• The Journal of KAIRB
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• v.6 no.2
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• pp.33-37
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• 2024

Recently, with the development of biotechnology and molecular genetics, research using human biological materials has been receiving attention, and the demand for the use of human- biological materials has also increased significantly. In particular, human biological materials contain the personal information of the person providing them, so special care must be taken to protect personal information throughout the entire process from drafting the human biological materials research plan, Institutional Review Board (IRB) review, and research progress. In addition, it is important to appropriately utilize residual human biological materials obtained during medical diagnosis and treatment at medical institutions to achieve scientific results, while protecting the rights of human biological materials providers and improving the method of expressing consent so as not to damage the trust of human biological materials providers in researchers. To this end, it is necessary to provide sufficient information and education so that researchers and IRB members can understand and apply related laws such as the Bioethics Act and the Personal Information Protection Act.

• 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.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 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.

• Applied Biological Chemistry
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• v.41 no.4
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• pp.273-274
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• 1998

In vitro cytotoxicity of sambutoxin was measured by using various human and murine tumor cells and $IC_{50}$ values of sambutoxin ranged from 46.2 to 1,425.6 ng/ml.

• Korean Journal of Materials Research
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• v.25 no.11
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• pp.616-621
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• 2015

Atmospheric pressure plasma is used in the biological and medical fields. Miniaturization and safety are important in the application of apply atmospheric plasma to bio devices. In this study, we made a small, pocket-sized inverter for the discharge of atmospheric plasma. We used pulse power to control the neutral gas temperature at which the, when plasma was discharged. We used direct current of 5 V of bias(voltage). The output voltage is about 1 to 2 kilo volts the frequency is about 80 kilo hertz. We analyzsed the characteristics of the atmospheric plasma using OES(Optical emission spectroscopy) and the Current-Voltage characteristic of pulse power. By calculating of the current voltage characteristics, we were able to determine that, when the duty ratio increased, the power that actually effects the plasma discharge also increased. To apply atmospheric plasma to human organisms, the temperature is the most important factor, we were able to control the temperature by modulating the pulse power duty ratio. This means we can use atmospheric plasma on the human body or in other areas of the medical field.

• Hwankyungkyoyuk
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• v.15 no.2
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• pp.1-13
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• 2002

The progress of environmental science and technology in the developed countries has been rapid in recent years. Particularly remarkable has been the advancement of various pollutant control measures, which have brought the pollution of inorganic factors such as air and water under control. In contrast, diversity of the ecosphere, of which man is a part, is being steadily impoverished and the biological community is getting unvaryingly uniform. These phenomena were brought about by the expansion of artificial environment such as new industrial complexes, transportation facilities and urban development. Man has constructed uniform and artificial environment, believing in the premise of confrontation with nature, to such a scale that the natural environment and biological community have lost their balance. This will increasingly endanger the soundness of the biotic environment of nature, which constitutes the potential foundation both for the survival environment of man as biological entity and for the development of human civilization. In order to guarantee the soundness of man's body, intelligence and sensitivity as wholesome gene pool on the earth and for the future of man, primarily important environmental education is the understanding of how man can everlasting exist in and with the survival environment. In view of this reality, it is vitally important to create ecologically diverse and well-balanced environment with living materials, i.e., vegetation in order to secure lasting survival environment for man. This task is urgently required in highly artificial environment where non-biological materials have forced the impoverishment of the biological community. Therefore, environmental education for the future should not be totally oriented to technology as that in the past nor it is limited to the medical aspect where well-being of human is the sole object of concern. That is to say, environmental education for the future should be one that provides knowledge that human can understand his place based on the ecological concept and thereby make him to have ethical consciousness that he can control his behavior within the reasonable level for ecological niche who he is located.

• Hwankyungkyoyuk
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• v.15 no.1
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• pp.137-147
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• 2002

The progress of environmental science and technology in the developed countries has been rapid in recent years. Particularly remarkable has been the advancement of various pollutant control measures, which have brought the pollution of inorganic factors such as air and water under control. In contrast, diversity of the ecosphere, of which man is a part, is being steadily Impoverished and the biological community is getting unvaryingly uniform. These phenomena were brought about by the expansion of artificial environment such as new industrial complexes, transportation facilities and urban development. Man has constructed uniform and artificial environment, believing in the premise of confrontation with nature, to such a scale that the natural environment and biological community have lost their balance. This will increasingly endanger the soundness of the biotic environment of nature, which constitutes the potential foundation both for the survival environment of man as biological entity and for the development of human civilization. In order to guarantee the soundness of man's body, intelligence and sensitivity as wholesome gene Pool on the earth and for the future of man, primarily important environmental education is the understanding of how man can everlasting exist in and with the survival environment. In view of this reality, it is vitally important to create ecologically diverse and well-balanced environment with living materials, i.e., vegetation in order to secure lasting survival environment for man. This task is urgently required in highly artificial environment where non-biological materials have forced the impoverishment of the biological community. Therefore, environmental education for the future should not be totally oriented to technology as that in the past nor it is limited to the medical aspect where well-being of human is the sole object of concern. That is to say, environmental education for the future should be one that provides knowledge that human can understand his place based on the ecological concept and thereby make him to have ethical consciousness that he can control his behavior within the reasonable level for ecological niche who he is located.

• Journal of Environmental Health Sciences
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• v.28 no.3
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• pp.64-71
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• 2002

Hair provides important information about the body's mineral status. Therefore, we have studied the trace elemental distribution in human hair under different inhalation and ingestion environment using neutron activation analysis (NAA). NAA is a powerful analytical method which can be used successfully to determine trace elements in environmental and biological materials. Total diet and six different herbal medicine were analysed to study ingestion environment. Airborne dust in foundry was analysed and compared with outdoor dust to study inhalation environment. Human hairs of common person, herbal medicine taker and foundry worker were analysed to estimate the trace elemental distribution of people under different inhalation and ingestion environment. Analytical results show that herbal medicines contain higher micronutrients such as Ca, Mg, Mn and Cu that total diet and airborne dust in foundry has high Cr. The concentration of Ca, Mg and Mn in hair of herbal medicine taker is two times higher than in hair of common person and Cr con-centration in hair of foundry worker is about three times higher than in hair of common person. These results show that NAA can be used importantly to monitor human health through biological and environmental samples.