Ethical,legal, and social issues of genome research--new phase of genome research desperately requires social understanding and safeguards on the use of medical records and other personal information

This article provides an overview of the use of human materials and information (human subject) in the new phase of pharmacological research and development in the current context, especially as it relates to the progress of the human genome project. In a sense, humanity has been drastically reduced to an array of DNA sequences that can be universally used in comparing living things. Pharmacological studies now acquire a unique status in bridging chemical substances to human body function. To perform the full activity of the nature of pharmacology, it requires both genotype and personal information, i.e. medical records and life style information, as research resources. In the UK, the Medical Research Council, the Wellcome Trust, and the Department of Health had started to plan UK Biobank for promoting and supporting the new stage of medical and pharmacological research and development. UK Biobank will collect DNA samples, medical records, and life style information of 500,000 people between the age range of 45 to 69 years old. It will follow the changes in health status of the participants for more than 10 years. The Biobank will provide researchers chances to correlate the genotypic traits to phenotypic ones, i.e. common diseases. In relation to the secondary use of medical records in health research, National Health Service (NHS) initiated a new strategy on the governance of patient information. These movements clearly demonstrated the indispensable nature of infrastructures for promoting and supporting pharmacological and medical research. We discuss on the necessary policies in constructing the Japanese infrastructure.