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KMID : 1011120080020010001
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Bioethics Policy Studies
2008 Volume.2 No. 1 p.1 ~ p.20
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Problems in the Law for a Gene Bank and Its Management
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Lee Jung-Nyum
Choi Kyung-Suk
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Abstract
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A biobank is supposed to play an important role for the development of biomedical science. Bioethics and Safety Act (2005) in Korea regulates a gene bank, the function of which is almost the same as a biobank. This act has some problems related to a gene bank. First, the term "gene bank" is not appropriate. It has to be replaced by “a biobank” in order to include most of units keeping human materials for studies. Second, a gene bank is legally allowed to directly use its own human material for research within its unit. This kind of use must be prohibited. Third, the government has a power to permit the establishment of a gene bank. But all of gene banks must be registered by notification in order to make them be covered by the act.
According to a report of a survey and a site-visit, there are lots of gene banks whose standard operating practice is not fully developed and detailed. Most of gene banks have difficulties in hiring a full-time person for information security due to the financial burden. The government has a policy that human materials for research is distributed for free. One solution of this problem is a mutual exchange among gene banks for mutual benefits with the condition that all banks must be registered.
For the improvement of operating a gene bank, we need a regularlyscheduled educational program. Especially, this program should focus on the unique characteristics of the different units
We also must give an effort to the clarification of notions related to a gene bank. For example, ‘personal information’ must be distinguished from ‘personal identification information’. The latter is one type of personal information. But the latter is not identical to the former. Especially, there is a confusion of anonymization. We have to distinguish anonymous data from anonymized data. Anonymized date can be divided into data unlinked to personal identification information and data linked to it. In the United Kingdom, even linked anonymized data are also divided into data whose key of code is held within a research team and held by the third party.
One may think that researchers can be free from ethical review if they use anonymized human material or data. Anonymized information is not personal information that should be protected by Privacy Rule. But anonymization does not guarantee the exemption of IRB"s or Steering committee"s review. The fact that a certain information is not PHI(Protected Health Information) is one thing, and the requirement that a protocol must be reviewed by IRB or Steering committee is another.
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KEYWORD
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Genetic information, Biobank, Gene bank, Anonymization, Bioethics and Safety Act, Human material, Institutional Review Board, Steering committee
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