This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from U.S. and low- and middle-income country (LMIC) institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, infections that frequently occur as co-infections in HIV infected individuals or infections associated with non-communicable disease conditions of public health importance in LMICs. Training related to prevention, treatment or public health approaches to any technical area of basic, epidemiology, clinical, behavioral or social science health research may be supported. Research Training programs should incorporate didactic, mentored research and career development skills components to prepare individuals for careers that will have significant impact on the priority health research needs of LMICs. This Funding Opportunity Announcement (FOA) allows support of [trainees] as the lead investigator of an independent clinical trial; or a separate ancillary clinical trial or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

PAR-24-174: Global Infectious Disease Research Training Program (D43 Clinical Trial Optional)

Posted Date: April 17, 2024 Expiration Date: August 07, 2026

Participating Organization(s): National Institutes of Health (NIH) Components of Participating Organizations: Fogarty International Center (FIC), National Institute of Allergy and Infectious Diseases (NIAID)

Special Note: Not all NIH Institutes and Centers participate in Parent Announcements. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements at the Table of IC-Specific Information, Requirements and Staff Contacts website. ICs that do not participate in this announcement will not consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged.

Funding Opportunity Title: Global Infectious Disease Research Training Program (D43 Clinical Trial Optional) Activity Code: D43 Announcement Type: Reissue of PAR-21-120

Related Notices:

• March 31, 2025: This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 04, 2024: Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
• June 5, 2024: Notice of Change to Funding Opportunity - Update of Foreign Eligibility Criteria for Global Infectious Disease Research Training Program (D43 Clinical Trial Optional). See Notice NOT-TW-24-007
• October 26, 2022: Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available. See Notice NOT-OD-23-012
• August 8, 2022: New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023. See Notice NOT-OD-22-195

Funding Opportunity Number (FON): PAR-24-174 Companion Funding Opportunity: None Number of Applications: See Section III. 3. Additional Information on Eligibility. Assistance Listing Number(s): 93.989, 93.855

Funding Opportunity Purpose: This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from low- and middle-income country (LMIC) and U.S. institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research (not including HIV/AIDS). FIC will support research training programs that focus on 1) major endemic or life-threatening emerging infectious diseases, 2) neglected tropical diseases, 3) infections that frequently occur as co-infections in HIV infected individuals or 4) infections or microbiomes associated with non-communicable disease conditions of public health importance in LMICs. Advanced scientific training related to prevention, treatment or public health approaches to any technical area of basic, epidemiological, clinical, behavioral or social science health research may be supported. Research training programs should incorporate didactic, mentored research and professional development skills components to prepare individuals for sustainable careers that will have significant impact on the priority health research needs of LMICs.

This Notice of Funding Opportunity (NOFO) allows appointment of Trainees (D43) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Key Dates:

• Posted Date: April 17, 2024
• Open Date (Earliest Submission Date): July 06, 2024
• Letter of Intent Due Date(s): The letter of intent is due 30 days before the application due date.
• Application Due Dates:
  • New: August 06, 2024
  • Renewal / Resubmission / Revision (as allowed): August 06, 2024
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable
• Review and Award Cycles:
  • Scientific Merit Review: November 2024
  • Advisory Council Review: January 2025
  • Earliest Start Date: August 06, 2025
  • New: August 06, 2025
  • Renewal / Resubmission / Revision (as allowed): August 06, 2025
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable
  • Scientific Merit Review: November 2025
  • Advisory Council Review: January 2026
  • Earliest Start Date: August 06, 2026
  • New: August 06, 2026
  • Renewal / Resubmission / Revision (as allowed): August 06, 2026
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable
  • Scientific Merit Review: November 2026
  • Advisory Council Review: January 2027
  • Earliest Start Date: March 2027

All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date: August 07, 2026 Due Dates for E.O. 12372: Not Applicable

Required Application Instructions: It is critical that applicants follow the Training (T) Instructions in the How to Apply Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the 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.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• 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.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose and Background Information

