Biomedical sample destruction stirs debate
By Lydia Lin, The China Post Monday, November 7, 2011, 12:14 am TWN
The stringent laws also fail to take into consideration the multi-purpose nature of samples in researching similar diseases. Academician Chen Ding-shinn (陳定信), an expert in hepatitis, cited as an example, researchers who obtain participant samples to study the hepatitis B virus.
If later development showed that the same biospecimen can abet hepatitis C research, the department must track down the participant in hopes that he or she will consent to taking part in the hepatitis C virus study.
The senior fellow also had issue with Article 15 of Human Biological Database Management statute, which prohibits biological samples in the database from being sent overseas. Chen said the ban effectively excludes Taiwan from participating in any multinational clinical trials conducted by pharmaceutical companies.
Human Rights Advocates Push for Sample Destruction
As the biomedical industry supplicates to the DOH to rescind the statute, Taiwan Association for Human Rights (TAHR, 台灣人權促進會) and other civil groups yesterday issued a joint statement calling on the Department of Health to remain firm by enforcing the law.
If instead, the DOH becomes the administration that openly defies legislation, the group said it will appeal to the Control Yuan to investigate.
The committee — consisting of rehab associations, HIV support groups, and gay rights advocates — stressed that of the millions of biological samples collected and stored without provider consent or authorization, several continue to be re-used in different studies without their knowledge
If the biomedical industry must resort to covertly exploiting human subjects for development and breakthrough, "then such a human rights-violating industry is not worth cultivating."
The civil rights groups referred to policy guidelines guaranteeing the rights of study subjects, recalling the infamous case in 2007 of a local hospital's unauthorized use of saliva samples collected from an indigenous community, which resulted in a "storm of protest."
The statement also brought up the case of doctor Ko Ying-chin from Kaohsiung Medical University, whose gout research findings were found to involve blood samples obtained from aboriginals without gaining prior consent.
When the reports came to light, the researchers were forced to destroy the blood samples, they pointed out.
If issues arise with the Statute on Human Biological Database Management, then the government should amend the law accordingly; The DOH should not, however, take the lead in breaking the law and allow millions of unauthorized biomedical samples to exist outside of ethical regulations, the committee said.
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