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5 CONTENTS Common Rule and the Rights of Donors in Stored Biospecimens Park, Soo Hun A Study on Informed Consent for using the Assisted Reproductive Technology: Focusing on the comparison of the UK & KOREA Informed Consent Form and System Kim, Eunae Philosophical Understanding of Death Ku, In-Hoe The Medical Human Rights of Migrant Workers Boo. Jong-sik Legal Aspects of Issues Associated with Emerging Technologies in Biomedicine Kim, Ki Young

System Kim, Eunae Philosophical Understanding of Death Ku, In-Hoe The Medical Human Rights of Migrant Workers Boo.

6 1 DNA Deoxyribonucleic acid RNA Ribonucleic acid Informed Consent Common Rule any exculpatory

7 2 language = any exculpatory language C.F.R.

8 3 : Federal Wide Assurance

9 4 Schloendorff v Society of New York Hospital N E N Y C F R exculpatory language C F R

10 5 Genitourinary Biorepository GB / / GB donation / /

11 6 Medical Consent & Authorization Form Medical Consent & Authorization Form : GB

12 7 clear and convincing evidence

13 8 repossess

14 9

15 10 donation tissue Supremacy Clause

16 11 OHRP / /

17 12 harm

18 13 = OHRP OHRP GB DNA

19 14 OHRP

20 15 OHRP

21 16

22 17 : GB

23 18 GB

24 19 DNA

25 20 general HIPAA Privacy Rule open-ended

26 21 Abstract Common Rule and the Rights of Donors in Stored Biospecimens Park, Soo Hun Catalona court decided who had the rights to dispose the stored biospecimens among donors, an investigator(=dr. Catalona), and an institute(=washington University). According to the jurisdiction of the case, the court gave the institute rights to dispose the stored biospecimens based Sookmyung Women s University/Associate Professor/SJD.

27 22 Bioethics Policy Studies, Vol.6 No.1, 2012 June on the common law donation theory. However, there s a critical opinion on this decision. Especially, it insisted that the decision violated the Supremacy Clause in the Amendment VI of the Federal Constitution. That is, the decision violated the general principle of Informed Consent that the rights of the human research subjects should not be waived by including exculpatory language. As you know, to obtain informed consent from the human research subjects is the critical element in conducting ethical research. But, according to Catalona decision, if there s informed consent when the investigator or the institute collected the biospecimens, it s allowed to use the stored biospecimens in any kind of research without obtaining additional informed consent from the donors. In fact, current Common Rule provided that the research could be conducted without obtaining additional informed consent from the donors if the identifiers were stripped. However, it s necessary to consider that the complete anonymatization is not possible, especially, in the field of genomics. Changing technology in this field has dramatically increased the amount and nature of information about individuals that can be obtained from their DNA. It s necessary to consider that the rights of donors should be protected as well. Under the Common Rule, investigators may be allowed in certain situations to obtain a general consent for future research with stored biospecimens. However, this violates HIPAA Privacy requiring that authorizations for research be study-specific. Therefore, the current Common Rule should be amended to provide the sufficient safeguards to protect the rights of donors in disposing their stored biospecimens. In order to do that, the suggestions would be helpful: the Common Rule should explicitly stipulate that it applies to research using biospecimens, the Common Rule should explicitly provide that donors retain certain rights in their biospecimens, the Common Rule should explicitly include that donors must give fully informed consent, the Common Rule should explicitly stipulate that blanket consent be prohibited, and the Common Rule should explicitly stipulate that investigators cannot anonymize a sample after its donor has requested withdrawal from research.

28 Institute for Biomedical Law & Ethics Ewha Womans University 23 Actually, OHRP published the Proposed Rule for the current Common Rule in the Federal Register in July 26, 2011 and received all the comments. OHRP is still working on making final rule. I hope that the final rule guarantee full informed consent of donors in research using stored biospecimens and provide additional safeguards to protect and enhance the rights of human research subjects. Key words : Biobank, Blanket Consent, Human Subject Research, Biospecimens, Informed Consent, Common Rule

29 25

30 26 Informed Consent Assisted Reproductive Technology

31 27 Human Fertilisation and Embryology Authority HFE

32 28

33 29

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35 31

36 32

37 33 Human Fertilisation and Embryology Act HFE A regulatory non-departmental public body HFE HFE HFE HFE

38 34 HFE HFE c A HFE a

39 35 HFE Code of Practice HFE HFE HFE Code of Practice A

40 36 HFE guidance note HFE

41 37 HFE

42 38 HFE HFE HFE HFE / HFE HFE female patient partner

43 39 donor HFE Female Patient registration form Partner registration form Donor information form guidance note

44 40 HFE mother agreed fatherhood condition agreed female parenthood condition father parent

45 41 / HFE PP - Consent to being the legal parent WP - Consent to your partner being the legal parent father parent father parent

46 42 HFE HFE WT form - Your consent to the use of your eggs and embryos for your treatment and the storage of your embryos

47 43

48 44 HFE WC form - Withdrawing your consent or stating your lack of consent HFE HFE HFE HFE HFE

49 45 HFE CD form - Consent to the disclosure of identifying information

50 46

51 Bioethics Policy Studies, Vol.6 No.1, 2012 June 47 Abstract A Study on Informed Consent for using the Assisted Reproductive Technology: Focusing on the comparison of the UK & KOREA Informed Consent Form and System KIM, Eunae In receiving the medical treatment service like as the assisted reproductive technology for the pregnancy and the gamete donation, Informed Consent is the most important thing to protect the right to self determination as well as to manage the human gamete and embryo. To the appropriate informed consent, the Informed Consent Form and System should be prepared appropriately. In UK, Human Fertilisation and Human Research Protection Center, ASAN Medical Center.

