Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity announcement (NOFO) invites applications for the Clinical and Translational Science Award (CTSA) Program hubs that will be part of a national, collaborative consortium focused on bringing more treatments to all people more quickly through advancing clinical and translational science (CTS) by (1) developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination; (2) promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally; (3) creating, providing, and disseminating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all; (4) creating and implementing scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research; (5) providing a national resource for the rapid response to urgent public health needs; and (6) creating, providing, and disseminating CTS training for clinical research professionals of all disciplines on the research team.

Key Terms, Definitions, and Uses in this NOFO

• Collaborator/Collaborating Institution(s): Have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application.  For the purposes of this NOFO, NIH funding to the collaborating institution is not included for determination of maximum direct cost budget requests. 
• Consortium/Program: Describes the CTSA Program, as a whole, which includes the CTSA hubs and other CTSA Program initiatives such as: the Trial Innovation Network (TIN), the Collaboration Innovation Awards (CCIAs), the Evolve to Next-Gen ACT (ENACT) informatics resource, the Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board (SMART IRB), and the Coordination, Communication, and Operations Support (CCOS). Consortium and Program are used interchangeably to describe the entirety of the CTSA ecosystem.
• CTS: Clinical and translational science
• CTSA Program: 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.
• Health Equity: Health equity is the principle underlying the continual process of assuring that all individuals or populations have optimal opportunities to attain the best health possible. One of the goals of the CTSA Program is to “Create, provide, and disseminate innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all.” Used in the context of community engagement research and outreach to underserved populations (e.g., minority, rural, communities with disparate health outcomes) to decrease health inequities.
• Hub: Medical research institutions / academic health centers with CTSA hub awards maintain an integrated research and training environment for CTS. Hubs play a central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers.
• Institutional Commitment: Access to and utilization of substantial and well-integrated resources. This does not include voluntary committed cost share, which is not required for applications submitted to this NOFO.
• Partner/Partnering Institution(s): Must be effectively integrated into the proposed activities of the CTSA UM1 hub and necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. For the purposes of this NOFO, NIH funding to the partner/partnering institution is used for determination of maximum direct cost budget requests. (See Section IV. Application & Submission Information, 2. Content and Form of Application Submission, R&R Budget, Award Budget).
• Stakeholder: Includes individuals and/or organizations representing community members or advocacy groups; health care providers and health care systems; research participants; and patients.
• Translation: Defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and communities – from diagnostics, preventions, and treatments to medical procedures and behavioral changes.
• Translational Research (TR): Defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease.
• Translational Science (TS): Translational science is the field that addresses longstanding scientific and operational challenges along the translational science spectrum through innovations that transform the way research is conducted, making it faster, more efficient, and more impactful.

Background

The development and implementation of clinical interventions is a complex, iterative, and time-consuming process that takes years before discoveries in biomedical research result in health benefits for patients and communities. The National Center for Advancing Translational Sciences (NCATS) has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist in the translational process and developing innovative solutions that will ultimately benefit research across a range of diseases and conditions. This disease-agnostic approach to enhancing the efficiency and effectiveness of all translational research is known as translational science, which focuses on building the evidence base for effective scientific and operational approaches in translational research. NCATS conducts and supports research in the science of translation to discover the scientific, mechanistic, and operational principles of the intervention development and dissemination processes, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

The NCATS Strategic Principles that underlie the NCATS mission are:

• Catalytic: NCATS is a catalyst that enables others to perform more efficient and effective translation.
• Generalizable Principles: NCATS uncovers fundamental principles shared among diseases and translational processes; widespread implementation of such generalizable principles will accelerate translation.
• Innovative: NCATS programs lead to profound improvements in translational understanding and effectiveness, producing innovation that establishes fundamentally new ways of doing translation that are multiplicative in their effects.
• Collaborative: Translational research endeavors require the expertise of multiple people and groups, particularly as the research is carried across through different phases of the translational science spectrum. NCATS approaches translation as a “team sport.”
• Patient-focused: At all phases of translational science, NCATS is committed to patients and their communities and looks for opportunities to include the patient perspective. The ultimate goal of translation is tangible improvement in health, so the perspectives of and collaborations with patients are crucial.
• Measurable: NCATS continuously improves translational effectiveness, so programs must be designed and implemented with explicit indicators of success for translational progress.

'Translation' is defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and communities – from diagnostics, preventions, and treatments to medical procedures and behavioral changes. ‘Translational research’ (TR) is defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease. ‘Translational science’ (TS) is the field that addresses longstanding scientific and operational challenges along the translational science spectrum through innovations that transform the way research is conducted, making it faster, more efficient, and more impactful. Whereas translational research focuses on the specific case of a target or disease, translational science is focused on the general case that applies to any target or disease; advances in translational science are the focus of this NOFO. A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects (e.g., incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment). Many of these causes are the same across targets, diseases, and therapeutic areas; therefore, advances in translational science will increase the efficiency and effectiveness of translational research to enhance health, lengthen life, and reduce the burdens of illness and disability. Like any other science, translational science seeks to elucidate general operative principles to transform translation from an empirical, phenomenological process into a predictive science. The application of scientific and operational innovation and strategies to improve the efficiency and effectiveness of all research is at the heart of developing, demonstrating, and disseminating the science of translation.

An example - for illustration only - to help clarify the relationship between TR and TS follows. An investigator initiates a study evaluating whether a particular drug can improve specific outcomes in diabetes. The investigator could utilize commonly used TR methodology, such as testing effectiveness of the drug using a limited number of traditional clinical endpoints and employing established recruitment methods. By contrast, an investigator could approach from a TS framework. In the diabetes example, the same drug could be evaluated, yet an underlying common problem in TR such as recruitment and retention in underserved communities consistent with the NIH Inclusion Policies, could be addressed at the same time. From this TS perspective, the investigator could include in the study an understanding of the fundamental barriers to recruitment and test an intervention directed at hypothesized causes and mechanisms of the barriers in a particular underserved  population. Engagement with this population before protocol development may lead to some interesting potential Patient Reported Outcomes (PRO) that may not only impact recruitment and retention but may also predict future adherence (that could be the focus of a future study). Ultimately, the questions to be answered in this TS version would be if the innovation accomplishes full recruitment and retention of a desired population more effectively and efficiently than without the innovation. Of note in this TS version of the study, the intervention utilized to overcome the recruitment challenges, if determined to be effective, would likely be more generally applicable for other interventions that target not only diabetes but potentially clinical trials in other disease areas where similar recruitment barriers occur. Of further note, although the study itself was focused on a particular disease and drug, its TS version delivers knowledge that is more generally applicable.

CTSA Program

The CTSA Program is one component of the NCATS Strategic Plan to advance 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. As one of the largest NIH clinical and translational science programs and an exemplar of team science, NCATS envisions the CTSA Program progressing toward a standards-based, interoperable network in a cloud environment where informatics assets, e.g., data, software, and algorithms, can be co-developed and shared across the CTSA consortium in a common repository.

NCATS solicited feedback on the CTSA Program goals, structure, and operations, as well as the NOFO, peer review, and grants management of CTSA Program awards. Feedback about application structure and submission was incorporated into the prior (PAR-21-293) and related NOFOs, including simplification; delinking of the K and T components from the U component in the U54 application; increased flexibility in determining levels of effort and corresponding budgets within the application; the opportunity for hubs to specialize via a Research Program; separate funding opportunities for companion institutional training, career development, and research education programs; and specialized innovation programs and CTS research resource centers.

CTSA Program Goals

NCATS amended the CTSA Program goals in response to the feedback and the maturation of the existing CTSA Program and will use a variety of mechanisms to achieve these goals, including this UM1 NOFO and other training and research opportunities.

1. Advance CTS: develop, demonstrate, and disseminate scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination.
2. Promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally.
3. Create, provide, and disseminate innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all.
4. Create and implement scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research.
5. Provide a national resource for the rapid response to urgent public health needs.
6. Create, provide, and disseminate CTS training programs for clinical research professionals of all disciplines on the research team.
7. Create, provide, and disseminate CTS training and career support programs for translational scientists.
8. Foster the development of the emerging field of translational science.

CTSA UM1 Hub

A CTSA UM1 hub is an integrated research and training environment for CTS, which catalyzes the development, demonstration, and dissemination of methods and technologies that dramatically improve efficiency and quality across the translational research spectrum. The medical research institutions / academic health centers that make up the CTSA Program are referred to as “hubs” to indicate their central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers. Each CTSA hub functions as a local center of innovation in CTS and operations, the nature of which will build on local institutional strengths and focus on specific needs of the community in their local environment. In aggregate, the CTSA hubs and other components of the CTSA Program form a consortium that is much greater than the sum of its parts, with hubs bringing complementary strengths to each other via the CTSA Program locally, regionally, and nationally. Thus, hubs are expected to have certain foundational capabilities to both serve as field-leading centers for CTS innovation locally, and as participants in multi-hub collaboratives regionally and nationally. CTSA hubs should be agents of continuous improvement as they identify gaps and opportunities in the research process, develop and instantiate innovative solutions at their institutions, and share those solutions with the other CTSA hubs. This UM1 NOFO for support of CTSA hubs strives to address the first 6 of the 8 CTSA Program goals listed above.

This approach will maximize the progress at both individual hubs and in translational science broadly, obviating duplication and leveraging each hub’s strengths to bolster the others and translational science as a whole. This synergistic aspect of the CTSA Program, actualized via various funding mechanisms, including training and career development grant awards, will facilitate innovation in multi-center research, harmonization of standards and best practices, enhanced training through sharing curricula and online training modules/courses on translational science, and will provide opportunities for cross-hub and sector research training and career development opportunities, both within and outside of the CTSA Program. Realizing these synergies will also maximize the nation’s investment in the CTSA Program. It is not expected that every UM1 hub will have the expertise or capability to address all aspects of CTS science, but the aggregate CTSA Program can and should. An important operational principle of all NCATS programs, including the CTSA Program, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in CTS and operations that currently limit the efficiency and effectiveness of CTS research. Importantly, the CTSA Program strives to build and disseminate an evidence base of validated CTS improvements.

