혐오의 자기장이 매우 중층적으로 구성돼 있음을 드러낸다. 마냥 차이나는 것보다는 같은 듯 다른 미세한 차이, 즉 모호한 동질성이 더 섬뜩함을 불러일으켜 혐오 정동으로 작동할 수 있다는 ‘섬뜩한 계곡’ 이론도 후루쿠라에 대한 혐오를 사유하는 데 매우 시사적이다. 양자 역학 실험 속 인간관찰자의 뜻밖의 영향력의 의미를 반추함으로써, 인간과 사물을 포함한 모든 존재들은 독립적으로 존재하지 않으며 대상과 주체가 복잡하게 얽혀 있음을 주장한 캐런 버라드의 주장은 ‘편의점-인간’이라는 새로운 정체성을 파악하는 데 영감을 준다. 이처럼 탈인간중심주의를 지향하더라도 ‘인간’이라는 존재 조건에서 완전히 자유로울 수는 없다는 버라드의 입장은 인간 주체의 존재론적 한계를 인정한다는 점에서 윤리적이다. 태생적 공감 불가능성으로 인해 부단한 노력에도 불구하고 사회 규범 및 상식에 동일화할 수 없는 후루쿠라에게 편의점은 분리될 수 없는 존재이지만, 이 또한 자명하거나 영원하지 않음을 그는 안다. 이것이야말로 존재와 앎, 윤리와 앎이 하나 되는 새로운 정체성 ‘편의점-인간’의 윤리-존재-인식론일 것이다. 편의점과 연결될 때 비로소 의미를 발견할 수 있는 후루쿠라의 윤리는 인간과 비인간 존재를 분절하는 동시에 관통하는 윤리이다.

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.

신유물론자의 기계: 레비 브라이언트의 기계지향존재론과 1920년대 로봇

이재준 인천대학교 인문학연구소 2023 인문학연구 Vol.39 No.-

Machine-Oriented Ontology (MOO) challenges the traditional concept of ‘object’ by introducing the concept of ‘machine’, advocating for a posthuman media ecology that emphasizes the interactions and interdependencies between humans and non-human machines. MOO also puts forth correlational presuppositions that consider machines as tangible entities, intentionally designed artifacts, and hybrid forms of instrumentality. This paper examines R.U.R. (1920), significant narrative showcasing correlations, and explores how it aligns with MOO. In R.U.R., robots initially conform to humans’ narcissistic mirror logic but ultimately attain liberation through the deconstruction of this mirror. The concept of the “power to work” establishes a horizontal ontology, placing humans and non-human robots on equal footing. Humans who do not engage in work are deemed unproductive and self-destructive. As working robots dissolve the instrumental relationship that centers around humans in all productive interactions, a paradigm shift occurs. Concurrently, Eric and Televox, the actual robots of R.U.R.’s era, challenge traditional humanistic relationships by interacting with humans beyond their predetermined design while also engaging in an instrumental relationship with them. This subversion of the expected human-robot dynamic introduces a disruptive element. The unexpected behaviour of actual machines operating outside their designated roles and contrary to human intentions creates a crack in the humanist mirror. As humans attribute materiality to the machines themselves, interspecies connections and transitions with non-humans become apparent. These relationships suggest an interconnected assemblage of machines. Through the exploration of MOO, this discussion opens up possibilities for a community that encompasses both human and non-human machines.

인체유래물연구에 대한 동의 소고(小考)-개정 생명윤리법 제42조의2를 계기로 –

이동진,이선구 대한의료법학회 2019 의료법학 Vol.20 No.2

The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation. 생명윤리 및 안전에 관한 법률은 인체유래물연구와 인체유래물은행에 관하여 일련의 규율을 가하고 있다. 같은 법은 인체유래물연구에 대하여는 연구목적을 정하여 설명 후 동의를 받게 하는 반면, 인체유래물은행의 경우 연구목적을 정하지 아니한 채 기증받게 한다. 나아가 보건복지부령으로 정하는 인체유래물 연구 동의서식을 보면 연구목적을 정하는 경우에도 ‘포괄적으로 연구에 대하여’ 동의하는 개방동의․백지동의가 허용된다. 덧붙여 2019. 4. 23. 개정된 제42조의2는 진단․치료과정에서 채취된 인체유래물의 잔여검체에 대하여 본인이 거부의사를 명시하지 아니하는 한 목적도 정하지 아니한 채 인체유래물은행에 제공하는 것을 허용한다. 이러한 입법은 과도하다고 보인다. 국제적으로 인체유래물기증자의 자율성과 인체유래물은행 및 인체유래물연구의 특성을 고려할 때 포괄동의를 수용할 필요가 있음은 부정하기 어렵다. 그러나 인체유래물연구에는 생명윤리 및 안전에 관한 법률 이외에 종종 개인정보 보호법도 적용되고 국내․외적으로 이 영역에서는 개방동의․백지동의는 물론, 포괄동의의 허용성도 논란의 대상이었음을 염두에 둘 필요가 있다. 또 근래의 발전된 정보통신기술에 비추어볼 때 완전한 동적동의는 아니라 하더라도 특히 위험한 경우에는 동적동의를 통한 특정동의요건의 충족이 필요하고 가능한 사안도 있다. 이는 인체유래물의 제2차적 사용 내지 인체유래물은행의 운영에 관한 거버넌스 설계와 그에 대한 설명 후 동의 및 인체유래물기증자에 대한 투명성, 인체유래물기증자의 참여권 보장을 포함한다.

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.

Decellularized Human Adipose Tissue as an Alternative Graft Material for Bone Regeneration

Ahn Woo Beom,Lee Yu Bin,Ji Yi-Hwa,Moon Kyoung-Sik,Jang Hyon-Seok,Kang Sun-Woong 한국조직공학과 재생의학회 2022 조직공학과 재생의학 Vol.19 No.5

BACKGROUND: Tissue engineering approaches to treat damaged bone include various tissue transplants such as autologous, allogeneic, and xenografts. Artificial materials have been widely introduced to meet the demand for graft materials, but insufficiency in supply is still not resolved. In this study, human adipose tissue, easily obtained from the human body, was harvested, and the tissue was decellularized to fabricate a decellularized human adipose tissue matrix (DM) as an alternative graft material. METHODS: Human adipose tissue was obtained via liposuction. The obtained fresh adipose tissue sample was cut into pieces then put into decellularization solution (1% antibiotic–antimycotic solution and 1% phenylmethanesulphonyl fluoride). Lipids were further removed via treatment in isopropanol. The sample was then subjected to another enzymatic digestion and lipid removal processes. The obtained decellularized adipose tissue matrix was lyophilized to form a graft material in disc shape. RESULTS: Decellularization was confirmed by nuclear staining methods and detection of RNA and DNA via PCR. Bone morphogenetic protein 2 (BMP2)-loaded DM showed the ability to form new bone tissue when implanted in subcutaneous tissue. In recovery of a mouse calvarial defect model, BMP2-loaded DM exhibited similar levels of bone tissue regeneration efficiency compared with a well-defined commercial product, BMP2-loaded CollaCote. CONCLUSION: The DM developed in this study is expected to address the problem of insufficient supply of graft materials and contribute to the treatment of bone defects of critical size as an alternative bone graft material with preserved extracellular matrix components.