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 Neurological Disorders and Stroke (NINDS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers listed above. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

 

Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Fogarty Global Trauma and Injury Research Training Program (D43 Clinical Trial Optional)

Activity Code

D43 International Research Training Grants

Announcement Type

Reissue of RFA-TW-16-001

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-TW-21-003

Companion Funding Opportunity

none

Assistance Listing Number(s)

93.989, 93.853

Funding Opportunity Purpose

The overall objective of this Funding Opportunity Announcement (FOA) is to strengthen trauma and injury research capacity at academic institutions in low- and middle-income countries (LMICs) through support for research training programs. Research training and capacity training programs should:

  •  Provide in depth training in research design, methods, and analytic techniques appropriate for trauma and injury research;
  •  Support trainees to conduct mentored research using state-of-the-art methods;
  • Provide training in scientific presentation and publication;

  •  Support trainees to obtain advanced degrees (Master’s or Ph.D.) in trauma and injury research; and
  •  Support research faculty/mentors to strengthen trauma and injury research capacity at LMIC institutions, and to contribute to national and global trauma and injury research initiatives and networks.
  • This Funding Opportunity Announcement (FOA) allows trainees to propose 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

February 17, 2021

Open Date (Earliest Submission Date)

March 16, 2021

Letter of Intent Due Date(s)

March 16, 2021

Application Due Date(s)

April 16, 2021

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

June 2021

Advisory Council Review

September 2021

Earliest Start Date

October 2021

Expiration Date

April 17, 2021

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. 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

       

      Program Objective

      This Funding Opportunity Announcement (FOA) requests applications for the Fogarty Global Trauma and Injury Research Training Program from eligible LMIC and U.S. research institutions. Proposed support for LMIC scientists may include a combination of advanced degree and non-degree training at LMIC or U.S institution. Applicants must propose a collaborative research training program that will strengthen the capacity of institutions in LMICs to conduct human trauma and injury research that is of public health importance in those countries.

      The World Health Organization (WHO) indicates that "intentional" and "unintentional" injuries and trauma, continue to be among the leading causes of death and disability in the world, particularly amongst 5 to 49-year-olds. Much of these injuries and trauma result from traffic collisions, drownings, poisonings, falls or burns, natural disasters, acts of war/unrest, self-inflicted violence and assault. More than five million people die from consequences of trauma and injury worldwide annually, with millions more living with post-injury disabilities. Prevalence of trauma and injury has remained stable over the past twenty years and continues to account for about 10% of all deaths globally, which is more than the combined deaths due to HIV/AIDS, tuberculosis, malaria and Ebola. 

      While the global burden of injuries has decreased over the past two decades by about 30%, some countries and regions have seen sharp increases of 10-50% due to road injuries and falls, specifically in sub-Saharan Africa and Southeast Asia. Additionally, deaths caused by unintentional injuries, accounting for about 10% of all deaths, present a significant concern in LMICs. Moreover, even though intentional injuries cause only 3% of all deaths in LMICs, they tend to afflict individuals in the most productive years of life, having a significant economic and social impact.

      Further breakdowns of injury mortality indicate that road traffic injuries, suicide and homicide will overtake Alzheimer's disease, breast cancer and tuberculosis as the leading causes of death by 2030 (https://www.who.int/violence_injury_prevention/key_facts/VIP_key_fact_3.pdf?ua=10). In addition, the impact of natural and man-made disasters, pandemics, and wars on trauma and injury must be accounted for when examining their effects on healthcare systems, infrastructure, and availability of properly trained research and healthcare professionals.

      The United Nations General Assembly adopted the Sustainable Development Goals in 2015, which included an ambitious proposal to "halve the number of global deaths and injuries from road traffic accidents by 2020". Now five years later, the importance of decreasing mortality and morbidity from trauma and injury is more important than ever.

      This Funding Opportunity Announcement (FOA) is seeking to strengthen trauma and injury research capacity at academic institutions in LMICs through research training programs designed to: 

      • Provide in depth training in research design, methods, and analytic techniques focused on trauma and injury research;
      • Strengthen trauma and injury research capacity in LMICs so that scientists are better prepared to develop and/or enhance evidence-based trauma and injury interventions, and to conceptualize and think through research problems with increasing independence;
      • Support trainees to conduct mentored research using state-of-the-art methods;
      • Provide training in scientific presentation and publication;
      • Provide opportunities to interact with members of the scientific community at appropriate scientific meetings and workshops;
      • Support trainees to obtain advanced degrees (Master’s and Ph.D.) in trauma and injury research; and
      • Support research faculty/mentors to strengthen trauma and injury research capacity at LMIC institutions, and to contribute to national and global trauma and injury research initiatives and networks.
       
