Facing the possibility that they might have to destroy stored human blood and tissue samples because of a law on human biomedical samples passed last year, researchers yesterday urged the government to help them find a different solution.
Adopted on Feb. 3 last year, the Human Body Biological Database Management Act (人體生物資料庫管理條例) includes a one-year buffer period for researchers to obtain the required permits or consent to store human blood and tissue samples. After the deadline next year, all samples without proper paperwork have to be destroyed.
The biomedical industry estimates that by Feb. 5, it might have to destroy more than 1 million samples stored by hospital laboratories, biotech companies, or genetic databases that were before the legislation was enacted.
Epidemiologist Chen Chien-jen (陳建仁), who is a research fellow at Academia Sinica, said many important research projects, such as one on a lung cancer gene, have been suspended because the deadline is approaching.
He said that researchers took years to establish human biological databases. If they want to keep the samples, researchers now have to go back to ask the providers whether they agree that the samples can be used for new research, to submit the renewed agreement papers to the ethnics committee and then continue their research only after the renewed agreement passes a committee review, he said.
Academia Sinica researcher Chen Ting-hsin (陳定信), who specializes in hepatitis studies, said he had obtained human biological samples for research on Hepatitis B and gained consent from the providers to use the specimen in research.
“Now researchers have found that they could use the same samples for research on Hepatitis C, but have to go back to the patients to get their consent for using their samples for Hepatitis C studies,” he said. “It may seem easy in words, but it’s hard to do.”
Chen Chien-jen said that because the new law puts restrictions on exporting human biological samples, it would become more difficult for Taiwan to be included in transnational clinical studies.
Director of the Department of Health’s (DOH) Bureau of Medical Affairs, Shih Chung-liang (石崇良), said there were two possible ways to resolve the problem researchers face under the new law.
If the sample provider did not specify which research projects their samples were authorized to be used on, researchers may use the sample for new studies as long as the ethics committee approves, Shih said.
Shih said that researchers may also hide all information related to the sample provider so that it would be impossible to find out who that person was, or keep the sample temporarily until obtaining renewed consent before initiating new research.
However, several human rights groups, including the Taiwan Association for Human Rights, the Human Sample Protection Association Taiwan, the Taiwan Tongzhi Hotline Association and Taiwan Women’s Link, issued a joint statement yesterday calling on the DOH to execute the law as it is and destroy all unauthorized samples on Feb. 5. If the department violates the law, the statement said, they would report the case to the Control Yuan.