The National Institute of Mental Health has recently announced that researchers who are funded by NIMH will be required to deposit all raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) from experiments involving human subjects into an informatics infrastructure which will enable the sharing and use of this data.
Unless NIMH stipulates otherwise in the terms of award, the policy applies to all grant applications and awards that involve human subjects research which are submitted after January 1, 2020 and applies to all Funding Opportunity Announcements in which NIMH participates. This notice does not, however, apply to Fellowship (F), Career Development (K), Training (T), Small Grant (R03), and Education (R25) awards. Additionally, the policy also does not apply to AIDS-related applications.
According to NIMH, the notice substantially changes the data sharing expectations for genomic data and for data related to biosamples and genomic data. It does not, however, supersede the general NIH Genome Data Sharing policy (NOT-OD14-124). Rather, the notice does mandate that the NIMH Data Archive (NDA) serve as the repository for genomic data funded by NIMH unless NIMH agrees to a different data archive during the negotiation of the terms of the award.
As part of the notice, NIMH emphasizes that all applications that are submitted to or referred to NIMH are expected to include a Resource Sharing Plan as part of the application. The portion of that plan that deals with data must include:
- a summary of the data that will be shared;
- a description of the standards and/or data dictionaries that will be used to describe the data set;
- the proposed schedule to validate that the data are compliant with the data dictionary that is being used.
Compliance with this plan will become a special term and condition in the Notice of Grant Award.
NIMH’s general expectation is that data from NIMH funded awards will be submitted to the NDA every 6 months. Awardees will have to provide a Data Submission Agreement, signed by the PI and OSP, within 6 months of the original award.
Any investigators who currently receive, or expect to receive, funding from NIMH are highly encouraged to read the entire notice at: https://grants.nih.gov/grants/guide/notice-files/NOT-MH-19-033.html.