Notice Number: NOT-NS-17-029
Key Dates
Release Date: May 31, 2017
NOT-NS-12-016
NOT-NS-14-022
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 publically-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.
To optimize current FITBIR resources and maximize data sharing compatibility and quality, the NIH, DoD, and the FITBIR Policy committee have made several changes to FITBIR policy. These changes include a reduction in the overall scope of data to be shared in the FITBIR system, modification of the data submission schedule and account management procedures. In looking to the future, the utility of the FITBIR informatics system will only be realized if there is a commitment by the TBI community to use NINDS Common Data Elements (CDE) in TBI clinical research.
FITBIR Research Scope:
Initially, as expressed in NOT-NS-12-016 it was expected that data from all NIH-funded TBI clinical research projects regardless of the size of the budget, or NIH grant funding mechanism were expected to submit data to FITBIR. The new NIH FITBIR data submission policy streamlines the types of studies to be submitted to FITBIR, but retains the policy that any TBI genomic studies that generate large-scale genomic data, regardless of the size of the budget, or NIH grant funding mechanism, should follow the guidance of the NIH GDS Policy on data sharing. The new NIH TBI research data sharing via FITBIR policy will be limited to the following types of NIH research: (1) TBI-related clinical trials; (2) all unsolicited clinical TBI research grants with a budget greater than or equal to $500,000/year in direct costs; (3) ancillary studies, regardless of budget, to either TBI-related clinical trials or clinical TBI research grants with budgets greater than or equal to $500,000/year in direct costs; and (4) clinical TBI research grants awarded under funding opportunity announcements (FOAs) with specific requirements for FITBIR data submission. In rare instances, NIH program staff may request data from clinical research projects not covered under the new FITBIR data submission policy. Investigators involved in TBI research studies that do not meet the new data submission criteria may also request permission to submit data from their NIH Program representative. The NIH program representative will present the request to the FITBIR Data Integration Committee for a decision.
Data Submission Schedule:
The new FITBIR data submission policy requires annual submission of all clinical research outcome and non-outcome data. For NIH grants, reporting of FITBR data submission progress should be included as part of the studies’ annual Research Performance Progress Report. Funds may be restricted if studies fail to comply with the annual data submission policy. Furthermore, the previous accelerated sharing of Core and Basic CDEs in FITBIR as outlined in NOT-NS-14-022 is no longer applicable.
FITBIR Account Management:
FITBIR Data Submission accounts will now be valid for the duration of the period of performance of the grant.
NINDS Common Data Element Compliance:
The NIH and DoD provides support for the development of TBI CDEs. This effort involves TBI expert working groups forming consensus recommendations for TBI-related outcome instruments and non-outcome measures to be used in clinical research. These evidence-based recommendations are founded in existing literature and can be applied to clinical research across all severities of brain injury. 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, particularly those with a FITBIR data submission requirement. 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 or through FITBIR. For any grant with a FITBIR data submission requirement, non-compliance with NINDS CDEs will require programmatic approval.
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. As with non-CDE usage, incorporating non-TBI CDEs requires prior Programmatic approval.
Inquiries
Please direct all inquiries to:
FITBIR Operations TeamEmail: FITBIR-ops@mail.nih.gov
Website: https://fitbir.nih.gov/
and Human Services (HHS)