Innovations in the following and related areas will be catalytic to translational efficiency and the development and delivery of interventions that improve the health of individuals and communities:

• Understanding of translation
• Processes and programs to support and advance translation, e.g., collaborative structures; integration of project management; incentives/credit for team science; incentives/credit for health improvements; education/training (scientific and cultural); biomarker qualification process.
• Data-related improvements and tools, e.g., data interoperability; electronic health records (EHRs) for research; data transparency/release; real-world data integration as novel clinical evidence; digital health and its impact on clinical research
• Clinical research improvements and tools (e.g., clinical trial networks, digital health technologies); clinical outcome criteria (e.g., patient-reported outcomes); clinical diagnostic criteria; contemporary clinical trial designs; single Institutional Review Board (IRB) implementation; regulatory science; shortening time of intervention adoption.
• Clinical study recruitment improvements and tools (e.g., identification, recruitment, engagement and/or retention of populations and/or subpopulations in clinical trials and studies).
• Community and stakeholder engagement
• Methods to better measure impact on health (or lack thereof)

Essential Characteristics of Successful CTSA Hubs

Successful CTSA Program hubs require demonstrated expertise and capabilities in a variety of areas. Qualities important for success include, but are not limited to:

• A vision and strategic goals that will create a successful CTS environment that integrates with and helps to advance CTS research projects at the hub and throughout the CTSA Program and research ecosystem.
• Leadership team experienced in running complex and impactful CTS programs and collaborating with multiple partners; a critical mass of research faculty who represent a wide variety of disciplines focused on a broad spectrum of state-of-the-art CTS, with strong records of productivity, training, and mentoring that together provide a supportive research environment; and engaged and effective organizational governance and leadership structures that respond to needs of the community and input from advisory committees.
• Demonstrated institutional commitment from academic leadership and focus on promoting an inclusive working environment; institutional commitment should include access to and utilization of substantial and well-integrated resources, but does not include monetary support, which is neither required nor recommended by this NOFO.
• Research-friendly environment where patients, clinicians and other stakeholders have easily accessible opportunities and resources to contribute to research and be fully engaged as partners.
• Commitment to reducing health disparities through research that addresses the significant burden of conditions that disproportionately affect rural, minority, and other populations with health disparities.
• Embody and demonstrate a culture of collaboration within the applicant hub and across any partner and collaborator institutions; with other hubs and components of the CTSA Program; and with local, regional, and national stakeholders.
• Capabilities and capacity to adopt and implement innovative policies and infrastructure that improve the quality of human subject protections and promote a culture of responsibility, while minimizing investigator burden and measurably decreasing administrative delays.
• Develop tools and methods directed at identified chokepoints in the translational process demonstrating their value across the CTSA Program, and ultimately, disseminating successful strategies more broadly; capacity to conduct single and/or participate in, multi-site clinical studies and trials, and incorporate quality standards into clinical research; and experience with continuous quality improvement to assess the CTS research enterprise.
• Commitment to broad-based CTS research workforce development and fostering teamwork among scientists and clinicians.
• Well-integrated and developed informatics and digital health capabilities.

CTSA Program UM1 Hub Application Structure

Each CTSA Program hub application must include the five Elements, and where appropriate, the associated Modules:

• Element A: Overview (no Leader)
• Element B: Strategic Management (SM Module Leader & Application PI)
• Element C: Training and Outreach
  • Module C1: Workforce Development for Clinical Research Staff Professionals (WD Module Leader)
  • Module C2: Community and Stakeholder Engagement Research (C&SE Module Leader)
• Element D: Clinical and Translational Science Resources and Pilots
  • Module D1: Resources and Services (R&S Module Leader)
  • Module D2: Clinical and Translational Science (CTS) Pilot (Pilot Module Leader)
  • Module D3: Data Science (DS Module Leader)
• Element E: Clinical and Translational Science Research Program (Research Program Leader)

In the structure above, a single individual may have more than one Leader role and any Module or Element may have multiple co-leaders if sufficiently justified. Leader effort should be commensurate with the anticipated role and responsibilities described in the budget justification. It is not required that the hub PD/PI(s) be the leader(s) of any Module or Element except Element B. Further, Element B will have a Hub Liaison Team (HLT) scientific lead and an operations lead (described below). An overview diagram of the application elements can also be found here.

Hubs are expected to innovate in and include all areas above in the application (Elements and respective Modules) relative to their individual core strengths (e.g., personnel of institution, partner, collaborators, other) and capabilities / resources (e.g., institutional, community, other stakeholders). The goal is for each hub to showcase their unique strengths and capabilities ultimately strengthening the consortium, as a whole, and advancing CTS. As such, applicants do not need to develop extensive programs in each area above – simply determine the appropriate balance of resources across all Elements and Modules that can accelerate the individual hub’s impact to CTS.

Element A: Overview

The Overview Element includes 1) the overall vision for establishing a successful CTS research environment within the CTSA hub and with the CTSA Program nationally. The vision should define the strategic goals and how those goals will be approached and attained, incorporating unique strength(s) and other specific research areas of focus that will facilitate the accomplishment of the goals; 2) a description of the assembled team; 3) the CTS accomplishments and high impact achievements that are generalizable to the advancement of CTS by the assembled participating Partnering and Collaborating institutions; and 4) expected accomplishments and scientific and public health impact.

Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. For the purposes of this NOFO, NIH funding to the partner/partnering institution is used for determination of maximum direct cost budget requests. Collaborating Institution(s) have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application. For the purposes of this NOFO, NIH funding to the collaborating institution is not included for determination of maximum direct cost budget requests (See Section IV. Application & Submission Information, 2. Content and Form of Application Submission, R&R Budget, Award Budget).

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 populations with health disparities.

CTSAs also are encouraged to collaborate with other institutions of higher education, research organizations, independent hospitals, community service organizations and/or the Veterans’ Administration (VA).

Element B: Strategic Management

The Strategic Management Element includes all activities related to management of the hub and its partners and collaborators to ensure the successful execution of the proposed UM1 application objectives. The contact PD/PI must be designated as the Strategic Management Module Leader.

Strategic Management Module

Strategic management of the CTSA hub involves many aspects, including:

• Relationships of the applicant institution and all participating partners and collaborators, including what each partner/collaborator will contribute and any tangible commitments; how each partner/collaborator will have input and participate in decision making; and how the partners/collaborators will maintain ongoing communication are key to a successful CTS program. The participation of any partner/collaborator must be strongly justified with a well-described anticipated role.
• Integration of the leadership team into the overall institutional structure and a forward-thinking succession plan.
• Use of resources to significantly influence new approaches in CTS.
• Creation of an effective collaboration, coordination, and communication infrastructure to support scientific, training, governance, workgroup, and other types of CTSA consortium activities.

Strategic management also includes the ongoing planning, monitoring, analysis, and assessment of all that is necessary for an organization to meet its goals and objectives; CTSA hubs are expected to undertake all these activities. Monitoring is tracking the implementation of the adopted strategies through periodic data collection to provide early indicators of progress and areas for improvement. Analysis is conducted to determine the effectiveness of a specific program or model to understand why it may or may not be working with the goal of improvement. Each CTSA hub is expected to have a strong Continuous Quality Improvement (CQI) program, which is an ongoing cycle of collecting data and using it to make decisions to gradually improve program processes. The methods (e.g., Lean Methods, Six Sigma, Kaizen Method, Plan-Do-Study-Act, Value Stream Mapping, and any other method common to quality improvement program) chosen to perform this CQI are not specified in this NOFO to allow flexibility for the applicants to choose the method(s) that are most appropriate for their proposed hub’s needs.

Recent events have shown that public health emergencies/situations may have a substantial impact on CTS research by affecting processes and services, clinical research participant and staff safety, and available resources. These events have called for adjustments in and re-conceptualization of the approaches to clinical research. In the event of a public health or other emergency, CTSA hubs should be prepared to rapidly realign activities to support research of direct relevance to the emergency or public health need. Each CTSA hub must have a plan to pivot to a virtual leadership structure in the event of an emergency, a plan to rapidly realign activities to assist response efforts, and a succession plan for leadership positions, including the PI(s)/MPI(s), which is critical even under normal circumstances. Note: The succession plan should be within the Strategic Management Module.

Hub Liaison Team. Each CTSA hub must appoint a Hub Liaison Team (HLT) to function as an interface between the hub and the national collaborative activities of the CTSA Program as well as be the primary source of dissemination, to these activities, in terms of their hub’s unique strengths and capabilities. Current national collaborative activities of the CTSA Program include using informatics tools to use Electronic Health Records to conduct research; collaborative infrastructure to support scientific, training, governance, workgroup, and other types of CTSA consortium activities; consideration of participation in clinical trials; and identification and dissemination of innovations in clinical trials. Applicants should describe their commitment to interfacing with current as well as potentially new national collaborative activities. Personnel from the CTSA hub leadership (e.g., from Elements B, C, D, and E) and the HLT may be completely separate, overlap, or be the same.

