Opportunity Information: Apply for RFA NS 13 008
Apply for RFA NS 13 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "International Traumatic Brain Injury Research Initiative NIH Cooperative Program for Comparative Effectiveness of Clinical Tools and Therapies (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Dec 14, 2012 and posted on Dec 14, 2012.
- Applicants must submit their applications by Apr 1, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education City or township governments For profit organizations other than small businesses Special district governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The International Traumatic Brain Injury Research Initiative NIH Cooperative Program for Comparative Effectiveness of Clinical Tools and Therapies (U01) was a National Institutes of Health (NIH) funding opportunity designed to support a U.S.-based, multicenter research team that would join the broader International Traumatic Brain Injury Research (InTBIR) Initiative. InTBIR is an international partnership involving the NIH, the U.S. Department of Defense (DOD), the European Commission research directorate, and the Canadian Institutes of Health Research (CIHR). The central goal behind this program was to help build and contribute to a large, open-source international patient registry for traumatic brain injury (TBI), enabling researchers to compare real-world differences in how TBI is diagnosed and treated across sites and health systems and then link those differences to patient outcomes. By examining variations in care and outcomes among otherwise similar patients, the initiative aimed to identify clinical tools, approaches, and therapies that appear to be associated with better recovery, thereby informing evidence-based practice and improving TBI care.
The award mechanism was a Cooperative Agreement (U01), which typically signals substantial scientific involvement from the NIH in coordinating the program and ensuring that funded teams work in a harmonized, collaborative way. In practical terms, this kind of structure is well suited to multicenter registry work where consistency in data elements, definitions, and data sharing expectations is critical. The program focus was comparative effectiveness in a clinical context, meaning it emphasized learning from routine clinical practice and systematically comparing the performance of diagnostic tools and therapeutic strategies rather than limiting evidence generation to tightly controlled single-site studies. The registry emphasis also reflects a commitment to scale, standardization, and long-term utility: data collected in a common format across many sites can be reused to answer multiple questions over time, including questions that were not anticipated at the start of the project.
Administratively, the opportunity was listed as a discretionary grant program within the health category and carried NIH Catalog of Federal Domestic Assistance (CFDA) numbers associated with neuroscience and neurological disorders research (93.853) and related areas. It did not require cost sharing or matching. The opportunity was posted and created on December 14, 2012, with an original and final application due date of April 1, 2013, and it was later archived on May 2, 2013, indicating the solicitation is no longer open.
Eligibility was broad across U.S. domestic organizations and governmental entities, reflecting an intent to attract strong clinical-research networks and institutions capable of multicenter coordination. Eligible applicants included public and private institutions of higher education; nonprofits with or without 501(c)(3) status (with the noted exception categories); small businesses and other for-profit organizations (other than small businesses, also eligible); state, county, city or township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations. The eligibility listing also explicitly included a range of mission-focused institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, the FOA clearly restricted applications to U.S.-based entities: non-domestic (non-U.S.) entities were not eligible to apply, non-domestic components of U.S. organizations were not eligible, and foreign components (as defined by NIH policy) were not allowed. This structure fits the program’s intent to fund a U.S. multicenter team that would then participate in the international collaboration through coordinated data standards and registry contribution rather than through direct foreign subawards or foreign-led applications.
Overall, this FOA can be understood as an NIH-driven effort to strengthen TBI research infrastructure by building an internationally interoperable patient registry and using it to study which clinical diagnostic and treatment practices are linked with better outcomes. The cooperative agreement design, multicenter requirement, and open-source registry orientation all point to an emphasis on coordination, shared standards, broad data accessibility, and real-world clinical impact. For applicants, the core expectation would have been the ability to recruit and manage multiple clinical sites, collect high-quality standardized clinical and outcomes data, and participate actively in the international InTBIR framework so that U.S. data could be compared meaningfully with data generated by partner organizations in other regions.
Frequently Asked Questions (FAQs)
What was the International Traumatic Brain Injury Research Initiative (InTBIR) NIH Cooperative Program (U01)?
It was a National Institutes of Health (NIH) funding opportunity intended to support a U.S.-based, multicenter research team that would participate in the broader International Traumatic Brain Injury Research (InTBIR) Initiative. The program emphasized comparative effectiveness research focused on clinical tools and therapies for traumatic brain injury (TBI) using real-world clinical data.
What was the main goal of this funding opportunity?
The central goal was to help build and contribute to a large, open-source international patient registry for TBI. The registry was intended to enable comparisons of how TBI is diagnosed and treated across different sites and health systems, and to link differences in care to patient outcomes.
What is InTBIR and who were the partners involved?
