Notice Number: NOT-MH-19-033
Key Dates
Release Date: June 17, 2019
Related Announcements
Rescinded Announcements
Issued by
National Institute of Mental Health (NIMH)
Purpose
Widespread data sharing by research communities adds significant value to research and accelerates the pace of discovery. The National Institute of Mental Health (NIMH) has established an informatics infrastructure to enable the responsible sharing and use of data collected from and about human subjects by the entire research community. Consistent with authorities under the 21st Century Cures Act, researchers who are funded by NIMH are 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 this infrastructure.
Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications and awards that involve human subject research submitted after January 1, 2020 and applies to all Funding Opportunity Annoucements (FOAs) that NIMH participates in. The Notice does not apply to following types of applications:
- Fellowship (F)
- Research Career Development (K)
- Training (T)
- Small Business (SBIR/STTR)
- Small Grants (R03)
- Education (R25)
- Awards related to AIDS applications
Non-NIMH funded researchers with relevant data are welcome to deposit their data if they are willing to adhere to the archive’s data sharing terms and conditions (https://nda.nih.gov/contribute/contribute-data.html).
The data archive is a rich source of data that can be used in a variety of ways, including the development of preliminary data to support an application. Investigators are strongly encouraged to explore the data and the data dictionaries that are available before submitting an application.
This Notice substantially changes the data sharing expectations for genomic data and for data related to biosamples and genomic data. This Notice, including the timeline in the preceding paragraph, does not supersede the general NIH Genome Data Sharing Policy (NOT-OD-14-124). However, this 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 and conditions of the grant award. Awardees who are measuring human genomic data will register with dbGaP (https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=HowToSubmit.pdf). After registration, all data (including but not limited to clinical, genomic, imaging, and phenotypic data) will be deposited in the NDA. A link to the NDA collection will be added to the dbGaP registration. Aggregating the genomic data in a single cloud based data archive will facilitate the re-analysis of these important data sets. Computational credits (https://nda.nih.gov/get/computational-credits.html) may be applied for to do such analysis in the cloud.
All data associated with new projects at the NIMH Repository and Genomics Resource (https://www.nimhgenetics.org/) will be deposited in the NDA. Appropriate data will then be transmitted to the NIMH Repository and Genomics Resource for quality control and to allow the research community to identify samples that are relevant to their research efforts.
Resource Sharing Expectations for Grant Applications
All applications involving human subjects 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 dealing with data must include: 1) a summary of the data that will be shared 2) a description of the standard(s) and/or data dictionaries that will be used to describe the data set, and 3) the proposed schedule to validate that the data are compliant with the data dictionary that is being used. Compliance with this data sharing plan will become a special term and condition in the Notice of Award.
The NDA can be found at https://nda.nih.gov/. This data archive provides the infrastructure and support to enable mental health researchers to deposit their data and to share that data with the research community.
Prior to applying for a grant, investigators should review the planning section of the web site (https://nda.nih.gov/contribute/contribute-data.html). Applicants are strongly encouraged to use clinical and phenotypic data collection instruments/data dictionaries that have already been defined rather than create new versions of those data dictionaries. There are several required data collection instruments, mostly related to demographic and sample information, that must be used by all researchers for data harmonization purposes (https://nda.nih.gov/standards.html). Applicants should also plan to collect the data needed to generate global unique identifiers (GUIDs) for each study subject (https://nda.nih.gov/contribute/harmonization-standards.html#guid). Informed consent documents should describe how study data will be shared with NDA and the research community (https://nda.nih.gov/contribute/contribute-data.html#infocon).
The necessary funds for submitting data to the NDA should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs.
Post-Award Data Management
The general expectation is that data from NIMH funded awards will be submitted to NDA every 6 months. Within 6 months of the original award, awardees will provide a Data Submission Agreement signed by the principal investigator and an institutional business official. In most cases, a single NDA Collection containing the data associated with each grant award will be established. Submitting data to this Collection is distinct from sharing that data with the research community. Submitted data will generally be held in a private enclave open only to the awardee until the data are shared with the research community. Data submission requires that data undergo validations and other quality control checks as the data are deposited. Performing these checks improves the reliability and reproducibility of the data. While the general data sharing expectation is for data to be submitted every 6 months, researchers are strongly encouraged to use the NDA validation tool (https://nda.nih.gov/vt/) much more frequently. Awardees are strongly encouraged to submit the full study or clinical trial protocol if one exists, as additional information for each Collection.
Data will be shared with the research community when papers using the data have been accepted for publication or at the end of the award period (including the first no cost extension), whichever occurs sooner. Applicants are encouraged to share basic demographic and raw baseline data shortly after data submission to encourage collaborations in the research community.
In addition to submitting the data associated with a grant award as they are collected, researchers are expected to separately submit to NDA the specific data that was used for each resulting publication by creating an NDA Study. NDA assigns a digital object identifier to each study, so studies should be created prior to publication and will only be shared when papers are accepted for publication. Creation of these studies encourage rigor and reproducibility (https://nda.nih.gov/training/modules/study.html).
As a general reminder, NIMH expects a statement of progress on data sharing in non-competing renewals and progress reports. Further instructions are available in the RPPR Instruction guide under section C.5.b. Resource Sharing.
Inquiries
Please direct all inquiries to:
For technical assistance with data submission, please contact the NDA help desk (NDAHelp@mail.nih.gov).
For other inquiries please contact:
Gregory K. Farber, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0778
E-mail: farberg@mail.nih.gov
and Human Services (HHS)