Each CTSA hub is required to engage in Dissemination and Implementation (D&I) activities to support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. Information, tools and interventions deemed efficacious within clinical or community-based trials need to be made readily available for adoption and implementation within the context of a learning health system (LHS). Methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine health care and public health settings to improve the impact on population health are needed. Despite significant investments in biomedical science, some interventions are slow to reach the targeted beneficiary and may not be perceived as appropriate or useful, resulting in persistently poor health outcomes. The CTSA consortium is poised to address these translational science problems that no one hub can solve alone or disseminate a solution to a translational science problem developed at one hub to other hubs. Robustness will be tested in different hub environments and structures and adaptations made for further dissemination within and outside the CTSA consortium, if appropriate. Each hub is expected to have a plan for building and disseminating an evidence base for each CTS science endeavor, including Pilot projects (Element D) and CTS Research Program (Element E). Each hub is expected to leverage the HLTs, coordinating centers, CTSA funding opportunities, and governance structures of the CTSA Program to engage in D&I activities as well as LHS activities. Foundational capabilities and activities in the area of D&I and LHS are required to support and enhance the impact of the CTSA hub.

Each CTSA hub must also establish both internal and external advisory committees which must meet at least annually to review progress and offer recommendations. The expertise of the members must be broad and include those with a range of important perspectives such as community representatives, patients, community-based clinicians, health systems representatives, experts in informatics, and industry.

Element C: Training and Outreach

The Training and Outreach (TO) Element includes two Modules, Workforce Development and Community and Stakeholder Engagement, to provide an environment where CTS and training for clinical research professionals can flourish.

Workforce Development for Clinical Research Staff Professionals Module

Professional development must be directed towards members of CTS research teams and other clinical professionals such as clinical investigators, co-investigators, clinical researchers, research nurses, pharmacists, administrators, coordinators, consultants, data managers, quality assurance managers, regulatory affairs managers or educators in clinical trial management. These professions must be guided by the principles of Good Clinical Practice (GCP) and be provided foundational education and training in CTS. Team science should be emphasized, as CTS is a collaborative endeavor that requires approaches to solving problems that cut across disciplinary boundaries. CTSA Program hubs must develop and support academic promotion criteria that help create a viable career path for translational scientists. Institutions and investigators should create a culture where members of CTS research teams and other clinical professionals are encouraged to engage in collaborations and professionally recognized (through academic promotion and tenure process) for these efforts. This is expected to support and enhance the impact of the CTSA hub activities by laying the foundation for high-quality research by creating and maintaining a skillful and translational workforce. It is expected that required and optional companion training and education activities will be conducted as an integrated endeavor with the Workforce Development for Clinical Research Staff Professionals Module.Coordination, integration, synergy, and mutual reinforcement between the UM1, the required K12 program, and any additional selected optional companion programs such as the research education (R25), and/or pre-and post-doctoral training (T32), as well as scientific and administrative integration of the proposed programs is expected to be catalyzed by this Module.

Examples of activities that may be supported:

• Providing development (training, education, and mentoring).
• Providing training and educational activities in CTS (e.g., educational seminars, workshops, e-learning courses, experiential opportunities).
• Developing innovative or improved approaches to the dissemination of educational content (e.g., use of interactive online platforms to optimize the end-user’s experience).
• Operationalizing online learning platforms, including a plan to sustain the platform independent of direct CTSA funding support.
• Developing user agreements or licenses to maximize the utilization/adoption/enhancement of educational content, platforms, and software by other CTSA hubs.
• Conducting outreach efforts to grow and diversify the pool of prospective researchers and clinical professionals applying to participate in education and training activities (e.g., identifying culturally and linguistically appropriate strategies to identify hard to reach underrepresented populations for CTSA education and training activities).
• Integrating new employees into the hub program.

Community and Stakeholder Engagement Research Module

Progression from scientific discoveries to demonstrated improvements in public health requires translational research teams of scientists, clinicians, research participants, patients, and other stakeholders with a wide range of expertise and perspectives. Collaborating with and engaging stakeholders in all aspects of translational research are important for advancing CTS, and NCATS views the science of stakeholder engagement as a key area for exploration and innovation. Stakeholder engagement is how an organization involves people who may be affected by the decisions it makes or can influence how the decisions are carried out. Stakeholders may be engaged in identifying, developing, demonstrating, disseminating, or adhering to an intervention, method, or tool. Advancing through the phases of the translational science spectrum requires the creation of productive and mutually beneficial collaborations that depend on individual excellence as well as teamwork, coordination, cooperation, and communication.

As part of community and stakeholder engagement, NCATS is specifically committed to accelerating CTS research to address the significant burden of conditions that disproportionately affect rural, minority, and other underserved populations. Promoting health equity throughout CTSA projects,  enrolling underserved populations in research projects, and engaging patients as full collaborators will help ensure that research findings are meaningful to their individual communities. Foundational capabilities and activities in the area of community and stakeholder engagement are required to support and enhance the impact of the CTSA hub. 

Examples of activities that may be supported:

• Conducting hypothesis-driven observational or interventional studies to determine how best to build trust, membership on teams, participation in clinical research/trials, implementation in practice and communities, and adherence.
• Identifying and disseminating fundamental principles of successful patient and community participation.
• Human-centered design approaches leveraging community input in the research process.
• Developing educational and training resources for clinical professionals on best practices for patient and community engagement.
• Developing evidence-based tools and resources.
• Collaborating with other CTSA hubs to identify, adopt, and utilize new tools and recruitment methods for enhanced engagement of underserved populations.
• Implementing methodological innovations to promote an inclusive working environment in translational research for all researchers and staff, includingindividuals from underrepresented groups.
• Providing tailored materials to help clinical researchers recruit and retain research study participants from underserved populations in clinical trials and clinical studies consistent with the NIH Inclusion Policies.
• Establishing evidence-based interventions and/or tools used to remedy gaps or differences observed among groups in health outcomes to ultimately achieve health equity.

Element D: Clinical and Translational Science Resources and Pilots

This Element provides support for clearly defined activities, services and resources that are instrumental to the completion of a project. While it is the expectation of NCATS that clinical research infrastructure and personnel will be supported by the academic health institutions where CTSA hubs are located, or from other sources, NCATS recognizes that in compelling cases, e.g., an emergent need in response to a public health emergency, there may be a need to provide limited, additional support for clinical research activities, including staff, central coordination of trials, and patient-level evaluations.

Resources and Services (R&S) Module

The R&S Module provides core resources and services that address the many stages of CTS research, including planning, conduct, analyses, implementation and dissemination. The R&S Module is intended to provide discrete resources or services that fill an otherwise unsupported need and is separate from support for distinct, well-described projects, which is provided under Element E: Clinical and Translational Science Research Program, and separate from support for Pilot projects, which is provided under Element D: Clinical and Translational Science Resources and Pilots; R&S activities (e.g., biostatistical support, research design) associated with these projects should be requested within Elements D and E, as appropriate.

The R&S Module must promote broad access and provide clear funding expectations. The structure, organization, and specifics of the R&S Module are expected to vary among applicants. However, a formalized management plan is required that addresses policies for solicitation, review, prioritization, funding level with justification, progress tracking, and evaluation. The particular resources and services selected must be well justified and offer significant value to investigators at participating and collaborating institutions. Institutions must also provide a process to ensure compliance with all federal regulations and NIH policies, including, but not limited to, human research protections, genetic material, stem cells, and animal studies. Furthermore, the R&S Module may be utilized to augment research activities supported by other non-NCATS funding sources (e.g., providing CTSA hub R&S Module services to investigators for other NIH-supported research studies) and does not require NCATS prior approval.

An overarching expectation is that hubs will ensure that clinical research adheres to current Good Clinical Practices (cGCP) and quality principles.

Examples of activities that may be supported:

• Biostatistics, epidemiology, research design (BERD) research resources and support
• Regulatory support (e.g., consultations for IND application submission or other regulatory matters)
• Informatics, computing, digital health and data resources
• Development, dissemination, and implementation of clinical trial standards
• Clinical research activities
  • Protocol and informed consent development, adverse event reporting, safety and regulatory management, and compliance
  • Personnel and tools to coordinate clinical research, e.g., nursing and coordinator services
  • Recruitment services
  • Patient-level evaluations such as laboratory testing or imaging
  • Human specimen collection
• Ancillary pre-clinical and clinical studies
• Access to core laboratory equipment
• Vertebrate animal research activities
  • Pathology services
  • Specimen collection, processing, analyses
• Development of and access to courses and other training opportunities

Clinical and Translational Science (CTS) Pilot Module

The CTS Pilot Module provides modest research support for new and innovative research projects relevant to CTS. The CTS Pilot Module must support both the management and oversight of the CTS Pilot Program and the Pilot projects. Pilot projects must be focused on translational science, i.e., focused on understanding a scientific or operational principle underlying a step of the translational process with the goal of developing generalizable principles to accelerate translational research. Projects are intended to: (1) explore possible innovative new leads or new directions for established investigators; (2) stimulate investigators from other areas to lend their expertise in research in CTS; and (3) provide initial support to establish proof of concept. Projects must be feasible within the proposed timeframe, have high methodological and scientific quality, and answer important scientific questions. Pilot project support is not intended for large projects by established investigators that would otherwise be submitted as separate research grant applications.

The CTS Pilot Module should include the description of the overall administration, implementation, and process to ensure compliance of the Pilot Module as well as the various advisory committees. Descriptions of specific Pilot projects must not be included in the UM1 application and will not be reviewed by the panel evaluating the UM1 application. Pilot projects will be solicited and awarded by the hub after the UM1 hub award has been received; progress on all Pilot projects awarded with UM1 funds must be submitted annually with the recipient’s Research Performance Progress Report (RPRR) or by another method as directed by NCATS.

A management committee representing all aspects of the CTSA hub must be appointed to assist the Pilot Module Leader. To provide each hub with needed flexibility for effective and efficient program management, all responsibility for review and funding of Pilot projects will reside within the Pilot Module itself. The Pilot Module Leader/Co-Leader and the committee will be responsible for ensuring that Pilot projects are focused on advancing aspects of CTS, maintaining oversight and review of the ongoing Pilot Program and projects; arranging and presiding over a rigorous scientific merit review of proposals patterned after the NIH peer review process; ensuring that Pilot projects detail the procedures to be followed and discuss how the data will be analyzed and disseminated if successful; ensuring appropriate oversight and mentoring of junior investigators; and reporting the progress and impact of Pilot projects on a regular basis.