Infectious diseases continue to impose a tremendous health burden in resource-poor countries throughout the world, claiming millions of lives annually and inflicting severe morbidity that results in significant losses in economic productivity and social progress. Attempts to control infectious diseases endemic to low- and middle-income countries (LMICs) suffer due to an incomplete understanding of the pathogens, disease manifestations and transmission mechanisms, inadequate preventive measures and interventions, and insufficient health services and disease control efforts. A major barrier to improved, evidence-based treatment and control of infectious diseases in LMICs is insufficient capacity to conduct locally relevant infectious disease research. LMIC scientists and health professionals with relevant research expertise can generate new knowledge and strategies for infectious disease prevention and healthcare implementation to address high priority needs in their countries. Therefore, the overall intent of this funding opportunity is to engender scientific knowledge and skills in LMIC trainees that will enhance capacity at LMIC institutions to conduct research directly related to prevention, treatment and control of infectious diseases causing major morbidity and mortality. Applications that include LMICs with little current research capacity are especially encouraged.

This announcement encourages joint applications for the Global Infectious Disease Research Training program from LMIC and U.S. research institutions. FIC will support innovative research training programs that are designed to build sustainable infectious disease research capacity at an institution in an endemic LMIC. Sustainable infectious disease research capacity is known to require a critical mass of scientists and health research professionals with in-depth scientific expertise and complementary leadership skills that enable the institution to conduct independent, internationally recognized infectious disease research relevant to the health priorities of their country.

The application should propose a collaborative research training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research that focuses on 1) major endemic or life-threatening emerging infectious diseases, 2) neglected tropical diseases, 3) infections that frequently occur as co-infections in HIV infected individuals, or 4) infections or microbiomes associated with non-communicable disease conditions of public health importance in LMICs. Advanced scientific training related to infectious disease prevention, treatment or public health approaches in any technical area of basic, epidemiology, clinical, behavioral or social science health research may be supported. Research training programs should incorporate didactic, mentored research and professional development skills components to prepare individuals for sustainable careers that will have significant impact on the priority health research needs of LMICs.

This program does not support HIV/AIDS research training. Applicants interested in HIV research training should apply to the Fogarty HIV Research Training Program funding opportunities (see http://www.fic.nih.gov/Programs/Pages/hiv-aids-research-training.aspx).

Program Objective

The objectives of the Global Infectious Disease Research Training program are:

• To develop research training opportunities and professional development activities for a collaborative group of LMIC scientists and health research professionals at an LMIC institution to strengthen its capacity to conduct independent, sustainable infectious disease research.
• To provide mentored infectious disease research experience that is directly relevant to the health priorities of the LMIC of the trainees.
• To strengthen the capabilities of trainees at the proposed LMIC institution to lead, manage and train others in infectious disease research.

Each program should provide LMIC trainees rigorous research training, i.e., relevant advanced coursework, mentored research experience and appropriate technical and professional skills' development. Research training should provide each LMIC trainee with:

• A strong foundation in research design, methods, and analytic techniques appropriate for the proposed infectious disease research area;
• Enhancement of their ability to conceptualize and analyze research problems with increasing independence;
• Experience conducting infectious disease research using state-of-the-art methods as well as presenting and publishing their research findings;
• Opportunities to interact with members of the scientific community at relevant scientific meetings and workshops; and
• The enhancement of their overall understanding of the health-related sciences and the relationship of their research training to the health and disease situation in their LMIC.

Research Capacity:

The Global Infectious Disease Research Training programs should be designed to move beyond training a number of individuals for the next career level to demonstratively increasing sustainable, independently resourced infectious disease research capacity at the proposed LMIC institution. It is expected that the training strategies proposed will contribute to measurable enhancement of explicitly defined infectious disease research capacity outcomes.

Other LMIC institution research training programs:

The proposed institutional infectious disease research training program may complement other ongoing research training and career development programs at the LMIC institution, but the proposed program must be clearly distinct from related programs.

