The following describes the procedures to be followed for use of human data available from the NBDC Human Database.

 Unrestricted-access Data (marked as "Unrestricted-access" under the column with the heading "Type of Data" in the list of available research data)

1. Carefully read the latest NBDC Guidelines for Human Data Sharing.

2. Read the description of the study of interest (the description can be accessed by clicking on the corresponding research ID in the list of available research data) and download the data.

 Controlled-Access Data (marked as "Controlled-Access" under the column with the heading "Type of Data" in the list of available research data)

== The NBDC application system was available from Sep. 30, 2020 (application via e-mail attachment was closed) ==

  Past applications and reports for data use will be incorporated as they become available into the application system.

The procedure to apply for data use is as follows

1. Carefully read the latest NBDC Guidelines for Human Data Sharing
2. Read the description of the study of interest (the description can be accessed by clicking on the corresponding research ID in the list of available research data) and note the dataset ID of the desired data set. You will need the dataset ID when applying for data use. At that time, please make sure that the user requirements (shown at the comments in the molecular data section) for each dataset are met. It is possible to include multiple access-level datasets in a single application.
3. Collect the following information and documents that are required in the application for data use.
   • The information (name, title, e-mail address, researcher ID, ethics training) on the principal investigator (PI) and all research collaborators who wish to use data. Research collaborators working at the same affiliated organization can be registered in one application.
   • Information on publications related to the study for which the PI is applying for data use.
   • The name, title, and e-mail address of the head of the PI’s affiliated organizaion or signing official. *The head of the organization refers to the person who endorses the institutional review board (IRB) approval or the decision that IRB is unnecessary.
   • The research proposal (application form for IRB) for the study in which the data will be used.
   • Notification from IRB approval, and permission to conduct the research given by the head of the PI's affiliated organization.
4. Read and understand the latest NBDC Security Guidelines for Human Data (for Data Users) and take necessary measures according to the level of access restriction (Type I or Type II) for the desired data set. Download the checklist for the NBDC Security Guidelines for Human Data and complete it. If you plan to use an "Off-Premise-Server", please ask Off-premise-server Providers^*1 to have their checklist and confirm it if the server fulfilled the NBDC Security Guidelines for Human Data.
5. To apply a data use application, a D-way account for each researcher (PI, applicant, and data downloaders) is required. If you do not have the account, please create it before application. The account for the head of PI's affiliated organization is NOT required.
6. Register the public key for dataset encryption in the NBDC data use application. Generate a public/private key pair for each data use application. Please see "Generate public and private key pair" for details.
7. Please log-in to the NBDC application system with your D-way account and password (recommended browsers: Chrome, Firefox). You need JavaScript enabled to use it.   **Please note that it takes about 10 minutes to reflect the creations/alterations of your D-way registration information.**
   • Please create a group. Select [Create Group] in the menu box and enter group informatoin: Group Name, Description, Type (Data User Group). Please save the information. Then, select [Member tab] and press [Invite] button. Please invite your collaborators in the same affiliated organization with the PI in the Data User Group. A Data User Group need to include following investigators: PI, applicant, and data downloaders. The member who has no D-way account at this point, please enter his/her e-mail address issued by his/her affiliated organization. An e-mail is sent to the invited members, and they accept the invitation, they will be registered as a member of the group. PI of the data use application must be set as "PI" in the group. It can be change with radio button in the Member tab.
   • After the member registration, please start data use application (press [Application for data use]).
   • Please select "Language” and press [Create new applicaiton] button. Researchers conducting research activities in Japan, in principle, should select Japanese language.
   • Please select your Data User Group. Information of PI and collaborators registered to the group are entered automatically. If any information need to be revised, please revise the registered information of the Data User Group. "Other research collaborators" is the researcher who is a collaborator but not necessary to access the data.
   • Please fill out the application form and attach the required documents. Finally, press [Apply] button.
     • A head of the organizaion: The person who permits the implementation of the research plan approved by an Ethical Review Board (ERB) is applicable, so please enter the information of the head of the organization to which the researcher belongs to as indicated on the notification from the ethical review results.
     • Title of the Study: Please write the same study title which was shown in the research proposal approved by ERB.
     • When you attach documents, please specify the file type; multiple file types can be specified for one file.
8. The Data User Group Member will be notified the decision of the review by e-mail (normally, within a couple of weeks after complete the information and documents needed for the review). After the application for data use is approved by NBDC Human Data Review Board, metadata, encrypted data files and decryption tools is created in the download directory in the JGA server. Please follow the instruction to access the approved data.
9. When you use the data for multiple years: You need to report on data use and security status every year. Please apply "The application for reporting on the use of Controlled-Access Data" via the NBDC application system. [Menu] > [Application for data use] > press the appropriate DU number in the List > select [The application for reporting on the use of Controlled-Access Data] then press [Start] button. *Please note that failure to report on time may result in your data being unavailable for a breach of the guidelines.
10. When you need to use the dataset beyond the term originally stated in the application for data use: One month prior to the original expiration of the data use period, a request for the desired data use period may be appied together with a document such as the approval notification by an Ethical Review Committee (by which document the term approved can be confirmed) via the NBDC application system. [Menu] > [Application for data use] > press the appropriate DU number in the List > select [The application for extending the period of data use] then press [Start] button.
11. When you find additional attractive datasets: Please apply via the NBDC application system. [Menu] > [Application for data use] > press the appropriate DU number in the List > select [The application for additing dataset that you plan to use] then press [Start] button.
12. When you finish to use the data: You must promptly delete all data (all data downloaded from the NBDC Human Database or all of the data if part of the data is stored) and all data that can restore the data according to the NBDC Human Data Security Guidelines and report his/her data use and deletion via the NBDC application system. At the same time, you may apply for retention of secondary data (e.g., results of calculations based on controlled-access data) and may retain the secondary data. Depending on the degree of data processing and the storage period, however, the application may be rejected. [Menu] > [Application for data use] > press the appropriate DU number in the List > select [The application for reporting on the deletion of Controlled-access data] then press [Start] button. Even if you do not use the data for some reason, you are required to report on the use and deletion of the data.

*1: Learn more about the "Off-premise-server", please check the NBDC Guidelines for Human Data Sharing and the site.

*2: Should your affiliated organization change, contact us at your earliest convenience and complete the necessary procedures in a timely manner because continuation of the study requires ethics review for the study at the new organization and submission of an application for data use (for the new organization). We appreciate your cooperation.

# Note in advance that the approval for data use may be rescinded due to a request from the data providers or study participants.

# Information on the users of controlled-access data (the name of the PI, his/her affiliated institution, the data set ID, and the period of data use) will be showed on the web page of each study.

 # If, due to incidental findings, you would like to utilize the currently used data for a separate study that is clearly different from the study approved for data use, you must submit a new application for data use.