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KMID : 1234820190200020111
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Korean Society of Law and Medicine
2019 Volume.20 No. 2 p.111 ~ p.171
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Consent for using human biological material in research: based on the revised Bioethics and Safety Act
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Lee Dong-Jin
Lee Sun-Goo
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Abstract
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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.
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KEYWORD
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Human biological material, Biobank, Informed consent, Broad consent, Bioethics and Safety Act
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