Part 1. Overview Information

Key Dates

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

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

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



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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development  website.

The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of “protected time” (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, recipients will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

Program Description

Opportunities to advance global health research careers are central to building a robust global health workforce, yet it remains a challenge for researchers to establish independent international research careers given the requisite time spent away from their home institutions. Prolonged field experience is critical for global health research and for establishing sustained research partnerships, but gaining this field experience can be difficult for junior faculty, who are balancing administrative and teaching requirements, or for individuals in standard postdoctoral positions. The International Research Scientist Development Award (IRSDA) program addresses this need and fills an important global health career development gap. The IRSDA program provides opportunities to conduct mentored global health research in low- and middle-income country (LMIC) settings and to foster long-term research collaborations that strengthen global health research.  

The objective of the IRSDA program is to prepare qualified advanced postdoctoral research scientists and recently-appointed junior faculty (see Eligible Individuals) for research careers that will have a significant impact on the health-related research needs of LMICs. IRSDA awardees will conduct their research and career development activities under the guidance of experienced U.S.-based and LMIC-based mentors, in any health-related discipline that is relevant to the health priorities of the LMIC.

Awardees must spend a minimum of 50% of the cumulative effort over the project period (all years) physically in-country conducting collaborative research at the LMIC institution. In addition, in each year of the award, the recipient must spend a minimum of three months in the LMIC (see In-country requirement under Eligible Individuals in Section III). Awardees are expected to gain increased capabilities in collaborative research skills in low-resource settings, advanced research methodology, analysis and data management, research administrative skills, responsible conduct of research, scientific presentation, and manuscript and grant writing. Through this program, it is expected that awardees will launch independent global health research careers, continue to collaborate with LMIC scientists on research that addresses the health needs of their countries, and become competitive for new research project grant (e.g., R01) funding in global health.

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).

Interests of Participating NIH Institutes and Centers

The Fogarty International Center (FIC) is interested in applications from individuals seeking to become independent investigators and global health research leaders in any therapeutic or scientific area of health priority and scientific importance to the LMIC. FIC is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular focus on LMICs. The IRSDA is responsive to the FIC Strategic Plan to build research capacity through individuals, institutions and networks by building future research leaders in the U.S. and in LMICs.

The National Cancer Institute (NCI) is interested in applications from individuals committed to an independent career in global cancer research, who propose mentored research projects in topics relevant to the LMIC where the research will be conducted. NCI is interested in applications that include, but not limited to, studies in cancer biology and genetics, cancer epidemiology, research in cancer primary and secondary prevention, clinical and translational research, implementation science and health systems research, health surveillance and cancer informatics research, studies in integrative oncology and cancer survivorship as well as investigations that employ technology (including mhealth and ehealth) to address cancer control. Applications that propose capacity development in research methods across disciplines that might be relevant to LMIC setting including, but not limited to, clinical and translational research, behavioral and social sciences research, patient reported outcomes research, are encouraged. The career development plan should include training in advanced scientific skills, research methodology, data management and analysis, grant and manuscript writing, and research administration skills that are appropriate for the LMIC. The proposed career development and mentoring must be focused on developing independent researchers in the field of cancer in a manner that increases the research capacity at the LMIC institution. Mentors should have a track record of research in cancer.

The mission of the National Institute on Deafness and Other Communication Disorders (NIDCD) is to improve the lives of the millions of people with hearing loss and other communication disorders, spanning functions of hearing, balance, taste, smell, voice, speech, and language. For the purpose of this initiative, NIDCD is especially interested in applications focused on the following topics within the NIDCD mission: otitis media, hearing loss, early hearing detection and intervention including newborn screening programs, chemosensory loss, health services, habilitation and rehabilitation services, dissemination and implementation research, and cultural and linguistic adaptations of diagnostic and intervention tools for communication disorders. Applications from US institutions including components at institutions within a geographic region that share the same spoken language (e.g., Spanish in Latin America, Arabic in the Middle East and North Africa, etc.) could offer special opportunities for regional collaboration. Prospective applicants are encouraged to review the current NIDCD Strategic Plan on the NIDCD website.