Institutions must also provide a process to ensure compliance with all federal regulations and NIH policies, including, but not limited to, human subject protections, genetic material, stem cells, and animal studies.

Examples of activities that may be supported:

• Development of new research methodology and/or new technologies/tools/resources that will advance CTS and thus increase the efficiency and effectiveness of translation.
• Early-stage development of innovative therapy/technology with generalizable application to an identified translational challenge.
• Demonstration in a particular use case(s) that the new methodology or technology advances translational science by successfully making one or more steps of the translational process more effective or efficient.
• Demonstration of new methods or technologies to enhance outcomes for decentralized clinical research.
• Biostatistics, epidemiology, research design (BERD) research.
• Dissemination of effective tools, methods, processes, and training paradigms in CTS.
• Feasibility/proof of concept studies to support future CTS projects.
• Secondary analysis of existing data (e.g., real-world data sets to discover real-world evidence, projects using the National COVID Cohort Collaborative (N3C) Data Enclave).
• Validation of digital health technologies to produce digital biomarkers as novel endpoints.

Data Science Module

The CTSA Program is uniquely positioned to harness the power of digital assets by making them interoperable for research, ensuring data security, and implementing innovative informatics solutions, all with the goal of improving human health. Data Science programs are required to specifically support the CTSA Program goals of advancing clinical and translational science and increasing the quality of clinical research. Further, informatics capabilities and a commitment to open science principles across all aspects of the CTSA hub are critical to a successful clinical and translational science environment that can translate knowledge into practice and improve health. The capability to share and implement resources across CTSA hubs, when appropriate, offers opportunities to accelerate scientific discovery as well as improve the efficiency, quality, and impact of translational research.

To meet these goals, CTSA hubs and their partners are required to utilize a range of expertise and capabilities in the areas of data science including: 1) Health Informatics (applied research and practice of informatics across the clinical and public health domains); 2) Clinical Research Informatics (the use of informatics in the discovery and management of new knowledge relating to health and disease, including management of information related to clinical trials, and informatics related to the secondary research use of clinical data.); and 3) Translational Bioinformatics (the development of storage, analytic, and interpretive methods to optimize the transformation of increasingly voluminous genomic, digital health, and other biomedical data, into proactive, predictive, preventive, and participatory health, including research on the development of novel techniques for the integration, and subsequent multimodal analysis, of biological and clinical data and the evolution of clinical informatics methodology to encompass biological and Real-world observations). Novel research and resources that can be disseminated to a variety of stakeholders, including biomedical scientists, clinicians, and patients, should be the end product of these integrated efforts within this module.

CTSA hubs and their partners are expected to embrace a culture of Open Science and Data Sharing that promote the F.A.I.R. principles (see: NIH Strategic Plan for Data Science). Open Science is the practice of science in such a way that others can collaborate and contribute, where research data, lab notes and other research processes are freely available, under terms that enable reuse, redistribution and reproduction of the research and its underlying data and methods. The sharing of data, tools, algorithms, methodologies (e.g., machine learning, predictive analytics), governance principles and policies, and software; making research tools compatible with common data elements (CDEs), including social determinants of health CDEs in its domain areas (see https://cde.nlm.nih.gov/home ); and deploying research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services (DHHS) for use in U.S. health care and public health operations will promote the translation of scientific discoveries into health improvements. Embracing this culture, Data Science Modules are encouraged to use the Fast Healthcare Interoperability Resources (FHIR®) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122).

Examples of activities that may be supported:

• Education and technology support for users of research informatics and open science (e.g., data management and sharing, tools, analytics, software, computing resources and other capabilities)
• Natural language processing, generative AI, and text mining approaches
• Clinical decision support and treatment planning tools
• Technology to support next generation clinical trials and clinical trial matching
• Behavioral intervention tools
• Tools, platforms and/or applications to collect and validate DHT-derived data for its use as Real-World Data and subsequent linking to other sources (e.g., other reliable clinical and/or public health data sources) to support Real-World Evidence
• AI/ML algorithm validation and quality control tools
• Statistical, graph and network theory, and machine learning methods research to advance analytical AI and CTS
• Development of data standards, data exchange formats, data quality assurance methods, and data security and privacy management tools
• Performance evaluation of software tools, algorithms, and data collection methods
• Platforms for research collaboration and algorithm performance evaluation
• Data management, storage, organization, and data sharing resources; data processing methods such as data compression, data provenance, and data wrangling; data mining, visualization, and analytics tools and platforms; data annotation tools, including common data elements, and ontologies; and data integration and workflow tools and platforms
• Environments for interactive modeling and simulation

Element E: Clinical and Translational Science Research Program

The Clinical and Translational Science Research Program Element will support discrete research project(s) that should address a truly significant challenge in CTS (a single CTS project per hub is required to be described in the application). Consistent with the NCATS mission to catalyze translation of discoveries, the Program must be focused on CTS rather than on basic discovery research. Research project(s) should not only address a translational research question in a particular disease or intervention development/dissemination context, but also provide generalizable CTS innovations or insights that can be applied to other translational research projects and thereby increase the overall efficiency or effectiveness of translation. The overall Research Program should be described in terms of its goals, impact and significance. Additionally, a single discrete and well-defined project must be described in the application with an associated and defined budget. This single project must include specific aims, significance, and a detailed approach to addressing the specific aims and / or study proposed. The research project is suggested to be 2-3 years in length and may not exceed 7 years. Other proposed research project(s) may be proposed, as they relate to the overall CTS Research Program, however, must not provide a detailed description(s) nor budget for any of the other proposed research project(s).

Each CTSA hub has the flexibility to tailor its Program’s research activities to address local priorities; however, focus on a select disease category or disease specialty must be justified as to how it helps achieve the overall strategic goals of the CTSA Program. The described Program is intended to be of the type of CTS research that the applicant considers to be of high priority. The described research program, or projects in it proposed, may include application partners, collaborators, communities, other active CTSA hubs, or other as long as their active role(s) are justified.

Required and Optional Companion Applications 

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion Institutional Career Development Award (K12 – NOT-TR-24-008). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral – NOT-TR-24-008), the Research Education Grant (R25 – NOT-TR-24-008), and the Specialized Innovation Program (RC2 – PAR-24-054). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1. (See Section III. Eligibility Information of this NOFO and the respective NOFOs for more information).

Resources Provided by NCATS

Specified support services will be provided through grants, contracts, and/or NCATS for certain CTSA consortium activities, e.g., use of a specified NCATS vendor for organization of workshops or provision of certain UM1-related data. Specific requirements for UM1 recipients are described in the Terms and Conditions of Award.

In support of the NCATS goal of promoting and facilitating the development and dissemination of interoperable assets, such as algorithms and software, the NCATS Information Resources Technology Branch (ITRB) may provide access to various public cloud services and high-performance computing services for the needs of the recipients. This enables the recipients to offer their systems, projects, and research in a secure environment with simplified implementation, deployment and operational reliability. Through these services, NCATS ITRB will enable the recipients to gain a self-service capability. NCATS ITRB may provide the following, pending consultation with the recipient and the NCATS Program Official:

• Infrastructure as a Service (IaaS) on any of the major public cloud providers via NCATS' Federated Authorization Service.
• Access to NCATS' Federated Authorization Software as a Service (SaaS) to any of the CTSA recipients systems and applications, various Common Cloud Engineering and Support Services.

Non-Responsive Applications

The following types of applications will be considered non-responsive and will not be reviewed.

• Applications that do not answer “Yes” to the involvement of Human Subjects.
• Applications in which the PDs/PIs do not commit at least two months effort each.
• Applications that lack the required institutional research career development K12 companion application in accordance with the eligibility requirements (see Section III. Eligibility Information).
• Applications that do not submit all of the required attachments.
• Applications that do not describe, in detail, a single initial, discrete project for Element E including a detailed budget for the project described.
• Applications that include Partner(s) which are already Partners on another UL1 award or UM1 award or application.
• Applications that are submitted as not having clinical trials, but NIH determines that there are clinical trials (See https://grants.nih.gov/policy/clinical-trials/definition.htm).

Application information, including Frequently Asked Questions and Technical Assistance Webinars, are found on https://ncats.nih.gov/research/research-activities/ctsa/applicant-information. 

Clinical Trials:

Please note that misclassified clinical trial applications may be withdrawn. Applicants are strongly encouraged to consult with appropriate Program Staff for guidance.

As detailed in NOT-TR-18-025, NCATS is limited to direct support of clinical trials through phase IIB with the exception of phase III (21 CFR definition) clinical trials for treatment of a rare disease or condition.

A human subjects research study meets the NIH definition of a Clinical Trial if a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on the participants, and the effects being evaluated are health-related biomedical or behavioral outcomes. For help with the NIH’s definition of a clinical trial, please see Does Your Human Subjects Research Study Meet The NIH Definition of a Clinical Trial?

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• 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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

The CTSA application may include domestic institutions of higher education, universities, medical research institutions / academic health centers, or non-profit research organizations other than institutions of higher education that conduct clinical and translational research; however, a graduate school accredited to award higher degrees related to clinical or translational science (e.g., M.S. or Ph.D. in topics such as Clinical Research, Public Health, Pharmacology, Nursing, Informatics, Health Economics, or Epidemiology) must be included (applicant or partnering institution). Partnerships are encouraged among various disciplines including medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering and others. Organizations with active grants funded under NOFOs PAR-15-304, PAR-18-464, PAR-18-940 & PAR-21-293 that have more than 16 months of support remaining on the day of the submission deadline are not eligible to apply. NCATS encourages multiple institutions to participate in a single hub application, where this may further advance the goals of the program. A single contact institution would receive and administer the award.

