Project Outline


The mission of National Research Centers for Advanced and Specialized Medical Care (National Center: NC), which consists of six National Centers (6NCs), is to explore and overcome particular diseases that have a significant impact on national health.

Our staff strives constantly to provide patients with medical care of the highest level in relation to each disease. In addition, we are working to develop new diagnostics, treatments and preventive techniques, especially for diseases that are difficult to diagnose and treat. However, in order to make such progress in medicine, it is absolutely necessary to use the blood, the fluid or tissue subjected to medical care to patients, the tissue removed through surgery, etc. and the blood collected for the research.

The results obtained from this research have the potential to cure not only people currently suffering from each disease, but also their children and grandchildren: people of future generations.

The following document explains the maintenance procedure for the storage of human biological materials such as blood, tissue, among others, for the cooperative researches of the 6NCs for medical “breakthroughs”.

We sincerely appreciate your cooperation and support for the mission of the NC.


The etiology and clinical course of many common diseases (cancer, lifestyle-related diseases such as cardiovascular disease, dementia, etc.) are very complicated and an integrated research approach is needed to overcome them. To develop an effective treatment for a currently incurable disease, it is necessary to develop basic and clinical research from surveys on the actual disease conditions in patients.

Thus, the human biological samples—bio-resource—have been collected and used for research to promote a movement to develop cutting-edge technologies for the past decades. As the technical innovations of genomic medicine and regenerative medicine have markedly progressed especially in recent years, the banking of bio-resources has been recognized as more important, and each developed country competes to establish a “biobank”.

Although Japan is maintaining some advantage over other developed countries in “the processing technology of cell lines such as iPS (induced pluripotent stem) cells,” and “highly precise medical information and its tracking system,” unfortunately, Japan is not necessarily maintaining a sufficient advantage in the area of biobank establishment.

Six NCs in Japan, which are in charge of specialized medical research and treatment, cover the main disease categories, and are the institutions that study disease biology and development of cures to protect national health. They are actively working on establishment of a joint biobank and have been developing a structure that facilitates industry-academic-government cooperation of bio-resources through broad joint research. Further promoting such 6NCs’ efforts is the purpose of this project.


An Outline of the National Center Biobank Network (NCBN)

The NCBN Project is managed by a network overarching the 6NCs. The Central Biobank of the NCBN employs experts in organizations such as the Central Database Management Sector and the Secretariat of the NCBN to provide highly effective and sustained research support services. The Biobank Management Committee was organized to promote the collection and practical use of bio-resources within a multicenter structure.

While each NC member actively expands bio-resource collection and maintenance, a “common platform” for bio-resource collection should be established for the 6NCs. This will create a structure that supports broad joint research with allied medical institutions and others.

NCBN Management Structure

The management structure to promote this Biobank project by 6NCs is as follows:

Regular meetings/committees

Regular meetings/committees Agendas (including future plans)
NC Biobank Presidents' Meeting  · Organize registration, control and use of samples and clinical information
 · Discuss ethical matters/future plans
 · Establish necessary WGs
Information-related Working-level Meeting  · Organize 6NC Information Network
 · Establish common data formats for catalogue data
 · Conduct catamnestic follow-up study
 · Adopt 6NC common sample numbering system
Ethics Working-level Meeting  · Management of Central IRB/providing responses and assistance regarding incidental findings
 · Maintenance of procedure documents such as MTAs (Material Transfer Agreements) and Joint    Research Agreements


WGs Agendas (including future plans)
Creative Publicity WG  · Review publicity related to efforts to deal with 6NCs' main diseases
 · Review presentation of whole NCBN website
 · Review publicity related to utilization of samples, etc.
 · Study means of gaining wider recognition for NCBN
Research Utilization WG  · Organize standardization of paid sample transfer in each NC
 · Review and organize procedures for paid sample transfer
 · Review framework for utilizing bioresouces involved in paid sample transfer
Quality Control WG  · Research international standardization such as ISO, and share information
 · Review quality control in NCBN
 · Provide SOPs for each NC and establish NCBN standards

Organization units for implementation

Organization units for implementation Business (including future plans)
Secretariat  · Provide administrative and support functions as Central Biobank unit in charge of integrated    assistance functions
 · Monitor progress of process control for 6NCs' Biobank Projects
 · Provide one stop site service to those wishing to utilize samples
Central Database/Publicity Division  · Associated with the following activities:
   Creation, management, and operation of NCBN Electronic-Catalogue-based Database (including    disease registry and common interview sheet)
 · Creation of network/platform providing efficient linking of sample and medical information among    6NCs
 · Creation, management and operation of NCBN website
 · Public relations activities with respect to government, industry and academia, and developing links    with other research organizations
 · Promotion of sample utilization using NCBN Electronic-Catalogue-based Database.

Information Security (Ethical Considerations)

This project deals with clinical information and genetic information of sample providers and informants; therefore, it should be a top priority to maintain appropriate control to protect the privacy, based on “Ethical guidelines for human genome and the reasonable enforcement of genetic analysis” (first proclamation on March 29, 2001, and overall revision on February 8, 2012 by the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry.)

In accordance with the clause of “state of the sample and information collection and distribution” provided in the ethical guidelines above-mentioned, which have been recently reviewed, 6NCs members should consider the requirements, procedures, etc. carefully. In addition, in the case of having adequate approval from sample providers and informants, and being approved by the institutional ethical review board, it is scheduled that samples, etc. collected by each NC will be provided to other research institutes in a securely anonymized condition.

Each NC members as well as the organization of this project will commit themselves to proper management and protection of the relevant information and will maintain ethical considerations.

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