Additional Information

For applications proposing HIV/AIDS research projects, applicants are encouraged to review the NIH HIV/AIDS Research Priorities, and the NIH Plan for HIV-Related Research for the year they are applying.

Candidates are encouraged to review answers to frequently asked questions about the IRSDA K01 program at IRSDA FAQs, which will be updated on a regular basis.

Individuals who are unable to meet the requirement to spend a minimum of 50% of the cumulative effort over the total project period (all years) and the additional requirement to spend a minimum of three months each year conducting research physically in the LMIC are encouraged to consider other NIH career development awards (see https://researchtraining.nih.gov/programs/career-development), many of which support global health research in LMICs.

Individuals from LMICs (individuals who are not U.S. citizens, non-citizen nationals or permanent residents) are not eligible for the IRSDA but may be eligible for the Fogarty Emerging Global Leader Award (K43).

Applications Not Responsive to this NOFO

• Applications that do not include both a U.S. primary mentor based at the applicant institution and an LMIC primary mentor whose primary appointment is at the collaborating LMIC institution.
• Applications from candidates whose doctoral degree was conferred less than two years before the application deadline.
• Applications that do not provide a plan to meet the in-country time requirement (at least 50% of requested effort over grant period and at least 3 months each year must be at the LMIC research site).

Note: This Funding Notice of Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PAR-24-113).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

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

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

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Mentors 

The primary mentor at the U.S. institution and the primary LMIC mentor must have eRA Commons accounts. Obtaining an eRA Commons account can take up to 2 weeks.

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Current and former PDs/PIs (including Multiple PDs/PIs) on NIH research project (R01), program project (P01), research training (D43), or center (P50) grants, sub-projects of program project (P01) or center (P50) grants, other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent to these grants/awards (including non-NIH equivalent grants/awards from other research funding organizations) are not eligible. Current and former PDs/PIs (including Multiple PDs/PIs) of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21/R33), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. Individuals supported by institutional K awards (K12 or KL2) remain eligible but cannot exceed 6 years of combined institutional K plus individual K01 funding. 

Candidates for this award must have a research or health-professional doctoral degree (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees) received at least two years prior to the application deadline and have research experience beyond their doctoral training.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (See NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-18-157.

At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

In-country requirement: Awardees must be able to spend a minimum of 50% of their cumulative effort over the total project period (all years) physically in-country conducting research at the LMIC institution. In addition, in each year of the award, awardees must spend a minimum of three months at the LMIC institution. For example, a candidate with 75% effort on a 5-year IRSDA K01 must spend 22.5 months at the LMIC institution.

Mentor(s)

Before submitting the application, the candidate must identify a primary mentor based at the U.S. applicant institution and a primary mentor based at the collaborating LMIC institution who are accomplished investigators in the research area proposed and have experience in successful development of independent investigators. Together, the two primary mentors will supervise the proposed career development and research experience. The LMIC primary mentor should hold a primary appointment at the collaborating LMIC institution and should not be a U.S. citizen who holds a joint appointment at the LMIC institution. The institutional affiliations of the mentors should be clear from the biosketches, mentor support letters, and institutional letters. The mentors should be active investigators in the area of the proposed research and committed both to the career development of the candidate and direct supervision of the candidate's research. The primary mentors must document the availability of sufficient research support and facilities for the candidate's research. Candidates are encouraged to identify additional co-mentors to form a mentoring team if this is deemed advantageous for providing expert advice in all aspects of the research career development plan. Additional co-mentors can be from other LMIC or high income countries. The candidate must work with all mentors (primary and co-mentors) in preparing the application.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management, and implementation of the proposed research and clinical trial.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

The U.S. and LMIC institutions must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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.

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

The following additional instruction applies:

Include the applicant institution and all of the collaborating institutions, both U.S. and LMIC, as performance sites.

