• 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.

• 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.

• 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.

• 의료법학
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• 제20권2호
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• pp.111-140
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• 2019

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.

• Journal of the Korean Institute of Landscape Architecture International Edition
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• 제2호
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• pp.94-101
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• 2004

This study aimed at providing suggestions in designing open space so that parks and bordering facilities are well related to each other in terms of the visual access and human activities. The design survey was conducted in the center of Osaka City, using parks there as the study material. The relation between parks and their bordering facilities was evaluated in terms of the visual access and human activities. Through the results of this study, as the design methods for improving relations between parks and their bordering facilities, unified design and creation of square in the boundary area between them, placing access paths to facilities in parks, and planting trees to create Vista, Screen, and Framework landscapes are of great importance.

• Natural Product Sciences
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• 제27권4호
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• pp.274-279
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• 2021

The therapeutic effects of the leaves of Couroupita guianensis, a large tropical tree in the family of Lecythidaceae improving testosterone-induced Benign Prostatic Hyperplasia (BPH) were tested in vitro and in vivo. In BPH rats induced by castration and testosterone treatment, the prostate index was improved in groups administered with the extracts of C. guianensis extracted with 50%-, 100%-ethanol or boiling water, which was comparable with positive control, finasteride. The extract C. guianensis leaves showed significant inhibition on the expressions of type 2 5-alpha reductase (5αR) in RWPE-1 human prostatic epithelial cells, and effectively attenuated the expressions of androgen receptor, type 2 5αR and proliferating cell nuclear antigen in LNCap human prostatic adenocarcinoma cells. The leaves of C. guianensis that exerted evident suppression on BPH-related biomarkers in vitro and improvement of prostate index in vivo has a potential therapeutic use for the treatment of BPH.

• 대한화장품학회지
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• 제37권3호
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• pp.211-218
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• 2011

Glycogen synthase kinase 3 beta (GSK3${\beta}$)의 선택적 저해제인 Kenpaullone가 B16 멜라노마 및 사람의 멜라노사이트에 미치는 멜라닌 합성능을 조사하였다. Kepaullone은 B16 멜라노마 및 사람의 멜라노사이트에 대하여 세포증식에는 영향이 없는 범위 내에서 농도 의존적으로 멜라닌 합성을 촉진시켰다. B16 멜라노마 세포에 Kenpaullone을 첨가 48 h 후 tyrosinase 활성이 증가하였으며, 농도별 처리에 대하여 tyrosinase 단백질의 발현 및 tyrosinase mRNA양이 증가함을 관찰하였다. 결론적으로 Kenpaullone는 B16 멜라노마 세포에서 tyrosinase 효소의 발현을 증가시켜 멜라닌 합성을 촉진하는 것으로 판단되어진다. 따라서 GSK3${\beta}$ 저해제가 멜라닌 합성을 촉진시키는 결과는 백반증과 같은 저색소관련 질병의 치료제 개발의 가능성을 갖고 있는 소재로서 응용가능하리라고 판단되어진다.

• 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.

• 기술혁신학회지
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• 제11권2호
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• pp.219-240
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• 2008

본 연구는 새로운 국가자원인 생물자원에 대한 최근의 국제적인 이슈와 주요국의 정책의지 및 관리 체계 등을 살펴 본 것이다. 그렇지만 논의의 전개를 위해 생물자원과 관련된 이론적인 논의, 역사 등을 먼저 검토하였다. 생물자원과 관련된 최근의 이슈는 지적재산권, 보관과 배송의 안전과 관련된 국제규약의 강화, 생물자원의 생물학적 표준강화, 생물자원센터의 윤리문제 등으로 특징지어진다. 이러한 논의를 바탕으로 본고는 생물자원정책의 방향, 체계 및 내용을 간단히 권고하였다. 특히 범부처적 차원에서의 생물자원의 관리와 확보를 위한 종합 조정과 시스템 구축의 필요성을 강조하였다.

• 대한약학회:학술대회논문집
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• 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.286.1-286.1
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• 2002

Recent industrial society has human widely exposed to PAHs that are comming from the incomplete combustion of organic material as widespread environmental contaminants. Biological activities of PAHs are not known although PAHs are considered as carcinogens. PAHs in the mammalian cells affect CYP 1A1 gene expression as well as other phase II drug metabolizing enzymes as UDPGT, NMOR etc. The mechanism of action of PAHs has been studied extensively, however it is not clear how PAHs turn on CYPIAI in human breast cancer. (omitted)