52 48 Institute for Biomedical Law & Ethics Ewha Womans University Embryology Authority has offered all Informed Consent Form related to using the assisted reproductive technology officially. The UK HFEA forms are classified so much according to the right holder of the consent. And the contents of these forms are concreted so much according to the details to be obtained the consent as well as offered with the explanation of the details to be obtained. In Korea, some Informed Consent Forms related to using the assisted reproductive technology has offered by the law and some Informed Consent Forms has offered by the Ministry of Health and Welfare. But some necessary Informed Consent Forms has not offered by both of them. Also, these offered Informed Consent Forms is not appropriate to protect the right to self determination as well as to manage the human gamete and embryo because they are not enough to confirm so many details to be determined by the right holder of the consent. This article analyzes the UK HFEA Informed Consent Forms and System related to the assisted reproductive technology and compares them and KOREA Informed Consent Forms and System to seek the way to improve them. Key words : right to self determination, gamete, embryo, informed consent, obligation to explain written consent, consent form, gamete donation, embryo donation, Bioethics and Safety Law, UK Human Fertilisation and Embryology Act, UK Human Fertilisation and Embryology Authority

53 49

54 50

55 51

56 52 Hades

57 53

58 54

59 55

60 56 : : : : ü ü

61 57 E E : E E E :

62 58

63 59 ö

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65 61 :

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67 63! : : äß ü

68 64 :

69 65 ü

70 66 Abstract Philosophical Understanding of Death Ku, In-Hoe In many cultures death is seen as a natural and inevitable end to life. For the Greeks and early Chinese the acceptance of death as a natural event meant that questions could be posed regarding the possibility of some kind of life after death. Death has been legally defined as the absence of life. In general, unlike the definition of death, which physicians, physiologists and neuroscientists make, traditionally the problem of death in philosophy is the problem of life and also it shall be considered as a matter of human nature. ä ü ä ö The Catholic University of Korea, Nicholas Cardinal Cheong Graduate School for Life.

71 Bioethics Policy Studies, Vol.6 No.1, 2012 June 67 All mortal beings will die in someday. Everyone dies. And human being, who cannot avoid his mortality, doesn t know about whether he will be alive tomorrow, or not. It is an uncertain way, which we are destined to go. It cannot not be measured, as well as cannot be inferred through technology. People die only once, after death it is irreversible. Philosophically inquiring about the death are the questions regarding the meaning of death, and the epistemological question on death. Without consideration of human death, questions about the nature of man cannot be handled perfectly. Life and death are inseparable. There must be death, where there is life and there is no death in a lifeless material world. Because there is nothing to die. It means, there is no life in a world without death. Living things change. Immutability is the essence of death. Key words : death, understanding of death, immutability, experience of death, essence of death

72 69 3D 3D

73 70 migrant worker foreign worker

74 71

75 72 H-2 H-2 E-9

76 73 ILO

77 74 A

78 75 D- 7 D-8 D-9 F-4 F-5

79 76

80 77

81 78 NGO

82 79 NGO %

83 80 3D

84 Bioethics Policy Studies, Vol.6 No.1, 2012 June 81 Abstract The Medical Human Rights of Migrant Workers Boo. Jong-sik The number of migrant workers are dramatically increased since This was caused by the scarce of labour force of -so called- 3D job avoidance due to speedy economic growth of Korea until 1980s and elevated education level which drove higher labour cost. Therefore, the number of migrant workers reaches 594,875 as of As a Law, Korea guarantees Social security Act, National Pensions Act, Employment Insurance Act, Industrial Accident Compensation Insurance Act and the system of Health Insurance while there are supporting systems such as Health Insurance Policy and Government Paid Emergency Health Care to stand by them. However, these systemic guards are served based on migrant workers legal status. In case of illegal migrant workers, it relies on NGO support only. Unfortunately, it is actual situation that they are facing deficit of financial, medical supplies and medicines as well as the relationship with higher level of examination. In order to improve the medical right of migrant workers, it is absolutely necessary to train business owners by government and support NGO actively. Key words : Migrant worker, The medical human rights, ILO(International Labour Organization), Convention concerning Migration for Employment Attorney at Law, The Korean bar association member of the subcommittee for the medical human right.

85 83 stomach tube biomedical ethics

86 84 CT MRI Biotechnology Convention on Human Rights and Biomedicine research in the field of biology and medicine research in the field of biomedicine biomedicine Biolaw Arztrecht Medizinrecht Gesundheitsrecht

87 85 biomedical law Biorecht Embryo in vivo ü ü Ü

88 86 nasciturus

89 87 Cour de Cassation ü ü é è ü ä ä ä ü ü ä

90 88 lege artis ESchG ü ü ü ü ü

91 89 Menschheit Menschwerdung ü

92 90 Artificial Insemination by Husband: AIH AID AIH AID

94 92 HIV ä ü ü Ä ü

96 94 Recht auf Kenntnis der eigenen Abstammung ü ü ü

97 95 BGH ü ü

98 96 TPG Vermittlungsstelle ä Ä ö

99 97 München Zwickau München München ü ü ü ö ö ü ö

100 98

101 99 BGH ü ü

102 100

103 101 ü ü ü ä ü

104 102 OLG München OLG München

105 103 in dubio pro vita

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112 111 A4 35mm 30mm 30mm

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114 ISSN Bioethics Policy Studies Vol.6 No.1 June 2012 ISSN Publisher Kyoon Seok Cho Editor Kyoon Seok Cho Published by Institute for Biomedical Law & Ethics Ewha Womans University #417 Law B/D 11 1, Daehyun dong, Seodaemun gu, Seoul , Korea Tel: Fax:

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204 205 -Road Traffic Crime and Emergency Evacuation - 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 Abstract Road Traffic Crime