Part 1. Overview Information

Key Dates

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. 

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

This is a limited competition. The overarching goal of this R25 program is to provide support to recipients of Clinical and Translational Science Awards (CTSA) for research experiences that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs. To accomplish this over-arching goal, this Notice of Funding Opportunity (NOFO) will support creative educational activities with a primary focus on:

• Research Experiences:
  • Research experiences are expected to be relevant to NCATS’ mission of studying translation on a system-wide level, agnostic to a specific disease, to better understand the scientific and operational principles underlying each step of the translational process. The goal is not to focus on specific diseases, but on what is common among them and the translational science process. Examples of research experiences appropriate for career levels include, but are not limited to:
    • Undergraduates (including those at community colleges): to provide hands-on exposure to research that reinforces their interest in clinical and translational science and/or prepares them for graduate school matriculation and/or careers in clinical and translational science for graduate and medical, dental, nursing and other health professional students.
    • Graduate Research and Clinical Students, Postdoctoral Fellows and Medical Residents: to extend their skills, experiences, and knowledge base in order to engage in clinical and translational science research activities.
    • Junior Faculty: to enhance their research skills, experiences, and knowledge base relative to clinical and translational science by working with faculty members at a partnering institution.

Proposed research experiences should involve an innovative approach to provide hands-on exposure to clinical and translational science research in a laboratory or a field setting for a full-time (40 hours per week) period of 10 to 15 weeks in order to stimulate the interest and advance the knowledge base of participants to consider further education and training for future careers as clinical and translational science researchers. The proposed programs should provide research experiences that are not available through formal NIH training mechanisms.

R25 programs that propose at least 10 weeks, but fewer than 15 weeks, of full-time research experiences are allowed to request continued part-time support for the participants to work on their research projects, up to the equivalent of 15 weeks of full-time participation, as long as the entire research experience is completed within a 12-month period. Successful participants may be appointed for additional periods of short-term research experiences. If awarded, an R25 program is expected to provide training experiences to a cohort of participants in each year of the award, including year one.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Background

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. Translation, translational research, and translational science are related but different. Translation turns observations in the laboratory, clinic, and community into diagnostics, therapeutics, medical procedures, and behavioral changes that improve people’s health. Translational research moves a project to the next step in the translational process. Translational science enables these projects to reach their goals faster and more efficiently. At NCATS, we define translational science as the field that generates scientific and operational innovations that overcome the long-standing barriers along the translational research pipeline. With its focus on improving the process, translational science ultimately leads to more treatments for all people more quickly.

The NCATS Translational Science Principles characterize effective approaches for advancing translational progress. These principles are described on the NCATS website (https://ncats.nih.gov/about/about-translational-science/principles). These principles are intentionally broad and apply to research anywhere along the translational continuum. While they exemplify translational science approaches, they are not intended to be comprehensive.

The goal of the NCATS Clinical and Translational Science Awards (CTSA) Program is to develop 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 the public. Sustaining a vibrant clinical and translational research enterprise requires a 21^st century workforce that can advance clinical and translational science that will, in turn, increase the efficiency and efficacy of translation with the ultimate goal of getting more treatments to more patients more quickly.

Examples of research experiences include:

• Research experiences centered on the conduct of translational science research. Participants should be exposed to the spectrum that represents each stage of translational science research that includes the path from the biological basis of health and disease to interventions that improve the health of individuals and the public https://ncats.nih.gov/translation/spectrum.
• Providing research experiences within and outside of academia (e.g., industry, regulatory agency, nonprofit patient-advocacy group) beyond the home CTSA hub.
• Research experiences focused on entrepreneurship and commercialization that broaden the impact of scientific findings beyond the laboratory.
• Support research experiences for participants from less research-intensive partner institutions to gain clinical and translational science research experiences.
• Support faculty from less research-intensive partner institutions to gain research experiences on improving instruction and mentoring capacity in clinical and translational science at their home institutions.

Applications Not Responsive to this NOFO

The following types of applications will be deemed nonresponsive and will not be reviewed:

• Applications that are not submitted concurrently with the required UM1 PAR-21-293 or PAR-24-272 Clinical and Translational Science Award) application, or while the required UM1 application is either in review, under consideration for funding, or has been awarded.
• Applications that do not meet the criteria noted under the eligibility criteria (see Section III). 
• Applications that do not submit all of the required attachments.

