Required Application Instructions

It is critical that applicants follow the 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.

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

Purpose

The purpose of this program is to foster the next generation of global health scientists in the U.S. and in low and middle income countries (LMICs) by giving scientists, early in their careers, a mentored research training experience in global health at established biomedical and behavioral research sites in LMICs. In addition, it seeks to enhance research capacity at the foreign research sites by providing financial support and training for young researchers at those institutions.

Established in 2004, the Fogarty Scholars Program provided early research training and career opportunities for doctoral students in the health professions from the U.S. and LMICs to participate in one-year mentored clinical research projects in LMICs. An expansion of the Program added opportunities for post-doctorates from the U.S. and LMICs (Fellows Program) in 2008. The program was restructured in 2012 and reissued as the Global Health Program for Fellows and Scholars (R25). Collectively, these programs have supported over 900 individuals, both post-doctoral and post professional degree participants and current PhD, MD and other Health-related professional participants, who have published over 1200 peer-review publications in a wide variety of infectious and non-communicable disease areas. In the current program, awards were made to 5 U.S. consortia to support research training at over 80 collaborating U.S. government-supported sites in 27 LMICs. For more information on the current program, see: http://www.fic.nih.gov/Programs/Pages/scholars-fellows-global-health.aspx .

This FOA provides opportunities for up to five consortia (each composed of up to four U.S. universities and their collaborating partners in LMICs) to develop and support global health research training programs that meet the following objectives:

• Provide one year mentored research training opportunities for trainees in diverse areas of global health research at established biomedical and behavioral research sites in LMICs.
• Encourage research projects that lay a strong foundation in rigorous research design, methods, and analytic techniques appropriate for the proposed research area.
• Enhance the ability of trainees to conceptualize and think through research problems with increasing independence.
• Enhance the global health research career potential of the participants.
• Strengthen global health programs at U.S. academic institutions and enhance the capacity to sustain global health research at institutions in LMICs.

Consortia for this program are expected to provide supportive mentorship, research opportunities and a collaborative research training environment for trainees from the U.S. and LMICs to enhance their global health research expertise and careers. The program will provide research training opportunities in priority health areas in LMICs such as communicable diseases including HIV/AIDS; chronic non-communicable diseases such as cancer, cardiovascular diseases, lung diseases, blood diseases, mental health, and neurological diseases and stroke; women’s health; and behavioral and social aspects of health and illness. Cross-cutting global health research areas are also encouraged.

These awards may be used to strengthen existing partnerships between U.S. and LMIC research institutions. This program should also aim to enhance global health research capacity at the participating institutions and contribute to the use of research to improve treatment, identify preventive measures, promote evidence-based policy, and groom future generations of health scientists who can ultimately improve the health outcomes related to these areas in the applicants' community and country (both U.S. and LMIC).

The research training sites in LMICs are expected to have existing capacity to provide an outstanding mentored research training experience. Each site is expected to have capacity for strong ethical review and oversight of research, committed interest and expertise in mentoring trainees, appropriate research facilities, and at least one active multi-year research training grant, research education grant, or on-going research project funded by NIH and/or other international funding agencies.

Applicants should form a consortium that may include up to 4 U.S. academic institutions and six or more additional collaborating institutions or research project sites in LMICs. In choosing consortium partners, consideration should be given to U.S. and LMIC institutions and research training sites that provide faculty and mentors with diverse expertise, have established ongoing relevant and high quality research projects, have a prior history of successful collaboration among the partners, and provide a wide pool of outstanding trainee candidates. Applicants may wish to consider including collaborating LMIC sites that hold grants supported by the NIH participating components on this FOA. While not required, it is strongly suggested that one of the U.S. consortium institutional partners be a designated "minority-serving institution" (see also instructions on "enhancing diversity").