      Interests of Participating NIH Institutes and Centers

      The National Institute of Neurological Disorders and Stroke (NINDS) encourages the development of innovative research training programs in mechanistic, epidemiological, prevention, translational and clinical research in the areas of neurotrauma and traumatic brain injury, relevant to the mission of the institute (please see: http://www.ninds.nih.gov/disorders/disorder_index.htm for specific diseases and disorders of interest to NINDS).

      The Office of Research on Women’s Health (ORWH) is interested in funding applications that address trauma associated with intimate partner violence, domestic violence, and violence against women. Information about the ORWH mission and strategic plan can be found at:  https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-research.

      Fogarty International Center (FIC) supports a diversity of research and research training grants that advance basic to implementation science with a focus on priority health areas of LMICs. Applicants are encouraged to review the FIC Strategic Plan at http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx.

      Applications focused on the direct impact of environmental and occupational factors on trauma and injury will not be considered. Please refer to the FIC Global Environmental and Occupational Health Program at https://www.fic.nih.gov/Programs/Pages/environmental-occupational.aspx.


      Program Considerations

      Applicants should establish processes to 1) Examine the selection and performance of all mentored trainee research projects by a scientific oversight committee; 2) If needed, provide faculty mentors and trainees with education in the protection of human subjects; 3) If needed, obtain ethical approval for trainee research from the applicant institution or, if different, at the institution where the research will be conducted. 

      Trainee Selection

      Applicants should design a training plan to fill specific gaps in human injury and trauma research expertise at the applicant or collaborating LMIC institutions. Research training may be offered to a wide range of scientists, including laboratory scientists, clinicians, social scientists, and other health professionals to meet the needs for research capacity gaps at the LMIC institution. The end result should be a critical mass of scientists and health professionals who will be able to conduct and strengthen injury and trauma research at their institutions.  Applicants are also strongly encouraged to include women, individuals with disabilities, and LMIC ethnic minorities as trainees and faculty.    

      Types of training

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

      Applications may incorporate a combination of a wide range of long-, medium- and short-term research training opportunities, including specialized clinical, laboratory, research methodology, research ethics and compliance issues, program and grants administration, accounting, financial management, grant writing, peer review, preparation of scientific manuscripts, data management, technology transfer, medical informatics, and any other research skills necessary to support research that is planned or ongoing.

      Training emphasis should be on long-term training that will lead to advanced degrees in trauma and injury research for the trainees. Training can take place in the LMIC or U.S., but training-related research should be carried out mainly in the LMIC.

      In addition, institutional capacity-building efforts are encouraged, including but are not limited to, in-country training workshops in advanced techniques, distance learning, and interaction with other national and regional efforts to strengthen the ability of institutions to support research and research training.

      Applications may propose research training that addresses any scientific area related to trauma or injury that is a significant public health issue in the LMIC that is the focus of the application.  Among the reasons for LMICs having devastating impacts from injury and trauma are inadequate systems of emergency care at both the community and hospital levels and inadequate infrastructure, such as paved roads, inequities in access to emergency response systems, as well as inequities in access to pre-hospital and hospital emergency services between urban and rural areas. Other factors include constrained resources, limited recognition in various government agencies on the impact of trauma on national health, and inadequate public education and public communication around injury prevention issues.  Applications that propose multi-agency and multi-sector engagement including public health, criminal justice, labor, health and environmental infrastructures, and road safety, among others are highly encouraged. 

      Therefore, proposed research training should substantially enhance the expertise of trainees from LMICs in human trauma and injury, including the scientific, clinical, legal, ethical and social aspects. Furthermore, research training should contribute to the development or strengthening of systems focused on mitigation/management of the impacts of natural and humanitarian disasters, and emergency situations on trauma and injury. Research training should strengthen inter- and multi-disciplinary research within the LMIC institutions, including skills related to connecting health research with other non-health sectors. Because injuries affect everyone regardless of age, gender, income or geographic region, some populations are more vulnerable than others.  Therefore, mentored research is expected to enhance trainee consideration of potential age, sex, gender and other differences in the design and analysis of trauma and injury research. 