Other Project Information

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

SF424(R&R) Senior/Key Person Profile Expanded

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

The following additional instructions apply:

Both the primary US and primary LMIC mentor must insert "Other" or "Other Professional" in the Project Role field, and enter "Mentor" in the Other Project Role Category field.

When listing other individuals with a substantive role in the project, clearly label roles to distinguish "Co-Mentor", "Consultant", "Collaborator", etc.

When listing the applicant's research support in the Biographical Sketch, clarify PD/PI status on awards (direct recipient).

R&R Budget

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

The following additional instructions apply:

Applicants should identify specific expenses such as: (a) non-degree related tuition or registration fees for specific PD/PI career development activities; (b) research expenses such as supplies, equipment and technical personnel; (c) statistical and computational services, including technical personnel and computer time; (d) mentor and grantee communication costs; and (e) PD/PI travel and per diem expenses to field research sites, collaborating institutions, research or networking meetings, or research skills workshops or courses in the appropriate budget form category.

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix

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

Candidate Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's commitment to a global health-related research career. 
• Describe prior training and research experience beyond doctoral training and how it relates to the objectives and long-term global health research career plans of the candidate. 
• Provide evidence of the candidate's potential to develop into a successful independent global health researcher (such as lead authorship of and/or significant contribution to research publications in peer-reviewed journals, presentations at international meetings, prior research interests and experience, and research fellowships) without duplicating information in the biosketches. 
• Describe all the candidate's professional responsibilities at the grantee institution and elsewhere and show the relation of these responsibilities to the proposed activities on the career development award.

• If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
• If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives​

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent global health investigator. 

• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan.  A career development timeline is often helpful.  
• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. 
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person months (75% full-time professional effort) commitment to the career award.  Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• Describe the candidate's career goals and the specific objectives to reach each goal under this award, indicating linkages to prior experience and current research support. 
• Provide a detailed description of the career development activities, including plans to obtain the necessary research skills and experience to launch an independent global health research career. 
• The plan should include a description of the primary mentors, any secondary co-mentors, and any collaborators, contributors or consultants, as appropriate for the research and career development of the candidate. 
• Describe how the plan utilizes the relevant field, clinical, research and educational resources of the U.S. and LMIC institutions. 
• The description of the career development plan should include items such as advanced level courses, seminars, and opportunities for collaboration and interaction with other scientists, especially in the proposed LMIC.
• Training in career skills such as grant-writing and making effective scientific presentations, is strongly encouraged. 
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher. 
• For junior faculty, describe how this award will relieve the candidate of current duties so that a greater portion of the candidate's effort (at least 9 person-months, equivalent to 75% full-time professional effort) may be devoted to research and related career development activities. 
• For postdocs, describe how the award would provide additional research and career development opportunities beyond the standard postdoctoral experience. 
• Describe how the candidate plans to fulfill the requirements that he/she 1) spend at least 50% of cumulative effort over the total project period (all years) physically in-country conducting research at the LMIC site, and 2) spend a minimum of three months in the LMIC in each year. A timeline outlining time in country is strongly recommended. 
• Applicants are encouraged to describe plans for outreach and dissemination of research findings both in the LMIC and in the U.S.

Research Plan Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

• A sound global health research project that addresses an area of scientific importance to the LMIC and is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate's research capabilities thus far, and the proposed research question, design and methodology should be novel, scientifically significant and creative in approach.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.Although the research strategy may be related to the research activities of the mentors, it should not be a duplication of the mentors' research.
• Applicants may propose research in any global health related discipline. 
• Applicants should provide a detailed explanation of the relevance of the proposed research to the health priorities of the LMIC. 
• If applicable, candidates should describe how the proposed research is related to ongoing NIH and U.S. government supported research initiatives in the LMIC.

