• 의료법학
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• 제8권1호
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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.

• 의료법학
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• 제10권2호
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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.

• 한국지능시스템학회논문지
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• 제25권2호
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• pp.97-104
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• 2015

본 논문에서는 중량물을 들어 올리는 작업자를 돕기 위한 2차원 와이어 구동식 중량물 권양 시스템과 퍼지제어기를 제안한다. 2차원 와이어 구동식 중량물 권양 시스템은 사람이 전체 제어루프에 포함된 인간지원시스템의 일종이다. 기존 인간지원시스템 대부분의 제어 방식이 사용자의 특성을 고려하지 못하는 단점을 해결하기 위하여 물건을 들어 올리는 작업자의 힘을 덜어주어야 하는 요구조건과 사람의 작업 모션을 고려한 퍼지제어기 설계 방식을 제안한다. 실험을 통해 제안된 시스템의 2차원 작업 모션의 성능을 검증한다.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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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.

• 의료법학
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• 제18권1호
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• pp.199-235
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• 2017

생명공학 연구자들의 중요한 이해 관심 중 하나는 연구를 목적으로, 현재 사용될 수 있거나 미래를 위해 보관될 수 있는 인체유래물을 다루는 것에 관한 논의이다. 본 논문은 인체유래물 연구에서 동의서 없는 폐기용 인체유래물의 재활용을 위한 정당성 모색을 목적으로 한다. 미래의료가 유전체 연구를 통해 예방 의료로 패러다임을 바꿀 것이라는 것은 널리 알려진 사실이다. 선진국들은 인간 유전체 연구를 위해 바이오 뱅크를 설립하여 연구자들을 지원해 오고 있으며, 한국 역시 마찬가지이다. 그런데 현재 한국의 인체유래물 연구자는 기증자의 동의서가 미비된 경우, 인체유래물을 보관할 수는 있으나 사용할 수는 없다. 뿐만 아니라, 인체유래물 연구 자원이 사용 기간이 한정 표시된 동의서로 인해 폐기되기도 한다. 그러나 필자들은 동의서 미비로 인해 현재 폐기되기만을 기다리는 바이오뱅크의 인체유래물이 매우 제한된 조건 하에서는 활용가능하며, 이러한 재활용에 정당한 근거가 있음을 주장한다. 이를 위해 바이오뱅크 및 인체유래물 활용과 관련된 법조문을 고찰하며 동의없는 인체유래물의 활용과 관련하여 제기될 수 있는 윤리적 문제에 대해 검토하고, 바이오뱅크의 폐기용 인체유래물의 재활용 근거를 모색한다.

• 항공우주시스템공학회지
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• 제3권1호
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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.

• 동의생리병리학회지
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• 제19권3호
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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).

• 의료법학
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• 제18권1호
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• pp.37-60
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• 2017

전통적인 법이론에 의하여 인간은 권리의 주체이기 때문에 인체로부터 유래한 생물학적 물질은 권리의 객체가 될 수 없다. 하지만 의학과 생명과학의 발전으로 인하여 인체로 부터 유래한 생물학적 물질은 다양한 용도로 사용되고 있으며 인체로부터 유래한 생물학적 물질의 객체성 여부와 소유권 인정 여부에 대한 논의는 지속적으로 제기되고 있다. 인체로부터 유래한 생물학적 물질을 법적으로 파악하는 이론은 전통적으로 자율성에 근거한 모델이었으며 현재도 그것이 가장 보편적으로 받아들여지고 있다. 하지만 자율성 모델에 의하여 인체로부터 유래한 생물학적 물질을 파악할 경우 인체로부터 유래한 생물학적 물질을 다루는 현실을 제대로 설명할 수 없을 뿐만 아니라 오히려 배분적 정의의 측면에서 볼 때 적절하지 못한 결론에 도달할 수도 있다는 의문이 제기되고 있다. 인체 유래 생물학적 물질을 소유권의 객체로 파악하려는 소유권 모델은 인간의 존엄과 가치에 반하는 이론 구성이라는 의혹을 받고 있다. 하지만 소유권은 단일한 권리가 아니며 다양한 권리들의 집합체이며 그 내용이 어떻게 구성될 것인가는 객체의 특성 등을 고려하여 판단하면 될 것으로 생각된다. 본 논문은 인체 유래 생물학적 물질의 소유권 전체 보다는 일단 사체로부터 유래한 물질의 소유권 인정 여부를 중점적으로 다루었다. 이를 통하여 인체 유래 생물학적 물질전반에 대한 법이론적 고찰이 현재의 과학적 사실에 적합한 형태로 이루어지기를 기대한다.

• Asian Pacific Journal of Cancer Prevention
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• 제15권14호
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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.

• 한국지능시스템학회논문지
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• 제23권5호
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• pp.436-443
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• 2013

본 논문에서는 중량물을 들어 올리는 작업자를 돕기 위한 와이어 구동식 권양 시스템의 제어기와 제어기 설계를 위한 작업자 모델링을 제시한다. 와이어 구동식 중량물 권양 시스템은 사람이 전체 제어루프에 포함된 인간지원시스템의 일종이다. 사람의 제어 특성 모델과 물건을 들어 올리는 작업자의 힘을 덜어주어야 하는 요구조건을 고려한 퍼지제어기 설계 방식을 제안한다. 또한 권양 초기 구간에서 중량물의 무게를 자체적으로 측정하여 구동될 수 있는 방식도 소개한다. 마지막으로 성능 검증을 위해 실험을 통하여 제어기의 무게 측정의 정확도를 분석하고 중량물을 작업자가 작은 힘으로 편하게 들어 올릴 수 있는지 그 결과를 분석한다.