Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title
Clinical and Translational Science Award (UM1 Clinical Trial Optional)
Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type
New
Related Notices

  • August 4, 2021 - Technical Assistance Webinar for: Clinical and Translational Science Award (UM1) (PAR-21-293). See Notice NOT-TR-21-031.
  • NOT-TR-21-030 - Notice of Intent to Publish a Suite of Funding Opportunity Announcements (FOAs) for the National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Awards (CTSA) Program
None

Funding Opportunity Announcement (FOA) Number
PAR-21-293
Companion Funding Opportunity

PAR-21-336K12 Physician Scientist Award Program (PSA)

PAR-21-339 , R25 Education Projects

PAR-21-340, RC2 High Impact Research and Research Infrastructure Programs

PAR-21-338, T32 Institutional National Research Service Award (NRSA)

PAR-21-337, T32 Institutional National Research Service Award (NRSA)

Assistance Listing Number(s)
93.350
Funding Opportunity Purpose

This funding opportunity announcement (FOA) 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 more patients 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.

Along with this solicitation for the UM1 CTSA hub application, NCATS plans to publish a separate, companion FOA that solicits applications for a required K12 Clinical Scientist Institutional Career Development Program Award (NOT-TR-21-030) ); both a UM1 hub application and the required K12 application must be submitted. If there is no companion K12 application submitted, the UM1 hub application will not be reviewed. However, if the UM1 application is funded and the companion K12 application is not funded, a resubmitted K12 application will be accepted. Additional companion FOAs solicit applications for optional training, career, and research education programs.

Key Dates

Posted Date
July 30, 2021
Open Date (Earliest Submission Date)
December 26, 2021
Letter of Intent Due Date(s)

30 days before the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
January 26, 2022 January 26, 2022 Not Applicable June 2022 October 2022 December 2022
May 13, 2022 May 13, 2022 Not Applicable October 2022 January 2023 April 2023
September 16, 2022 September 16, 2022 Not Applicable March 2023 May 2023 July 2023
January 13, 2023 January 13, 2023 Not Applicable June 2023 October 2023 December 2023
May 12, 2023 May 12, 2023 Not Applicable October 2023 January 2024 April 2024
September 15, 2023 September 15, 2023 Not Applicable March 2024 May 2024 July 2024
January 12, 2024 January 12, 2024 Not Applicable June 2024 October 2024 December 2024
May 17, 2024 May 17, 2024 Not Applicable October 2024 January 2025 April 2025
September 13, 2024 September 13, 2024 Not Applicable March 2025 May 2025 July 2025

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
September 14, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Key Terms, Definitions, and Uses in this FOA

  • 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.
  • Consortium/Program: Describes the CTSA Program as a whole and includes hubs and other CTSA Program projects and initiatives, such as the Trial Innovation Network (TIN), the National Center for Data to Health (CD2H), CTSA Program Coordinating Center (CLIC), Collaboration Innovation Awards (CCIAs), and the Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board (SMART IRB). 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.
  • Diverse/Diversity: Includes, but is not limited to race, ethnicity, socioeconomic status, background, gender, and mental or physical ability. (see: Notice of NIH’s Interest in Diversity NOT-OD-20-031)
  • Health Equity: Ensuring that all persons have the opportunity to achieve their best health. 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; does not include monetary support, which is neither required nor recommended for applications submitted to this FOA.
  • 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. (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): The field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.
  • Underrepresented: For the purposes of this FOA, used in the context of the workforce; being represented in numbers that are disproportionately low. Underrepresentation in extramural programs is tied to national representation ratios, not institutional demographic data. (see: Notice of NIH’s Interest in Diversity NOT-OD-20-031)
  • Underserved: For the purposes of this FOA, used in the context of Health Disparities related to population-based health. A population is defined by the Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525) as a health disparity or underserved population if there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population.

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 of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. 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 FOA. 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 – may help clarify the distinction between TR and TS. An investigator who wishes to test whether a particular drug improves outcomes in diabetes will need to recruit sufficient underserved participants; this is a TR problem and will be addressed from the standpoint of effectiveness for the drug’s effects and the diabetes community, using established recruitment methods. By contrast, an investigator who wishes to understand the fundamental underlying barriers to recruitment for clinical trials generally, and test an intervention directed at those hypothesized causes and mechanisms, is engaging in TS. To test the hypothesis, the TS investigator may choose a use case that may in fact be the same as that used by the TR researcher – in this example a drug for diabetes – but the question to be answered is primarily whether the TS innovation accomplishes full recruitment of the desired underserved population more effectively and efficiently.