• Describe the proposed timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.
• Applicants are strongly encouraged to include courses and activities offered at the LMIC site, if applicable, to get a perspective of the issues involved in RCR where they will be engaged in research.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name two primary mentors (one U.S. primary mentor at the applicant institution and one LMIC primary mentor at the collaborating site) who, together with the candidate, are responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program. Where feasible, individuals from diverse backgrounds, including women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. 
• Together, the mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Each mentor statement should describe the research support, if any, that will be available to support the proposed candidate research project. 
• Include a statement that the candidate will commit at least 9 person months (75% of full-time professional effort) to the career development program and related career development activities. 
• The application must include signed statements from both primary mentors providing: 1) an assessment of the candidate's qualifications and potential for an independent global health research career; 2) information on the mentor's research qualifications and previous experience as a research supervisor; 3) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 4) a plan for career progression for the candidate to move from the mentored stage of their career to independent research investigator status during the project period of the award; and 5) a plan for monitoring the candidate’s research, publications, and progression towards independence. 
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. 
• Both the U.S. primary mentor and the LMIC primary mentor must agree to provide separate annual evaluations of the candidate’s progress as required in the annual progress report.
• Mentor statements should include a statement that the candidate will meet the NOFO's time-in-country requirement (50% of requested effort over the entire award period). 
• Mentor statements should clearly describe how they will coordinate mentoring of the candidate with other proposed mentors, both primary and secondary co-mentors, including the mechanism(s) and frequency of communication with the candidate and other mentors and the frequency of face-to-face meetings.

• The mentors or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 
• The LMIC Institutional Commitment letter should also be included in this section, following page limit requirements for this section. It should provide a statement of commitment to the candidate's development into a productive, independent researcher and provide assurances that appropriate time and support for the proposed mentor(s) and/or other staff consistent with the career development plan will be provided. 
• All letters should be combined and submitted as a single PDF.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Description of Institutional Environment

• Both the applicant U.S. institution and the LMIC institution must provide descriptions of the scientific environment, resources, and facilities that will be available to the candidate. 
• The U.S. and LMIC institutions must document strong, well-established research and career development programs related to the candidate's area of interest, and key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the U.S. and LMIC research environments are particularly suited for the development of the candidate's global health research career and the pursuit of the proposed research plan.

• Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate’s Research Career Development

• Both the U.S. institution and the LMIC institution must provide a statements of commitment to the candidate's development into a productive, independent global health investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. 
• The applicant U.S. institution must provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent global health scientist. 
• Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan. 
• Provide assurance that appropriate time and support will be available for the proposed mentors and/or other staff consistent with the career development plan
• The U.S. institution should provide assurance that the candidate will be able to spend at least 50% of the cumulative effort over the entire project period and at least three months in each year of the award at the LMIC site conducting research and career development activities. 
• The U.S. Institutional Commitment letter should be submitted in this section. The LMIC Institutional Commitment letter should be submitted via "Letters of Support from Collaborators, Contributors, and Consultants", following page limit requirements. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

PHS Assignment Request Form

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

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov. 

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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 the Fogarty International Center (FIC), NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

In addition, for applications involving clinical trials:

The reviewers will consider that the clinical trial may include study design, methods, and interventions that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through K awards may be sufficient to support only small feasibility studies.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

• 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

• Geographic balance considerations.
• Relevance to the interests of co-funding organizations.
• Potential to contribute to other NIH- and U.S. government-supported research initiatives in LMICs.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

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

Section VII. Agency Contacts

.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Christine Jessup, PhD
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email:[email protected]

Alberto L Riverarentas
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-496-1804
E-mail: [email protected]

Sudha Sivaram, DrPH, MPH
Center for Global Health
National Cancer Institute (NCI)
Telephone: 240-276-5804
Email: [email protected]

Thomas Beres, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1175
Email: [email protected]

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

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: [email protected]

Dawn M. Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

Section VIII. Other Information

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

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Awards are made under the authorization of Sections 301, 307, and 405 of the Public Health Service Act as amended (42 USC 241, 284, and 287(b)) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.