Japan to tighten human gene research rules

Human geneticists in Japan will soon be required to obtain informed consent from anyone providing them with a DNA sample, under draft guidelines released by the Ministry of Health and Welfare last week. The new ethics rules will apply to all research funded by the ministry, including a large study of human genetic variation due to start in April.

Earlier this month, several research institutions admitted using thousands of samples without informing patients. The revelations provoked intense media debate, and observers say the scientists may have gone public in anticipation of the new guidelines. An ethics panel at the Council for Science and Technology, which funds most human genome research in Japan, is drawing up similar rules.

But critics say the new guidelines will not convince patients of their privacy, particularly as Japan lacks data-protection laws. 'The focus is mainly on how to obtain and how to use human material', says Yusuke Nakamura of Tokyo University's Institute of Medical Science. 'But it's unclear how to ensure the rights of patients whose privacy has been violated, and who may be subject to various forms of genetic discrimination.' There are also fears that insufficient regulation could provoke further media criticism, making it harder to obtain samples. Nobuyuoshi Shimuzi, director of the Center for Genomic Medicine at the Keio University School of Medicine says that national facilities are needed to prevent the commercialization of the supply of human samples.