For the purposes of this NOFO, NIH funding to the Partner/Partnering Institution must be included for determination of maximum direct cost budget requests. Partner/Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. An organization named as Partner/Partnering Institution in a CTSA UM1 application (and subsequent UM1 award), or a CTSA UL1 award funded previously under PAR-18-940, PAR-18-464, PAR-15-304 or PAR-21-293 may be listed as a Partner with only one UM1 or UL1 unless the UM1 and UL1 are from the same organization.

An organization named as a Partner Institution in a CTSA UM1 application, UM1 award, or a CTSA UL1 award funded previously under PAR-18-940, PAR-18-464 or PAR-15-304, PAR-21-293 may not apply as an applicant organization to this NOFO under the following scenarios:

• While the UM1 application or UL1 award on which they are listed as a Partner is under review consideration
• While the UM1 application or UL1 award on which they are listed as a Partner is under consideration for funding
• While the UM1 application or UL1 award on which they are listed as a Partner is funded

CTSA UM1 applications from organizations named as a Partner Institution in a funded CTSA UM1 or CTSA UL1 award are not allowed, except under rare circumstances with compelling justification.

A list of partnering institutions of active CTSA UL1/UM1 awards will be updated on an annual basis (by October 1, here: https://ncats.nih.gov/research/research-activities/ctsa/applicant-information/CPUBRT). Applicants are strongly encouraged to verify their budget tier calculation with NCATS in advance of application submission through the CTSA NOFO Questions mailbox (send to: [email protected]). Applicants should list the primary applicant organization and any partner institution(s) that contribute to the budget tier calculation (See Section IV. Application and Submission, R&R Budget). Requests to verify the budget tier calculation should be submitted by the institution’s authorized organization representative. Once NCATS verification is received and recorded, the applicant should include a note in the R&R Budget Section of the application that NCATS has reviewed and accepted the funding calculation prior to submission.

For the required (K12) and optional companion applications (T32s, R25, RC2), only the primary UM1 hub institution is eligible to apply; Partner/Partnering and/or Collaborator/Collaborating institutions are not eligible. Further, the primary institution is limited, if awarded, to one award each for the required and optional companion applications except for the optional RC2 (PAR-24-054) which is limited to two awards per institution.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

NCATS encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and skill set to the hub. Designate an appropriately qualified PD/PI (or multiple PD(s)/PI(s)), including an individual who will be primarily responsible for UM1 hub operations and will be designated as contact PD/PI. The contact PD/PI must be designated as the Strategic Management Module Leader.

It is expected that any UM1 award PD(s)/PI(s) will be an experienced clinician/scientist who reports directly to an official with broad trans-institutional authority, and who personally has the authority and influence necessary to successfully promote translational and clinical research locally, to partner with internal and external stakeholders, support the CTSA Program activities as described below, and fully integrate the hub into the CTSA Program nationally. This may include authority, perhaps shared with other high level institutional officials, over requisite space, protected time, promotions, institutional review boards, contracting, budgeting for clinical research, and staff qualification and certification. In loosely coupled organizations that consist of university and hospital units, the CTSA Program PD(s)/PI(s) should have the authority or influence, personally or on their leadership team, to integrate these independent parts of the organization toward CTSA Program goals. If the PD/PI oversees the institution's business office, a plan on how potential conflicts of interest will be managed must be developed. 

All PD(s)/PI(s) are expected to be research scientists with recognized stature and relevant subject matter expertise in his/her scientific discipline with the demonstrated ability to ensure quality control, administrative oversight, and integration of all elements of a Program. All PD(s)/PI(s) must each commit at least two months and preferably three to six months effort to the award. If the PD(s)/PI(s) do not commit at least two months effort each, the application will be considered non-responsive and will not be reviewed. Module and Program Leaders/Co-Leaders are expected to have the appropriate expertise and qualifications of the Module or Program being led, at the time of submission of the application, and have the time commitment to lead/co-lead the Module and/or Program. 

The UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the required companion K12 and/or the optional companion T32, and/or R25 application or award in order to ensure the PD(s)/PI(s) have adequate time to devote to the respective programs.  UM1 PD(s)/PI(s) may serve as the PD(s)/PI(s) on the optional RC2. 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

This NOFO only accepts applications that are part of a collaborative set of multiple applications.

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion institutional research career development (K12 – NOT-TR-24-008). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral – NOT-TR-24-008), the Research Education Grant (R25 – NOT-TR-24-008), and the Specialized Innovation Program (RC2 – PAR-24-054). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1. Adhering to the submission eligibility below, a set must contain 1 application to this UM1 NOFO and 1 application to the K12 NOFO; it may also contain 1 application to the T32 predoc NOFO, 1 application to T32 postdoc NOFO, 1 application to R25 NOFO, and/or up to 2 applications for the RC2 NOFO.

Additional Eligibility Requirements

The K12 required UM1 companion application must be submitted in accordance with the UM1 and K12 NOFOs application submission dates under the following scenario:

• Initial concurrent submission of both a UM1 application and a K12 application.

The K12 required companion application may be resubmitted in accordance with the applicable NOFO application submission dates under the following scenarios:

• concurrently with the resubmitted UM1
• while the UM1 application is under review consideration
• after the UM1 application is funded
• while the UM1 is under consideration for funding

The K12 required companion application will only be awarded if the UM1 is awarded.

Companion optional applications (NOT-TR-24-008, RC2 PAR-24-054) may be submitted in accordance with the applicable NOFO application submission dates under the following scenarios:

• concurrently with the UM1
• while the UM1 application is under review consideration
• after the UM1 application is funded
• while the UM1 is under consideration for funding

Optional companion applications will only be awarded if the UM1 is awarded.

A companion (K12 and/or optional) application may be considered for funding up to 14 months after Council review before becoming ineligible.  Applicants will need to submit a new or resubmission application if the companion application may become ineligible prior to the UM1 being awarded.  

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

NCATS Letters of Intent
Telephone: 301-827-9549
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Specific Aims. Briefly summarize the aims for the entire application, including all Modules and Projects. 1 page. 

The Research Strategy must consist of the following sections with the indicated page limits:

Element A. Overview; one required, 6 pages

Element B. Strategic Management; one required, 12 pages

Element C. Training and Outreach; one required, 12 pages

Element D. Clinical and Translational Science Resources and Pilots; one required, 18 pages

Element E. Clinical and Translational Science Research Program; one required, 12 pages (Note: description of the Element E CTS Research Program may be up to 2 pages; and a single initial, discrete and clearly defined CTS research project for Element E may be up to 10 pages)

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

Descriptive Title of Applicant's Project: Titles may not exceed 200 characters in length.

Cover Letter Attachment: The Cover Letter is one pdf file only. Applications that are part of a collaborative set must include a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD(s)/PI(s) name(s), 2) the NOFO number, 3) the Title of the application, and 4) the Applicant Institution. Each application that is part of the collaborative set should submit an identical listing.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments: The following "Other Attachments" must be included to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. Except for Attachments 1 and 7, supportive data should be in a table format; applicants may use suggested Template Data Table formats described in CTSA Program Summary Data Guide (CPSDG; https://ncats.nih.gov/ctsa/funding/CPSDG) or similar table formats that address all fields shown in the CPSDG; specified page limits apply to Template Data Table or similar table formats and Attachments 1 and 7 documents. For each document, please use a separate attachment and title as suggested. Required attachments should be uploaded only once. Information provided in the required attachments should not be repeated in the narrative. Applications that lack any of the attachments specified below will be considered incomplete and will not be reviewed.

1. Institution (use filename Hub Institution Organization): Include a description of the following in a single attachment:

Provide 1) a chart/diagram indicating the hub’s organizational status within the institution and how the hub leadership is integrated within the institution and 2) a chart/diagram indicating the working relationships between the hub and included partnering institution(s).

2. Hub’s Senior Leadership (use filename Hub Senior Leadership): Provide information and role of each Contact PD/PI, Other PDs/PIs, Module, and Program Leaders and Co-Leaders. Limited to ONE page.

3. Information on Hub Partners and Collaborators (use filename Hub Partners and Collaborators): Include a table listing of all partnering and collaborating institutions with contributions and justifications for the participation of each; justifications must be commensurate with the specified role. 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. Collaborating institutions have a significant role in one or more aspects of the CTSA UM1 hub. Limited to THREE pages.  Please note that the race, ethnicity, or sex of an institution’s current students will not be considered in the application review process or when making funding decisions. 

4. Resources to Achieve CTSA Objectives (use filename Resources to Achieve CTSA Objectives): Include a table listing of SPECIFIC resources that are anticipated to be used during the performance period of the UM1. (Note: this Other Attachment does not replace and is separate from the required Facilities and Other Resources Attachment in the R.230 – Project/Performance Site Locations(s) Form. All instructions in the SF424 (R&R) Application Guide must be followed. Limited to FIVE pages.

5. Clinical Trial Experience (use filename Clinical Trial Experience): Include a brief description of all single and multi-site clinical trials with site activation during the 6 months up to and prior to the application from the hub and participating partners and collaborators. Applicants should indicate the time-frame they are reporting. This information is used to demonstrate the clinical trial experience of the institutions involved in the UM1 application and likely to participate in clinical trials. The clinical trials included may be both NIH-funded and those funded by other sources (e.g., institutional, grant, contract, and/or non-profit) as long as they are added in order to showcase the breadth of clinical trials’ experience at the hub. Applicants are encouraged to prioritize trials with which the applicant institution was engaged as well as trials that demonstrate the breadth of expertise across hub, partners and collaborators. Limited to FIVE pages.

