Joint Press Release with the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and WelfareFull Revision of the Ethical Guidelines for Analytical Research on the Human Genome/Genes

METI, MEXT, and MHLW (hereinafter referred to as the "ministries") established the Guidelines as an ethical guideline that should be complied with in research fields which analyze and research the human genome and genes, aiming at advancing the research properly and other purposes. The ministries have been making efforts for proper implementation of the Guidelines.

In recent years, technology for analyzing the human genome and genes has advanced rapidly with faster, larger-scale, and simpler analysis having become possible. As a result, the subjects and methods of analysis research have become greatly diversified. To cope with this fact, efforts for revision of the Guidelines have been requested.

As a response to such requests, the ministries jointly started a study for such revision and decided to promulgate a full revision of the Guidelines on February 8, 2013, as well as to enforce them on April 1, 2013.

1) Providing the public with existing samples and information

In order to properly conduct long-term follow-up studies, the ministries have streamlined requirements and procedures necessary for providing the public with existing samples and information stored by external organizations, under a linkable anonymizing status.

2) Informed consent

The ministries have revised provisions of informed consent. When users request the provision of samples and information which are expected to be used in other analysis research of the human genome and genes or to be provided to other research organizations in the future, they are required to obtain informed consent from the donors of the samples and information after providing sufficient explanation about future possibilities and procedures in which such samples and information may be used.

3) Disclosure of genetic information

The ministries have revised provisions of the requirements and procedures on disclosure of genetic information resulting from analysis research on the human genome and genes so as to overcome such problems as the information not being accurate or reliable enough to evaluate health and other conditions of donors of the samples and information.

4) Handling genetic information while paying attention to management of security

The ministries have improved provisions relating to the clarification of measures for management of security in handling genetic information as well as to the education and training of researchers and members of ethical review boards.

The ministries will endeavor to hold explanatory meetings on the revision of the Guidelines for organizations involved to raise awareness of the revision.

February 8, 2013

Bio-Industry Division, Manufacturing Industries Bureau