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 GitHub repository.

NCATS recently solicited feedback on the CTSA Program goals, structure, and operations, as well as the FOA, peer review, and grants management of CTSA Program awards. Approaches for feedback included a 2019 public Request for Information (NOT-TR-19-027) and general feedback from CTSA application peer reviewers (see video for an overview presentation of feedback received). Feedback about application structure and submission was incorporated into this and related FOAs, 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. In addition, in recognition of the importance of clinical research accomplishments and capabilities to accomplish the goals of the CTSA Program, an emphasis on the NIH clinical research funding of all partnering institutions has been included for determination of maximum direct cost budget requests.

CTSA Program Goals

NCATS amended the CTSA Program goals in response to the recent feedback and the maturation of the existing CTSA Program and will use a variety of mechanisms to achieve these goals, including this UM1 FOA 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 geographic/demographic needs. 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 FOA 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 for research; data transparency/release
  • Clinical research improvements and tools, e.g., clinical trial networks; 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 a culture to enhance workforce diversity; 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 FOA.
  • 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 by addressing the significant burden of conditions that disproportionately affect rural, minority, and other underserved populations
  • 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 & 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: Health Informatics (HI Module Leader)
  • Element E: Clinical and Translational Science Research Program (Research Program Leader)

An individual may have more than one Leader role, and co-Leaders are allowed. Element B will also include a Hub Liaison Team (HLT) scientific lead and an operations lead. An overview diagram of the application elements can be found here.

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. 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.

CTSAs are encouraged to work with partners and collaborators that could enhance and/or accelerate the CTSAs’ capacity to advance the CTSA Program goals and to address the burden of conditions that disproportionately affect rural, minority, and other underserved populations, e.g., Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), institutions participating in an Institutional Development Award (IDeA), and/or the Research Centers in Minority Institutions (RCMI).

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.

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. Current national collaborative activities of the CTSA Program include development and application of innovative approaches to collection, analysis, use and sharing of various types of data; collaborative infrastructure to support scientific, training, governance, workgroup, and other types of CTSA consortium activities; consideration of participation in clinical trials; identification and dissemination of innovations in clinical trials; and a collaborative informatics community.

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. 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 solve 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. Foundational capabilities and activities in the area of D&I are required to support and enhance the impact of the CTSA hub. While hubs are expected to innovate in this area, an extensive research program in this area is not required.

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 & 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. 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, multidisciplinary, and diverse 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. While hubs are expected to innovate in the area of education and training to identify best practices in translational research and workforce education, an extensive research program in this area is not required.

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  
  • Enhancing diversity of underrepresented persons participating 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, developing an underrepresented workforce, 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. While hubs are expected to innovate in this area, an extensive research program in this area is not required.

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
  • 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 for engagement of underserved populations
  • Implementing methodological innovations to integrate members of underrepresented communities into translational research
  • Providing tailored materials to help clinical researchers recruit and retain underserved populations in clinical trials and clinical studies 
  • 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. The use of R&S to augment research activities supported by other funding sources, i.e., non-NCATS funding, 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, and regulatory support, e.g., consultations for IND application submission or other regulatory matters
  • Informatics, computing, 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. Translational research projects, i.e., projects focused on crossing a particular step of the translational process for a particular target or disease, are not allowed. 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.

Only the CTS Pilot Module should be described in the application; 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 grantee’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 new therapy/technology with generalizable application to an identified translational roadblock
  • 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
  • Dissemination of effective tools, methods, processes, and training paradigms
  • Feasibility/proof of concept studies to support future CTS projects
  • Secondary analysis of existing data (e.g., projects using the National COVID Cohort Collaborative (N3C) Data Enclave)

Health Informatics 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. Health Informatics programs are required to specifically support the CTSA Program goals of advancing clinical and translational science and increasing the quality of clinical research. 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 Health Informatics (applied research and practice of informatics across the clinical and public health domains); 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 Translational Bioinformatics (the development of storage, analytic, and interpretive methods to optimize the transformation of increasingly voluminous genomic and other biomedical data, into proactive, predictive, preventive, and participatory health, including research on the development of novel techniques for the integration of biological and clinical data and the evolution of clinical informatics methodology to encompass biological observations). Newly found knowledge that can be disseminated to a variety of stakeholders, including biomedical scientists, clinicians, and patients, is the end product of these integrated efforts.