InTBIR was described as an international partnership involving the NIH, the U.S. Department of Defense (DOD), the European Commission research directorate, and the Canadian Institutes of Health Research (CIHR).
What kind of research approach did the program emphasize?
The program focus was comparative effectiveness in a clinical context. That means it emphasized learning from routine clinical practice and systematically comparing the performance of diagnostic tools and therapeutic strategies, rather than relying only on tightly controlled single-site studies.
What does it mean that the award mechanism was a Cooperative Agreement (U01)?
A Cooperative Agreement (U01) typically indicates substantial scientific involvement from the NIH. In this opportunity, that structure was intended to support coordination across multiple sites and ensure harmonized, collaborative work, which is especially important for multicenter registry efforts where consistent data elements, definitions, and data sharing expectations matter.
Why was a multicenter team required or emphasized?
The opportunity was designed to support a U.S.-based, multicenter research team. The multicenter setup supports collecting standardized data across many sites, comparing real-world differences in practice, and increasing the scale and usefulness of the registry over time.
What was the purpose of building an open-source international TBI patient registry?
The registry was meant to create a shared, standardized data resource that could be used to compare diagnostic and treatment practices across sites and health systems, evaluate how those differences relate to outcomes, and identify tools or therapies associated with better recovery.
How would the registry help improve TBI care?
By examining variations in care and outcomes among otherwise similar patients, the initiative aimed to identify clinical tools, approaches, and therapies that appear to be associated with better recovery. The intent was to inform evidence-based practice and improve TBI care.
What types of questions could registry data help answer over time?
The standardized, common-format data could be reused to answer multiple questions over time, including questions not anticipated at the start of the project, because a well-structured registry supports future analyses beyond the initial study aims.
Was this opportunity focused on infrastructure, research, or both?
Based on the description, it was both: it aimed to strengthen TBI research infrastructure by building an internationally interoperable registry, and it also aimed to use that registry to study which diagnostic and treatment practices are linked with better outcomes.
What administrative category and CFDA numbers were associated with the opportunity?
It was listed as a discretionary grant program within the health category and carried NIH CFDA numbers associated with neuroscience and neurological disorders research (93.853) and related areas.
Did the opportunity require cost sharing or matching?
No. The opportunity did not require cost sharing or matching.
When was the opportunity posted and when were applications due?
The opportunity was posted and created on December 14, 2012. The original and final application due date was April 1, 2013.
Is this funding opportunity still open?
No. It was later archived on May 2, 2013, which indicates the solicitation is no longer open.
Who was eligible to apply?
Eligibility was broad across U.S. domestic organizations and governmental entities. Eligible applicants included public and private institutions of higher education; nonprofits with or without 501(c)(3) status (with noted exception categories); small businesses and other for-profit organizations; and a wide range of government entities (state, county, city or township, special district governments, independent school districts, public housing authorities/Indian housing authorities), as well as Native American tribal governments and tribal organizations.
Were minority-serving institutions and community-based organizations included in eligibility?
Yes. The eligibility listing explicitly included institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also included faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
Could a non-U.S. (foreign) organization apply?
No. The FOA restricted applications to U.S.-based entities. Non-domestic (non-U.S.) entities were not eligible to apply.
Could a U.S. organization include a non-domestic component in its application?
No. Non-domestic components of U.S. organizations were not eligible.
Were foreign components allowed under NIH policy for this opportunity?
No. Foreign components (as defined by NIH policy) were not allowed.
If foreign entities could not apply, how was this still an international initiative?
The structure was intended to fund a U.S. multicenter team that would participate in the international collaboration through coordinated data standards and registry contribution, enabling comparisons with data generated by partner organizations in other regions.
What would have been core expectations for applicants?
The description points to expectations such as the ability to recruit and manage multiple clinical sites, collect high-quality standardized clinical and outcomes data, and participate actively in the InTBIR framework so U.S. data could be compared meaningfully with data from international partners.
Why is harmonization of data elements and definitions mentioned as important?
In multicenter registry work, consistency in data elements, definitions, and sharing expectations is critical so that data from different sites can be combined and compared reliably. The cooperative agreement structure was presented as well suited to supporting that kind of harmonized approach.
What does "real-world differences" in diagnosis and treatment refer to in this program?
It refers to variations in routine clinical practice across sites and health systems, such as differences in diagnostic tools or therapeutic strategies used for TBI, and then analyzing how those differences relate to patient outcomes.
What is meant by linking differences in care to patient outcomes?
It means using registry data to compare patient recovery and other outcomes across different care patterns, especially among otherwise similar patients, to identify which practices appear to be associated with better recovery.
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