Program Considerations

Scientific Focus

As stated in the rationale for a proposed training program, applications must identify an infectious disease scientific focus directly relevant to the LMIC health priorities for which research capacity is limited at the LMIC institution. Applications may focus on research training on infectious diseases which are:

1. Major endemic (malaria, tuberculosis, etc.) or life-threatening emerging infectious diseases (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens)
2. Neglected tropical diseases (https://www.niaid.nih.gov/research/neglected-tropical-diseases-types)
3. Infections or microbiomes associated with non-communicable disease conditions of public health importance or
4. Infections that frequently occur as co-infections in HIV infected individuals. However, applications that focus exclusively on research training to address HIV/AIDS or co-infections in the context of HIV will not be supported in this program.

This FOA can support research training related to infectious disease prevention, care and treatment in a broad range of technical areas:

• basic, epidemiologic, clinical, behavioral, and social science research;
• bioengineering;
• bioinformatics, biostatistics, disease modeling;
• genetics/genomics;
• vector biology;
• pathophysiology, diagnostics and therapeutics research;
• implementation, health economics, health services and systems research or;
• clinical trials.

Applicants are also encouraged to design multidisciplinary research training programs with a focus on a global infectious disease cross-cutting theme, for example, common modes of transmission, pathophysiology or virulence such as (but not limited to):

• environmental transmission (air, water, soil, etc.);
• vector transmission;
• anti-microbial resistance;
• vaccination or;
• nutritional effects.

Training PDs/PIs are encouraged to develop training programs that will expose LMIC trainees to a diversity of scientific approaches, systems for study, research approaches, and tools and technologies. The research training should incorporate research methods, and processes that enhance research rigor and reproducibility (https://grants.nih.gov/policy/reproducibility/training.htm). Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed training program.

Types of Training

The program application should incorporate an appropriate mix of training opportunities to address the infectious disease-related research training capacity needs identified at the LMIC institution.

• Advanced degree or non-degree research training may be supported at a U.S. or foreign institution.
• Research trainees who are also training as clinicians must devote full time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.
• Research training may be delivered by interactive distance learning technology, if appropriate and sustainable for the LMIC participants and institutions involved. Applicants are encouraged to maximize training in the use of information technology to facilitate trainee data management and analysis, access to online scientific information and communication.

Mentorship:

Each trainee should be matched a LMIC and a U.S. mentor (if appropriate) to provide scientific and career guidance. Proposed faculty mentors should have research expertise directly relevant to the proposed scientific focus of the research training program. Mentorship training may be provided for faculty mentors involved in the proposed program. Training programs should make available structured, professional development advising activities (for example, Individual Development Plans (https://www.nigms.nih.gov/training/strategicplanimplementationblueprint/Pages/IndividualDevelopmentPlans.aspx), career related practicum experiences and rotations, workshops or networking activities). Through such activities, trainees are expected to obtain a working knowledge of various career paths that will make use of the knowledge and skills gained during research training as well as the steps required to move to the next stage of their career.

Career Development Skills:

Successful transition of LMIC trainees to the next research career stage should be an important consideration in designing the proposed training program. Applicants should include training plans for strengthening skills necessary for long-term research career sustainability, such as scientific writing and presentation, grant writing, and expertise in data management, research ethics, good clinical practice, good laboratory practice, biosafety, research administration and the management of intellectual property. English as a second language training may be supported, if needed.

Short Term Training:

Short term training (less than 1 month) may be proposed in addition to long term training to meet the specific objectives of the proposed program. Short-term training should provide competitively selected LMIC trainees with a thorough exposure to the principles and skills of research methods or competencies (such as research leadership or management) that can be immediately incorporated into their research or professional development. Mentorship should be provided to ensure short term training meets this expectation. Evaluation plans (see section below) should include specific assessment of the effectiveness of the short-term training activities proposed. Short-term training in medical care or public health program practice cannot be supported.

Trainee Research

Proposed mentored research training may take place in the U.S. or a foreign country, however, training-related research should be carried out in the LMIC as much as feasible.

All training-related research projects must be independently reviewed through rigorous scientific review procedures established by the program and obtain required approvals for human subjects and animal research from the applicant institution and if different, at the institution in which the research is conducted.

It is expected that LMIC trainees will be supported to disseminate the results of their research at scientific conferences and in peer-reviewed publications.