Applicants are encouraged to recruit graduates from NIH-funded T32 post-doctoral research training programs as one source of U.S. post-doctoral candidates for the program. Applicants are also encouraged to include advanced doctoral students (taking time off from their degree programs or incorporating the research training into their doctoral research) and post-doctoral scientists in the health professions (e.g., medicine, dentistry, nursing, public health, as well as veterinary students interested in One Health) from both the U.S. and LMICs as potential trainees. LMIC partners may consider graduates of other FIC and NIH training and education programs at their institutions, or students trained under NIH research grants, as one source of LMIC trainees. However, this program should not duplicate other funded research training opportunities at the participating institutions.

Specifically, applicants are expected to:

• Develop and implement a global health research training program, including research experiences and technical and/or professional skills development appropriate for the selected trainees.
• Develop strategic partnerships with established research, research training and research education sites (preferably long-standing NIH-funded programs) in LMICs. Applicants should collaborate with at least six LMIC institutions or research sites appropriate for training,
• Develop and implement a process for recruitment, selection, and placement of participants every year (for U.S. and LMIC trainees), and describe specific selection criteria to be used.
• Provide additional technical training for trainees, as needed, at either U.S. or LMIC institutions to enhance the quality of the research performed. This may require bringing LMIC or US trainees to US institutions for short supplemental training to augment the one year research training at the LMIC site
• Recruit both U.S. and LMIC trainees. Applicants may propose a "twinning" model, where appropriate, that would allow U.S. and LMIC scientists in the same field or in divergent but complementary fields to work together on projects or both participate in the same larger research project or research site. Projects focused on single health issues that require multidisciplinary teams may also be considered.
• Develop and implement mentoring and research training plans for all trainees. This may also include Individual Development Plans.
• Develop an evaluation plan to track trainees and the outputs, outcomes, and impacts of the program on the careers of trainees and the capacity of participating U.S. and LMIC institutions.
• Provide research training opportunities for participants in diverse global health priority areas that significantly impact morbidity and pre-mature mortality in LMICs.
• At least 50% of trainee projects should focus on HIV/AIDS, or HIV/AIDS comorbidities in the context of people living with HIV/AIDS, and be consistent with the NIH guidance for "high priority" HIV/AIDS projects (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html ).
• The number of trainees from LMICs should be no more than 50% of the total, recognizing that additional opportunities for LMIC trainees are also available through other FIC research training and research education programs at these sites.

The Fogarty International Center (FIC) is interested in all eligible applications relevant to its mission. The FIC Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) states the following relevant goals: 1) Build research capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5) Build and strengthen partnerships to advance global health research and research capacity.

The National Institute of Mental Health (NIMH) is interested in applications that focus on mental disorders in LMICs, specifically conditions and disorders of brain structure and function that affect cognition, social and emotional processing, and behavior and are leading causes of disease burden worldwide, estimated on the basis of disability adjusted life years (DALYs). For example, disorders of interest include, but are not limited to depressive disorders, schizophrenia, bipolar disorder, autism spectrum disorders, and posttraumatic stress disorder. NIMH is particularly interested in research that addresses disparities in access to mental health care in LMICs, early detection and early intervention, integration of mental health care into care for chronic, non-communicable or communicable diseases and/or implementation science in LMIC contexts. These themes are consistent with B, C, E, and F of the Grand Challenges in Global Mental Health (i.e., advance prevention and early intervention; improve treatments and expand access to care; build human resource capacity; and transform health system and policy responses; http://www.nature.com/nature/journal/v475/n7354/pdf/475027a.pdf). NIMH is also interested in applications that investigate the optimal combination of mental health interventions (e.g., screening and care) to ensure the most effective HIV testing, linkage to care, and treatment approaches.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting trainees with relevant research projects across the spectrum of neurological, neuromuscular and neurovascular diseases and disorders in all ages. In addition to prevalent neurological disorders and stroke, NINDS is also interested in supporting research in areas of rare and neglected neurological diseases that are relevant to the Low- or Middle-Income Countries (NINDS Disorder Index http://www.ninds.nih.gov/disorders/disorder_index.htm).

