Biomedical sample destruction stirs debate

By Lydia Lin, The China Post

Millions of biomedical samples are set to be destroyed next February due to lack of official participant consent, sparking a heated debate between the research industry and human rights groups — an ethical and scientific dilemma on the genetic material’s research value versus the rights of human subjects. According to the Statute on Human Biological Database Management (人體生物資料庫管理條例) promulgated last year, all biospecimens and biological data must have the participants’ written letters of consent or face destruction on Feb. 5, 2012. By that date, both public and private repositories nationwide must supply the Department of Health (DOH) with all necessary documents and information, or see their stored genetic material and biomedical data go to waste.

The Academia Sinica, Taiwan’s leading research institute, pleaded against the destruction of millions of human blood and surgical tissue samples. Such measures would impede ongoing disease research and flush both valuable genetic material and the hard work of research doctorates down the drain, academics argued. Civil rights groups, on the other hand, steadfastly pushed the DOH to follow through with the Human Biological Database statute, pointing out the unlawfulness of database operators using biomedical samples without prior provider consent. The DOH projected that by next February, there will be roughly 20 approved biological databases with fully authorized biomedical samples. As a result, selling the invaluable and legal data could prove to be lucrative business. The nation’s top scientists and researchers yesterday appealed to the government to save the millions of biological data samples from potential destruction. The laborious process of combing through provider samples for participant consent, they argued, has already stalled the progress of important studies. Search for Consent Stalls Research: Academia Sinica Biomedical research pertinent to the Taiwanese public on such issues as lung cancer and other genetic diseases have been halted as the February deadline draws near, said epidemiology expert and Academia Sinica senior fellow Chen Chien-jen (陳建仁).

It takes researchers years to accumulate and establish comprehensive biological databases, Chen explained. In order for the studies to proceed, researchers must go back and ask old participants to provide more biological data for new research, sign “re-agreement” documents, and then undergo review by the ethics committee.