This announcement allows support of trainees to serve as the lead investigator of an independent clinical trial; or a separate ancillary clinical trial; or to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Applications Not Responsive to the announcement:

• Applications that propose HIV/AIDS research training.
• Applications that propose research training exclusively at a U.S. or other high income country institution.
• Applications that propose exclusively short-term training (less than 1 month) experiences.
• Applications that propose clinical care or public health program (including surveillance) training.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

• New
• Renewal
• Resubmission

The OER Glossary and the How to Apply Application Guide, provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose training in 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

• New Awards: Application budgets are limited to $230,000 per year (total direct costs).
• Renewal Awards: Application budgets are limited to $276,000 per year (total direct costs).

Award Project Period

The maximum project period allowed is 5 years.

Other Award Budget Information

• Stipends, Tuition, and Fees: Awards may provide stipends as a subsistence allowance to help defray living expenses during research training. The cost of tuition and fees at the rate in place at U.S. or foreign institutions can be supported. Trainees may be paid a stipend comparable to their professional experience and U.S. or foreign institutional requirements.
• Trainee Travel: Trainee travel for research training at a collaborating institution or to attend courses or workshops that the training program determines are necessary for the individual’s research training experience is an allowable expense for long term trainees. Awards may support trainees to present their research results at scientific conference. Funds may be requested for lodging and per diem expenses for short term trainees required to travel significant distances to the hosting institution.
• Training Related Expenses: NIH will provide funds to help defray other research training expenses, such as trainee visas, trainee health insurance, research training equipment (not exceeding $5,000), trainee research supplies, laptop computers and internet access for trainees, relevant scientific journal subscriptions, publication costs, and costs for research training short courses or workshops. One-time mentored research training project support for up to $20,000 for an advanced long-term trainee undertaken in his/her country may be requested.
• Personnel Costs: Individuals designing, directing, and implementing the training program at U.S. and LMIC institutions may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with trainees are considered a regular part of an individual's academic duties, then mentoring and other interactions with trainees are non-reimbursable from grant funds.
• Administrative and Clerical Staff: The salaries of administrative and clerical staff should normally be treated as indirect (F&A) costs. Direct charging of these costs may be appropriate only if all of the following conditions are met: (1) Administrative or clerical services are integral to a project or activity; (2) Individuals involved can be specifically identified with the project or activity; (3) Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and (4) The costs are not also recovered as indirect costs. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.
• Other Program Expenses: Training consultant costs and other program-related expenses may be included in the proposed budget. Funds for one trip per year may be requested for faculty mentors to conduct well justified training activities. Support for key personnel, faculty mentors or consultants to attend scientific meetings and conferences is not allowed. Funds should be requested for the PD(s)/PI(s) to attend an annual program networking meeting, usually held at NIH.
• Indirect Costs: Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Eligible Organizations

• Higher Education Institutions:
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
• Other:
  • Non-domestic (non-U.S.) Entities (Foreign Organizations)

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.

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this NOFO and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program documented by active research grants and recent relevant research publications. In many cases, it is anticipated that the proposed program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

Applications may be submitted by an eligible foreign institution in a LMIC with a collaborating U.S. institution or by an eligible U.S. institution that demonstrates ongoing collaborations with a LMIC institution named in the application. Evidence of collaboration may be documented by joint publications, research grants or previous research training activities. Applicants are encouraged to contact the FIC Scientific/Research Contact if more than one U.S. and one LMIC institution will be proposed as training sites.

LMICs are defined by the World Bank classification system (according to Gross National Income (GNI) per capita as "low-income," "lower-middle-income," and "upper-middle-income" (http://data.worldbank.org/about/country-classifications/country-and-lending-groups). See Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility (NOT-TW-12-011) (https://grants.nih.gov/grants/guide/notice-files/NOT-TW-12-011.html) for definition of “eligible LMIC”.

• Foreign Organizations: 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.
• Non-domestic (non-U.S.) Entities (Foreign Institutions): are eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations: are eligible to apply.

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with their organization and collaborators to develop an application for 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 How to Apply - Application Guide.

