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KMID : 0986720160240010075
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Korean Journal of Medicine and Law
2016 Volume.24 No. 1 p.75 ~ p.96
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Legal Issues of Human Materials Donors’ Consent and Withdrawal
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Lee Han-Joo
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Abstract
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There are two aspects to the law relating to human materials. One is how materials are obtained and the information provided to research participants to allow them to exert their autonomy with regard to participation. The other relates to the use of data related to individuals or materials.
On Feb, 2012, Ministry of Health and Welfare gave a legislation of entire revision of Bioethics and Safety Act. By means of that law, examination of research on human materials and consent to human materials were newly established.
These rules may be guaranteed by the rights of self-determination through human materials donors and can be an important basis in the scope of protection of freedom of the study for the researchers in constitutional aspects. In particular, the rights of self-determination in medical practice and biomedical research spheres are implemented by means of informed consent from patients or donors. However, excessive examination can violate freedom of the study, and in the event of a problem, such as withdraw consent of the donor, solution can be unclear.
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KEYWORD
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human materials research, the rights of self-determination, bioethics and safety act informed consent
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