Tokyo

Japan's Ministry of Health and Welfare announced plans last week to set up the country's first ethical guidelines for the management and use of human genetic information for biomedical research.

As an initial step in this direction, the ministry has created an ad hoc working group to address ethical issues on research using human DNA samples, including the protection of personal genetic data, and to discuss measures for obtaining adequate informed consent from patients giving samples.

The working group, whose members include directors of national medical institutes, academics and lawyers, plans to draw up draft guidelines by January. These would be made public as part of the ministry's plan to gather wide opinion from the general public which it intends to incorporate in the final guidelines to be compiled in March 2000.

The move reflects growing concern among researchers over the potential misuse of genetic information, which, the ministry says, “could not only violate privacy, but also lead to job and insurance discrimination”.

The launch of projects related to the human genome — such as the planned database of single-nucleotide polymorphisms (SNPs), or sequence variations that could be linked to common diseases such as cancer and mental illness — have raised concerns over the confidentiality of research records.

Researchers involved in the SNP programme, which involves collecting a vast number of DNA samples from medical institutions across Japan, have insisted that samples be anonymous to avoid concerns over linked or identifiable samples.

According to the ministry, methods to ensure the anonymity of DNA samples, such as creating codes to identify them, will be the main priority of discussions to be held by the working group.