The PD/PI should be an established investigator 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 responsible for overseeing the process for the selection of trainees to the research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee and using their recommendations to determine the appropriate allotment of funds.

Collaborator Requirements:

Proposed research training programs should be based on equitable and trusted collaboration. The PD/PI should have research and research training experience in the LMIC which is the focus of the application. PD/PIs proposed by non-U.S. institutions must be permanent residents of eligible LMICs (to be verified by the applicant institution). LMIC applicants must identify at least one U.S. scientist and U.S. applicants must identify at least one LMIC scientist with expertise in the infectious disease focus area of the proposed research training program from the proposed collaborating U.S./LMIC institution as the main collaborator for coordinating training program activities at that site. Due to the collaborative nature of this program, applicants are encouraged to designate the main collaborator who meets the research grant eligibility requirement as a Multiple PD/PI.

Research Grant Requirement:

Each PD/PI must be designated as the PD/PI of at least one research award that is directly relevant to the scientific focus of the research training proposed and with at least 18 months of support remaining at the time of submission of the application.

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 submit more than one application, provided that each application is programmatically distinct.

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)

Preceptors/Mentors

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers. Faculty mentors should have research and/or research training experience in the LMIC that is the focus of the application. Programs are encouraged to build a broadly diverse team of preceptors/mentors that includes, for example, faculty at different career stages (i.e., junior as well as senior faculty).

Trainees

• Only individuals who are citizens of LMICs (defined by the World Bank classification system) are eligible for research training support or other training activities (as verified by the PD(s)/PI(s)). Individuals who have dual citizenship or permanent residency in the U.S., other high-income countries or ineligible countries described above are not eligible for support.
• All long term trainees (more than 1 month) are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.
• Research training may be offered to a wide range of scientists, including laboratory scientists, social scientists, clinicians and other health professionals, as well as technical and administrative staff in order to fill research capacity gaps at the collaborating LMIC institution.
• Short Term Training: Short term training (less than 1 month) may be proposed in addition to long term training to meet the specific objectives of the proposed program. Short-term training should provide competitively selected LMIC trainees with a thorough exposure to the principles and skills of research methods or competencies (such as research leadership or management) that can be immediately incorporated into their research or professional development. Mentorship should be provided to ensure short term training meets this expectation. Evaluation plans (see section below) should include specific assessment of the effectiveness of the short-term training activities proposed. Short-term training in medical care or public health program practice cannot be supported.

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 Training (T) Instructions in the How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to: Barbara Sina Ph.D. Telephone: 301-402-9467 Email (preferred): [email protected]

Page Limitations

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

Instructions for Application Submission

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

• SF424(R&R) Cover: All instructions in the How to Apply - Application Guide must be followed.

• SF424(R&R) Project/Performance Site Locations: All instructions in the How to Apply - Application Guide must be followed.

• SF424 (R&R) Other Project Information: All instructions in the How to Apply - Application Guide must be followed.

• Project Summary/Abstract: Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and intended trainee outcomes. Provide the names of the collaborating institutions where research training will occur. Provide a plan for an Advisory Committee to monitor progress of the training program. Members should not be affiliated with the program. A majority of members should be from the LMIC focus of the application. The composition, roles, responsibilities, and desired expertise of the named committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will contribute to the selection of participants and their mentored research projects as well as evaluate the overall development, implementation and effectiveness of the program. 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.

• SF424(R&R) Senior/Key Person Profile Expanded: Follow all instructions provided in the How to Apply - Application Guide. Include the name of at least one person at each collaborating institution who will serve as the director of training at that site. List all members of the Advisory Committee.

• PHS 398 Cover Page Supplement: Follow all instructions provided in the How to Apply - Application Guide.

• PHS 398 Training Subaward Budget Attachment(s): Follow all instructions provided in the How to Apply - Application Guide.

