Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)
National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Global Infectious Disease Research Training Program (D43 Clinical Trial Optional)

Activity Code

D43 International Research Training Grants

Announcement Type

Reissue of PAR-18-840

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-20-229

Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) 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 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 not including HIV/AIDS. 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 professional 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 professional development.

Key Dates
Posted Date

June 10, 2020

Open Date (Earliest Submission Date)

July 14, 2020

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

August 14, 2020, August 3, 2021, August 3, 2022

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

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2020, October 2021, October 2022

Advisory Council Review

January 2021, January 2022, January 2023

Earliest Start Date

February 2021, February 2022, February 2023

Expiration Date

August 4, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    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 the low 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.

    Purpose and Background Information

    This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease Research Training program from U.S. and LMIC 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 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 professional development skills components to prepare individuals for 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) .

    Another funding opportunity PAR-17-058, Planning Grant for Global Infectious Disease Research Training Program (D71), provides one year of support for eligible LMIC applicants to develop full research training program applications for this funding opportunity.

    Program Objective

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

    - To develop research training opportunities and professional development activities for a cadre of LMIC scientists and health research professionals to strengthen the capacity to conduct independent, sustainable infectious disease research at a LMIC institution.

    - To provide mentored training-related infectious disease research experience that is directly relevant to the health priorities of the LMIC.

    - To strengthen the capabilities of trainees at LMIC institutions 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 think through 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 health and disease.

    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 employed will contribute to measurable enhancement of explicitly defined infectious disease research capacity outcomes.

    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 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 areas:

    • basic, epidemiologic, clinical, behavioral, and social science research;
    • bioengineering;
    • bioinformatics, biostatistics, disease modelling;
    • 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 (air, water, soil, etc.) transmission;

    -vectored transmission;

    -anti-microbial resistance;

    -vaccination;

    -microbiome effects 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/reproducibility/faqs.htm ). Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed training program.

    Proposed faculty mentors should have research expertise directly relevant to the proposed scientific focus of the research training program. 

    The 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.

    Successful transition of LMIC trainees to the next research career stage should be an important consideration in designing the proposed training program.  Each trainee should be matched to both a U.S. and LMIC mentor to provide scientific and career guidance.  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, 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.

    Applicants are also encouraged to include plans for strengthening associated skills and knowledge necessary for long-term research career sustainability, such as scientific writing and presentation, grant writing, and expertise in bioinformatics, 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 (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 a thorough exposure to the principles and skills of specific research methods or research related competencies that enable immediate incorporation into current trainee research or professional development. Mentorship should be provided to ensure short term training meets this expectation.  Evaluation plans (see section below) should include specific assessments of the effectiveness of the short-term training activities proposed. Short-term training in medical or public health practice cannot be supported. Short term training support is limited to:

    A.  Training specific research skills or methods directly applicable to trainee research projects.

    B.  Research leadership, management or professional development skills.

    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.

    Trainee Research

    Proposed research training may take place in the U.S. or a foreign country, but 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.

    Note: This Funding Opportunity Announcement (FOA) allows appointment of trainees 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.

    Applications Not Responsive to the FOA

    Applications submitted by an eligible foreign institution in a LMIC without a collaborating U.S. institution or by a U.S. institution without a collaborating LMIC

    Applications in which each PD/PI is not 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.

    PD/PIs proposed by non-U.S. applicants who are not permanent residents of eligible LMICs.

    Applications that propose HIV/AIDS research training.

    Applications that propose research training exclusively at the U.S. institution.

    Applications that propose exclusively short-term training (less than 1 month) experiences.

    Applications that propose clinical care or public health provision training.

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

    Section II. Award Information
    Funding Instrument

    Grant: A support 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 SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

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

    Award Budget

    Application budgets are limited to $230,000 per year for new awards and $276,000 per year for renewal awards (total direct costs).

    Award Project Period

    The maximum project period allowed is 5 years.

    Other Award Budget Information
    Stipends, Tuition, and Fees

    Personnel Costs

    Awards may provide stipends as a subsistence allowance to help defray living expenses during the research training experience and support the cost of tuition and fees at the rate in place at U.S. or foreign institutions.  Trainees may be paid a stipend comparable to their professional experience and U.S. or foreign institutional requirements.

    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.

    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.   

    Trainee Travel

    Trainee travel for research training at a collaborating institution or to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for long term trainees. 

    Training Related Expenses

    Other Program Related Expenses

    NIH will provide funds to help defray other research training expenses, such as trainee visas, health insurance, staff salaries, consultant costs, research training equipment (not exceeding $5,000), trainee research supplies, laptop computers and internet access, relevant scientific journal subscriptions, publication costs, costs for short courses or workshops and faculty/staff travel directly related to the research training program. 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.

    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 members 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. 

    These expenses must be justified as specifically required in the proposed research training program and must not duplicate items generally available at the applicant institution.

    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 FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
    • U.S. Territory or Possession

    Other

    • Non-domestic (non-U.S.) Entities (Foreign Institutions)

    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 rigorous research program in the area(s) proposed under this FOA. It is expected 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 domestic (U.S.) institution that demonstrates collaborations with an LMIC institution named in the application by documented joint publications, 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 for definition of "eligible LMIC" used in this FOA.

    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • 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. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) 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 should have research and research training experience in the LMIC which is the focus of the application.

    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.

    PD/PIs proposed by non-U.S. applicants must be permanent residents of eligible LMICs (to be verified by the applicant institution).

    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 LMIC institution as the main foreign collaborator for coordinating training program activities at that site.  Due to the collaborative nature of this program, applicants are encouraged to designate the main LMIC collaborator who meets the research grant eligibility requirement above as a Multiple PD/PI.

