The NCATS intends to publish several FOAs for the CTSA Program to bring more treatments to more patients more quickly by advancing high quality clinical and translational science locally, regionally, and nationally, and by fostering innovation in research methods, training, and career development.
The suite of FOAs and their funding mechanisms includes:
- Clinical and Translational Science Award (UM1; CTSA hub)
- Specialized Innovation Program (RC2)
- Institutional Career Development Award (K12)
- Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Predoctoral Research Training Grants (T32)
- Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Postdoctoral Research Training Grants (T32)
- Research Education Grant (R25)
NCATS will solicit the submission of one set of companion applications for the Clinical and Translational Science Award (UM1) with a separate companion FOA for the required Institutional Career Development Award (K12). The Specialized Innovation Program (RC2), the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32s) and the Research Education Grant (R25) are optional and available only to CTSA Program UM1 applicants and grantees. Additional consortium-wide activities and program funding opportunities are supported (see here).
This Notice of Intent to Publish (NOITP) is being provided to allow potential applicants sufficient time to develop responsive applications. The content and requirements in the published FOAs supersede the information provided in this NOITP.
The FOAs are expected to be published as follows with an application due date in January 2022 for all six FOAs.
- July/August 2021: UM1
- September/October 2021: RC2, K12, T32s, R25
Research Initiative Details
Background
The CTSA Program is a national network of more than 50 medical research institutions / academic health centers and their partners and collaborators working together to speed translation of research discoveries into improved patient care by tackling system-wide problems in clinical and translational research that no single team can overcome. The CTSA Program is one component of the NCATS Strategic Plan to advance clinical and translational science (CTS); it is designed to develop and implement innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and communities. The expertise, resources, and infrastructure of the CTSA Program facilitate innovation and provide support for all scientific/medical communities engaged in CTS research, including disease and condition-specific research supported by NIH Institutes and Centers.
Solicitation of Feedback on Enhancing the CTSA Program
Considering the maturation of the CTSA Program and advances in clinical and translational science, NCATS has solicited feedback from a wide variety of diverse stakeholders towards enhancing the CTSA Program goals, structure, and operations, as well as the FOA, peer review, and grants management of CTSA Program awards over the past two years. NIH has several policies and procedures governing the solicitation of programmatic feedback and the development of funding opportunities. NIH Program Officers are responsible for developing FOAs, an inherently governmental activity, in collaboration with NIH colleagues in grants management and scientific review. In all cases formal and informal input must adhere to NIH principles of ethical conduct for government officers and employees, which specifies that they must not give preferential treatment to any private organization or individual. NIH policy stipulates applications for grants be sought from all eligible entities and that awards shall be made only after maximum competition occurs; fair and open competition precludes the participation of any individuals or entities that might subsequently compete for NIH funding in the development of FOAs outside of activities that are open to the public. Therefore, extramural scientists such as recipients and applicants, including those who have attended a workshop, responded to a related Request for Information, and/or provided comments during a public meeting such as a meeting of an IC Advisory Council, should not play a direct role in developing or writing FOAs. In light of these practices, NCATS has shared pending FOA information with stakeholders as early as possible.
Feedback has been solicited through a variety of mechanisms:
- A 2019 public Request for Information (RFI; NOT-TR-19-027) (see video for an overview presentation of feedback received)
- General feedback from CTSA application peer reviewers over multiple study sections
- Informal discussions with CTSA Program consortium members, individually and in small group settings, over the course of typical program oversight and interactions
- NCATS staff working groups
- NCATS leadership
- Comments and discussion during the presentation of the CTSA FOA Concepts at the NCATS Advisory Council Open Session on June 11, 2021 (videocast link day 2: https://videocast.nih.gov/watch=42148). The Advisory Council unanimously approved the CTSA FOA Concepts.
- Comments received during the two-week open comment period following the June 2021 NCATS Advisory Council meeting
- High-level comments on the CTSA FOA Concepts stated during a listening session with the CTSA Program Steering Committee members
Stakeholder feedback centered around four distinct areas: (1) decreasing application administrative burden, (2) increasing Hub flexibility and Hub specialization opportunities, (3) expanding Hub funding options, and (4) preserving partnerships and collaborations. Three additional areas were identified by NCATS for improvement: (1) ensuring the CTSA Program’s sustainability by stabilizing and standardizing budget projections, as the current award formula does not enable stability in hub number and budget; (2) increased emphasis towards addressing health disparities; and (3) strengthening clinical research capabilities, which have been critical to the national responses to the opioid epidemic and the COVID-19 pandemic.