6. Clinical and Translational Science Track Record (use filename CTS Track Record): Provide institution, partners, and collaborators’ accomplishments and progress in CTS research efforts and high impact achievements that are generalizable to the advancement of CTS over the past 5 years; emphasize those that have advanced better methods and/or improved health. Applicants may use suggested Template Data Table formats described in CTSA Program Summary Data Guide (CPSDG) or similar table formats. All fields shown in the CPSDG must be provided. This information is used to demonstrate the clinical trial experience of the institutions involved in the UM1 application and likely to participate in clinical trials. Given the page limit, applicants are encouraged to prioritize trials with which the applicant institution was engaged and trials that show a breadth of expertise. Limited to FIVE pages.

7. Coordination and Integration Plan (use filename Coordination and Integration Plan). Include a specific plan describing the partnership between the UM1, the required K12 and any optional companion applications. The plan for the UM1 does not need to be identical to the plan that will be submitted for the K12 nor the other optional companion applications. The UM1 application must describe the overarching goals of each companion application and the coordination, integration, synergy, and mutual reinforcement of resources between the companion applications. Include a description of the roles of any shared partners and/or collaborators. Applicants should also indicate if optional companion applications are planned for future submission and describe the intent or future plans to coordinate and integrate those activities with the UM1. NOTE: The optional companion NOFOs also require a Coordination and Interaction Plan to be submitted in the application. As such, the companion application’s Coordination and Integration Plan should be used to provide more current plans at that time. Limited to THREE pages.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Award Budget

Determination of Allowable Budget Request Amount

CTSA UM1 hub applications submitted in response to this NOFO must be submitted by a single applicant institution, plus the option of one or more partnering institutions and one or more collaborating institutions. Partner/Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. Collaborator/Collaborating Institution(s) have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application. NIH funding to the collaborating institution may not be included for determination of maximum direct cost budget requests.

The maximum direct cost amount (DC) that may be requested for the UM1 budget is based on the sum of two NIH funding components: A) 5-year average of the most current NIH DC funding of the applicant institution, plus B) 5-year average of the most current NIH DC of any partner(s).

NIH aggregate fiscal year funding tables with the most current 5-year average of FY costs and the four maximum DC award tiers for CTSA UM1 hubs will be provided on an annual basis. All required information about levels of NIH funding is available at NIH RePORTER; however, for their convenience, applicants are encouraged to use Table A [Institutional NIH direct cost (DC) funding] provided by NCATS to generate a combined funding amount that defines their maximum DC amount allowable for the annual award. For our CTSAs, NCATS has tiered thresholds that range from $2,600,000 to $6,500,000. CTSA UL1 award recipients funded previously under PAR-18-940, PAR-18-464, or PAR-15-304 may request the appropriate tiered UM1 threshold shown on Table B but will not receive more than a 5% reduction in DC annual support for the core hub responsibilities (UM1) relative to the last budget period of the previous competitive project period of their UL1 award, exclusive of administrative supplements/competitive revisions and subaward F&A. Thus, those CTSA UL1 award recipients whose UM1 DC Tier calculation is more than a 5% reduction in DC annual support may submit a budget request at 95% of the DC level of the last budget period of the previous competitive project period of their UL1 award, exclusive of administrative supplements/competitive revisions and subaward F&A. To obtain details, applicants are also encouraged to review Table B to identify the four maximum DC award tiers for CTSA UM1 hubs. Requested DC budgets may not exceed the appropriate maximum DC award tier and the amount requested should be well justified and depend on the work proposed. All tables provided by NCATS will be updated on an annual basis and can be found here: https://ncats.nih.gov/research/research-activities/ctsa/applicant-information/CPUBRT.

Applicants are strongly encouraged to verify their budget tier calculation with NCATS in advance of application submission through the Clinical and Translational Science Award (CTSA) NOFO Questions mailbox ([email protected]). Requests to verify the budget tier calculation should be submitted by the institution’s authorized organization representative.

In the first paragraph of the budget justification, applicants must summarize how the maximum DC amount requested was determined by providing: a) the name of the applicant institution; b) the name of partnering institution(s) included for budget tier determination, if any; c) the NIH DC funding total amount for the applicant institution from the NIH DC Funding Table A; d) the NIH DC funding total amount for partnering institution(s) from the NIH DC Funding Table A; and e) the combined total of the figures specified in c) and d).

Budget tier requests (A, C, G, or T) of a companion K12 and/or optional T32 applications submitted in response to the CTSA NOFOs must be the same budget tier of the respective UM1.  

Funding tiers for any new or resubmitted K12 or T32 applications submitted within the UM1 7-year award project period will be tied to the awarded UM1 tier size (A, C, T or G). For example, if the UM1 was funded at a Tier G level then a new or resubmitted T32 postdoctoral application from the UM1 prime applicant institution must request an application budget that aligns with the Tier G level (2 postdoctoral trainee slots).  

A single budget is required; include funds requested, as per notes below. Budget justifications must be broken out by Element and Module. Subaward budgets should follow the same format.

Element A: Overview

Do not include a budget request for this element.

Element B: Strategic Management

Include funds for personnel, research, and other expenses, as appropriate. Additional guidance is noted. Because administrative structures will differ, carefully explain and justify requested support.

Strategic Management Module

Notes:

• Include support for the UM1 Contact PD/PI (also designated the Strategic Management Module Leader), and any multi-PDs/PIs and support staff not included in any other Element, as appropriate. The PDs/PIs must each commit at least two months and preferably three to six months effort to the award.
• Specific to the CTSA Program, include costs necessary for central administration of resources and services required for strategic management activities, fiscal management, and reporting activities. 
• Include travel expenses for appropriate personnel (up to five people) to attend an in-person CTSA Program meeting annually. If additional staff are identified to attend, additional justification is required as part of the Budget Justification.
• Include salary for one Quality Assurance / Quality Control (QA/QC) position (no less than 9 calendar months effort total; total effort may be split between two or more people) to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System (for prior approval of research with Human Subjects), submissions of proposed live vertebrate animal research for prior approval, and management of the overall quality review and submission process. 
• Include salary support for a HLT scientific lead (an experienced researcher with an advanced clinical and/or scientific degree), an operational lead (a research professional with experience and skills to administer and organize the HLT), and an appropriate number of additional staff with the following skills: knowledge of local resources, expertise in working with investigators, IRB expertise, contracting, clinical operations, data standards and exchange, informatics/IT, data analytics, communications, including social media, recruitment and retention, and project management.

Element C: Training and Outreach

For each of the Modules in this Element, include support for Module Leaders, Co-Leaders, personnel and other expenses, as appropriate. Additional guidance is noted.

Workforce Development for Clinical Research Staff Professionals Module

Notes:

• Include support for coordination, implementation and education and training of members of CTS research teams and other clinical research staff professionals.
• Personnel support for the required and optional companion training and education programs to ensure activities are conducted as an integrated endeavor with the UM1 may be included if costs are allowable and not duplicative. All personnel costs on the UM1 must be justified based on the role on the UM1 in relation to the scope of the UM1 grant activity. If effort on the UM1 is to solely support the leadership and administration of a single optional companion or required award, without a tie to UM1 specific activities, then these funds may be removed from the UM1 prior to award. Costs that are unallowable on individual NOFOs may not be budgeted on the UM1 to circumvent NOFO limits (e.g. T32 PI/PD effort). Personnel that have effort on the UM1 and on the companion application(s) should clearly describe the effort and distinct activities for the UM1 and for the companion application(s); or state if the effort is shared by either grant.  Applicant institutions should include a statement providing assurance that the activities and costs are not duplicative with the UM1 or other companion grant activities. Failure to provide an assurance statement may result in the removal of potential duplicative costs prior to award.  Support for activities may include, but are not limited to:
• coordination and integration activities;
• shared professional development activities and infrastructure, networking and seminar series that span different training and career development stages, creating economies of scale with support through the UM1;
• mentor training programs if not duplicative of the K, T32 and R25 programs;
• data collection, reporting, and evaluation for the Workforce Development for Clinical Research Staff Professionals Module and the required and optional companion training and education activities;
• central resources (e.g., training in responsible conduct of research training, rigor and reproducibility, Good Clinical Practice, and/or conduct of clinical trials);
• consultative support from CTSA UM1 Modules (e.g. Data Science, Resources and Services, Community and Stakeholder Engagement Research); and/or
• developing an equitable, inclusive, and accessible environment for all members of the research team and research professional staff, including those from groups underrepresented in the biomedical research workforce (e.g. development of curriculum, workshops, and/or seminars).

Element D: Clinical and Translational Science Resources and Pilots

Notes:

• Include salary support for each Module Leader/Co-Leader
• Clinical and Translational Science Pilot Module
  • Include costs for the review, tracking, management, and overall administration of the Module as well as the Pilot projects:
    • Number of Pilot Projects: A minimum of four and a maximum of eight active Pilot projects, per budget period.
    • Budgets: Must be between $25,000 and $50,000, direct costs.
    • Project Period: Cannot exceed 12 months.
  • Cost sharing is not allowed. Pilot projects must be fully supported with NIH funds awarded through this funding announcement (no other funding sources may be used to support these projects). The review process, resources, and expertise developed through this Module may be utilized for the review of other projects not funded through this application; however, NIH assumes no responsibility for those projects and should not receive any reports related to those projects.
  • Funds may not directly support any clinical trials beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. See NOT-TR-18-025.
• Space to conduct research cannot be charged to the CTSA Program budget. If research space is provided by the institution for inpatient and or outpatient participant evaluations, the application should describe the space in Facilities and Other Resources, potential availability, and if applicable, hourly or overnight rates charged for NIH-funded or other research. Similarly, inpatient and outpatient care costs cannot be charged to the CTSA Program budget.
• Recipient must ensure that the active number of pilot projects does not exceed the maximum number of pilot projects proposed to be supported per budget year in the competing application.