• Research & Related (R&R) Budget: Follow all instructions in the SF424 (R&R) Application Guide with the following additional modifications:

  • Use the Other Personnel section to submit costs for salary support for administrative staff.
  • Use the Travel section to submit costs for key personnel and faculty travel including the annual network meeting.
  • Use the Participant/Trainee Support Costs section to submit costs for trainees and training-related expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Do not use the Subsistence category. Provide details of trainees and training related expenses in the budget justification.
  • Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification.

• PHS 398 Research Training Program Plan: The PHS 398 Research Training Program Plan Form is comprised of the following sections:

  • Training Program including sub-sections on Background, Program Administration, Proposed Training (see below)
  • Faculty (see below), Trainees, and Training Record
  • Other Training Program Sections including sub-sections on Program Evaluation, Renewal Applications, Institutional Environment and Commitment to the Program, Plan for Instruction in the Responsible Conduct of Research (see below)
  • Appendix - None should be included in the application.

  Follow all instructions provided in the How to Apply - Application Guide. The following modifications apply:

  • Particular attention must be given to the required International Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of past participants, and other factors that contribute to the overall environment of the program.

  • Background: Provide the rationale for the proposed program in terms of the specific infectious disease research capacity needs for the LMIC and LMIC institution. Applications should document the existing infectious disease research capacity in the chosen scientific focus and define measurable research capacity parameters expected to increase as a result of the proposed research training activities at the end of the grant period. Applicants should outline the research training and LMIC institutional research capacity objectives of the program and the program activities that will be used to meet these objectives in the overview of the program plan.

  • Program Administration: Describe the leadership, administrative skills, scientific research and training experience of the PD(s)/PI(s) and major training site collaborator(s) and how these strengths are related to the management of the training program. This information should not duplicate content found in biosketches. Applicants should describe how decisions regarding the proposed components of the research training program will be made in consultation with the proposed U.S. and LMIC faculty and Training Advisory Committee. If a clinical trial training is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of clinical trials. Applicants should include analysis of how the proposed research training program will complement or synergize (but not duplicate) the activities of other ongoing research training and scientific career development programs at the LMIC institution. Descriptions of the current NIH supported research training grants can be identified using the NIH Research Portfolio Online Reporting Tools Expenditures and Results module (RePORTER) query form (https://projectreporter.nih.gov/reporter.cfm). Applicants should explain how the pool of faculty, potential trainees, and resources at the LMIC institution will be robust enough to support additional programs.

  • Proposed Training: The program plan should include detailed descriptions of the didactic and technical training components that will be supported. Include information about planned courses, mentored research experiences, and other activities designed to develop specific technical or other skills essential for the proposed research training. Applicants are encouraged to include a timeline which includes all proposed training activities. Program plans should consider how to transfer as many of the proposed training activities as feasible during the grant period to the LMIC institution consistent with the overall goals to build research capacity there. Describe how the proposed programs will provide all LMIC trainees with professional development skills and individualized career guidance. As part of these activities, program plans may propose mentorship training for proposed faculty. Training program plans must include a description of the process for independent scientific review of all training-related research projects. In addition, program plans should describe how approvals for human subjects and animal trainee research will be obtained. Documentation of trainee education in the protection of human subjects, compliance with required federal regulations (including those related to animal research), and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted is required. For applications proposing training in clinical trials, the recruitment and selection plans should include specific strategies to identify trainees who have the potential to organize, manage and implement clinical trials. For applications proposing training in clinical trials research, plans for training in data management and statistics relevant to clinical trials, good clinical practice (GCP) and good laboratory practice (GLP) should be included. If a clinical trial training is proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial at the training sites.

  • Program Faculty: Describe the leadership, administrative skills, scientific research and training experience of each faculty member and how these strengths are related to their specific role in the training program. This information should not duplicate content found in their biosketches. Information should be provided on the success of their trainees (or, for new applications, other past graduate students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success. Provide a description of how ongoing collaborative research among the PD/PI(s) and faculty as well as other relevant research at the collaborating institutions will provide opportunities for mentored trainee research. Applicants should explain in detail how the relevant research grant support and activities of the PD(s)/PI(s) and proposed mentors are related to the proposed research training plan. If clinical trials training is proposed, provide documentation of the faculty mentors' expertise, experience and ability to oversee the organization, management, and implementation of a clinical trial.

