The following describes the procedures for submission of human data (genomic and genetic information, clinical information, photographic information, etc.) to the NBDC Human Database.
- Carefully read the NBDC Guidelines for Human Data Sharing.
- 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) (pdf, 5 MB or less)
- The consent form (pdf, 5 MB or less) *Provide the "FORM", not the signed documents.
- The notification of approval received from the IRB regarding the content of the study(pdf, 5 MB or less)
- Read and understand the content of the NBDC Security Guidelines for Human Data (for Data Submitters). If submitting controlled-access data, complete Form 7 (the Checklist for the NBDC Security Guidelines for Human Data).
- Fill required information in Form 1 (Application Form for Submitting Data to the NBDC Human Database) and email it with the research proposal (application form for IRB), approval notification, and informed consent form to the NBDC Human Data Review Board Office () *1. The PI or an agent designated by the PI must handle the application. Data sets with different access restrictions (unrestricted-access or controlled-access) can be listed in one application form.
- The PI will be notified of the decisions of the review by e-mail (normally, within a couple of week after complete the information and documents needed for the review).
- If the application is approved, there will be a separate communication from the NBDC office with regard to data transfer and the information to be shown on the web portal.*2
- Fill required information in Form 6 (the Application Form for Updating Submitted Data) and email it to the NBDC office () if you are adding (or replacing existing data with) the data that were obtained under the same policy as the one used for already submitted data (i.e., data that were obtained with the same consent form and that were subject to the same IRB approval). Submit a new application for data submission if the data policy is different.
*1 Informed consent is not necessary for purchased specimens. The IRB of each institution determines whether ethics review is necessary. If it is determined at your affiliated institution that IRB is unnecessary, submit a document indicating this.
*2 Some data such as next-generation sequencing (NGS) data will be stored in the DNA Data Bank of Japan (DDBJ) Sequence Read Archive (DRA) or the DDBJ’s Japanese Genotype-phenotype Archive (JRA). For information on such data submission, see the flowchart for open data (DRA) or controlled-access data (JGA) . For information on data registration for the DRA/JGA and necessary metadata, see the relevant websites.
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.
# 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.
- Open 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 NBDC will continue to review data use and to distribute data to only approved data users.
# In referring to data sets in your paper, use the data set IDs that were issued (which can also be used as DRA/JGA accession numbers).