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

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

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

All applicant organizations and/or active award recipients for PAR-21-293 or PAR-24-272 Clinical and Translational Science Award (UM1 Clinical Trial Optional) are eligible to apply under this NOFO. Only the primary UM1 CTSA hub organization is eligible to apply. Partner/Partnering and/or Collaborator/Collaborating institutions are not eligible. 

Limited Competition: NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Program (R25 - Clinical Trial Not Allowed) companion optional applications may be submitted in accordance with the applicable NOFO application submission dates under the following scenarios: 

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

While optional companion applications may be submitted concurrently with the UM1 application or at any time the submitted UM1 new or resubmission application remains active, optional companion applications will only be awarded if the UM1 is awarded. 

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. 

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

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

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

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

The PD/PI should be an established investigator (successfully competed for an R01 or R01-equivalent grant) in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

 The UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the R25 application or award in order to ensure the PD(s)/PI(s) have adequate time to devote to the respective programs.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may NOT submit more than one application.

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

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

Only one R25 application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.  

Adhering to the submission eligibility below, a set must contain 1 application to the UM1 NOFO and 1 application to the K12 NOFO; it may also contain 1 application to the T32 predoc NOFO, 1 application to T32 postdoc NOFO, 1 application to this R25 NOFO, and/or up to 2 applications for the RC2 NOFO.

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women should be recruited to serve  as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Participants in R25 programs supported through this NOFO may include undergraduates, graduate research and clinical students (i.e., medical students, dental students, nursing students), postdoctoral fellows, medical residents, and junior faculty. Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of its scientific resources, including human capital.  The recruitment of individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women, is encouraged. See Notice of NIH’s Interest in Diversity (NOT-OD-20-031).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

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

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

Follow all instructions provided in the How to Apply - Application Guide, with the following additional instructions:

Descriptive Title of Applicants Project: Use the format “CTSA Research Education R25 at Name of Institution”

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 NOFO number, 3) the Title of the application, and 4) the Applicant Institution. Each application that is part of the collaborative set should submit an identical listing.

Follow all instructions provided in the How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

The applicant must ensure the peer reviewed sections (budget section) of the application focus on the participants to be supported by direct NIH funding via this funding opportunity. Descriptions of other institutional research education/training programs should be included in the Facilities & Other Resources attachment and/or the Institutional Environment and Commitment to Training section of the application.

Other Attachments

Coordination and Integration Plan (required, 3-page maximum). Provide a specific plan describing the partnership between the UM1 and any optional companion application(s). Describe the overarching goals of each companion application and the coordination, integration, synergy, and mutual reinforcement of resources between them. Include a description of the roles of any shared partners and/or collaborators. Include a description of any proposed team-based or near-peer mentoring aspects, if applicable. Describe the integration of these activities with the UM1, K12, and this research education program, as well as any other optional companion application(s) as well as with partners and collaborators. Please name the file “Coordination_Interaction_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Advisory Committee Plan (optional, 1-page maximum). An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. If an Advisory Committee is included, please name your file Advisory_Committee.pdf.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
• Within the budget section, include only line items for participants directly supported by NIH funding via this NOFO. 

Follow all instructions provided in the How to Apply - Application Guide.

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

Research Strategy

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

• Proposed Research Education Program
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Clearly state the goals and measurable objectives of the proposed research experiences program and how they will support research experiences designed to ensure that the participants receive exposure to the scientific and operational principles underlying each step of the translational process so that they can apply these principles to clinical and translational science research areas such as: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and 4) public health. Provide the underlying rationale and evidence supporting the need for the program. Describe the importance of the research experiences in meeting the needs of the intended participants and the likelihood of improving their knowledge and/or skills in clinical and translational science. Describe innovative aspects and explain the significance of the research experiences program. Describe the educational concepts and principles on which the program is based and the overall strategy, methodology, and analyses to be employed. Provide support for the feasibility of the proposed activities and describe the benchmarks to be used to assess the success of the research experiences program. Consider potential problems that may be encountered and describe alternative strategies that could be employed.Describe the timeline for the proposed program to include timing of recruitment, participant appointment, research education activities, and evaluation. Depict the timeline in reference to the proposed project start date and required annual reporting dates.  Note: It is expected that research education activities will take place in all years supported by the grant. 

Program Director/Principal Investigator. Describe arrangements for administration of the program.  Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Provide evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished.

