Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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.

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

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

The World Health Organization's (WHO) accepted definition of an injury is "the physical damage when a human body is suddenly subjected to energy in amounts that exceed the threshold of physiological tolerance - or else the result of a lack of one or more vital elements, such as oxygen." Causes of injuries are usually divided into "unintentional" and "intentional" categories. Although the terms injury and trauma are used interchangeably by WHO and other organizations, the American Psychological Association defines trauma as "an emotional response to a terrible event like an accident, rape or natural disaster."

Injury and trauma are among the leading causes of death and disability in the world. Injuries are among the top five leading causes of death globally among people ages 5 to 49 years. WHO estimated that more than 5 million deaths occur per year globally due to injuries, more than the combined deaths due to HIV/AIDS, tuberculosis, malaria and Ebola in 2014. Road traffic injuries are the leading cause of death globally among 15 to 29 year olds http://www.who.int/violence_injury_prevention/media/news/2015/Injury_violence_facts_2014/en/. The greatest proportion of the burden of injury falls in LMICs, where sufficiently trained health workers, infrastructure and financial support are limited.

Injury and trauma are also major contributors to disability globally. For every death due to injuries, several thousand injured persons survive and often suffer life-long health consequences. The Global Burden of Diseases study in 2010 estimated that injuries cost the global population about 275 million years of healthy life every year, causing 11% of disability-adjusted life years worldwide. The burden of disease attributed to injuries is expected to rise in the years ahead. By the year 2020, injuries are predicted to be the third leading cause of death and disability worldwide www.who.int/violence_injury_prevention/en.

Increasing burdens from injury and trauma demand effective and timely responses from the global community. In September 2015, the United Nations General Assembly adopted the Sustainable Development Goals which include "By 2020, halve the number of global deaths and injuries from road traffic accidents." Evidence-based interventions to prevent and reduce injury and trauma-related mortality and morbidity are especially needed in LMICs. One goal of this FOA is to strengthen injury and trauma research capacity in LMICs so that scientists are better prepared to develop and/or enhance evidence -based injury and trauma interventions.

The overall objective of this Funding Opportunity Announcement (FOA) is to strengthen injury research capacity at academic institutions in LMICs through research training programs. The specific objectives of this FOA are:

• Provide in depth training in research design, methods, and analytic techniques appropriate for the proposed research area(s);
• 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 and Ph.D.) in injury and trauma research; and
• Support research faculty/mentors to strengthen injury and trauma research capacity at LMIC institutions, and to contribute to national and global injury research initiatives and networks.

ORWH: 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: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf

FIC: FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular 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

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, nurses, 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

Applications may incorporate a combination of a wide range of long-, medium- and short-term research training opportunities. Training can take place in the U.S. or a foreign country, but training-related research should be carried out mainly in the LMIC. While a range of short-, medium- and long-term training is allowed, emphasis should be on long-term training that will lead to advanced degrees in injury and trauma research for the trainees.

• Long-term (master’s and/or doctoral degree and other training that is six months or longer) training for the full range of skills necessary to support research with the understanding that the focus of thesis and training-related research will be in the trainee's country. Part-time long-term training is permitted but should be described and justified in the application.
• Medium-term (three- to up to six-months) training or mentoring, including specialized clinical, laboratory, research or administrative/business skills necessary to support research that is planned or ongoing
• Short-term (less than three months) training or mentoring that focuses on 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 other relevant areas

Additional institutional capacity-building efforts are encouraged. These may include, 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.

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, and grant writing.

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 ministries of health of the impact of trauma on national health, and inadequate public education and public communication around injury prevention issues. Compounding the problem is the fact that responsibility for injury prevention cuts across many administrative domains including public health, criminal justice, physical, health and environmental infrastructures, and road safety, among others.

Therefore, proposed research training should substantially enhance the expertise of trainees from LMICs in human injury and trauma-related research including the scientific, clinical, legal, ethical and social aspects of injury and trauma research and strengthen inter- and multi-disciplinary research within the LMIC institutions, including skills related to connecting health research with other non-health sectors. Although injuries affect everyone regardless of age, gender, income or geographic region, some populations are more vulnerable than others. Data indicate that, for most types of injuries, people die at a higher rate in LMICs than in HICs, and in the poorest sections of LMICs. Mentored research is expected to enhance trainee consideration of potential age, sex, gender and race differences in the design and analysis of injury and trauma research.

Scientific Focus

Applications must identify areas of scientific focus of injury and trauma 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 injury and trauma by demographic characteristics including age, sex, gender, race and ethnicity;
• 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;
• Long-term impact of injury and trauma specific to rehabilitation needs, disability and loss of productivity;
• 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;
• Post trauma physical and psychological rehabilitation including low-cost prosthetics;
• 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;
• Formation of interdisciplinary disaster research teams and protocols for rapid data collection efforts after injury and trauma in conjunction with national, state, and local authorities and researchers;
• 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.