Element E: Clinical and Translational Science (CTS) Research Program

Include funds for personnel, research, and other expenses, as appropriate. Direct costs for the CTS Research Program must not exceed $500,000 per year in direct costs. Each CTS Research Project may not be less than $125,000 direct costs per year for a suggested period of 2-3 years each and may not exceed 7 years. Each hub must request only a single initial, discrete and clearly defined CTS research project for Element E. Although multiple projects ideas may be introduced, each application must include only one fully described CTS research project with a corresponding detailed budget for the project described. The budget justification must clearly delineate the costs associated with the defined Element E CTS research project and Element E administrative support for the CTS Research Program. Subsequent projects will require prior approval if the project includes research with human subjects, vertebrate animals, and/or foreign components. Subsequently, multiple projects may be undertaken concurrently.

Funds may not directly support any clinical trial beyond phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed. See NOT-TR-18-025.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims and Research Strategy apply to the entire CTSA hub UM1 application.

Specific Aims: Describe the specific aims to address the creation and promotion of an environment that establishes high-quality CTS research locally and nationally, including administration and operations.

Research Strategy: Describe the strategies and plans to advance CTS for each of the following Elements as directed.

Note: The required attachments detailed in Section IV. Application and Submission Information. 2. SF424 (R&R) Other Project Information: “Institution” and “Other Attachments” support the narrative information requested for the Elements below. The narrative should not repeat information provided in these attachments but should discuss the information in the relevant context.

Element A: Overview

This Element should describe how the CTSA hub meets or exceeds the Essential Characteristics of Successful CTSA Hubs (see Part 2. Section 1.), including a description of the overall vision and strategic goals for the period of performance and how those goals will be approached and attained. Include high level descriptions of the qualifications of the applicant, partner, and collaborator institutions, and indications of their adherence to, and promotion of, the specified CTSA Program goals. Incorporate unique strength(s) and other specific research areas of focus that will facilitate the accomplishment of the goals. Outline expected accomplishments and scientific and public health impact by the end of the grant term.

Include a description of the contributions of the applicant, partners, and collaborators institutions to CTS research over the past 5 years, with emphasis on high impact achievements that have advanced research towards better methods and improved health. This section should discuss prior accomplishments and progress in CTS research efforts.

Element B: Strategic Management

Strategic Management Module

Describe:

• Overall Management Plans
  • Leadership plan, including how the leadership team is integrated into the overall institutional structure and how it contributes to the overall success of the CTSA Program; succession planning for PI/MPI, Module and Program Leaders/Co-Leaders, and other critical positions; and integration of any partner(s) and collaborator(s).
  • The proposed relationship of the applicant institution and any participating partners and collaborators, including what each institution will contribute and any tangible commitments; how each institution will have input and participate in decision-making; and how the participating institutions will maintain ongoing communication. The participation of any partners must be well justified with a well-described role.
  • Emergency Plan
    • A plan to pivot to a virtual leadership structure in the event of an emergency
    • A plan, including resources, to support the response to a public health emergency or other public health need, including both continuing ongoing research during the event and redirecting resources for the emerging situation
    • Adaptive capacities of and strategies to be implemented to address research needs and continue to impact the CTS enterprise
  • Planning and coordination of research activities, integration of cross-disciplinary research, allocation of funds, management of resources, communication plans across all elements; and the parties responsible for these activities
  • Plans for managing competing institutional perspectives, differences across the institution in culture, and access to resources and sharing of institutional expertise and resources
  • How the composition and activities of the HLT align with the national CTSA Program activities and how the hub will execute activities in support of the ancillary activities of the CTSA Program
  • Plans for identifying and adopting best practices, developing innovations, and using innovations made by others to demonstrate utility and to ultimately disseminate successful innovations
• Continuous Quality Improvement and Evaluation
  • Plans for CQI, monitoring, and how interventions will be implemented when indicated
  • Plans to collect data to evaluate the impact of the CTSA award on the hub and provide data to NCATS for oversight and measurement of the impact of the CTSA Program
• Internal and External Advisory Committees
  • Plans to establish internal and external advisory committees. Describe the multi-disciplinary nature of the memberships and the types of expertise to be represented. Proposed external advisory committee members should only be named in the application if they are currently serving or have been approached to participate at the time the application is submitted.
  • How the internal and external advisory committees will be utilized, the frequency of meetings (no less than annually) and the plans for evaluation by the committees.

Element C: Training and Outreach

Workforce Development for Clinical Research Staff Professionals Module

Describe:

• Plans for professional development for members of CTS research teams and other clinical professionals such as clinical investigators, co-investigators, clinical researchers, research nurses, pharmacists, administrators, coordinators, consultants, data managers, quality assurance managers, regulatory affairs managers or educators in clinical trial management.
• Plans to ensure training in current Good Clinical Practice (cGCP)
• Plans to provide foundational education and training in CTS to prepare clinical research staff professionals for the multifaceted and collaborative nature of CTS
• Plans to innovate workforce education and training in CTS research.
• Coordination, integration, synergy, and mutual reinforcement between the UM1, the required K12 program, and any additional selected optional companion programs such as the research education (R25), and/or pre-and post-doctoral training (T32), as well as scientific and administrative integration of the proposed programs. Discuss the advantages or value added by conducting the proposed training and education as an integrated rather than separate effort (e.g., thematic cohesion, scientific justification of the interrelationship of individual projects and resources).

Community and Stakeholder Engagement Research Module

Describe:

• Plans to collaborate with and engage stakeholders in all aspects of CTS research
• Plans to accelerate CTS research to address the significant burden of conditions that disproportionately affect rural, minority, and other populations with health disparities.
• Plans to promote health equity
• Plans to promote participation of underserved populations as research participants and ensure that research participants are engaged as full collaborators early and often throughout the process

Element D: Clinical and Translational Science Resources and Pilots

Clinical and Translational Science Resources and Services (R&S) Module

Describe:

• Plans to establish and manage a resources and services module for small recurring research needs such as biostatistics, epidemiology, research design, regulatory support, computing and data resources; educational activities; ancillary preclinical and clinical research studies; information technology capabilities; community and stakeholder engagement; and CTS professional development
• Process to ensure compliance with all federal regulations and NIH policies, including, but not limited to, human subject protections, genetic material, stem cells, and animal studies, as oversight of the R&S Module activities are the responsibility of the institution.

Clinical and Translational Science Pilot Module

Describe:

• Overall administration of the Module, membership, and responsibilities of the management committee; and plans for data management and communications
• The various advisory committees, both internal and external, that will be consulted and the role they will play
• Plan for implementing the Module, including guidelines for applicants; eligibility and characteristics of applicants; processes and procedures for solicitation, scientific review, selection, award, communication, progress tracking and evaluation
• Process to ensure compliance with all federal regulations and NIH policies, including, but not limited to, human subject protections, genetic material, stem cells, and animal studies, as oversight of R&S Module activities are the responsibility of the institution.
• Specific pilot projects should not be included in the UM1 application. Pilot projects will be solicited and awarded by the hub after the UM1 hub award has been received. Pilot projects may conduct research with 1) Human Subjects (inclusive of clinical trials adhering to NOT-TR-18-025), or 2) Vertebrate Animals, or 3) both, or 4) none of the above.
• Refer to Study Record: PHS Human Subjects and Clinical Trials Information section for more information about human subjects and clinical trials in Element D

Data Science Module

Describe:

• An overarching plan to assess, develop, deploy, and enhance research informatics and information technology capabilities across the spectrum of clinical and translational science research activities at the hub, focusing on:
  • Governance and Leadership:
    • Plans for strategic planning, leadership engagement and governance; proposed investments in health information technology; adherence to open science and data sharing; and education, training, data access, and technology support for users of the informatics capabilities, over the course of the project period.
    • Progressive plans towards a standards-based, interoperable network in a cloud environment where informatics assets (e.g., data, software, and algorithms) can be co-developed and shared across the consortium in a common repository.
• Software and Data Licensing:
  • How policies will contribute to defining intellectual property ownership of research and scholarly outputs, sharing data and software, and ultimately supporting the guidance on specific practices that impact the reuse and attribution of data and software (licensing).
• Research Informatics Deployment:
  • How analytics will be developed, disseminated and supported [e.g., natural language processing (NLP) and text mining; queries to the research enterprise data warehouse (EDW) and electronic health records (EHRs); putting data into common data models (CDMs) and ensuring its quality; creation of data marts of reusable data; and the development and dissemination of a de-identified or synthetic database].
  • Plans for the maintenance and expansion of a sustainable research EDW, including integration of data from differing external sources (e.g., clinical databases, research datasets, sensors, mobile technology, social media, patient-generated and publicly available data sources) and management of the research EDW team.
  • How systems are leveraged to manage clinical trials, and if applicable, how the multiple units of the involved institutions and partners are integrated so that queries may cross multiple EHRs.
  • How the privacy and security of study data, including that from human subjects, will be ensured.
  • How research computing, or high-performance computing (HPC), will be developed, deployed and used in bioinformatics, genomics, or other areas related to research informatics.
  • Enumeration of the standard terminologies currently being used and the development, sharing, and incorporation of new standards.