The Office of Research on Women’s Health (ORWH) is interested in funding applications that address issues associated with women s health and/or the influences of sex/gender in health and disease. Additionally, ORWH is committed to supporting women in the biomedical workforce. Information about ORWH’s strategic plan can be found at: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf.

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)

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(s) and their collaborating partners must have robust and high quality research ongoing in the areas proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities to conduct the proposed program. The proposed program may complement (but not duplicate) other ongoing research training programs occurring at the consortium institutions. It is anticipated that a substantial number of program faculty will have active research projects at the LMIC research sites in which trainees may gain relevant experiences consistent with their research interests and goals.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Only institutions and research sites in low and middle income countries, as defined by the World Bank classification system (http://data.worldbank.org/about/country-and-lending-groups) and as restricted by NOT-TW-12-011 'Notice of Change in Country Eligibility for Fogarty International Training Grants', are eligible to participate; foreign trainees must be nationals of these eligible countries.

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.

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 one of the scientific areas in which training is proposed, experienced in conducting research and research training in at least one of the proposed LMIC training sites, and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI, working with the leadership of the consortium including collaborating partners at LMIC research sites, 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(s) 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 Training Advisory Committee, and implementing their recommendations.

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

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).

Only one application per US institution is allowed. Each U.S. institution may have a role as the applicant institution or as a member of a consortium designated in an application from another U.S. institution, but may not participate in two different consortia.

Research training institutions or research project sites in LMICs can participate in more than one consortium if they have established collaborations with at least one U.S. faculty member of each consortium.

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.

U.S. trainees must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship are available in the NIH Grants Policy Statement. LMIC trainees must be a citizen of an eligible LMIC (see above), in most cases as a citizen of the country in which the research will be conducted.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.

Trainees are expected to spend 12 months in training, except with prior approval of the FIC Program Officer. In rare instances, an outstanding trainee may be renewed for a full or partial second year in order to allow promising research to be completed.

Pre-doctoral trainees must be enrolled in a graduate program leading to an MD, PhD or an equivalent doctoral or health professional degree. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs are also eligible.

Postdoctoral trainees must have received, as of the beginning date of the training period, a Ph., MD, DDS., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research.

Applicants must obtain 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:

Flora Katz, Ph.D.
Telephone: 301-402-9591
Fax: 301-402-0777
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.

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

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of training, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, ), and intended trainee outcomes.

Other Attachments. A Training Advisory Committee (TAC) is a required component of a training program. 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. A wide range of scientific expertise to reflect the scope of the training proposed is recommended. Do not name individual members. Describe how the Advisory Committee will evaluate the overall effectiveness of the program and may contribute to the selection of trainees. Advisory Committees may be composed of external members and/or individuals associated with the U.S. and LMIC consortium institutions. 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. Key collaborators at the LMIC training sites should be named and included as key personnel on the application. A lead LMIC collaborator should be named for each proposed research.

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

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

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 orientation meeting at NIH.
• 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 Include costs for each trainee to attend the annual orientation meeting at the beginning of their research training year.
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification section.

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

• Training Program Section
• Faculty, Trainees, and Training Record
• Other Training Program Section
• Appendix

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

Particular attention must be given to the following required Training Data Tables: 5A, 5B, 8A (Part I only), and 8C (Part I only). For renewal applications, only include participants (termed Fellows and Scholars) supported during the prior grant period of RFA-TW-11-001 and indicate this on the forms. For new applications, only submit data for individuals who were trained in the last five years by the key personnel listed on this application, and list only pre-doctoral and post-doctoral trainees from LMICs or U.S. trainees who conducted research projects in LMICs. Summarize this information in the text of the application, refer to these Tables, and describe how the data were restricted, as instructed in this paragraph.

No other Training Data Tables should be included.