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 developing 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, Health Informatics 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)
  • Data management, storage, organization, and data sharing resources
  • Data mining, visualization, and analytics tools and platforms
  • Data processing methods such as data compression, data provenance, and data wrangling
  • Data annotation tools, including common data elements, and ontologies
  • Data integration and workflow tools and platforms
  • 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
  • Statistical methods, graph and network theory approaches, and machine learning methods
  • Natural language processing 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
  • Platforms for research collaboration and algorithm performance evaluation
  • 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 roadblock in CTS (one project per hub is required). 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. 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.

REQUIRED AND OPTIONAL CAREER, TRAINING, AND RESEARCH EDUCATION OPPORTUNITIES

NCATS solicits the submission of one set of companion applications. With this solicitation for the UM1 application, a separate, companion FOA will solicit applications for a required K12 (NOT-TR-21-030). A UM1 hub application without the required companion K12 application will not be reviewed. The required K12 application will only be awarded if the UM1 application is awarded.

Additional companion FOAs solicit optional applications for the following awards: Ruth L.Kirchstein Institutional National Research Service Awards to support predoctoral trainees (NOT-TR-21-030); Ruth L.Kirchstein Institutional National Research Service Awards to support postdoctoral fellows (NOT-TR-21-030); and a Research Education Program (NOT-TR-21-030). Optional applications will only be awarded if the UM1 application is awarded. Optional applications (initial and resubmission) will be accepted concurrently or if the UM1 application is awarded.

The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional components. Applications that do not provide this specific plan will be considered non-responsive, incomplete and will not be reviewed. (See: Section IV. Application and Submission Information, 2. Content and Form of Application Submission, Other Attachments, Coordination and Integration Plan)

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 awardees 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 awardees. This enables the awardees 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 awardees to gain a self-service capability. NCATS ITRB may provide the following, pending consultation with the awardee 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 awardees systems and applications, various Common Cloud Engineering and Support Services.

Non-Responsive Applications

The following will be considered non-responsive. Non-responsive applications will be considered incomplete 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 K12 Clinical Scientist Institutional Career Development Program Award companion application.
  • Applications that lack a specific plan describing the partnership between the UM1, the required K12 and any optional components.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Award Budget

The amount of funding that applicants can request depends on the amount of NIH funding they receive. After calculating the total amount of NIH funding received as described in Section IV. Application and Submission Information, 2. Content and Form of Application Submission, R&R Budget, applicants may request the following amounts:

Size Eligibility Budget Tiers for FOA Applicants
(FOA receipt dates January 14, 2022, May 13, 2022, September 16, 2022)

Maximum Direct Cost Budget Requests for UM1

Hub Tier

5-year average of the most current NIH Direct Cost (DC) Funding of the applicant institution, PLUS 5-year average of the most current Total Cost (TC) NIH funding in Clinical Research category of any partner(s)*

(based on FY2016-FY2020 NIH Funding data)

UM1

A

>$250,000,000

$6,500,000

C

$250,000,000 - $200,000,000

$5,000,000

T

$199,999,999 - $125,000,000

$3,600,000

G

<$125,000,000

$2,600,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 7 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible 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 FOAs PAR-15-304, PAR-18-464 & PAR-18-940 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.

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)

Local Governments

  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

Eligible Individuals (Program Director/Principal Investigator)

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 SF424 (R&R) Application Guide.

NCATS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set to the hub. Designate an appropriately qualified PD/PI (or multiple PDs/PIs), including an individual who will be primarily responsible for UM1 Hub operations and will be designated as contact PD/PI. 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 SF424 (R&R) Application Guide. The contact PD/PI must be designated as the Strategic Management Module Leader. 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 PDs/PIs must each commit at least two months and preferably three to six months effort to the award. If the PDs/PIs 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 be fully established at their institution at the time of submission of the application.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicants should describe the institutional environment and available resources in the resources section of the application. Any applicant identifying voluntary committed cost share in the budget sections of the application will be bound to the cost share commitment for the entire approved project period. Personnel effort requested without salary support will be considered voluntary committed cost share and the applicant institution will be bound to the relevant salary, fringe and associated F&A costs for the entire approve project period. Voluntary committed cost share will not be accepted and will not be considered in the review score for the following categories: key personnel (PD/PIs, Module and Program Leaders/Co-Leaders), the Resource and Services Module, the CTS Pilot Module or the CTS Research Program Element. Voluntary committed cost share for other items identified after peer review will be considered; however, any alteration in cost share commitments for the specified categories prior to award will deem the application ineligible for award. Future award consideration would require submission of a revised application.