      Scientific Focus

      Applications must identify areas of scientific focus of trauma and injury directly relevant to the LMIC health priorities for which research capacity is limited at the LMIC institution. Applications should document the existing research capacity in the chosen scientific focus and define measurable increased research capacity parameters expected as a result of the proposed research training at the end of the grant period.

       
      Examples of research training areas may include, but are not limited to: 
      • Patterns and trends in morbidity and mortality from different sources of trauma and injury by demographic characteristics including age, sex, gender, and any relevant minority designations for the LMIC;
      • Prevention of road traffic injuries, and timely intervention and treatment of the consequences;
      • Prevention and care of injuries specific to girls and women;
      • Gender-based violence prevention and intervention;
      • Prevention and care of childhood injuries;
      • Impact of alcohol involvement in injury deaths, preventable years of life lost, and Disability Adjusted Life Years (DALYs) as well as alcohol-related injury prevention and care research in LMICs;
      • Research to inform impact of existing alcohol and drug policy on injury morbidity and mortality;
      • Comprehensive community interventions to reduce alcohol-related and non-alcohol-related injuries and deaths;
      • Treatment of injury and trauma in the acute phase at the scene or at the first healthcare institution;
      • Broad spectrum of disorders associated with injury and trauma, including neurologic and psychiatric impacts and consequences;
      • Development of preventive interventions to shorten the course of psychological trauma by early identification and timely intervention;
      • Development of research tools, models and algorithms that could facilitate assessment, utility and priority for injury services in LMICs;
      • Implementation science that addresses challenges to implementing proven interventions for trauma and injury;
      • Prevention and care of traumatic brain injuries and consequences including neurological disorders;
      • Ethical, legal and social implications of performing human injury and trauma research in LMICs; and
      • Development of low-cost diagnostic and treatment methods that might facilitate the recognition of specific sequelae to injury and trauma, and the development of preventive or ameliorative treatment options.
      New Areas of Interest
      • Post trauma physical and psychological rehabilitation including innovation and development of low-cost prosthetics and other rehabilitation support;
      • Long-term impact of injury and trauma specific to rehabilitation needs, disability and loss of productivity;
      • Research and research training on the impacts of humanitarian and natural disasters on all relevant aspects of trauma and injury prevention, clinical, epidemiological, social, economic, and other outcomes;
      • Formation of interdisciplinary disaster research teams and protocols for rapid data collection efforts at times of natural and humanitarian disasters with trauma and injury consequences, in conjunction with national, state, and local authorities and researchers.
      Training Outcomes

      In addition to research publications and presentations, mentored research training may:

      • Expand collaborative human injury and trauma research among inter-professional health scientists including doctors, nurses, bioengineers and imaging experts from HICs and LMICs;   
      • Provide a foundation for evidence-based and best practice-based human injury and trauma prevention and care guidelines in LMICs;
      • Increase the capacity of LMICs to plan for, adapt to and prevent the potential trauma and injury-related consequences of natural and humanitarian disasters; and
      • Enhance the implementation of internationally validated interventions in specific LMIC contexts, and share lessons learned on Dissemination and Implementation Science related to injury and trauma research training programs.

      Applications Not Responsive to this FOA:

      Applications that propose exclusively short-term training experiences of less than one month are not responsive to this FOA and applications proposing such activities will be deemed non-responsive and will not be reviewed.

      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.

       

      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

      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

      FIC and partner components intend to commit an estimated total of $1.9 million for FY2022. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications

      Award Budget

      Applicants may request up to $270,000 per year in total costs.

      Award Project Period

      The scope of the proposed project should determine the project period. The maximum project period is 5 years.

      Other Award Budget Information
      Stipends, Tuition, and Fees

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

      Trainee Travel

      Trainee travel for training, attendance of scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for predoctoral and postdoctoral trainees. 

      For short-term trainees, the NIH awarding component may provide grant funds to cover the costs of trainee travel, including attendance at scientific meetings, which the organization determines is necessary to the individual’s training. Trainees must be appointed to the training grant at the time of the actual travel for this to be an allowable cost.

      Training Related and Other Program Related Expenses

      NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program.

      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. 

      Faculty Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for the Principal Investigator to attend the annual program network meeting, normally in the U.S.  Funds may be requested for faculty travel to conduct well-justified training activities. Support for senior/key personnel, faculty and collaborators to attend other scientific meetings and conferences is not allowed. 