Training Program

Program Plan

Program Administration. Describe the strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI and U.S. and LMIC consortium leadership. 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. A leadership plan for each consortium is required. 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.

Program Faculty. The application must include information about the U.S. and LMIC 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 stages from the U.S. and from LMICs. A significant number of the U.S. and LMIC faculty should have HIV/AIDS research experience, and the faculty overall should have the breadth of expertise to cover the range of scientific areas proposed for training. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation. Describe prior collaborations between U.S. and LMIC faculty. Key LMIC faculty should be named and included as key personnel on the application. Describe their roles in recruitment, selection, and mentoring of trainees in the program.

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. The applicants should propose a training program where the majority of trainees receive a one-year rigorous, mentored training experience at an LMIC research site. Applicants should describe how all training research projects will receive an independent scientific review, according to scientific review procedures established by the consortium. If it is anticipated that trainee research projects will involve human subjects, applicants should describe how these trainees will receive education in the protection of human subjects and obtain approval from an institutional (or ethical) review board or committee at the U.S. applicant institution and at the institution where the research will be conducted. In rare instances, at the discretion of the PDs/PIs or leadership committee, outstanding trainees may be extended for up to one additional year, to allow them to complete their projects and to provide a bridge to subsequent grant funding or career positions.

The program should include both pre-doctoral/pre-professional degree trainees and post-doctoral/post-professional degree trainees early in their careers. At least 60% of training slots should be reserved for postdoctoral trainees. Applicants should describe plans for how the most qualified U.S. and LMIC trainees will be recruited for the proposed research training program. It is expected that the majority of trainees will be recruited from the participating U.S. and LMIC institutions involved in the consortium. 50% of trainee projects must focus on HIV high priority research areas (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html).

The focus of the program should be to provide all trainees with instruction and training in rigorous research design, research ethics and statistical analysis through mentored research training experiences. In addition, short supplemental training may be provided for individual trainees in specific research skills or methods directly applicable to trainee research projects; or for enhancing research leadership, management or career development skills, including in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should be provided with instruction in laboratory, field, and/or project management. Supplemental training may take place at any participating institution in the U.S. or the LMIC.

Special workshops to enhance the quality of the research training, such as workshops to strengthen faculty mentoring skills at the collaborating LMIC institutions, may also be supported and would contribute to research capacity building at those institutions.

Selection of Research Training Sites and Capacity Building in LMIC.

Based on the experience from the current Global Health Fellows and Scholars program, we encourage applicants to include at least 6 LMIC research collaborating sites in each consortium to provide diverse research training experiences in a wide range of health areas for the trainees. A significant number of LMIC training sites must have HIV/AIDS research opportunities and grant support. For each proposed collaborating LMIC research site:

• Document that it has at least one active multi-year research, research training or research education grant, funded by the NIH (preferred) or by other U.S. government or international funding agencies; strong ethical review and oversight of research; committed interest and experience in mentoring students; appropriate research facilities; appropriate faculty expertise to oversee trainee projects (as documented by publications and funding in those areas); written personal safety procedures in place; and the ability to comply with U.S. government regulations for research grants;
• Document that it has an established collaboration (of at least two years duration) with at least one faculty member of the U.S. consortium institutions in research, research training or research education;
• Give examples of the types of potential research projects that can be supported and relate these areas to important health challenges in the LMIC or critical issues in Global Health.
• One goal of this program is to enhance the research capacity at the collaborating foreign institutions. Describe how this program will contribute to the research training needs and research capacity of the collaborating LMIC institutions.
• Applicants with existing related research training programs must explain what distinguishes the proposed program from existing programs at the U.S. or LMIC institution, how these programs will synergize with one another, if applicable, and demonstrate that the pool of faculty, potential trainees, and resources are robust enough to support an additional program.

Institutional Environment and Commitment to the Program

Applicants should describe the institutional environment and commitment of the US and LMIC members of the consortium. This might include the availability of T32 programs at the U.S. institutions and other sources from which U.S. trainees will be recruited, and training programs and other sources from which LMIC trainees will be recruited. Applicants are required to have letters of collaboration and commitment from all participating U.S. and LMIC consortium members.

