• 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.

• 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.

• 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.

• Journal of Yeungnam Medical Science
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• 제35권1호
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• pp.36-39
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• 2018

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

• 한국의류산업학회지
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• 제10권1호
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• pp.92-100
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• 2008

When designing protective clothing, there are something to be considered such as physiological feature of human body, acting range not to restrict physical activity, and effectiveness of material. Because the primary objective of protective clothing is to protect human body from danger and it is designed through complex designing process not likely general clothing design. However, current evaluation techniques-such as the ISO, the ASTM and the CEN, and KS-provide only the standard to evaluate the primary feature of material (testing, performance requirements, material specification, selection and application, test and care, and so on). There are no standard to evaluate influence for the human body while protective clothing put on. Especially, in Korea, there is KS to evaluate protective clothing, but it is partially translated version from ISO because of lack of core technology about this field. However, developed countries recognize it is new competitive means in the time of Global Standards and they are competing to make their own standard to global standard for the protective clothing. Therefore, it can be great opportunity for Korean clothing and textile industry to revitalize if focusing on research and development for protective clothing design based on physical activity of human body, fit evaluation technique and sizing which is currently no global standard for it and developing our standard to global standard.

• 한국분말야금학회:학술대회논문집
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• 한국분말야금학회 2006년도 Extended Abstracts of 2006 POWDER METALLURGY World Congress Part2
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• pp.918-920
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• 2006

Metal sulfide powders such as MnS, $MoS_2$ and FeS are simply used to the machinery processing improvement agent and solid lubricant in powder metallurgy industrial. And then, metal sulfide powders have received relatively little attention from powder metallurgy. Recently, the portable machine is one of the important interfaces between human or human and electronic machine. With the increase of the intelligent activity, the social and industrial demands for information display device and power source are increasing. The transition metal sulfide materials (FeS, ZnS) have received considerable attention due to the large variety of its electric, optical and magnetic properties. Among the metal sulfide, $FeS_2$ is appealing superior material for applications in $Li-2^{nd}$ battery because of high capacity. ZnS is also a famous phosphor material with various luminescence properties, such as photoluminescence (PL) and electroluminescence (EL). So generally used in the fields of display, sensors and laser. Metal sulfide materials, therefore, are provided for most widely application in all industries. In recent years, material researchers have become increasingly interested in studying with synthesis of metal sulfide.

• 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).

• 한국의류산업학회지
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• 제1권3호
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• pp.239-245
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• 1999

The purpose of this study is to suggest the direction of the future fashion by grasping the cyber fashion, which is discussed outstandingly in the recent fashion world, into internal expression and external features. The result of this study is as follows: Cyber fashion means the application of the electronic image, dynamic phenonmenon of machine, and the effects of light to fashion, and it has some external features of geometrical pattern, dynamic structure, and high-tech material and color: Aside from this noticeable characteristics, cyber fashion has some internal features of the direction toward future, the anti-culture, and the surreal. In this cyber fashion, first, computer will be introduced and used as the means to realize a dream of human being. Second, it will be designed with the ideal feature of future society. Third, it will be possible to develope material and design to solve ecological issue of human beings. Fourth, the fashion to give the peace and stability to human being will be popular.

• 복식문화연구
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• 제7권1호
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• pp.13-26
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• 1999

The purpose of this study was to identify the origin of diversity of costume material caused by environmental difference. For this purpose, this research involved theoretical studies and studies based on historical data obtained from previous related studies. The common truth was proved that environmental including the geographical distribution of plants and animals determines costume material. Also, It was found that the unique traditional costume styles were developed through unique combination of costume material and their culture. The major results of this study are as follow : 1. The traditional costume of North American Indian was well-developed and closely related to geographical distribution of plants and animals. Also, their costume was so diverse that it could not be categorized. 2. The traditional costume of North American Indian showed ideal har mony between nature and human being surrounding environment into their costume. 3. The application of plants and animal materials into their costume was one of the environment-friendly human activity and it seems to give us an important message.