Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

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

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed)
Activity Code
K43 International Research Career Development Award
 
Announcement Type

Reissue of PAR-19-098

Related Notices

See Notices of Special Interest associated with this funding opportunity

None

Funding Opportunity Announcement (FOA) Number
PAR-21-252
Companion Funding Opportunity

PAR-21-251 - Emerging Global Leader Award (K43 Independent Clinical Trial Required)

Assistance Listing Number(s)

93.989, 93.398, 93.172, 93.121, 93.113, 93.242, 93.853

Funding Opportunity Purpose

The purpose of the Fogarty Emerging Global Leader Award is to provide research support and protected time (three to five years) to an early career research scientist from a low- or middle-income country (LMIC) who holds a junior faculty position at an LMIC academic or research institution, as defined by the World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups, including “low-income,” “lower-middle-income,” and “upper-middle-income” countries). This intensive, mentored research career development experience is expected to lead to an independently funded research career at the LMIC institution or in another LMIC. This Funding Opportunity Announcement (FOA) invites applications from LMIC scientists from any health-related discipline who propose career development activities and a research project that is relevant to the health priorities of their country under the mentorship of LMIC and U.S. mentors.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA PAR-21-251.

Key Dates

Posted Date
September 08, 2021
Open Date (Earliest Submission Date)
October 03, 2021
Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

November 3, 2021, November 3, 2022, and November 3, 2023 by 5:00 PM local time of the applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)

Decemer 9, 2021, December 9, 2022, and December 11, 2023 by 5:00 PM local time of the applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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

Scientific Merit Review

March 2022, March 2023, March 2024

Advisory Council Review

May 2022, May 2023, May 2024

Earliest Start Date

July 2022, July 2023, July 2024

Expiration Date
December 12, 2023
Due Dates for E.O. 12372

Not Applicable

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

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

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

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


  4. Table of Contents

Part 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 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 Extramural Training Mechanisms website.

The objective of the NIH International Research Career Development Award (K43) is to support research scientists from low-or middle-income countries (LMICs) who hold a junior faculty positions at academic or research institutions. In many LMIC institutions there is little support for junior faculty with long-term research training to launch an independent research career due to lack of protected time for research activities, inadequate pilot research project funding opportunities, insufficient training in advanced research methodology and data analysis, lack of mentorship in manuscript and grant writing and meager institutional support for developing, submitting and administering research applications and awards. This intensive, mentored research career development experience under the guidance of experienced LMIC and U.S. mentors is expected to foster an independently funded research career for the most promising LMIC junior research scientist faculty. Overall, it is expected that this program will increase the scientific capacity for health research at LMIC institutions and foster long term research collaborations with U.S. scientists.

The award will provide salary and research project support. Awardees are expected to increase their capabilities in advanced research methodology, analysis and data management, research administrative skills, responsible conduct of research, scientific presentation, and manuscript and grant writing. Applications should propose targeted activities and research projects that will propel awardees to become competitive principal investigators for new research project grant funding by the end of the grant period. This FOA invites applications from eligible LMIC research scientists at LMIC academic or research institutions who propose both critically needed career development activities and a research project that are highly relevant to the health priorities of their countries. The research activities should take place primarily in the LMIC.

Interests of Participating NIH Institutes, Centers and Offices

The Fogarty International Center (FIC) is interested in applications from individuals at LMIC institutions seeking to become independent investigators and international 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 Fogarty Emerging Global Leader Award is responsive to the FIC Strategic Plan (http://www.fic.nih.gov/about/pages/strategic-plan.aspx) 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 are 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, 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 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 National Human Genome Research Institute (NHGRI) is interested in applications from individuals pursuing careers as researchers in the area of the ethical, legal, and social implications (ELSI) of genetics and genomics research or the use of genetics in clinical settings.  Examples of topics appropriate for exploration can be found on the ELSI Research Priorities website at: http://www.genome.gov/27543732. NHGRI may also support applications from individuals who are developing methods and research resources that support, or are conducting basic and translational research in: genomic sciences, informatics, implementation of genomics in clinical care (genomic medicine), and cost-effectiveness of genomic interventions.  The specific research topic proposed should apply across a broad spectrum of diseases and health conditions and should not be specific to just one disease, except to the extent that a particular disease may serve as a model with projects that capitalize on unique opportunities to use, as models, diseases and conditions that are more difficult to study in the U.S. because of prevalence or other factors will be considered.  Examples of such conditions might include, but are not limited to, sickle cell disease and thalassemias, apoA associated kidney disease, and severe adverse drug reactions with higher frequency outside the U.S., such as Stevens Johnson Syndrome (SJS).