Applicants should describe the research environment, potential research training scientific areas, and corresponding scientific expertise for mentoring trainees available at these sites.

Recruitment Plan to Enhance Diversity

Include a recruitment plan to enhance diversity, including gender diversity. Minority and disadvantaged categories apply to the U.S. trainees.

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.

Letters of Support

Letters of support from the lead collaborator at each LMIC training site and any key collaborators at the LMIC training sites should be included

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.

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

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

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.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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 at the proposed LMIC research sites conducive to preparing trainees for successful careers as biomedical research scientists in the context of global health?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
• Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
• Does the training program focus on important problems or critical issues in global health?
• Are the research facilities and research environment at the U.S. institutions conducive to provide any supplementary training proposed in the application?
• Do the LMIC research sites chosen provide sufficient scientific breadth and opportunities for training in a wide enough variety of scientific areas to meet the goals of the training program?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Is the proposed training program likely to prepare trainees for and motivate trainees to pursue careers in global health?
• Will the mentoring plan improve the research skills as well as the career trajectory of the trainees (both U.S. and LMIC)?
• Do the collaborating LMIC research training sites chosen leverage high quality, funded research projects?
• Will the proposed training plan contribute to enhancing research capacity at the collaborating LMIC institutions and/or research sites?
• Will the proposed training plan strengthen global health programs and capability at the collaborating U.S. institutions?
• Is there evidence of strong prior collaboration between the participating institutions and individuals?

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

• Does the PD(s)/PI(s) have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program related to global health?
• Does the PD(s)/PI(s) 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 PD(s)/PI(s)?
• Do the multiple PDs/PIs have complementary scientific expertise that is likely to contribute to providing diverse and rigorous training experiences for the trainees?
  
  
• 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?
• Do the multiple PDs/PIs have complementary scientific expertise that is likely to contribute to providing diverse and rigorous training experiences for the trainees?

Preceptors/Mentors

• Are sufficient numbers of experienced U.S. and LMIC preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees 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 in global health?
• Do the preceptors/mentors have strong records of training individuals at the level of trainees proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program from both the U.S. and from participating LMIC research institutions?
• Are there well-defined and justified selection criteria and a well-defined selection process?
• Is the proposed plan to balance postdoctoral and doctoral trainees, and U.S. and LMIC trainees, well described and justified?

Training Record

• Has the training program (or, for new applications, other training programs at the institutions) provided training in a wide variety of fields and drawn from a wide pool of applicants in multiple scientific fields to expand the global health pipeline?
  Has the training program ensured that trainees are productive (or, for new applications, other past students/post-doctorates 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?

• 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?

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, including on the Recruitment Plan to Enhance Diversity, and 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 is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

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 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 scores.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted 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 appropriate participating IC Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Relevance to the priorities of the participating ICs.
• Geographic balance in the distribution of collaborating LMIC institutions

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.

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.

Based on the need to strengthen the Global Health Fellows and Scholars Program, additional collaborating training sites in LMICs that meet the eligibility requirements for the Program can be included in the consortium after the awards are made, with prior approval from FIC.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

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.

Applicants are encouraged to use the FIC CareerTrac System, https://careertrac.niehs.nih.gov/auth/login to annually update data on trainees during their training period.

A final Progress Report, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement.

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

Flora Katz, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9591
Email: [email protected]

Pamela Y. Collins, MD, MPH
National Institute of Mental Health (NIMH)
Telephone: 301-443-2847
Email: [email protected]

Claudia S. Moy, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Jennifer Plank-Bazinet, Ph.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-496-8931
Email: [email protected]

Hilary D. Sigmon, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-357-9236
Email: [email protected]

Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: [email protected]

Tamara Kees

National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Tijuanna E. DeCoster, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
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.