October 7, 2022
Effective Date: January 25, 2023
NOT-OD-14-124, NIH Genomic Data Sharing Policy
NOT-MH-20-067, Notice Announcing the National Institute of Mental Health (NIMH) Expectations for Collection of Common Data Elements
NOT-OD-21-013, Final NIH Policy for Data Management and Sharing
NOT-OD-21-014, Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
NOT-OD-22-189, Implementation Details for the NIH Data Management and Sharing Policy
NOT-MH-23-105, Notice Announcing the Expectations for the Collection of Common Data Elements for HIV-Funded Research at the National Institute of Mental Health
NOT-MH-19-033, Notice of Data Sharing Policy for the National Institute of Mental Health
National Institute of Mental Health (NIMH)
The purpose of this Notice is to revise and replace the current NIMH Data Sharing Policy (NOT-MH-19-033), to align with the NIH Policy for Data Management and Sharing (NOT-OD-21-013), and to extend the NIMH data sharing policy to include HIV-related applications funded by the NIMH that involve human subjects research which had previously been exempted.
Widespread data sharing by the research community adds significant value to research and accelerates the pace of discovery. The 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, research funded by the NIMH are required to deposit all raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) from studies involving human subjects into the NIMH Data Archive (NDA).
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 on or after January 25, 2023, and applies to all Funding Opportunity Announcements (FOAs) that NIMH participates in. NOT-MH-19-033 will continue to be in effect for all applications submitted through January 24, 2023.
While all applications that generate scientific data must abide by the NIH Policy for Data Management and Sharing (NOT-OD-21-013), awards made using the following activity codes are not required to deposit data into the NIMH Data Archive specifically, but they are welcome to do so:
For HIV-related research, grantees WILL be expected to deposit their human subjects data into the NDA unless granted an exception in writing by NIMH. Applicants applying to FOAs that use the activity codes above who have questions about whether they will be expected to deposit their data into NDA should contact the program staff listed below.
The NDA 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, and investigators are strongly encouraged to explore the data and the data dictionaries that are available before submitting an application to the NIMH. Furthermore, non-NIMH funded projects with human subjects data are welcome to deposit their data in the NDA if they are willing to adhere to the archive’s data sharing terms and conditions (https://nda.nih.gov/contribute/contribute-data.html).
This Notice continues the data sharing expectations for genomic data, and for data related to biosamples, but does not supersede the general NIH Genome Data Sharing Policy (NOT-OD-14-124, NOT-OD-22-198). This Notice, however, does continue to mandate that the NDA serve as the repository for genomic data funded by the NIMH unless the NIMH approves a different data repository during the negotiation of the terms and conditions of the award. Awardees who are measuring human genomic data are required to register with the Database of Genotypes and Phenotypes (dbGaP Submission Process;). After registration, all data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) will be deposited in the NDA. A link to NDA will be added to the dbGaP registration. Aggregating the genomic data in a single cloud-based data archive will facilitate the re-analysis, replication, and additional analyses of these important data sets. Computational credits may be available to conduct these analyses in the cloud.
All data associated with new projects at the NIMH Repository and Genomics Resource 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.
Division of AIDS Research Use of the NIMH Data Archive
HIV-related human subjects research assigned to NIMH was previously excluded from submitting data to the NDA. The NIMH applications submitted on or after January 25, 2023, will be required to submit data to the NDA in the same way that other NIMH investigators were doing under NOT-MH-19-033.
The NDA provides the infrastructure and support to enable researchers working on HIV-related projects to deposit and share their human subjects data with the broader research community. Several common data elements are recommended to be used by all HIV-funded investigators for data integration purposes (see companion notice for HIV-related NIMH-supported research, NOT-MH-23-105) and should be specified in the data management and sharing plan. The costs associated with data management and sharing should be included in the requested budget. The NDA website provides a cost estimator to facilitate the calculation of these costs.
Previously funded HIV-related NIMH awardees with human subject data are strongly encouraged to deposit their data in the NDA if they are willing to adhere to the NDA’s data sharing terms and conditions (https://nda.nih.gov/contribute/contribute-data.html).
Data Management and Sharing Plans
All applications submitted to or assigned to NIMH on or after January 25, 2023, must follow the NIH Policy for Data Management and Sharing (NOT-OD-21-013; see also Elements of an NIH Data Management and Sharing Plan). In addition, the Data Management and Sharing Plan must propose a schedule to validate the quality of the data being uploaded so these data are compliant with the data dictionary or other standards that are being used. In cases where a data dictionary has been defined in the NIMH Data Archive, the NDA validation tool (https://nda.nih.gov/tools/nda-tools.html#vt) should be used. Compliance with the approved data management and sharing plan will become a term and condition in the Notice of Award and will be monitored by the NIMH throughout the duration of the award.
Examples of data management and sharing plans can be found at NIMH Data Sharing for Applicants and Awardees.
Sharing Data in the NIMH Data Archive Infrastructure
The NDA can be found at https://nda.nih.gov/. This data archive provides the infrastructure and support to enable researchers funded by the NIMH and other Institutes at NIH to deposit their data and to share that data with the research community.
Prior to submitting an application, investigators should review the planning section of the website (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 except for HIV-related applications (https://nda.nih.gov/contribute/harmonization-standards.html). In addition, NIMH expects that funded investigators will collect a set of common data elements (see NOT-MH-20-067 for non-HIV research; for HIV-related research, see NOT-MH-23-105).
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 is available to facilitate the calculation of these costs (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx).
Post-Award Data Management
The general expectation is that data from NIMH-funded awards that involve human subjects will be submitted to NDA every 6 months throughout the duration of the award (typically January and July). Awardees will provide a Data Submission Agreement signed by the principal investigator and an institutional business official within 6 months of the notice of award. In most cases, a single Collection containing the data and metadata 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 uploaded to the NDA. 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/) more frequently. Awardees are strongly encouraged to submit the full study protocol and the clinical trial protocol, if applicable, 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. Awardees are encouraged to share basic demographic and raw baseline data shortly after data submission to encourage collaborations in the research community.
In addition to regular submission of data associated with an award, awardees are expected to separately submit to NDA the specific data that was used for each resulting publication by creating an NDA Study. A Digital Objective Identifier (DOI) is automatically issued for each study and is expected to be included in the subsequent publication as a persistent link to the data (https://nda.nih.gov/contribute/manuscript-preparation.html). Creation of these studies encourages rigor and reproducibility (https://nda.nih.gov/training/modules/study.html).
Any changes to the data management and sharing plan must be submitted with the approval of the Authorized Organization Representative and reviewed and approved by the NIMH. As a general reminder, NIMH also expects a statement of progress on data management and sharing in non-competing renewals and progress reports. Further instructions are available in the RPPR Instruction guide under section C.5.b.
For questions related to data sharing for HIV-related applications:
Lori A.J. Scott-Sheldon, Ph.D.
National Institute of Mental Health (NIMH)
For other inquiries please contact:
Gregory K. Farber, Ph.D.
National Institute of Mental Health (NIMH)