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The National Bioscience Database Center (NBDC) of the Japan Science and Technology Agency (JST) develops and operates the NBDC Human Database in accordance with the NBDC Guidelines for Human Data Sharing (hereinafter, the Data Sharing Guidelines). For data users, we have the NBDC Security Guidelines for Human Data (for Data Users) (hereinafter, the User Security Guidelines). For data submitters, security measures that are stronger than those taken by data users are required because data submitters handle not only controlled-access data, which are defined in the Data Sharing Guidelines, but also data for future release (data held prior to publication of a paper or acquisition of a patent). Based on the User Security Guidelines, the “NBDC Security Guidelines for Human Data (for Data Submitters)” set forth the security measures to be taken by the data submitters.
1. Application of the User Security Guidelines
When controlled-access data or data for future release are handled, in principle the standard-level (Type I) security measures, which are listed in the User Security Guidelines, must be put in place, and high-level (Type II) security measures are implemented as needed. All data provided must be de-identified.
Some definitions in Section 1 (Definitions) of the User Security Guidelines are changed as follows, and the sections starting with Section 2 (Measures to Be Taken under Standard-Level (Type I) Security) apply to this document.
- Controlled-access data and data for future release that are provided to the NBDC by the data submitter.
- Principal investigator (PI)
- The investigator registered as the PI at the time of application for data submission.
- Data user
- The PI or a person who accesses data under supervision of the PI.