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KMID : 1011120150090020001
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Bioethics Policy Studies
2015 Volume.9 No. 2 p.1 ~ p.24
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A Study on the Regulation of American NIH on the Gene Therapy Research
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Park Soo-Hun
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Abstract
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The concerns on the gene therapy which gives benefits according to the characteristics of the individual patients are increasing and the risks of it are proportionally increasing as well. At the same time, the concerns on the necessity and promotion of the gene therapy research and the protection of the patients and the human subjects participating in the gene therapy research are increasing accordingly. In our Bioethics & Safety Act, there are very strict requirements to conduct the gene therapy research. In addition, there’s no provision to provide the additional safeguards for protecting the human research subjects. In contrast, there’s no restrictions in the American regulatory legislations on the gene therapy research. Rather, NIH regulates and promotes the gene therapy research under NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules by providing the safeguards on the safety of research and protecting human research subjects. In order to ensure the safety of research, the guidelines divides 6 categories according to the character of research and classifies four-tier danger group according to the assessment of risks of materials used in the research. In so doing, the research protocol should be reviewed and approved by IRB, IBC, RAC, OBA, director of NIH and the level of protecting the human research subjects would be enhanced accordingly. In addition, the rights, safety, and well-being of the human research subjects could be improved by the additional requirements on the informed consent form. According to the policy of this guidelines and the global trend to enlarge the gene therapy research, it is suggested in this article that the current requirement provision for allowing the gene therapy research in Bioethics & Safety Act should be amended such as just allowing it. And the specific information like potential risks and benefits, reproductive considerations, long-term follow-up, and request for autopsy, interest of the media and others in the research should be added to the general contents in the consent form of the human research subjects in Bioethics & Safety Act as well. Also, it is suggested that the mechanism should be established to promote the gene therapy research, to ensure the safety of it, and to protect the human subjects by cooperation and communication between governmental agencies and the general public through RAC, IBC, GTPC, GeMCRIS, OBA etc.
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KEYWORD
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Bioethics & Safety Act, Gene Therapy Research, Informed Consent, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Recombinant DNA Advisory Committee(RAC)
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