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.  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 NOT-OD-11-101).

This FOA only accepts applications that are part of a collaborative set of multiple applications. A set must contain 1 application to this UM1 FOA and 1 application to K12 FOA; it may also contain 1 application to T32 predoc FOA, T32, postdoc FOA and/or R25 FOA. Please see NOT-TR-21-030.

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 FOA. 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 SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the 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:

Carol Lambert, Ph.D.
Telephone: 301-435-0814
Email: lambert@mail.nih.gov

Page Limitations

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 Project; one required, 6 pages

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a “1/N” indicator + Identical Title (e.g., “1/3”, where the 1/3 means this is site 1 of 3 sites in the set. The other sites will be labeled 2/3, etc.) Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.

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

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

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& 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&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): 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): 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.

4. Resources and Facilities (use file name Resources and Facilities): A table listing of SPECIFIC resources that are anticipated to be used during the performance period of the UM1. Limited to FIVE pages.

5. Clinical Trial Experience (use filename Clinical Trial Experience): A brief description of all NIH–funded 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. Limited to FIVE pages.

6. Clinical and Translational Science Track Record (use filename CTS Track Record): 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. Limited to FIVE pages.

7. Coordination and Integration Plan (use filename Coordination and Integration Plan). The application must include a specific plan describing the partnership between the UM1, the required K12 and any optional components, such as the research education (R25), and/or pre-and post-doctoral training (T32) awards. The UM1 application must describe the overarching goals of each component and the coordination, integration, synergy, and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Limited to THREE pages.

Other Requirements:

Given the clinical and translational science purpose of UM1 hub applications, research involving human subjects is anticipated to be initiated during the grant period; thus:

        1.  
  1. All applicants must answer Yes to the involvement of Human Subjects during the period of award and complete all related sections. Applications that do not answer Yes to the involvement of Human Subjects during the period of award, and complete all related sections, are incomplete and will not be reviewed.
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Award Budget

Determination of Allowable Budget Request Amount

CTSA UM1 hub applications submitted in response to this FOA 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 DC NIH funding of the applicant institution, plus B) 5-year average total cost (TC) NIH funding in the Clinical Research category 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] and Table B [Institutional NIH total cost (TC) funding in the Clinical Research category] 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. To obtain details, applicants are also encouraged to review Table C 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/ctsa/funding/CPUBRT.

Partners that are Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, or Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) may use either the A) institutional NIH direct cost (DC) funding; or B) institutional NIH total cost (TC) funding in the Clinical Research category, whichever is higher.

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 funding tier determination, if any; C) the DC NIH funding total amount for the applicant institution from the appropriate NIH DC Funding table; D) the TC NIH funding total amount in the Clinical Research category for partnering institution(s) from the appropriate NIH TC Clinical Research Funding table; and E) the combined total of the figures specified in C) and D).

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. 
  • 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, and management of the overall 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 & 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 activities to ensure activities are conducted as an integrated endeavor may be included if costs are not duplicative. Applicant institutions should include a statement providing assurance that the activities and costs are not duplicative with the UM1 activities. Failure to provide an assurance statement may result in the removal of potential duplicative costs prior to award.

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 Pilot projects, per year.
      • 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.

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 for a suggested period of 2-3 years. Multiple projects may be undertaken concurrently. Each hub must request at least one project in this application. Subsequent projects will require prior approval if the project includes research with human subjects, vertebrate animals, and/or foreign components.

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 SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) 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.  
    • Plans to promote diversity in the leadership and staff (see: Notice of NIH’s Interest in Diversity NOT-OD-20-031)
    • 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 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 in CTS research and workforce education and training
  • 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 underserved populations
  • Plans to promote health equity
  • Plans to promote participation of underserved populations 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.

Health Informatics Module

Describe:

  • An overarching plan to assess, develop, deploy, and enhance 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 GitHub 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 proposed project(s) within the Program should address a truly significant roadblock in CTS that if successful would have generalizable application.