      These expenses must be justified as specifically required by the proposed 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)

      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 FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs 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.

      Additional eligibility requirements:

      An application may be submitted by 1) an eligible foreign institution in a LMIC or 2) 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.

      Direct applications from LMIC institutions are encouraged for both renewals and new submissions. For projects previously led by U.S. institution/PI(s), applicants are encouraged to transfer the leadership to the LMIC partner. If such decision is not made, please explain the reasoning why the shift is not being proposed.

      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 additional information: https://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx.

      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 eligible to apply.

      Applications from a non-domestic (non-U.S.) component of a U.S. Organization must include an LMIC partner that is not a component of a U.S. organization.

      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 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/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, using their recommendations to determine the appropriate allotment of funds.

      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.

      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 in order to fill research capacity gaps at the LMIC institution.

      All long- and medium term (more than one month) 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.

       

      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 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:

      Marya Levintova, Ph.D.
      Telephone: 301-496-9535
      Email: levintovam@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 appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and intended trainee outcomes.

      Other Attachments.

      Training Advisory Committee

      While a Training Advisory Committee (TAC) is not a required component, applicants are encouraged to include a TAC to improve the oversight of the training program.  However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training [program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file “Advisory_Committee.pdf”.

      Progress Report

      A “Progress Report” attachment is required if the type of application is a renewal.

      Follow the Training (T) Instructions in the SF424 (R&R) Application Guide regarding the content for reporting accomplishments of the training program.  Please name your file “Progress_Report.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.

      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, with the following additional modifications:

      Training Budget

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

      • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff
      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- NOT ALLOWED
      • 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:

      • International Program Training Data Tables are required.
      • 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

       

      Program Administration.

      Describe the strengths, leadership and administrative skills, training experience, trauma and injury expertise, and active research of the PD/PI(s). Relate these strengths to the proposed management of the training program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize but not overlap with the “Multiple PD/PI Leadership Plan” section of the application.

       

      In the event that a clinical trial may be proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by Trainee(s).

       

      LMIC institutions with existing FIC research training programs must explain what distinguishes this program from the others, how the programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential trainees and resources are robust enough to support additional training programs.

       

      When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate the program must be included in the application.

      Proposed Faculty

      For U.S. and other High-Income Country (HIC) faculty mentors, describe their international trauma and injury research and research training experience in the LMIC country that is the focus of the application.

       

      Describe in detail the roles faculty and mentors from LMICs with trauma and injury expertise will play in the proposed programs to insure the LMIC relevance of the proposed research training.

       

      For applications proposing clinical trials, describe the expertise, experience and ability of the faculty mentors to provide guidance on the organization, management and implementation of clinical trials.

      Proposed Training

      The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in project management. 

      In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by Trainee(s). 

       

      Applicants are encouraged to include a timeline which includes all proposed training activities.

      Trainee Candidates

      Describe the size and qualifications of the pool of trainee candidates including information about the types of prior trauma and injury educational background and applied experience, clinical and research training and career level required for the program. Do not name prospective Trainees.

      LMIC predoctoral and postdoctoral trainees should be selected based on academic achievements, interest in trauma and injury research, or documented evidence (trauma and injury or related degrees or experience, publications, fellowships or grants), as well as interest/commitment to training/career in trauma and injury research and related fields.

      Applicants are encouraged to develop strategic plans for the recruitment, selection and training of a cohort of predoctoral and postdoctoral trainees most likely to result in a sustainable critical mass for leadership in LMIC relevant trauma and injury research as well as teaching, clinical care and consultation at the LMIC institution.

      For applications proposing training in clinical trials, the recruitment and selection plans should include specific strategies to identify trainees who have clinical trials experience or the potential to organize, manage and implement clinical trials.

      For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the training program.

      Institutional Environment and Commitment to the Program

      The sponsoring and collaborating 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 protected time for LMIC trainees selected for the program to complete all proposed training activities. This commitment may also include PD/PI or faculty salary, stipend or tuition support for individuals involved in the proposed training program, or other resources essential to a successful training program.

       

      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.

       

      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.

       

      Applicants are strongly encouraged to develop and/or adapt predoctoral and postdoctoral courses in the responsible conduct of research that take the local context into consideration and include LMIC faculty.

      Program Faculty.

       

      If any mentors will supervise a Trainee proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.]

       

      Trainee Candidates.