Element E: Clinical and Translational Science Research Program

The Clinical and Translational Science Research Program Element will support discrete research project(s) that should address a truly significant challenge in CTS (a single CTS research project per hub is required). Describe:

• The overall focus or theme of the CTS Research Program (may be up to 2 pages):
  • The overall Research Program focus or theme should be described in terms of its goals, impact and significance
  • The described Program is intended to be of the type of CTS research that the applicant considers to be of high priority. Each CTSA hub has the flexibility to tailor its Program’s research activities to address local priorities; however, focus on a select disease category or disease specialty must be justified as to how it helps achieve the overall strategic goals of the CTSA Program
  • The described research program, or projects in it proposed, may include application partners, collaborators, communities, other active CTSA hubs, or other as long as their active role(s) are justified
  • Other proposed research project(s) may be discussed as they relate to the overall CTS Research Program, however, must not provide a detailed description(s) nor budget
  • A plan for dissemination of successful projects; include a proposed impact statement should the project(s) ultimately be successful
  • Refer to Study Record: PHS Human Subjects and Clinical Trials Information section for more information about human subjects and clinical trials in Element E
• One initial discrete project described in detail (may be up to 10 pages):
  • Specific Aims and approach of the proposed CTS research project must be included
  • The rationale as to how the project will provide generalizable innovations or insights that increase the overall efficiency or effectiveness of translation should be discussed
  • The initially described research project is suggested to be 2-3 year in length and may not exceed 7 years

Letters of Support:

All Partnering Institutions must provide a letter of support signed by the authorized organizational representative (AOR) stating its role as a Partnering Institution and affirming its unique relationship with the CTSA UM1 hub applicant institution; applications that do not contain Partnering Institution letter(s) of support are incomplete and will not be reviewed. Only Collaborating institutions with substantial involvement in the application should submit a letter of support.

Letters of support/agreement should be included for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support should be clear expressions of commitment consistent with achieving the goals of the Program. If appropriate, reference the corresponding Element/Module within the letters of support. 

For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the partner/collaborator as well as the off-site institutional officials, must be submitted with the application; applications that do not contain corresponding letter(s) of assurance or comparable documentation are incomplete and will not be reviewed.

Applicants are encouraged to limit the numbers of letters of support to no more than 30.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• Specific to this NOFO, all applicants must address all UM1 Elements (and/or Modules) in their Data Management and Sharing Plan (DMSP) that may generate data in accordance with the NIH Policy for Data Management and Sharing. The DMSP must account for all potential sources of data that may be generated by the UM1 and how they will be managed and/or shared across the entire award cycle

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Element D: CTS Resources & Pilots

Note: Specific pilot projects should not be included in the UM1 application. Pilot projects will be solicited and awarded by the hub after the UM1 hub award has been received.

New UM1 CTSA Program Pilot Projects that include human subjects research deemed by the Institutional Review Board (IRB) to be Greater Than Minimal Risk or meet the criteria for an NIH-defined Clinical Trial continue to require entry of the study into the eRA Human Subjects System (HSS)  and official notification of NCATS prior approval before the project can begin.

The entry of all studies into the eRA HSS along with modified NCATS-specified documentation continues to be required. For studies that are non-NIH defined clinical trial with minimal risk or exempt (45 CFR 46), NCATS prior approval will not be provided, but studies may not begin until all required documentation has been submitted into the eRA HSS. Failure to submit the required documentation prior to initiating the pilot study will result in non-compliance enforcement actions.

The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/human-subjects-research

(Note that a separate process for Pilot Projects conducting research with live vertebrate animals is described here: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/prior-approval)

Element E: Clinical and Translational Science Research Program

Note: For Element E project(s) described in the application, if the research project(s) involve human subjects or an NIH-defined Clinical Trial please see the instructions in Section PHS Human Subjects and Clinical Trials Information in the Application Guide Instructions (https://grants.nih.gov/grants/how-to-apply-application-guide.html) Further for Element E project(s) that are described in the application, applicants must determine whether any proposed human subjects study, meets the definition of delayed start or delayed onset and submit accordingly. A delayed start study involves a study that can be described at the time of application, even if it will not begin immediately (will occur later in the funding period). As such, applicants should add a complete study record for each proposed study involving human subjects if your described project(s) would classify as being delayed start. Additional Element E projects not described in application and undertaken after award, if they are conducting research with Human Subjects and/or Vertebrate Animals, will still require prior approval in similar method as Element D pilot projects.

As a reminder, if any part of the application (Element D and/or Element E) meets, or could meet, the definition of a clinical trial, then the entire application should be submitted accordingly.

All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information". 

Funds may not directly support any clinical trials beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. See NOT-TR-18-025.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Center for Advancing Translational Sciences (NCATS) NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Each application of a collaborative set must be complete and compliant.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

The CTSA hub UM1 application will be evaluated as an integrated effort consistent with the goals and objectives outlined in the Description.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCATS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate Advisory Council or Board.  The following will be considered in making funding decisions, consistent with applicable law:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to programmatic priorities, including but not limited to geographic distribution of CTSA Program Hubs, partners and collaborators that could enhance and/or accelerate the CTSAs’ capacity to advance the CTSA Program goals.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Prior Approval of Pilot Projects (Element D) and Clinical and Translational Science Research Projects (as described under Element E) proposing to conduct research with Human Subjects and/or Live Vertebrate Animals. 

Recipient-selected projects that involve human subjects research require prior approval by NIH prior to initiation. 

The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/human-subjects-research. 

Recipient-selected projects that involve live vertebrate animals research require prior approval by NIH prior to initiation. 

The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/prior-approval.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining research objectives and milestones; determining approaches; and designing and implementing activities for advancing translational and clinical science, including workforce development and oversight of the CTS Research Program (Element E).
• Providing overall scientific and administrative leadership.
• Creating a culture that incentivizes and appropriately recognizes collaboration and communication; facilitating workforce development; and engaging with stakeholders in all aspects of translational science research.
• Ensuring that all participating entities implement and adhere to the policies, procedures, best practices, and other measures established by NCATS/NIH.
• Ensuring the performance of quality reviews of CTSA-related submissions to NCATS, (e.g. submission of information for the approval of proposed live vertebrate animal research and/or Human Subjects Research prior to commencement, etc.) in line with NCATS procedures. 
• Implementing a plan to create and maintain a broad culture of responsibility for safe and ethical conduct of research involving human subjects at all participating institutions, including ensuring that scientifically and ethically flawed studies are not conducted; enrollment is tracked; futile studies are closed in a timely manner; and results are analyzed and disseminated promptly.
• Ensuring all partnering institutions are fully integrated into CTSA hub activities and ensuring effective communication strategies for partnering and collaborating institutions.
• Implementing a resource sharing plan and/or a data management and sharing plan that achieves the goal of sharing research resources or research data in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.
• Ensuring timely public dissemination, including publication of results, data and other products, concordant with governance policies and protocols; publications and oral presentations of work performed under this cooperative agreement require appropriate acknowledgment of support by NCATS/NIH.
• Establishing both internal and external advisory committees and ensuring they meet at least annually.
• Considering and acting upon recommendations of the advisory committees.
• Agreeing to accept close coordination, cooperation and participation of NCATS Program staff in those aspects of scientific and technical management as described under the responsibilities of the NCATS Project Collaborator.
• Providing disease-agnostic clinical and translational science support.
• Participating in annual meetings and other CTSA consortium activities, as appropriate.
• Managing, implementing, and tracking Pilot Program activities, including future scientific studies/products that stem from the support provided.
• Utilizing a range of expertise and capabilities in the areas of Data Science to make digital assets interoperable for research, ensuring data security, and embracing a culture of Open Science and Data Sharing that adhere to the F.A.I.R. principles, across all aspects of the CTSA hub and the CTSA Program consortium.
• Use of Common Data Elements during the planning phases of a project to optimize data collection and facilitate broad data sharing (e.g., https://cde.nlm.nih.gov/home)
• Establishing professional development opportunities for clinical research staff that encourage work in clinical and translational science research.
• Obtaining written Prior Approval from the NCATS Grants Management Specialist in consultation with the NCATS Project Collaborator before undertaking certain activities or incurring specific costs.
• Providing information to the NIH Project Collaborator concerning progress and activities on a regular basis, no less than monthly, and in the recommended format.
• Collecting data to evaluate the impact of the CTSA award on the hub and provide data to NCATS for oversight and measurement of the impact of the CTSA Program.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Collaborators (PC) will:

• Assist in coordinating and communicating CTSA Program consortium activities.
• Assist in coordinating ongoing activities with other CTSA Program hubs to avoid duplication; encourage collaboration and leveraging of resources; and enhance the development of innovative tools, methodologies, and processes.
• Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other NIH funding mechanisms.
• Facilitate interactions among investigators across CTSA Program hubs as well as with other non-CTSA institutions.
• Coordinate access to resources, including specialized technologies, available through CTSA Program hubs.
• Facilitate access to fiscal and intellectual resources provided by industry, private foundations, and NIH and other federal agencies.
• Participate on steering and operations committees as a non-voting member or in other functions that facilitate the course of long-term projects or activities (e.g., annual and advisory committee meetings), including any supplemental funding.
• Participate in the annual external advisory committee meetings.
• Review and approve all major transitional changes (e.g., change in any of the key personnel identified in the Notice of Grant Award) of the CTSA Program hub's activities prior to implementation to ensure consistency with the goals of the CTSA Program.
• Assist the CTSA Program hubs in responding to emerging areas of high priority or national impact, including public health emergencies.

Additionally, the NCATS CTSA Project Collaborator, acting as the NIH Program Official, will be responsible for normal stewardship of the award and will be named in the notice of award.  The Project Collaborator may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this program. 

Areas of Joint Responsibility

• Participate in meetings to discuss priorities, progress, obstacles, solutions and other issues related to ongoing and planned activities (no less than monthly).
• All responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Specific to this NOFO, all applicants must address all UM1 Elements (and/or Modules) in their Data Management and Sharing Plan (DMSP) that may generate data in accordance with the NIH Policy for Data Management and Sharing. The DMSP must account for all potential sources of data that may be generated by the UM1 and how they will be managed and/or shared across the entire award cycle.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Christopher M. Hartshorn, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-0264
Email: [email protected] 

Victor Henriquez, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0813
Email: [email protected] 

Stacia Fleisher
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0851
Email: [email protected] 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.