Describe:

  • The overall focus of the CTS Research Program.
  • Specific Aims, rationale, and approach to the selection of the proposed CTS research project(s); and how the project(s) will provide generalizable innovations or insights that increase the overall efficiency or effectiveness of translation.
  • A plan for dissemination of successful projects; include a proposed impact statement should the project ultimately be successful.

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. A letter of support that mentions all Elements by name should be considered a general letter of support and included once, in the Overview section only. Letters of support for individual Elements must be included in the appropriate Element of the application.

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 SF424 (R&R) Application Guide, including 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan, with the following modifications:

• This section should encompass the Resource Sharing Plan for all the Elements.

• The CTSA Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication.

To provide further clarification of the NIH policy on disseminating unique research resources, NIH published Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; http://- grants.nih.gov/grants/intell-property_64FR72090.pdf). This document will assist recipients in determining reasonable terms and conditions for disseminating and acquiring research tools. For the purposes of this FOA the research tool may include, but is not limited to, software, algorithms and code. This may be for extraction and use of data for research from clinical systems; implementation of new efficient workflows for research studies; innovative networking to connect scientists, patient communities, industry, resources, data, and ideas; novel analytic and analysis programs; and educational tools. The Resource Sharing Plan must include the following goals:

  • The software should be freely available to biomedical researchers, health care systems, and research institutions or organizations.
  • The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages.
  • The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.

• Data Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. For applications submitted for due dates on or after January 25, 2023, applicants should adhere to the NIH Final NIH Policy for Data Management and Sharing and Supplemental Information https://osp.od.nih.gov/scientific-sharing/nih-data-management-and-sharing-activities-related-to-public-access-and-open-science/. Applicants are strongly encouraged to use Common Data Elements during the planning phases of a project to optimize data collection and facilitate broad data sharing (e.g., https://www.nlm.nih.gov/cde/)

• Genomic Data Sharing Plan: Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype “dbGaP” (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub “DASH” (https://dash.nichd.nih.gov/) or other equivalent broad-sharing data and/or biospecimen repositories.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

All applicants must answer Yes to the involvement of Human Subjects during the period of award and complete all related sections. Applications that do not answer Yes to the involvement of Human Subjects and complete all related sections are incomplete and will not be reviewed.

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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Although applicants must be prepared for clinical trials, definite plans for such involvement will not be possible at time of application. A Study Record should not be completed.

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 SF424 (R&R) Application Guide must be followed.

Note: Applicants must enter any anticipated delayed onset study record and check the box “Anticipated Clinical Trial?” if appropriate.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. 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. Overview Information 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 Policy on Late Application Submission. Each application of a collaborative set must be on-time. Considerations for late applications that are based on the institution or PD/PI apply only to his/her individual application.

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 SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions 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. Reviewers will provide an overall impact score for the entire application to reflect their assessment of the likelihood for the CTSA hub to exert a sustained, powerful influence on CTS, in consideration of the following standard review criteria and review criteria specific to this FOA.

In addition, for applications involving clinical trials: 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.

Overall Impact

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).

Scored Review Criteria

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, an element project that by its nature is not innovative may be essential to advance a field, or strengths in certain Elements may outweigh weaknesses in others.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: To what extent does the UM1 application clearly describe and justify a strategic vision to innovate CTS and further CTSA Program Goals; to what extent do applicants provide a plan to measure these innovations and progress towards the goals?

  • To what extent will the hub contribute to the overall CTSA Program, a high-performance consortium marked by not only individual hub excellence but also by a nimble, highly responsive aggregate able to develop, demonstrate and quickly disseminate advances in diagnosis, treatment and prevention of human diseases? To what extent is the plan for dissemination and the proposed impact statement appropriate for the stated hub activities?
  • Will there be coordination, interrelationships, cohesiveness, and synergy among the Elements as they relate to the stated research focus of the CTSA? How will the governance, collaboration, communication, and succession planning result in successful management of the proposed CTSA Program hub?
  • To what extent do the proposed resources, services, and educational activities (exclusive of the required K12 activities and any activities in companion FOAs) address important needs or critical barriers for CTS researchers and research teams, including planning, conduct, analysis, and dissemination and will they enable investigators to achieve their research goals?
  • To what extent have the applicants articulated plans to lay the foundation of high-quality research by creating and maintaining a skillful, multidisciplinary, and underrepresented translational workforce?
  • To what extent does the CTSA hub appear to encourage studies consistent with the goals of the CTSA Program through the proposed Pilot Module?
  • To what extent does the CTSA hub support a commitment to a culture of open science and to sharing and implementing resources across CTSA hubs?
  • To what extent do the Element E Program and project(s) propose to address a truly significant roadblock in CTS science that if successful would have generalizable application?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: To what degree do the applicant and any partner(s) and/or collaborator(s) have a strong record of CTS research with high impact achievements in useful methods and procedures leading to improved diagnoses, treatments, and strategies for disease prevention? Have the contributions of each partner and collaborator been well justified and integrated into the UM1 structure?

