The Executive Yuan yesterday approved draft legislation regulating the establishment of human biological databases that would require providers of genetic information to be informed of how the data might be used.
Cabinet spokesman Su Jun-pin (蘇俊賓) told a press conference after the Executive Yuan’s weekly meeting that the Department of Health (DOH) proposed the bill as part of a response to ethical issues.
He said it constituted a significant step in protecting the privacy of those who provide genetic samples for medical research.
The bill will be submitted to the Legislative Yuan for review.
COMMITTEE
If the legislature passes the bill, it would authorize the DOH to issue permits to entities that file applications for establishing human biological databanks and require that the founders of the databases to set up a committee in charge of ethical issues.
Those who fail to obtain a permit would be fined between NT$1 million (US$30,000) and NT$5 million, while the genetic samples in the databanks would be destroyed.
Under the bill, only adults would be allowed to give biological samples, with the exception of members of specific groups, such as patients suffering from rare genetic disorders.
Participants in the genetic pools would have the right to know how their samples would be used, how long they would remain in research labs, possible complications that may take place during collection of the samples or the risks to the providers and their family members as a result of information gleaned from DNA data.
CONTRACTS
Biological databanks would be allowed to store and use the genetic information of a deceased participant unless existing contracts state otherwise.
The draft would also empower participants to withdraw their samples from databases.
All personnel involved in the databases would have to maintain confidentiality, the draft said.
Those who use the genetic information for purposes other than medical research would be liable to fines of NT$300,000 to NT$1.5 million.
Biological databases established prior to the legislature’s passage of the bill will be required to file applications at the DOH and follow due procedures stated in the draft within one year.
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