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in applications with a research focus on dental, oral, or craniofacial conditions that occur more frequently in the LMIC or are of a high public health burden; research addressing health disparities in dental, oral, or craniofacial conditions; and research to achieve national or regional goals in oral and dental health such as those articulated by the World Health Organization. Examples include, but are not limited to: working with local communities to establish the best means of delivering preventive oral health care; establishing successful approaches to deliver fluoride to a local population, particularly in areas without potable water; studying oral pre-malignant lesions associated with betel nut use; and studying the interplay of genes and environment in dental, oral, or craniofacial health by leveraging environments specific to the country. The program and these topics are responsive to goals 2, 3, and 4 of the NIDCR Strategic Plan (http://www.nidcr.nih.gov/research/ResearchPriorities/StrategicPlan/).

The National Institute of Environmental Health Sciences (NIEHS) is interested in applications that address or seek to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and activities that lead to the development of prevention and intervention strategies to reduce environmentally induced diseases in LMICs. Examples of environmental exposures relevant to the mission of the NIEHS include industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources (https://www.niehs.nih.gov/about/strategicplan/). Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders, children’s environmental health and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease.  Career development applications that focus on the effects of alcohol, chemotherapeutic agents, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents are not of interest to NIEHS. 

The National Institute of Mental Health (NIMH) is interested in applications that focus on mental disorders in LMICs, specifically conditions and disorders that affect cognition, perceptions, mood, social and emotional processing, daily functioning, behavior and relationships. Mental Disorders are a leading cause of disease burden worldwide, estimated based on disability adjusted life years (DALYs). Mental disorders of interest include, but are not limited to depressive disorders, schizophrenia, bipolar disorder, autism spectrum disorders, anxiety disorders, trauma and stressor-related disorders such as posttraumatic stress disorder. NIMH is particularly interested in research that addresses disparities in access to mental health care in LMICs, better understanding the root causes, risk and protective factors, early detection and early intervention, integration of mental health care into care for chronic, non-communicable or communicable diseases. NIMH is also interested in applications that investigate the optimal combination of mental health interventions (e.g., screening and care), including those that leverage implementation science in LMIC contexts, and address the care of individuals living with HIV, or placed at risk for HIV. These themes are consistent with many of the Grand Challenges in Global Mental Health (i.e., identify root causes, risk and protective factors; advance prevention and early intervention; improve treatments and expand access to quality care; build human resource research capacity; and transform health system and policy responses; Grand Challenges in Global Mental Health). NIMH is also interested in applications that target HIV-related research topics such as the epidemiology, natural history and pathogenesis of HIV-associated CNS dysfunction before and after treatment initiation in adult and pediatric populations; HIV persistence and cure in the CNS; examination of the neurobehavioral consequences of in-utero exposure to antiretroviral medication and/or HIV; basic and applied behavioral and social science to prevent new HIV infections and limit morbidity and mortality among those living with HIV, use of data science to support HIV prevention and care, and implementation science to determine the best strategies for implementing and scaling up evidence-based interventions to prevent or treat HIV.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting basic, mechanistic, epidemiological, prevention, translational and clinical research 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 National Institute on Aging (NIA) mission is to support and conduct biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA is pursuing this initiative to recruit early-stage investigators who have begun to establish research programs and who, through this award, will be prepared to assume leadership roles in their field of expertise and will be poised to influence theory, practice, and health outcomes related to the health of older individuals. Research topics in aging include (but are not limited to) the basic, clinical and epidemiological studies that investigate neural and behavioral processes associated with normally aging brain and dementias; the behavioral and social research on life course health, aging, and AD/ADRD using NIA-supported international studies in low and middle income countries; testing relationships between human microbiomes and accessible biomarkers in blood and plasma in relation to age-dependent changes in immune function; and research for the development of new interventions for age-related conditions, prevention and treatment of multiple chronic conditions, and studies that help to promote evidenced-based geriatric care. Applicants should review the Strategic Directions for Research, 2020 – 2025. Applications whose research focuses on Alzheimer’s disease should also review the AD/ADRD Research milestones for more information on research priorities.

