The following describes the procedures for submission of human data (genomic and genetic information, clinical information, photographic information, etc.) to the NBDC Human Database.

1. Carefully read the latest NBDC Guidelines for Human Data Sharing and NBDC Security Guidelines for Human Data (for Data Submitters)
2. Collect the following information and documents.
   • Information on the data to be submitted: a summary of the study (its purpose, method, subject, published papers, etc.) and the kind of data (the name, size, access restriction category, potential release date, etc.).
   • The name of the principal investigator (PI), his/her affiliated institution, and contact information.
   • The name, title, and e-mail address of the head of the PI's affiliated institution. *The head of the institution refers to the person who endorses the institutional review board (IRB)'s approval or the decision that IRB is unnecessary.
   • The research plan (application form for IRB) that you obtained the data to be provided.
   • The consent form used to give an informed consent to research subjects. *Provide the "FORM", not the signed documents.
   • Notification from IRB approval, and permission to conduct the research given by the head of the PI's affiliated organization.

   * Documents concerning ethics review will be used only for the purpose of reviewing applications for data use / submission by the Human Data Review Board

3. To apply an application for data submission, a D-way account for each researcher (PI, applicant, and data uploader) is required. If you do not have the account, please create it before the application. The account for the head of PI's affiliated organization is NOT required.
4. 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.**
   • If you are adding or replacing data with the data that were obtained under the same policy as the data you have already provided (i.e., data that were obtained with the same consent form and that were subjected to the same research proposal), please submit the application for Updating Submitted Data (see 7.). Submit a new application for data submission if the data policy is different.
   • When the data submitter provides data that is clearly not the subject of “Ethical Guidelines for Human Genome/Genetic Analysis Research” or “Ethical Guidelines for Medical and Health Research Involving Human Subjects” to the NBDC Human Database, the data submitter must submit a “statement requesting a simplified review of application for data submission” (in an arbitrary format) signed by the PI (see example). Submission of this statement can be a substitute for submission of documents concerning ethics review (e.g., research protocol, informed consent form, and notice of approval).
   • It is possible to apply for data with different access levels (unrestricted-access and controlled access) at once.
   • Please create a group. Select [Create Group] in the menu box and enter group informatoin: Group Name, Description, Type (Data Submitter Group). Please save the information. Then, select [Member tab] and press [Invite] button. Please invite your collaborators to the Data Submitter Group. Data Submitter Groups are needed to be included following investigators: PI, applicant, and data uploaders. 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 submission 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 submission application (press [Application for data submission]).
   • 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 Submitter 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 Submitter Group.
   • 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.
5. The Data Submitter 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).
6. If the application is approved, the secretariat of NBDC Human Data Review Board will contact you separately about how to upload the data and request confirmation of the dedicated website (draft)^*1.
7. If you are adding or replacing data with the data that were obtained under the same policy as the data you have already provided, please submit the application for Updating Submitted Data linked to the previous application for data submission. Please apply "The application for Updating Submitted Data" via the NBDC application system. [Menu] > [Application for data submission] > press the appropriate J-DS number in the List > select [The application for Updating Submitted Data] then press [Start] button. When you submit the application for updating submitted data, you need to prepare a list of files to be updated or added. Please download this form and fill it out. When adding data, columns B, E, F, H to K are required. When replacing data, columns G and L are also required in addition to columns B, E, F, H to K. If the research plan and other related documents have been updated, please attach them as well.

 

*1 Depending on the access level and type of data, you will be asked to upload your data in a designated database. Please refer to the respective websites for information on how to upload your data, and if you are unsure of which database to register to, please check this website.

- Unrestricted-access data (sequence reads derived from Next Generation Sequencers): DDBJ Sequence Read Archive (DRA)

- Unrestricted-access data (Expression data): Genomic Expression Archive (GEA)

- Unrestricted-access data (Annotated/Assembled Sequences): DDBJ

- Controlled-Access data: Japanese Genotype-phenotype Archive (JGA)

 

# In referring to data sets in your paper, use the data set IDs that were issued (which can also be used as DRA, E-GEAD, AP, JGAS/JGAD).

# Some of the information provided in the application for data submission (the summary of data) and researcher information (the name of the PI, the name of his/her affiliated institution, relevant funding/grant, and related publications) will be made public on the web page for the study found in the NBDC Human Database website.

For an example of published information, please see the list of research data and the web page for each study. Please contact us to discuss the information content and the timing of publication.

# It is possible that data will be shared in the future with domestic and overseas databases. The following policy will apply to such data sharing.

- Unrestricted-access data: sharing will be conducted through mirror sites, data exchange, etc.

- Controlled-access data: only metadata (descriptions of the main data) will be exchanged; the DBCLS will continue to review data use and to distribute data to only approved data users.

There is a trilateral cooperative relationship among the DDBJ, the National Center for Biotechnology Information (NCBI) , and the European Nucleotide Archive of the European Bioinformatics Institute (ENA/EBI) . For this reason, the data stored in the DRA are shared with the Sequence Read Archive (SRA) and the EBI Sequence Read Archive (ERA) . Some of the metadata (the supplementary data submitted at the time of data submission that explain the main data) is planned to be shared in the future with the database of Genotypes and Phenotypes (dbGap) and the European Genome-phenotype Archive (EGA) . We appreciate your understanding.