Last updated:2017.5.29.

Submission of research data from human subjects [20170530]

 

Before your submission

Since May 30th 2017, Japanese laws and policies, Act on the Protection of Personal Information are amended. In the context of them, Ethical Guidelines for Medical and Health Research Involving Human Subjects ([only in Japanese] 人を対象とする医学系研究に関する倫理指針) have been amended.
For all data from human subjects researches submitted to DDBJ, it is submitter's responsibility to ensure that the dignity and the right of participant (human subject) is protected in accordance with all applicable laws, regulations and policies of submitter's institute.
In principle, make sure to remove any direct personal identifiers of human subjects from your submissions.

Make sure the followings when you use samples derived from human subjects except specimens and information, the value of which has already been established academically, widely utilized in research and generally available.

  • The research plan with experimental methods and materials for the data from human subjects research was approved by the review board of submitter's institute.
  • The research plan and the documents of informed consents contain clear agreements to submit the data from human subjects research to our database in order to share them among researchers.

 

Controlled access and database

Before submission of data from human subjects research, please consider whether controlled access for the data is required or not (i.e. unrestricted access) on the basis of informed consents with human subjects.
For controlled access, submit your data to Japanese Genotype-phenotype Archive (JGA)
For unrestricted access, submit your data through DDBJ Sequence Read Archive (DRA) or Mass Submission System (MSS).

 

Review before your submission

Before submitting whole genome scale data from human subjects research, the research plan and the documents of informed consents should be assessed at National Bioscience Database Center (NBDC) as needed.

Required to review
Whole genome sequence of a specific person, patient
Not required to review
Specimens and information, the value of which has already been established academically, widely utilized in research and generally available, except HeLa
Metagenomic analyses for non-human subjects, human microbiome

 

References

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