The Office of Research on Women's Health (ORWH) mission is to improve the health of women. ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and ensures that research conducted and supported by the NIH addresses issues regarding women's health. ORWH works to stimulate and encourage basic and clinical research on the role of sex and gender in health and disease. ORWH promotes training and career development of a diverse biomedical research workforce to advance science for the health of women. ORWH also develops and supports initiatives to recruit, retain, and advance women in biomedical careers; programs that support both women and men in women’s health and sex differences research careers. ORWH is interested in supporting applications that fulfill goal 1 and goal 4 of the NIH Strategic Plan for Women's Health and Sex Differences Research, which can be found at: https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_508C_0.pdf

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.

Applicants are encouraged to review answers to frequently asked questions about the Fogarty Emerging Global Leader Award program at http://www.fic.nih.gov/Programs/Pages/emerging-global-leader.aspx , which will be updated on a regular basis.

Individuals who are citizens, non-citizen nationals or permanent residents of the United States, and who are based at US institutions, are not eligible for this K43 award but may apply for the International Research Scientist Development Awards (IRSDA (K01) PAR-21-104 or PAR-21-015 or other similar awards (see https://researchtraining.nih.gov/programs/career-development).

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA (PAR-21-251).

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. 

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

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

Award Budget
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period

The total project period should be a minimum of 3 years and may not exceed 5 years.

Other Award Budget Information

Salary

NIH will contribute up to $75,000 (for a minimum of 75% effort or 9 person months)  per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094.

Confirmation of LMIC institutional salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, may be requested in addition to salary.

The total NIH contribution to salary, may not exceed the legislatively mandated salary cap.  See: http://grants.nih.gov/grants/policy/salcap_summary.htm

Other Program-Related Expenses

NIH will contribute up to $30,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; (c) travel to research sites, research meetings or training; and (d) statistical services including personnel and computer time. 
 
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Applications for the K43 award must be submitted by academic education or research institutions in LMICs (as defined by the World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups; low-income, lower-middle-income, and upper-middle-income countries are included).

FIC's Country Eligibility Notice (NOT-TW-12-011 “Notice of Change in Country Eligibility for Fogarty International Training Grants”) applies to this FOA and states that for competing and re-competing research training grant applications (including the K43 mechanism), with the exception of Sub-Saharan African countries, FIC will no longer accept applications from, or applications that involve training of scientists from upper-middle-income countries that are also members of the G20 major economies (http://www.g20.org/en/members). For additional information see FIC's Country Eligibility page at https://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx.

Foreign Institutions

Only non-domestic (non-U.S.) Entities (Foreign Institutions) in Low- or Middle-Income Countries are 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. 
Required Registrations

    Applicant Organizations

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

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.

Mentors

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

Eligible Individuals (Program Director/Principal Investigator)

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 primary mentors (one U.S.-based and one LMIC-based)  and organization to develop an application for support. The candidate should be the PD/PI of the proposed activities. Individuals from underrepresented groups in the LMIC context, including racial and ethnic minorities, persons with disabilities, and women are encouraged to apply. Multiple PDs/PIs are not allowed.

An applicant must be a citizen or permanent resident of an eligible LMIC. Legal verification of LMIC citizenship or Permanent Residency status may be requested prior to award. It is the responsibility of the recipient institution to assure that the candidate remains eligible for the project period of the award. Individuals who are citizens, non-citizen nationals or permanent residents of the United States, and who are based at US institutions, are not eligible for this K43.