      In the event that a clinical trial may be proposed, discuss the potential of prospective Trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

      Appendix

       

      Not Allowed.

      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

      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 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 Fogarty International Center, 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.

      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 objectives, design and direction of the proposed research training program likely to ensure effective training?
      • Are the research facilities and research environment, including institutional commitment to the training program, administrative and research training support conducive to preparing trainees for successful careers as trauma and injury research scientists and to ensure the success of the program?
      • Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire skill and expertise in transparent, rigorous, and reproducible research methodologies and state-of-the-art scientific methods and tools applicable to the goals of the training program, including relevant areas of data science?
      • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
      • Does the proposed program provide suitable training for the level of trainees being proposed and the area(s) of science to be supported by the program?
      • When applicable, is there adequate documentation describing the responsibilities of the training advisory committee with regard to the provision of input, guidance and oversight of the program?
      • If clinical trials may be proposed by the Trainee(s), 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 feasibility or ancillary study at the proposed site(s) or centers?
      • If applicable, are there 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?

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

      • Does the PD/PI have the scientific background, 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?
      • 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?
      • With regard to the proposed leadership for the training program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?

      Preceptors/Mentors

      • Are sufficient numbers of experienced LMIC, U.S. or other HIC preceptors/mentors with appropriate trauma/injury expertise, and funded research projects, capable of supporting the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
      • Do the 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 preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) 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?
      • Do the preceptors/mentors who will supervise the Trainee(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of a clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

       

      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 and re-appointment criteria as well as retention strategies?

      • Do the grants plan to recruit trainees have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
      • Are there plans to provide instruction in data management, statistics and Good Clinical Practice (GDP), relevant to clinical trials to the prospective Trainees?

       

      Training Record

      • For renewal applications, how successful are the trainees (or, for new applications, other past students/postdoctoral trainees in similar training) in completing the program?
      • For renewal applications, has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctoral trainees 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?
      • For renewal applications, how successful are the trainees (or, for new applications, other past students/postdoctoral trainees 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?
      • To what extent do trainees’ subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their research training and directly benefit the broader biomedical research enterprise?
      • 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?

      ·        For applications that request short-term research training positions, is there a record of retaining health professional trainees in research training or other research activities for at least two years?

      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

      Not Applicable.

      Renewals

      For Renewals, the committee will consider the progress made in the last funding period, including on the Training in the Responsible Conduct of Research.

      Does the application describe the program’s accomplishments over the past funding period(s)?

      Is the program achieving its training objectives?

      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 (may not be applicable to short-term training)?

      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 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?

      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 for Scientific Review (CSR), 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.

      Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

      Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center's 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.
      • Consideration of programmatic, institutional 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 recipient’s business official.

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

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

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

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

      Institutional Review Board or Independent Ethics Committee Approval: 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).

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

      2. Administrative and National Policy Requirements

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

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

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

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

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

      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 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 (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

      Recipients are requested to annually update and maintain data regarding their trainees in NIH's CareerTrac (https://careertrac.niehs.nih.gov/).

       

      A final RPPR, the expenditure data portion of the Federal Financial Report, are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final Progress Report.

       

      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)

      Marya Levintova, Ph.D.
      Program Director
      Fogarty International Center (FIC)
      Telephone: 301-496-9535
      Email: levintovam@mail.nih.gov

      Richard T. Benson, M.D., Ph.D.
      National Institute of Neurological Disorders and Stroke (NINDS)
      Email: Richard.benson@nih.gov
      Telephone: 301-827-9071

      Jeremy Brown, M.D.
      National Institute of Neurological Disorders and Stroke (NINDS)
      Telephone: 301-827-8375
      Email: jeremy.brown@nih.gov

      Xenia Tigno, Ph.D.
      Program Director
      Office for Research on Women's Health (ORWH)
      Telephone: 301.496.3934
      Email: xenia.tigno@nih.gov

      Peer Review Contact(s)

      Yuanna Cheng, Ph.D.
      Center for Scientific Review (CSR)
      Telephone: 301-435-1195
      Email: chengy5@mail.nih.gov

      Financial/Grants Management Contact(s)

      Mollie Shea
      Grants Management Officer
      Fogarty International Center (FIC)
      Telephone: 301.451.6830
      Email: Mollie.Shea@nih.gov

      Chief Grants Management Officer
      National Institute of Neurological Disorders and Stroke (NINDS))
      Email: ChiefGrantsManagementOfficer@ninds.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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NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.