  • Are the qualifications, experience, and commitment of the Module and Project Leaders/Co-Leaders, management committees, and other personnel appropriate and sufficient?
  • To what extent are the roles of partners well described and is their participation justified?
  • To what extent do the staff have sufficient breadth and depth of technical and/or scientific knowledge to cover a wide range of CTS research activities and address the various educational needs of investigators or teams?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: To what degree do the plans include not only developing innovations but also using those made by others to demonstrate utility and to ultimately disseminate successful solutions?

  • To what extent are innovative methods evident, such as experimental approaches to identify best practices in translational research; workforce education and training; and stakeholder outreach?
  • To what extent do the applicants propose innovative informatics solutions in support of the broad range of CTS research activities at the CTSA hub?
  • To what extent does the Element E project(s) utilize innovative approaches to accomplish the stated aims?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are the proposed administrative organization and management plans appropriate and adequate for the following: (a) effective day-to-day management of the CTSA; (b) coordination of ongoing research between the separately funded projects and the CTSA hub, including mechanisms for internal monitoring; (c) establishment and maintenance of internal communication and cooperation among the CTSA or hub investigators; (d) mechanisms for selecting and replacing staff; and (e) responses to a public health emergency or other public health need?

  • To what extent do the plans describe a range of opportunities (e.g., scientific, regulatory, and operational) for the Workforce Development for Clinical Research Staff Professionals Module?
  • To what extent do the plans promote health equity?
  • To what extent have the applicants set forth an appropriate plan to establish a Hub Liaison Team with robust interactions with other national collaborative activities of the CTSA Program?
  • To what extent has the applicant described a comprehensive plan for hub evaluation and for continuous quality improvement?
  • To what extent have the applicants developed plans for professional development and CTS training for clinical research staff professionals?
  • To what extent are the plans to support the required K12 award and other selected, optional programs well integrated into the activities of the UM1? Is there adequate assurance that the activities are not duplicative with the required and optional programs?
  • To what extent does the Health Informatics Module enhance informatics capabilities and information technology across the spectrum of CTS research activities at the hub? To what extent do the plans include progression 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 CTSA consortium in a common GitHub repository?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: How will the hub institution demonstrate its commitment to participating in the larger CTSA Program, including capabilities to engage in NIH multi-site trials featuring single IRBs and pre-negotiated master subcontracts?

How will this CTSA hub benefit from unique institutional strengths such as human capital and infrastructure in the support of CTS research and education?

To what extent does an integrated program across the hub exist; how might this integrated program assist in establishing clinical trial feasibility and improve trial recruitment in an efficient and ethical manner?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not applicable.

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCATS Advisory Council. The following will be considered in making funding decisions:

  • 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 and to address the burden of conditions that affect rural, minority, and other underserved populations.
  • Policies consistent with goals for resource, data sharing, and sharing of software.

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 VI. Award Administration Information

1. Award Notices

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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 awardee 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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that 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 FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 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 award 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, although specific tasks and activities may be shared among the awardees and the 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.
  • 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 that achieves the goal of sharing research resources 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 Health Informatics 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://www.nlm.nih.gov/cde/)
  • 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.
  • Collection of 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.

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.
  • 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 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 awardees 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 award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: 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 awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Erica Rosemond, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8927
Email: CTSAFOAQuestions@mail.nih.gov

Peer Review Contact(s)

Victor Henriquez, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0813
Email: CTSAFOAQuestions@mail.nih.gov

Financial/Grants Management Contact(s)

Stacia Fleisher
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0851
Email: CTSAFOAQuestions@mail.nih.gov

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.

Authority and Regulations

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, 45 CFR Part 75, and 2 CFR 200.


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