About Revision of “NBDC Guidelines for Human Data Sharing” and “NBDC Security Guidelines for Human Data”
Department of NBDC Program (NBDC) of the Japan Science and Technology Agency (JST) partially revised “the NBDC Guidelines for Human Data Sharing” and “the NBDC Security Guidelines for Human Data” and the revised guidelines come into effect on April 1, 2022.
- Purpose of Revision
Revisions have been made to clarify the items to be complied with by the users of the "Registered-access Data," which were newly established at the time of the last revision, and to reflect the revisions of research ethics guidelines and laws related to the protection of personal information, which constitute the legal basis and guidelines for the "NBDC Guidelines for Human Data Sharing" and the "NBDC Security Guidelines for Human Data." These revisions and additions have been reviewed and approved by the Data-Sharing Subcommittee, Steering Committee of the NBDC and the Steering Committee of the NBDC, and will come into effect on April 1, 2022.
- Revision Points
- (1) Clarification of specific items to be complied with by "registered-access data" users
The "NBDC Guidelines for Human Data Sharing" and the "NBDC Security Guidelines for Human Data (for Data Users)" have been revised to specifically present the items to be complied with when using the "registered-access data."
- (2) Revisions due to implementation of new research ethics guidelines
The "Ethical Guidelines for Medical and Biological Research Involving Human Subjects" came into effect on June 30, 2021, and the "Ethical Guidelines for Human Genome/Gene Analysis Research" and the "Ethical Guidelines for Medical and Health Research Involving Human Subjects" were abolished on the same day. In line with the above, the revisions in related descriptions in the Guidelines have been revised. In addition, the following two items have been added regarding the provision of information to third parties in foreign countries (outside Japan), which is one of the revisions to the Act on the Protection of Personal Information, as amended in 2020.
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- (i) Sample statement in the explanatory document for obtaining informed consent
- An increasing number of journals are requiring that the data on which articles are based be registered in public databases and shared when the articles comprising research results are published. Since foreign third parties may be involved in data sharing through public databases, a sample statement has been provided for providing research participants with a necessary explanation of how data registered in public databases will be shared.
- (ii) Description of country and state name
- Information on data users is posted on each Research page of the NBDC Human Database. Revisions are made to add the name of the country and state to the information on data users, to clearly indicate which country and state researchers are using the data.
- (3) Other amendments
For clarification, the subjects for which redistribution prohibition is imposed and the procedures for storing and distributing secondary data have been added. In addition, the data that should be deleted at the end of data use by data users who used the off-premise server has been clarified.
- (1) Clarification of specific items to be complied with by "registered-access data" users
- Contact information for the 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: https://humandbs.biosciencedbc.jp/contact-us
