J Korean Med Assoc.  2013 Aug;56(8):665-675. 10.5124/jkma.2013.56.8.665.

Effect of Bioethics and Safety Act in medical research

• Park HW

• KMID: 1847868
• DOI: http://doi.org/10.5124/jkma.2013.56.8.665

Abstract

The ethics of medical research is an important area of physician ethics. Physicians are called to respect the life, health, and personality of human subjects. In contrast to other ethical fields, physician ethics, including the ethics of medical research, does not rely on the good faith of physicians alone; ethics and the law are intermingled. While respecting international norms related to medical ethics, individual countries have expanded legal interventions into medical research. The United States has regulated the research of human subjects receiving federal funding through the Common Rule. In Korea, legal interventions for human subjects protection have been applied to a limited extent in clinical trials under the Pharmaceutical Affairs Act and the Medical Devices Act in Korea. On January 29, 2004, the Bioethics and Safety Act was enacted, requiring embryo research institutes, gene banks, and gene therapy institutions to establish Institutional Review Boards. On February 1, 2012, the Bioethics and Safety act was completely revised, which was a significant turning point in medical ethics in Korea. Structural differences between the Common Rule of the United States and the Bioethics and Safety Act of Korea are as follows. First, the Bioethics and Safety Act shall be applied regardless of the presence or absence of government funding. Thus the Bioethics and safety act has a more comprehensive and compulsory effect than the Common Rule. Second, under the Bioethics and Safety Act, the Ministry of Health and Welfare has direct supervision over institutional review boards, rather than supervision of the research organization itself. This differs from the Common Rule, which regards the research organization as the counterpart to the government. Third, the Bioethics and Safety Act regulates the study of derivatives of human bodies, in addition to research on human subjects. The Bioethics and Safety Act has the following problems. First, it mandates that researchers, instead of IRBs, record and store data concerning medical research. Second, the Act does not provide a specific definition of "minimal risk". Third, as the Act does not allow the exemption of informed consent of children under the age of 18 even if specific prerequisites are met as in the case of adults, research involving children will atrophy significantly in Korea.

Keyword

Biomedical research; Human subject research; Institutional review board; Common rule; Informed consent

MeSH Terms

Academies and Institutes
Adult
Atrophy
Bioethics
Child
Embryo Research
Ethics Committees, Research
Ethics, Medical
Financial Management
Genetic Therapy
Human Body
Humans
Informed Consent
Jurisprudence
Korea
Organization and Administration
United States

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