• 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.

• 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.

• 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.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.111-140
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• 2019

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.

• Journal of the Korean Institute of Landscape Architecture International Edition
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• no.2
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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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• v.27 no.4
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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.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.37 no.3
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• pp.211-218
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• 2011

Effects of Kenpaullone, a specific inhibitor of GSK3${\beta}$, on melanin synthesis in B16 melanoma cells and human melanocytes were investigated. Kenpaullone showed a melanogenesis stimulation activity in a concentrationdependent manner in murine B16 melanoma cells and human melanocytes without any significant effects on cell proliferation. Tyrosinase activity was increased 48 h after treatment of B16 cells with Kenpaullone. The protein expression level of tyrosinase was dose-dependently enhanced after the treatment with Kenpaullone. At the same time, the expression level of tyrosinase mRNA was also increased after addition of Kenpaullone. The stimulatory effect of Kenpaullone mainly resulted from increased expression of tyrosinase. These findings suggest that the application of GSK3${\beta}$ inhibitors may be a potential therapeutic agent for the treatment of hypopigmentation disorder.

• Journal of Yeungnam Medical Science
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• v.35 no.1
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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.

• Journal of Korea Technology Innovation Society
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• v.11 no.2
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• pp.219-240
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• 2008

This paper aims to suggest a policy for biological resource based on a comprehensive understanding on biological resources. Biological resources are different from traditionally recognized viable organisms (Biodiversity) in ecosystems. Biological resources are culturable and replicable resources of living organisms such as tissues, cells and genes. Moreover, biological resources include human-derived biological materials. Biological resources is not simply a matter of science and technology. Biological resources should be dealt with as national resources. There are many international issues regarding biological resources, such as intellectual property rights (IPRs), safety on handling and distribution, material transfer agreements (MTAs) for mutual benefits and biological standards. Ethical debates are also being raised because biological resources are related with human-derived biological materials. Every nation has tendency to adopt its government policies to strengthen its sovereignty on biological resources and international cooperation. In addition, international linkages are essential for providing enhanced worldwide accessibility to biological resources. Japan has shown several international initiatives in the field of biological resources. Korea has just begun to design appropriate policies for the use and R&D of biological resources. Therefore, this paper suggests the following needs: 1) policy at the national level beyond the interests of researchers, 2) inter-ministerial coordination across government ministries, 3) expansion of scope and size of each BRC (Biological Resource Centers), and 4) building networks and systems such as national information center, representative centers by field, and each BRC.

• Proceedings of the PSK Conference
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• 2002.10a
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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)