Key Dates

Related Announcements

None

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System is supported by a collaboration between the National Institutes of Health (NIH) and the Department of Defense (DoD) with the expressed mission to accelerate the pace of discovery and advance research through data sharing, increase investigator collaboration, and comply with Federal policies relating to data sharing of publicly-funded research. The FITBIR Informatics System provides the traumatic brain injury (TBI) research community with a common platform for exchanging data, protocols, and research-related information.
 

There are no changes to the expectations and data sharing requirements for studies subject to the policy outlined in NOT-NS-17-029. Rather, the policy outlined below is designed to optimize use of the current FITBIR resources, maximize data sharing access, and centralize federally supported TBI-related research data. The policy modification outlined here applies to NINDS-funded TBI research data involving human subjects research that is not covered by the FITBIR data sharing requirements outlined below (taken from NOT-NS-17-029). This policy modification also aligns with and satisfies the requirements defined in the NIH Data Management and Sharing Policy, and will provide a consistent and sustainable data repository for all NIH-funded TBI-related human subjects research. Consistent with the overall NIH Data Management and Sharing Policy, this TBI-specific data sharing policy modification will be effective as of January 25, 2023. NINDS-funded TBI research data involving human subjects research that is not covered by the NOT-NS-17-029 will now be required to house data in the Meta Studies Module within FITBIR.

FITBIR Research Scope:
Previously, as expressed in NOT-NS-17-029, the NIH FITBIR data submission policy streamlined the types of studies to be submitted to FITBIR. This policy modification (NOT-NS-22-046) requires all data from NINDS-funded clinical TBI research projects, regardless of the budget size or NIH grant funding mechanism (that are not subject to the requirements outlined in NOT-NS-17-029), to submit data to FITBIR through the Meta Studies Module. Datasets submitted to the FITBIR Data Repository are harmonized using standardized common data elements (CDEs) available in the FITBIR Data Dictionary and allow for end-user querying and aggregate datasets. Whereas, the FITBIR Meta Studies Module is a flexible data store that does not require standardization and harmonization across studies. The module also allows for the generation of Digital Object Identifiers (DOIs), thereby allowing researchers to cite FITBIR data into publications to support making data more Findable. FITBIR does not accept PII/PHI regardless of whether data is submitted to the FITBIR Data Repository or Meta Study.

FITBIR Data Submission Criteria:

Investigators involved in clinical (i.e., human subjects research) TBI studies that meet at least 1 of the following criteria (taken from NOT-NS-17-029) must submit their data to the FITBIR Data Repository.

1. TBI-related clinical trials (i.e., studies funded under any of the NINDS Clinical trial FOAs),
2. all unsolicited clinical (i.e., human subjects research) TBI research grants with a budget greater than or equal to $500,000/year in direct costs,
3. NINDS ancillary studies, regardless of budget, to either TBI-related clinical trials or clinical TBI research grants (i.e., human subjects research) with budgets greater than or equal to $500,000/year in direct costs, or
4. clinical (i.e., human subjects research) TBI research grants awarded under funding opportunity announcements (FOAs) with specific requirements for FITBIR data submission.

Clinical TBI studies that do not meet at least 1 of the aforementioned criteria must submit their data to the Meta Studies Module within FITBIR, as opposed to the Data Repository.

Data Submission Schedule:

Studies submitting to the Meta Studies Module within FITBIR should adhere to the the timeline specified in the NIH Data Management and Sharing policy which states “Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first."”.

FITBIR Account Management:
FITBIR Data Submission accounts are valid for the duration of the period of performance of the grant.

NINDS Common Data Element (CDE) Compliance:
The purpose of the NINDS CDE effort is to provide a context to enhance rigor, reproducibility and transparency in clinical research. Consistent with the CDE framework of standardization, both the DoD and NIH strongly recommend CDE compliance for all clinical TBI studies. Moreover, it is highly recommended that investigators align their non-outcome measures with existing non-outcome CDE forms that have been developed and are available at the NINDS CDE website and/or through FITBIR. Studies investigating outcomes outside of the TBI CDEs should use NINDS CDEs found in other disease areas or through searching the FITBIR Data Dictionary that has over 400 form structures for standardized instruments available. To date, the FITBIR Data Dictionary has 9,387 published CDEs.

Inquiries

Please direct all inquiries to:

Please direct all inquiries to:

FITBIR Operations Team
Email: [email protected]
Website: https://fitbir.nih.gov/