NBDC_policy - NBDC Human Database

NBDC Data Sharing Policy (JGAP00000000001)

NBDC Guidelines for Human Data Sharing

5.3 Responsibilities of Data Users

5.3.1 Open Data

In using data, the user must take responsibility for and make judgments concerning the quality, content, and scientific validity of the data.
The data user must comply with the following rules.
Basic rules to be complied with in using data
- - The use of data is limited to the study being undertaken.
  - Identification of individuals is prohibited.
  - Redistribution of data is prohibited.
When the research results including the data which were downloaded from NHA/DRA, are published or presented somewhere, the data user must refer the papers which are originally reported, or include in the acknowledgment as follows.

The data used in this research was originally obtained by AAAA research project/group (led by Prof./Dr. BBBB) and available at the website of the National Bioscience Database Center (NBDC; http://biosciencedbc.jp/en/) of the Japan Science and Technology Agency (JST).

5.3.2 Controlled-Access Data

In using data, the user must take responsibility for and make judgments concerning the quality, content, and scientific validity of the data.
When using controlled-access data contained in the NBDC Human Database, the data user must comply with the “Ethical Guidelines for Human Genome/Gene Analysis Research” in Japan.1 That is, the data user must go through a review by the IRB of his/her affiliated institution or another organization with regard to the use of the NBDC Human Database and obtain approval from the review board. The application form for ethics review (the research proposal) must contain statements that are equivalent to the following.
Examples of Consent Forms and the Research Proposals:

* Although a sample statement is provided below, actual statements are not limited to this.

Items included in the application form for ethics review:

Required:
- Data contained in the NBDC Human Database JGAS****/hum**** is used for analysis in this research.
　　　　　1 “Ethical Guidelines for Human Genome/Gene Analysis Research” in Japan (tentative translation)
　　　　　Section 5: Handling of Specimens and Information
　　　　　15. Use of Existing Specimens and Information Held by an External Institution
　　　　　(1) The PI with an intention to conduct a study using existing specimens and information provided by an external institution must state in a research proposal the content of such specimens and information and the reasons for using them and must obtain approval from an IRB and permission from the head of the institution where the study is conducted.
The data user must comply with the following rules.
Basic rules to be complied with in data use
- - The number of users must be limited. (Access is limited to the PI and research collaborators who are members of the institution that the PI belongs to and whose names are listed in the application for data use (Form 2 / Form 7) submitted to the NBDC.)
  - The purpose of data use must be explicitly stated.
  - The use of data for purposes other than the ones stated in the application is prohibited.
  - The use of data is limited to the study being undertaken.
  - Identification of individuals is prohibited.
  - Redistribution of data is prohibited.
The data user must securely handle data, complying with the NBDC Security Guidelines for Human Data (for Data Users) which is found in a separate document. Attention should be paid to the fact that the security level to be maintained varies for different data.* The data user must accept an audit conducted by the NBDC Human Data Review Board or a third party commissioned by the NBDC with regard to the state of implementation of security measures.

* Security levels:

Standard-level (Type I) security is required in principle, but high-level (Type II) security may be required based on consultation between data submitters and the NBDC Human Data Review Board. For details on Type I and Type II security, see the NBDC Security Guidelines for Human Data (for Data Users).
The data user must create a security control system corresponding to each security level (Type I, Type II) and submit Form 5 (Checklist for the NBDC Security Guidelines for Human Data) to the NBDC Human Data Review Board Office in order to confirm that the system conforms to the standards put forth by the NBDC.
Should a security-related incident such as data leakage occur, the data user must immediately disconnect devices from the network and report the incident to the NBDC. The data user then promptly implements post-incident measures, following instructions from the NBDC.
When finished with using data, the data user must delete all data obtained from the NBDC Human Database and report on the use (and deletion) of the data, using Form 3 (Report on the Use (and Deletion) of Controlled-Access Data). With regard to keeping secondary data (e.g., results of calculations based on controlled-access data), see the section on the procedure for using controlled-access data (Section 5.4: Procedure for Data Use; Section 5.4.2: Controlled-Access Data).
When the research results including the data which were downloaded from NHA/JGA, are published or presented somewhere, the data user must refer the papers which are originally reported, or include in the acknowledgment as follows.

Example of a statement in the acknowledgment section The (or, A part of the) data used for this research was originally obtained by AAAA research project/group (led by Prof./Dr. BBBB) and available at the website of the National Bioscience Database Center (NBDC; http://biosciencedbc.jp/en/) of the Japan Science and Technology Agency (JST).
The data user agrees that the NBDC may publish certain statistical information or information about individual data users when it makes public how the NBDC Human Database is used. Published information on individual data users includes the name of the data set used, the date of application, the user name, the user's affiliated institution, and the starting date of the data use.
The data user agrees that, for the purpose of making public how the NBDC Human Database is used, the NBDC holds information on data usage, including information on the data users that is obtained from the time of application to the time of reporting the end of data use and information gathered at the time of incidents.

If violations of above conditions are found, the NBDC may rescind permission for data use and publish information on the violations on a web page. Also, the above conditions are applied to not only PIs but also research collaborators. The PIs are responsible for their research collaborators' compliance with the Guidelines (this document) and the NBDC Security Guidelines for Human Data (for Data Users).

5.3 Responsibilities of Data Users

5.3.1 Open Data

5.3.2 Controlled-Access Data

Examples of Consent Forms and the Research Proposals:

Items included in the application form for ethics review: