• Title/Summary/Keyword: Human material

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Material Transfer Agreement for Human Material (인체 유래 물질과 관련된 계약)

  • Kim, Jang-Han
    • The Korean Society of Law and Medicine
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    • v.8 no.1
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    • pp.9-34
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    • 2007
  • Human material is considered as an independent object after departing from human body. But unlike other materials, that is not allowed for the trading because of the nature of personality. According to the present legal system, the human material is only permitted to donate to the researcher or biobank for scientific study. Bur after the collection, the human materials are regarded as a valuable assets and the collectors want to get more economic gains. If the neutral modulators serve for the justifiable circulation. The economic motivations could be prevented within material transfer processes. In real life, the neutral modulator is hard to find and most of partipants are involved in the economic interests. In this situation, it may be justifiable to permit the person who donate his body material to pursue reach through right on his material. The problem is how to measure the value of human material and how to treat the informed consent. If the essential portion of human personality is contributed to the value of human material and if only his material can be served for the invention, the tissue donator can get economic interests on his body material as his property. That is based on the rule of processing of human efforts on civil law.

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Medicolegal Study on Human Biological Material as Property (인체 유래 물질의 재산권성에 대한 의료법학적 고찰)

  • Lee, Ung-Hee
    • The Korean Society of Law and Medicine
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    • v.10 no.2
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    • pp.455-492
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    • 2009
  • (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.

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Design of Fuzzy Controller for a 2-Dimensional Wire-Driven Heavy Material Lifting System (2차원 와이어 구동식 중량물 권양 시스템을 위한 퍼지제어기 설계)

  • Lee, Yong-Chan;Lee, Hyeng-Jun;Lee, Yun-Jung
    • Journal of the Korean Institute of Intelligent Systems
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    • v.25 no.2
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    • pp.97-104
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    • 2015
  • A fuzzy controller and a 2-dimensional wire-driven heavy material lifting system helping human operator are proposed in this paper. The 2-dimensional wire-driven heavy material lifting system is a kind of human-assistive systems in which a human is involved in the control loop. Most of the existing human-assistive control systems cannot consider human operator's characteristic. To consider human operator's characteristic, human's operating motion and requirement of reducing operator's force to lift a heavy material are considered in the design process of the proposed fuzzy controller. The performance of the proposed system is verified by experiments.

Legal issues of obtaining informed consent in pharmaceutical clinical trial as human material research : Focusing on the use of statutory form (인체유래물연구에 해당되는 의약품임상시험에서 동의 획득 기준의 법적 문제: <인체유래물연구동의서> 법정 서식의 사용을 중심으로)

  • Yoo, Sujung;Kim, Eunae
    • The Journal of KAIRB
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    • v.1 no.2
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    • pp.30-42
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    • 2019
  • In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

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How is it possible to use the human body material for research without the written consent of the donor? (바이오뱅크 내 동의서 없는 폐기용 인체유래물 자원의 재활용을 위한 정당성 모색)

  • JEONG, Chang Rok;HEO, Eusun
    • The Korean Society of Law and Medicine
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    • v.18 no.1
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    • pp.199-235
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    • 2017
  • A topic of particular interest for biotech researchers are handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal legitimacy of using human materials for research purposes with special attention to the issues of informed consent and confidentiality. The purpose of this paper is moral and for law legitimacy exploring of the utilization of the human material without donator's consent. It is a known fact that future medical care should be exchanged a paradigm by preventive health care through a human meterial research. The developed country have established a biobank for a human meterial research and supported a researcher. Korea is the same, too. When it is done a defect, as for the thing researcher derived from the Korean human meterial research. The written consent of the donator can keep a human meterial research origin thing, but cannot use it now. I will justify morally and for law that researcher can use the human material without written consent. We can change the concept of recycling of human material. It is not mean only burning that recycling of human materials for research.

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HPA(Human Powered Aircraft) Material Selection and Structural Design (인력비행기의 소재선정 및 구조설계)

  • Yun, Sungchan;Hu, Hyenoo;You, Saerom;Lee, Jaehong;Kim, Dooman;Oh, Janggeun;Lee, Heewoo
    • Journal of Aerospace System Engineering
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    • v.3 no.1
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    • pp.42-46
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    • 2009
  • The 1st development of "Human Powered Aircraft(HPA)" in Korea has been conducting by KAFA(Korea Air Force Academy) from Aug. 2008 to now. HPA is an aircraft powered by directly human energy. The thrust provided by the human power may be the only source and that is weak. Therefore, light weight and strong structure is first requirement. In this paper, treating a basic conceptual design of HPA and material property and material choice for HPA. Also analysing the structure and checking the safety of HPA.

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Study on Bioethics on the Basis of the Theory of Material Basis & Vital and Mental Activities (정기신(精氣神)의 입장에서 살펴본 생명윤리)

  • Kim, Gyeong-Cheol
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.19 no.3
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    • pp.600-604
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    • 2005
  • Following are the view points from the Bioethics on the foundation of the theory of material basis & vital and mental activities (精氣神) ; the whole idenity of the human is observed both materially and morally. The questions of the start and origination on the human life are the principal subject on the bioethics, and therefore the opinions on the bioethics on the foundation of the theory of material basis & vital and mental activities (精氣神) persist that the start and origination on the human life is the time of fertilization. The social issues as the abortion and suicide must judged basically on the bioethics on the foundation of the theory of material basis & vital and mental activities (精氣神).

Ownership of Human Biological Material - Concerning on Dead Body - (인체 유래 생물학적 물질의 소유권 - 사체를 중심으로 -)

  • Jung, Kyu Won
    • The Korean Society of Law and Medicine
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    • v.18 no.1
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    • pp.37-60
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    • 2017
  • Ownership is the bundle of rights that allow a person or institute to use and control an object. As the biomedical science is advanced, we should consider whether human biological material should be recognized as property. Whether separated parts of the human body can be objects of ownership is a different issue. Many thought that separated parts of the human body could not be objects of ownership. This idea is primarily based on this thought: even if a piece of human biological material is separated from a person, it still relates to that person, and if treated as a thing, human dignity may be harmed. However, some commentators have admitted separated parts of the human body into the realm of property. Though a person owns his/her body or body parts, this does not mean that he/she can do anything he/she desires. There are many natural and social limitations to exercise the ownership of human biological material as discussed above. Human dignity is the core consideration whether or not we recognize that ownership of human biological material biomedical research and knowledge.

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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
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    • v.15 no.14
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    • pp.5545-5550
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    • 2014
  • 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.

Operator Modeling and Design of Fuzzy Controller for a Wire-Driven Heavy Material Lifting System (와이어 구동식 중량물 권양 시스템을 위한 퍼지제어기 설계 및 작업자 모델링)

  • Song, Bo-Wei;Seo, Hyun-Duk;Lee, Yun-Jung
    • Journal of the Korean Institute of Intelligent Systems
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    • v.23 no.5
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    • pp.436-443
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    • 2013
  • This paper presents design methods of a fuzzy controller and an operator model for a wire-driven heavy material lifting system helping human workers. The wire-driven heavy material lifting system is a kind of human-assistive systems in which a human is involved in the control loop. Thus, human's control characteristics and requirement of reducing worker's force to lift a heavy material are considered in the design process of the proposed fuzzy controller. An automatic weight measurement algorithm during the early stage of lifting is also introduced. Finally, the effectiveness and performance of the proposed system are proved by experiments.