  • Program Evaluation: Describe a plan to review and determine the quality and effectiveness of the training program. Applications must include a plan for evaluating the proposed training and mentorship activities as well as the overall success in building sustainable, independently resourced infectious disease research capacity at the LMIC institution. This plan should include the metrics to be evaluated as well as plans to obtain feedback from current and former LMIC trainees and faculty to identify weaknesses and provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program for training and increasing institutional research capacity.

  • Renewal Applications: Renewal applications must propose new research training activities that will raise research capacity to the next level at the LMIC institution. Applicants should highlight how the training program proposed will be modified in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program. Applicants should provide a detailed description of the progress made in the previous funding period to achieve proposed infectious disease research training and sustainable capacity building objectives. Renewal applications from U.S. institutions must contain a plan to transfer substantial training program leadership to the collaborating LMIC institution during the next award period. Plans may include specific leadership activities to enable LMIC collaborators to meet the PD/PI or MPI requirements for this research training grant opportunity.

  • Institutional Environment and Commitment to the Program: The U.S. and LMIC institutions must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other program faculty to contribute to the proposed program, and that there will be full time release for trainees to participate in the program. As part of the Letters of Support, include a letter on institutional letterhead signed by a key leader with institution-wide responsibilities that contains a description of the U.S. and LMIC institution’s commitment to the planned program to ensure its success. In the same letters include a description of the U.S. and LMIC institutional commitment to harassment and discrimination protections that:

    1. Ensures proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.
    2. Responds appropriately to allegations of discriminatory practices.
    3. Adopts and follows institutional procedure for requesting NIH prior approval of a change in the status of the program director/principal investigator (PD/PI) or other senior/key personnel if administrative or disciplinary action is taken that impacts the ability of the PD/PI or other key personnel to continue his or her role on the NIH award described in the training grant application. (see https://grants.nih.gov/grants/policy/harassment/policy-requirement.htm for more information).

  • Plan for Instruction in the Responsible Conduct of Research: Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide. If this training is only available at the U.S. institution, applicants should provide a plan for how instruction in the Responsible Conduct of Research will be incorporated into the research training curriculum at the LMIC institution.

• Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions. No Appendices should be included.

• PHS Human Subjects and Clinical Trials Information: All instructions in the How to Apply - Application Guide must be followed, with the following additional modifications:

  • Study Record: PHS Human Subjects and Clinical Trials Information: DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
  • 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). If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study. If you check the “Anticipated Clinical Trial” box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.

• PHS Assignment Request Form: All instructions in the How to Apply - Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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.

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 Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained 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 the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Training Program and Environment

  • Are the research facilities and research environment at the U.S. and LMIC collaborating institutions conducive to preparing trainees for successful careers as biomedical research scientists?
  • Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
  • Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
  • Is the proposed training program likely to ensure LMIC trainees will be well prepared for research-intensive and research-related careers?
  • Is the level of U.S. and LMIC institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
  • Is it clear how the proposed training program is distinguished from other externally funded training programs at the U.S. and LMIC institutions?
  • Does the application identify an infectious disease scientific focus directly relevant to the LMIC health priorities for which research capacity is limited at the LMIC institution?
  • Are the expected contributions of the proposed research training likely to strengthen the capacity of the LMIC institution to sustainably conduct independent infectious disease research and research training of importance to that country?
  • Is the proposed research training nested in historical and ongoing research collaborations among the faculty of the participating U.S. and LMIC institutions documented in joint grants and publications?
  • If applicable, do the objectives, design, direction, and quality of the short-term training proposed provide selected LMIC trainees a thorough exposure to the principles and skills of specific research methods or research related competencies that will enable immediate incorporation into current trainee research or professional development activities?
  • Does the applicant propose sufficient program processes to address human subject protection, vertebrate animal care, biosafety and information technology access, collaborative research management and English as a second language (if needed) at the U.S. and LMIC institutions to support the research training proposed?
  • If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers at the U.S. and LMIC institutions, appropriate for the clinical trials training proposed? Does the application adequately address training in the capabilities and abilities needed for trainees to conduct the trial feasibility or ancillary study at the proposed LMIC site(s) or centers?

• Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

  • Does the PD/PI have the scientific background, LMIC expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
  • Does the PD/PI plan to commit sufficient effort to ensure the program’s success?
  • Does the application provide adequate information on how decisions regarding the proposed components of the research training program will be made in consultation with the proposed U.S. and LMIC faculty and Training Advisory Committee?
  • If applicable, do the PD/PI(s) have the expertise, experience, and ability to oversee training in the organization, management and implementation of clinical trials?
  • For applications designating multiple PDs/PIs, is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees, and is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

• Preceptors/Mentors

  • Are enough experienced U.S. and LMIC preceptors/mentors with appropriate expertise, and LMIC research experience, and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
  • Do the U.S. and LMIC preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
  • Do the U.S. and LMIC preceptors/mentors have strong records of training individuals at the level of trainees proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
  • If the program will support trainee clinical trial research experiences, do the U.S. and LMIC mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance?
  • Is the Advisory Committee proposed likely to achieve the functions defined in the application?

• Trainees

  • Is a recruitment plan proposed with strategies likely to attract well-qualified LMIC trainees for the training program?
  • Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?
  • Are there well-defined and justified selection criteria as well as retention strategies?
  • If clinical trials training is proposed, are strategies identified to select trainees who have the potential to organize, manage, and implement clinical trials, feasibility or ancillary studies? Are there plans to provide instruction in data management and statistics relevant to clinical trials to the prospective trainees? Are there plans to provide instruction in good clinical practice (GCP) and good laboratory practice (GLP) to the prospective trainees involved in clinical trials?

• Training Record

  • How successful are the trainees (or, for new applications, other past LMIC students/postdoctorates in similar training) in completing the program?
  • Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
  • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
  • Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

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.

• Protections for Human Subjects: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Inclusion of Women, Minorities, and Individuals Across the Lifespan: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Vertebrate Animals: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Biohazards: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Training in Methods for Enhancing Reproducibility: Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees?

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.

• Does the application describe the program’s accomplishments over the past funding period(s)?
• Is the program achieving its training objectives and overall goal to build LMIC institutional research capacity? Does the renewal application propose new research training activities that will raise research capacity of the LMIC institution to the next level as explicitly defined in the proposed research training objectives?
• If submitted by a U.S. institution, is the plan to transfer substantial research training program leadership to the collaborating LMIC institution realistic?
• Has the program evaluated the quality and effectiveness of the training experience and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

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.

• Training in the Responsible Conduct of Research: All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components:

  1. Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.);
  2. Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics?
  3. Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application?
  4. Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction?
  5. Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

  For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

  Applicants are encouraged to develop training in the responsible conduct of research that is especially relevant to the research environment at the LMIC institution and provide plans for integrating this training into the curriculum at the LMIC institution.

• 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).

• 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 Center for Scientific Review 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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.

Recipients 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 NOFO 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
• Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of the 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, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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, the Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. 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 addition to the information available in the responsibility/qualification records in SAM.gov, 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 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.

Cooperative Agreement Terms and Conditions of Award

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. Continuation support will not be provided until the required forms are submitted and accepted.

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.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

Other Reporting Requirements

In addition to the instructions in the SF424 (R&R) Application Guide, grantees will be asked to enter data on each long term trainee in the CareerTrac database (https://careertrac.niehs.nih.gov/public/home).

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out its stewardship of human resource-related programs, NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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 on-time submission, 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 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]

Scientific/Research Contacts

• Barbara Sina Ph.D. Fogarty International Center (FIC) Telephone: 301-402-9467 Email: [email protected]
• Patricia Strickler-Dinglasan, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 240-627-3384 Email: [email protected]

Peer Review Contact(s)

• Center for Scientific Review (CSR) Email: [email protected]

Financial/Grants Management Contacts

• Satabdi Raychowdhury Fogarty International Center (FIC) Telephone: 301-496-9750 Email: [email protected]
• Nicole Guidetti National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-761-6934 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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.

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