Developing a New Suite of CTSA Program FOAs
NCATS took the extensive public feedback, as outlined above, into consideration when deliberating changes to CTSA FOAs, including how these changes could contribute to stabilization for the awardees and to sustainability of the program for NCATS. To date, the application process for institutions applying for CTSA hub awards has been complicated and burdensome, notably with the administrative connection of up to three separate activities together into one package, the U54 application. The initial goal of linking Hub, Career Development and Training activities with a CTSA hub award was to serve as a magnet that concentrated basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry to facilitate the development of new professional interactions, programs, and research projects and to foster the development of a new discipline of Clinical and Translational Science. However, the linkage placed substantial burden on the applying institution in the form of developing large, complex applications, often containing several areas of duplicate information. The review of the combined application could pull an institution out of funding range, due to one of the activities not scoring well in review. Applicants that did not successfully compete faced a prolonged period of uncertainty for funding, while having to address, revise, and resubmit the entire U54 application package for a subsequent review cycle. These factors, combined with the duration of the awards five years raised the stakes of each application and contributed to an environment where applying and awarded institutions were in a constant state of application preparation.
To support continued sustainability and growing recognition of the CTSA Program as a national network of clinical research organizations capable of rapidly address public health needs, through innovations in translational science and in clinical research operations. One of NCATS objectives with the new FOAs is to ensure the long-term sustainability of the program while avoiding the need to reduce the number of hubs or impact hub budgets.
The extensive feedback received from the various stakeholders listed above has been considered and many of the suggestions have been incorporated into the new suite of CTSA Program FOAs, e.g., simplification of the application and its structure; separation of the K and T components from the U component; increased flexibility in determining levels of effort and corresponding budgets within the U application; enhanced opportunities for hubs to specialize; separate funding opportunities for companion institutional training, career development, and research education programs, as well as specialized innovation programs; and continued emphasis on Partnering Institutions.
The most recent comments and questions were received in response to the presentation and discussion of the CTSA Program FOA Concepts at the NCATS Advisory Council Open Session on June 11, 2021, and during the two-week open comment period. Council meeting minutes will be posted here when available. NCATS appreciates the interest that the brief Concept presentations stimulated and systematically considered all comments received. Some comments aligned with plans for the CTSA Program FOAs and have been incorporated into the FOAs as appropriate. Comments that addressed policies and/or regulations of NIH or the U.S. Department of Health & Human Services are beyond the scope of these FOAs. Because significant changes are being made to an established program, NCATS strives to promote transparency for all potential applicants and interested stakeholders. See below for clarifying information and answers to common questions.
Summary of Changes:
- The application mechanism will transition from a U54 (two-to-three individual applications submitted as one linked package) to individually submitted applications (hub UM1 plus required career development K12 plus optional T32s, R25, and RC2)
- The UM1, RC2, K12, T32, and R25 applications will be reviewed in appropriate study sections and will receive individual scores; no overall package priority score will be assigned
- UM1
- Maximum award project period of the UM1 is 7 years, replacing the U54 project period of 5 years. Other CTSA Program awards (RC2, K12, T32, and R25) will not be increased.
- UM1 will be awarded independently of any other component (RC2, K12, T32, R25)
- Application requirements will be simplified and streamlined
- Single UM1 budget will provide increased flexibility to the Principal Investigator(s)
- Enhancement of Clinical Resources and Capabilities. The clinical resources and capabilities of the CTSA Program have proven to be crucial to the national responses to the opioid epidemic and the COVID-19 pandemic. NCATS will increase emphasis on clinical research capabilities, which can be objectively assessed by NIH clinical research funding. The change is expected to encourage increased partnering overall. NOTE: NIH funding for the annual support level for various research, condition, and disease categories (RCDC) based on is publicly available here. The annual estimates for RCDC categories reflect specific research projects funded and the overall NIH budget. For the purposes of the UM1 FOA, the RCDC category Clinical Research will be used to develop a table with the institutional NIH total cost (TC) funding in the Clinical Research Category over a 5-year span. The table will be published annually to assist applicants with preparation of their applications. The definition of the RCDC Clinical Research term is Patient-oriented research - research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects and includes several subcategories such as clinical trials. A similar table for NIH direct cost (DC) funding will be developed and published for applicant institutions (see Data tab of NIH RePORT, NIH Awards by Location and Organization (https://report.nih.gov/award/index.cfm). Additional information will be provided in conjunction with the publication of the new suite of CTSA Program FOAs.
- Award Calculations. The UM1 award calculation will be modified to ensure program sustainability and stability, enhance ability to address health disparities, and increase clinical capabilities.
- Four levels of maximum requested direct cost (DC) that correspond to specified NIH funding ranges (to be published within the upcoming UM1 FOA).
- Previous 5 year rolling averages of the sum of portions of NIH funding by the Applicant and Partnering Institutions as follows:
- Applicant Institution: the NIH funding DC of the Applicant Institution (no change).
- Partnering Institutions: To encourage expansion of the CTSA Program’s clinical research capabilities, the NIH clinical research funding total cost (TC) will be used for Partnering Institutions in the determination of maximum DC request.
- CTSAs are encouraged to work with partners and collaborators that could enhance and/or accelerate the CTSAs capacity to advance the CTSA Program goals and to address the burden of conditions that disproportionately affect rural, minority, and other underserved populations. To encourage partnerships with Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). NCATS is seeking approval to allow the Applicant Institution to use either the NIH funding DC or the NIH clinical research funding TC, whichever is higher, for these Partnering Institutions.
