About Revision of “NBDC Guidelines for Human Data Sharing” and “NBDC Security Guidelines for Human Data”
In operating the National Bioscience Database Center (NBDC) Human Database, the NBDC of the Japan Science and Technology Agency (JST) has promoted appropriate data sharing by developing "the NBDC Guidelines for Human Data Sharing" and "the NBDC Security Guidelines for Human Data." We inform that both of the Guidelines have been partially revised, in response to: the recent revisions of "Act on the Protection of Personal Information" (Act No. 57, 2003), "Act on the Protection of Personal Information Held by Administrative Organs" (Act No. 58, 2003), and "Act on the Protection of Personal Information Held by Independent Administrative Agencies, etc." (Act No. 59, 2003), as well as associated revisions of "the Ethical Guidelines for Medical and Health Research Involving Human Subjects," "the Ethical Guidelines for Human Genome/Gene Analysis Research" and so on (hereinafter, Personal Information Acts etc.); the introduction of the "off-premise-server"; and the need that has arisen from the operation to date to make the both Guidelines suitable for more realistic data sharing. The purpose of the revisions and the main revision points are explained in the following sections.
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Purpose of Revision
We recognized the need for further revision of some parts of the Guidelines because of the revisions of Personal Information Acts etc., consideration to computing environments for analyses of big data produced in research using human-derived samples, and the experiences in operation since the last revision. Therefore, we decided to have "the Data Sharing Subcommittee, Steering Committee of the NBDC," "the Data Access Committee of the NBDC," and "the NBDC Human Database Ethics Review Committee" review and revise the Guidelines, and to have the revised versions come into force as from June 10, 2019.
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Revision Points
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(1) Amendments associated with the revisions of Personal Information Acts etc.
Due to the revisions of Personal Information Acts etc., it has been clearly defined that a part of genomic data corresponds to "individual identification code," and that various phenotype information used in medical research, such as medical history and the results of examinations by which health status is known, corresponds to "sensitive personal information." Accordingly, we made procedural changes in handling of personal information, such as "clear consent on provision to a third party in a foreign country," "correspondence to withdrawal of consent by a research subject or request to disclose the retained personal data, etc.,", and "improving the traceability of personal information." We also made changes to clarify "pseudonymization (coding)" as a security measures and "use in academic research and research contributing to the improvement of public health."
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(2) Amendments associated with introduction of available server outside of affiliated organization ("off-premise-server")
For utilization of diverse and huge amounts of data shared through the NBDC Human Database, we believe that it is desirable to provide an environment in which such data can be freely utilized under the full responsibility of data users. On the other hand, however, there is no security standard that works as an international standard for safely analyzing and storing data corresponding to personal information. Therefore, we have made only the servers managed by the data users' affiliated organizations available for analyzing and storing data. As a first step to expand the server or computer environments that can analyze and store the data, we made changes to make a "off-premise server" that is managed by an organization other than the users' affiliated organization available, in addition to those servers managed by the users' affiliated organization.
The site about the off-premise-server: /en/off-premise-server
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(3) Other amendments
We clarified the description in the Guidelines, concerning the following three points.
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Discontinuation of disclosure of published data when a data submitter provided them in violation of the NBDC Guidelines for Human Data Sharing etc.
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Use of data under full responsibility of a data user (including responsibility for third parties)
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Rules concerning handling of data obtained via the NBDC Human Database
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Contact information for operation of the Guidelines
We accept inquiries about the Guidelines from the NBDC Human Database Inquiry Form at the following URL and respond after consultation as appropriate. In addition, we provide information on the NBDC Human Database website by preparing and posting a list of questions and answers which includes representative answers to inquiries.
The NBDC Guidelines for Human Data sharing
The NBDC Security Guidelines for Human Data (For Data Users)
The NBDC Security Guidelines for Human Data (For Data Submitters)
#The NBDC Data Sharing Subcommittee Office and The NBDC Human Data Review Board Office
Address: 5-3, Yonban-cho, Chiyoda-ku, Tokyo, 102-8666
Tel : +81-3-5214-8491
Fax : +81-3-5214-8470
Inquiry Form: /en/contact-us