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 injury and trauma-related consequences of natural disasters, epidemics, and conflicts; 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.

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

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)

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 robust and high-quality research ongoing in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to contribute to the envisioned research training program. It is anticipated that participating training program faculty will have active, funded research projects in which potential LMIC trainees may gain relevant research training experiences consistent with their career interests and goals.

An application may be submitted by 1) an eligible foreign institution in a low- or middle-income country (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. 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.

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.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Non-domestic (non-U.S) components of U.S organizations are eligible to apply as U.S. partners, not the LMIC institutions.

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at: http://grants.nih.gov/grants/ElectronicReceipt/files/Tips_for_International_Applicants.pdf.
http://grants.nih.gov/grants/ElectronicReceipt/files/international_support.pdf
http://grants.nih.gov/grants/ElectronicReceipt/files/international_qa.pdf
http://grants.nih.gov/grants/ElectronicReceipt/preparing_grantsgov_reg.htm

Guidance for International Applicants Blocked from Registration Websites: NOT-OD-11-090.

An NIH supported webinar on Electronic Submission of Grant Applications for Foreign Institutions can be found at http://grants.nih.gov/grants/webinar_docs/webinar_20120927.htm

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 should have research and research training experience in the LMIC country that is the focus of the application.

Collaboration: U.S. applicants must identify at least one LMIC scientist with expertise in the 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. Applicants are encouraged to designate the main LMIC collaborator who meets the parent grant eligibility requirement as a Multiple PD/PI.

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

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).

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.

Only individuals from LMICs (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) are eligible for training under this FOA. Individuals who also have citizenship or permanent residency in the US/ or other high income countries, are not eligible for support under this FOA.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Myat Htoo Razak, M.B.B.S., M.P.H., Ph.D.
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]

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.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA). Include the applicant institution and all of the collaborating institutions, both U.S. and foreign, as performance sites.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modifications:

Foreign Award or With Foreign Component. Check YES and list the foreign countries for all performance sites listed in SF 424 (R&R) Project/Performance Site Locations Component

Facilities and Other Resources: Include descriptions of facilities and other resources to be used for research training at all U.S. and foreign performance sites.

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., masters, predoctoral, postdoctoral, short-term, faculty), and intended trainee outcomes.

Other Attachments. Provide the plan for a Training Advisory Committee (TAC). Responsibilities, frequency of meetings, and other relevant information should be included. The composition of the TAC, the roles people should fill, and the desired expertise of the members should be described. The TAC should be composed of expert faculty and relevant professionals from the applicant country and from the United States as well as other countries, if appropriate. TAC members should not be directly involved in the training program or in mentoring trainees.

Describe how the TAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, scientific review of trainees projects, and the 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.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

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

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the following additional instructions:

Program Plan

Program Administration. Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application.

Describe the management support and commitment from the applicant institution(s) for successful implementation of the proposed research training program.

The rationale for the scientific focus and specific research capacity needs of the LMIC institution as well as the research training strategies proposed to address these needs should be presented. The rationale should include a description of the expected impact of the program on the burden of injury and trauma in the LMIC. Applicants should describe the current level of research and expertise at the LMIC institution on the proposed scientific focus and justify the need for more research training. The proposed specific aims for training should define measurable increased research capacity that will result at the end of the proposed funding period.

Program Faculty. The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation. Faculty should commit to involvement throughout the total period of the trainee's participation in the proposed program. Applicants should explain in detail how proposed U.S. and LMIC faculty mentor research grant support and activities are related to the proposed research training plan. Describe the experience and track records of faculty in training researchers from LMICs. Describe the experience of faculty in research relevant to LMIC health priorities.

Proposed Training. Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among trainees. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how trainees will be educated in the human health- and disease-related aspects of their research training.

Describe the process by which the topics for trainee research projects will be approved, how each trainee’s program will be guided, and how each trainee’s performance will be monitored and evaluated. Describe a plan for mentorship that will support trainees while in any formal coursework and while conducting training-related research relevant to the specified scientific area(s). Describe the plans proposed for a scientific oversight committee to monitor the selection and performance of mentored research projects and their compliance with federal requirements for protection of human subjects in research and animal care and use in research

Include information about curricula, seminars, workshops, or tutorials that will be incorporated into the training program. Describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next steps in varied injury and trauma research career options available.

Provide a five-year training implementation plan that provides the rationale for the balance of training options (degree-related and non-degree, long-, medium- and short-term training), the areas/disciplines selected for training and the training sites selected for the training. Applicants are encouraged to submit a time line that includes proposed training activities. Describe courses and research opportunities that will be available to trainees at each of the participating institutions or other identified training sites. Describe a plan for mentorship that will support trainees while in formal coursework and while conducting training-related research relevant to the specified scientific topic. Describe the plans for the integration of the proposed training with other relevant capacity building activities at the LMIC institution. Provide information on the record of the applicant institution's achievements regarding success of the research trainees in their career paths.

Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences. Describe a plan for retaining students in the program until completion. Describe strategies that will be used to encourage and prepare trainees to pursue further research opportunities in their LMIC.

Proposed research training can take place in the U.S. or a foreign country, but training-related research should be carried out mainly in the LMIC.

Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs. Programs should provide all trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future fellowships as eligible and career development and independent research support. All postdoctoral trainees should also be provided with instruction in project management.

For programs that propose short-term training, any didactic training must be well structured and appropriately justified for the duration of the training experience. Short-term trainees must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career.

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

Program Evaluation. Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program and used to increased research capacity at the end of the five-year funding period in the specific scientific topic for which the training program is proposed. Describe how the data for those measures will be collected and how they will be monitored over the five-year period.

Trainee Candidates. Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for trainees reappointment to the program. Describe the role of the LMIC institution faculty and the TAC in the recruitment and selection process. Describe the evaluation criteria to be used in the selection of trainees. Criteria should include a list of standards that will be used to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and are likely to contribute to the increased capacity of the LMIC institution in the specified scientific area. Describe recruitment efforts to attract women and other populations who are under-represented in sciences in that LMIC to apply for training opportunities.

Institutional Environment and Commitment to the Program.

The sponsoring institution 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. The application must include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful training program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed program from existing ones at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.

Recruitment Plan to Enhance Diversity

Do not complete this section of the application.

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 Chapter 8 of the SF424 (R&R) Application Guide.

Progress Report

Renewal applications should include progress reports with detailed information about trainee and activities supported during the previous grant period. Describe any specific effects of this training program on curriculum and/or research directions. Applicants should summarize the major contributions to injury and trauma research capacity at the LMIC institution made by the research training program in the previous grant period.

Data Tables

Particular attention must be given to the required Training Data Tables. All applications must complete Data Tables 2 and 4. Data Tables 5a and 5b should be submitted with data for only pre-doctoral and post-doctoral trainees from the LMIC that is the focus of this application.

Renewal applications must submit Data Tables 6, 12A,12B for trainees supported by the grant. Training Data Tables 1, 3, 7a, 7b, 8a, 8b, 9a 9b, 10 and 11 are not required.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

This initiative is not subject to intergovernmental review.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

• Are the research facilities and research environment conducive to preparing trainees for successful careers as injury and trauma researchers? 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? Does the program provide appropriate inter- or multidisciplinary research training opportunities?
• Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as injury and/or trauma researchers?
• Is the proposed program of training likely to ensure that LMIC trainees will be prepared for successful and productive scientific careers in their country?
• Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?
• Does proposed LMIC institution have adequate existing injury and trauma research programs to support the proposal?
• If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
• Is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program
• Are there plans appropriate oversight of the selection and performance of mentored research projects in training related research areas, including compliance with federal requirements for protection of human subjects in research and animal care and use?

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?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• 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?

Preceptors/Mentors

• Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees 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 US and LMIC preceptors/mentors have strong records of training individuals from LMICs at the level of trainees proposed in the program?
• Are the quality and extent of the mentors roles in providing guidance and scientific advice to the trainees acceptable?
• Are the mentors currently engaged in research relevant to LMIC health priorities?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified candidates for the training program?
• Are the size and quality of the applicant pool adequate to support the program at each of the proposed levels?
• Are the recruiting procedures and trainee selection criteria as well as retention strategies appropriate and well defined?

Training Record

• How successful are the trainees (or, for new applications, other past students/post-doctoral trainees in similar training) in completing the program?
• How productive are trainees (or for new applications, other past LMIC students/fellows) in terms of research accomplishments and publications?
• How successful are the trainees (or, for new applications, other past students/post-doctoral 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?
• 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?
• Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

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 Children

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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period and the success of the program in attracting and retaining trainees and achieved its training objectives. Does the application describe the program s accomplishments over the past funding period(s)? Has the program evaluated the quality and effectiveness of the training experience? Is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that would improve or strengthen the training experience based on the results of program evaluation? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

Revisions

Not Applicable

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

Not Applicable

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, pre-doctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

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

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

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.

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

As part of the scientific peer review, all applications:

• 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 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 FIC 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.
• Relevance to the FIC Strategic Plan
• Scientific content for program balance
• Relevance to the interests of co-funding organizations.
• Geographic balance

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.

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

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.

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.

Not Applicable

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.

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

A final progress report 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. Evaluation results should be included as part of the final Progress Report.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Myat Htoo Razak, M.B.B.S., M.P.H., Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]

Ruth Brenner, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3530
Email: [email protected]

Bamini Jayabalasingham, Ph.D.
The Office of Research on Women’s Health (ORWH)
Telephone: 301-435-1040
Email: [email protected]

Eileen Bradley, D.Sc.
Center for Scientific Review (CSR)
Telephone: 301-435-1179
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: [email protected]

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

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