- Importance of Partners and Collaborators
- Partnerships and collaborations remain a core element, vital to achieving many of the CTSA Program goals in terms of advancing clinical and translational science, enhancing community engagement, and addressing health disparities. The selection of such partners and collaborators is important to Hubs for achieving their objectives and is considered during peer review.
- Partnering Institutions must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. They should be selected based upon the expertise and capabilities provided.
- Partnering and Collaborating Institutions are not required to receive NIH funding. A variety of partnerships and collaborations is key to achieving the goals of the CTSA Program and may include other institutions of higher education, research organizations, independent hospitals, community service organizations, the Veterans Administration (VA), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), institutions participating in an Institutional Development Award (IDeA), and the Research Centers in Minority Institutions (RCMI).
- Optional Modules (currently included in UL1) and Research Program to be included in the UM1 Application; and New Specialized Innovation Programs (RC2)
- UL1 Optional Modules will not be a component of the UM1. Investigators are encouraged to consider whether current Optional Model topics may be appropriate for inclusion in the UM1 under the CTS Research Program component or for applications to the new Specialized Innovation Programs (RC2). Investigators may also consider if their topic is appropriate for a different CTSA Program FOA titled Resources for Rapid Demonstration and Dissemination (U24) (PAR-21-203).
- UM1 CTS Research Project/Program is new and will be part of the UM1 application. It will be designed to allow the Hubs to showcase unique strengths and capabilities. The Hub will identify one or more significant, problematic translational science bottlenecks and propose a use case linked to its unique expertise and capabilities. The objective will be to discover advances that are universally applicable to translational science. Note that the UM1 CTS Research Project has evolved into a multi-project CTS Research Program.
- New Specialized Innovation Programs (RC2) will align with stakeholder feedback to increase flexibility and diversity across Hubs, to leverage strengths and drive innovation, allow recipients to specialize, and to balance local efforts with Consortium efforts. As with other CTSA Program initiatives, application eligibility will be limited to the primary UM1 hub applicant/recipient institution; partners and collaborators may be integrated [Multi-PI (MPI) or other]. Note that the RC2 FOA will be released after the release of the UM1 FOA; however, the RC2 and UM1 FOAs will have receipt dates for the same Council round.
- Career Development & Training
- The required career development component (KL2) will transition to a Clinical Scientist Institutional Career Development Program Award (K12). It is expected that each Hub will have one K12 award (limited to one). A K12 application will be required to be submitted concurrently with the UM1 application. If the UM1 application is meritorious and awarded and the K12 is not meritorious and not awarded, then the K12 may be resubmitted without the UM1 application. This will enable the UM1 award to be able to be issued more quickly than in the current approach. The UM1 application must be active for the K12 to be eligible to be resubmitted.
- The optional training component (TL1) will transition to three separate optional FOAs. Each Hub will be able to apply for and receive one of each.
- Ruth L.?Kirchstein?Institutional National Research Service Awards to support predoctoral trainees (T32)
- Ruth L.?Kirchstein?Institutional National Research Service Awards to support postdoctoral fellows (T32)
- Research Education Program (R25) provides the opportunity for expansion of training for the next generation of clinical and translational scientists that are underrepresented, the further incorporation of partners, faculty development at under-resourced institutions and development of externship programs.
- The separation of the TL1 into three distinct FOAs (T32 predoc, T32 postdoc and the R25 short-term research education experiences) will allow the applicant institution flexibility to invest in training the next generation of clinical and translational scientists where the institution will have the most local impact. Administratively, the separation will allow the budget start dates of these awards to be different from the UM1 start date, allowing the CTSAs to implement their training programs in harmony with local training needs and may allow for the ability to align the awards more closely with the academic calendar that, in turn, may enhance the recruitment of the physician candidates who are restricted by medical school or residency calendars.
Summary of Areas that will Not Change:
- Core mission: Innovating clinical and translational science to get more treatments to more people more quickly
- The overall number of hub awards (currently UL1s transitioning to UM1s)
- The award sizes of the UM1s will be similar to, if not greater than, the current UL1 awards for the vast majority of current and recent CTSA Program hub recipients
- The award sizes of the UM1 plus the K12 will be similar to, if not greater than, the current UL1 plus KL2 awards for the vast majority of current and recent CTSA Program hub recipients
- Total overall investments for hub, career development, and training components
- Institutional award limitations [hub institutions are limited to no more than one active K12, T32 (pre-doc), T32 (post-doc), and R25 and two RC2s under the CTSA Program FOAs]
- Competition for RC2, K12, T32s, and R25 limited to hub UM1 applicants and recipients
- The importance of local, regional, and national networking capacity
- The importance of partnerships and collaborations to meet CTSA Program and application objectives
- The primary Applicant Institution’s overall NIH funding direct cost will be used in the determination of the Applicant’s maximum direct cost request
Applications are not being solicited at this time.
NCATS plans to solicit questions from the public after publication of the new suite of CTSA Program FOAs. Common questions will be addressed in a public Technical Assistance webinar.