    The PD(s)/PI(s) will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) has responsibility for the day to day administration of the program and is responsible for appointing members of the Training Advisory Committee, using their recommendations to strengthen the program.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    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 relevant to the NIH mission.  Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

    Faculty mentors should have research and/or research training experience in the LMIC that is the focus of the application.

    Trainees

    Only individuals who are citizens of LMICs (defined by the World Bank classification system- also refer to NOT-TW-12-011"Notice of Change in Country Eligibility for Fogarty International Training Grants", for additional information) 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.

    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 LMIC institution.

    Attention should be given to recruiting and retaining LMIC trainees from groups underrepresented in infectious disease research in the LMIC context, including racial and ethnic minorities, persons with disabilities, and women.

    All trainees 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. Appointments are normally made in 12-month increments. All long-term trainees (more than 1 month) are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FIC 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
    Fax: 301-401-0779
    Email: sinab@mail.nih.gov

    Page Limitations

    All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

    Instructions for Application Submission

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

    SF424(R&R) Cover

    Follow all instructions provided in the SF424 (R&R) Application Guide. 

    SF424(R&R) Project/Performance Site Locations

    Follow all instructions provided in the SF424 (R&R) Application.

    SF424 (R&R) Other Project Information

    Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

    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 training, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, faculty), and intended trainee outcomes.

    Other Attachments. Provide a plan for an Advisory Committee to monitor progress of the training program.  Members should not be affiliated with the program and a majority of members should be from the LMIC focus of the application. The composition, roles, responsibilities, and expertise of 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 the development, implementation and evaluation of the overall 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 SF424 (R&R) Application. Include the name of at least one person at each collaborating institution who will serve as the director of training at the site. List all the members of the Advisory Committee.

    PHS 398 Cover Page Supplement

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Training Subaward Budget Attachment(s)

    Follow all instructions provided in the SF424 (R&R) Application Guide.

    Research & Related (R&R) Budget

    Follow all instructions provided 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 and identify by name any continuing trainees.
    • 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
    • Faculty, Trainees, and Training Record
    • Other Training Program Sections
    • Appendix-none should be included in the application.  Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    Particular attention must be given to the required International Program 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 participants, and other factors that contribute to the overall environment of the program.

    Training Program

    Program Plan

    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 scholars, and resources at the LMIC institution will be robust enough to support additional programs.

    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 biosketches.

    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.

    Proposed Training.

    The program plan should include detailed descriptions of the didactic and technical training components and the LMIC trainee Professional development activities that will be supported.  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.  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.

    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.

    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.

    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 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 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 supported 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 the president, the provost, a dean, or another key institutional 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. 

    Appendix

    No appendices should be included in the application.

    PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) 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

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

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

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

    4. Submission Dates and Times

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

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

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

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.  Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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.  Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

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

    Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood 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.

    Significance

     In addition, for applications involving clinical trials

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

    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 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 ensure human subject protection, vertebrate animal care, biosafety, biomedical library 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?
    • 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?

    In addition, for applications involving clinical trials

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

    Innovation

    In addition, for applications involving clinical trials

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

    Approach

    In addition, for applications involving clinical trials

    For all CT FOAs, add the following questions, after the standard questions for the Approach review criterion.

    Does the application adequately address the following, if applicable.

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

    Environment

    In addition, for applications involving clinical trials

    For all CT FOAs, add the following questions, after the standard questions for the Environment review criterion.

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

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

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

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

    Preceptors/Mentors

    • Are sufficient numbers of experienced U.S. and LMIC preceptors/mentors with appropriate expertise, LMIC research experience and research 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 clinical trial research training, do the mentor(s) who will supervise the trainee(s) have the expertise, LMIC clinical trial 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 research training fellowships or career development awards?
    • How successful are the trainees (or, for new applications, other past LMIC 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.

    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 goals and specific objectives?

    If submitted by a U.S. institution, is a realistic plan to transfer substantial research training program leadership to the collaborating LMIC institution included?

    Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term 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?

    In addition, for applications involving clinical trials

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

    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.

    Recruitment Plan to Enhance Diversity

    Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA 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?

    Applicants are encouraged to develop training in the responsible conduct of research that is especially relevant to the research environment at the LMIC institution.

    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.

    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 the Center of 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:

    • 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.
    • Will receive a written critique.

    Applications will be assigned  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  Fogarty International Center Advisory 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.  See FIC Strategic Plan: https://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx.
    • Consideration of programmatic and geographic distribution. 
    3. Anticipated Announcement and Award Dates

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

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that trainee research project protocols are reviewed by their IRB or IEC.

    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: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety

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

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

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

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

    Inventions and Copyrights

    Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

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

    Other Reporting Requirements

    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.

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

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the 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 Commons Help Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Barbara Sina Ph.D.
    Fogarty International Center (FIC)
    Telephone: 301-402-9467
    Email: sinab@mail.nih.gov

    Stephanie M. Coomes, Ph.D.
    Division of Microbiology and Infectious Diseases
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-6855
    Email: stephanie.coomes@nih.gov  

    Peer Review Contact(s)

    Tamora McNealy Ph.D.
    Center of Scientific Review (CSR)
    Telephone: 301-827-2372
    Email: tamora.mcnealy@nih.gov

    For PAR with special review arrangements and RFA only, replace the text block with exactly the same formatted information as shown for Scientific/Research Contact(s) and Financial/Grants Management Contact(s).

    Financial/Grants Management Contact(s)

    Satabdi Raychowdhury
    Fogarty International Center (FIC)
    Telephone: 301-496-9750
    Email: raychowdhurys@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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