Program Faculty. Researchers from diverse backgrounds, including individuals from underrepresented groups should be recruited for consideration  as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

List Program Faculty whose role is to develop, implement, direct, monitor, mentor, evaluate, consult, etc., in the proposed research experiences program as Key Personnel and provide their biographical sketches. Describe the experience of the participating faculty in mentoring students and teaching science, as well as their ability to serve as good role models for the participants by virtue of their own scientific accomplishments.

Program Participants. Applications must describe the intended participants, and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

Provide details about the pool of expected participants in the research experiences program and the sources of the applicant pool, including diversity of the pool of candidates.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Where appropriate, describe any unique features of the scientific environment, subject populations, or collaborative arrangements that may be leveraged to the advantage of the proposed research experiences program. If multiple sites are participating, describe how this will enhance the quality of the research experiences provided, as well as how activities will be coordinated and effective communication maintained among the multiple sites.

The applicant must ensure the peer reviewed sections (budget section) of the application focus on the participants to be supported by direct NIH funding via this funding opportunity. Descriptions of other institutional research education/training programs should be included in the Facilities & Other Resources attachment and/or the Institutional Environment and Commitment to Training section of the application.

Recruitment Plan to Enhance Diversity 

The applicant must provide a Recruitment Plan to Enhance Diversity. Include outreach strategies and activities designed to recruit prospective participants from underrepresented backgrounds.  See,   Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups. Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. For programs involving participants for 6 months or less, see the subsection on "Short-term training and research education programs" within the section on "Special Considerations by Type of Award" in NOT-OD-10-019.

Evaluation Plan. Applications must include a plan for evaluating the research experiences program that is appropriate for an education program, not a research project, and may include, for example, surveys completed by participants and/or publicly available information about participants. In particular, the application must specify baseline metrics (e.g., counts of participants, their educational levels, and their demographic characteristics), as well as measures to gauge the short- or long-term success of the program in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and provide suggestions for improvements. A timeline for conducting the evaluation must be described. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: “Institutional Environment and Commitment”). If this attachment is not included, the application will be considered incomplete and will be returned without review. 

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

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

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

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

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following: The goal of this R25 program is to support Research Experiences in clinical and translational science. Applications should be characterized by a high degree of creativity and scholarship and should provide documentation of a strong need for the proposed research experiences program.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this research education program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

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

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

2. Review and Selection Process 

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 program priorities.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

3. Data Management and Sharing

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide. Recipients must submit Training Table 8C. Program Outcomes: Short-Term, in Section B.4 What opportunities for training and professional development has the project provided? of the Research Performance Progress Report (RPPR). 

NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

Other Reporting Requirements

Meeting the nation’s biomedical, behavioral and clinical research needs and implementing short-term research educational activities might require participant recruitment outside of Clinical and Translational Science Award applicant institutions, such as from partner institutions, community colleges, HBCUs, less resource intensive institutions, and MSIs. Assessing the effectiveness of this investment also requires evaluating the reach of these programs and following participants over time to evaluate long-term impacts as described in the Evaluation section below. RPPRs must include sufficient detail on participants to assess the achievement of grant aims and to eventually evaluate the R25 program as a whole. 

RPPRs should include information on participants relevant to their career stage such as: current institution of enrollment, scientific, clinical and/or professional background, and translational stage of research (e.g., preclinical, clinical, clinical implementation, public health).

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement Section 8.6 Closeout.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below.  In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves.  Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NCATS expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Undergraduate Students:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress, including:
• Successful completion of an undergraduate degree focused on an area in the clinical and translational science field
• Enrollment in an advanced degree program in clinical and translational science research

Graduate, Postdoctoral and Medical, Dental, Nursing and Other Health Professional Student participants:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:
  • Successful completion of a clinical and translational science research-related graduate program
  • Subsequent participation in a formal research training or career development program in a clinical and translational science research-related field
  • Subsequent participation in clinical and translational science research
  • Subsequent employment in clinical and translational science research or research-related field
  • Subsequent authorship of clinical and translational science research-related scientific publications
  • Subsequent independent research grant support, from NIH or another source, in a clinical and translational science

Junior Faculty Participants:

• Aggregate number and demographic characteristics of participants
• Research grant support, from NIH or another source, in clinical and translational science
• Subsequent progress of participants, including:
  • Participation in clinical and translational science research
  • Research collaboration with faculty at the partner institution in clinical and translational science
  • Authorship of clinical and translational science research-related scientific publications

Section VII. Agency Contacts

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

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

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

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

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Irina Krasnova, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-480-7624
Email: [email protected] 

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

Stephen Elsberg
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0528
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.