Degree and Research Experience Requirements: 

 .  Candidates must hold at least a masters degree that required a research thesis. Candidates with doctoral research training are preferred. This award cannot support advanced degree training.

Current and former PDs/PIs (including Multiple PDs/PIs) on NIH research project (R01), program project (P01), research training (D43), or center (P50) grants, or Project Leads 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), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. A candidate for this award may not concurrently apply for or have an award pending for any other NIH career development award. Prospective applicants are strongly encouraged to contact the FIC Scientific/Research contact prior to preparing an application to discuss their eligibility.

Faculty Position Requirement:  Applicants must currently hold an academic junior faculty position or research scientist appointment supported by the applicant LMIC academic or research institution and have been in this position for at least one year at the time the application is submitted.   For this FOA, junior faculty are defined as those who hold entry to mid-level academic or research scientist positions, including but not limited to instructors, lecturers and assistant professors. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)
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 U.S. government 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-08-065.
Level of Effort

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 nine months of effort (i.e., 75% of full-time professional effort) to their program of career development. Candidates may engage in other duties as part of the effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-09-036 for more details.

Mentor(s)

Before submitting the application, the candidate must identify a primary mentor based at the applicant LMIC institution and a primary mentor based at a collaborating U.S. institution who, together, will supervise the proposed career development and research experience. The LMIC primary mentor must hold a primary appointment at the LMIC applicant 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. These primary mentors should be active researchers in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of 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 program. Additional 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, if proposed, clinical trial experience.

Institutional Environment

The LMIC applicant institution where the proposed K43 award's research will be conducted, and the collaborating U.S. institution (if activities at the U.S. institution are proposed) must have strong, well-established records of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to serve as mentors. The research career development program should maximize the use of U.S. and LMIC research institutional environments, including available facilities and resources.

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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 of PAR-21-251 and PAR-21-252 , 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 emailed to:

Christine Jessup, Ph.D.

Telephone: 301-496-1653

Email: FogartyK43@nih.gov

Page Limitations

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

The following modification also applies:

Institutional Commitment to Candidate's Research Career Development is limited to two pages.

Instructions for Application Submission

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

SF424(R&R) Cover

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

Under PD/PI Contact Information, Position Title is required.

SF424(R&R) Project/Performance Site Locations

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

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, with the following additional instructions:

  • Both the primary LMIC and primary US 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 applicant's research support in the Biographical Sketch, clarify PD/PI status (direct recipient) of awards. 
R&R Budget

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

with the following additional instructions:

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) travel for mentors to collaborating institutions; (e) mentor and grantee communication costs; and (f) 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.

In the Budget Justification, provide detailed information about  the total current salary amount that serves as the basis for calculating the salary support requested. Confirmation of LMIC institutional salary may be required prior to the issuance of an award.  

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

 

• Provide evidence of the candidate's potential to develop into a successful independent LMIC researcher and Describe the candidate's commitment to a health-related research career in an LMIC.

• Describe all the candidate's professional responsibilities at the recipient LMIC institution and elsewhere and show the relation of these responsibilities to the proposed activities on the research career development award.

• Explain how the career award will contribute to career goals and further the candidate’s research career and justify the candidate's need for an additional mentored research experience to become an independent research scientist.

• Describe prior training and how it relates to the objectives and long-term career plans of the candidate.

• Describe the candidate’s prior research experience, including lead authorship of and/or significant contribution to research publications in peer-reviewed journals, and presentations at international meetings.

Career Goals and Objectives?

  • 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.
  • Describe the candidate’s potential to develop into a successful, independent LMIC-based investigator.

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

  • The candidate and the mentors are jointly responsible for the preparation of the career development plan.
  • Describe a systematic and detailed plan that: (1) shows a logical progression from prior research and training experiences to the research and research career development activities proposed; (2) justifies the need for further research career development to become an independent researcher; and (3) utilizes the relevant research and educational resources of the LMIC institution and U.S. institution (if activities at the U.S. institution are proposed).
  • 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.
  • The application must describe the relationship between the mentors' research and the candidate’s proposed research plan. The respective areas of expertise and responsibility should be described for both mentors. Although the candidate's research strategy may be related to the research activities of the mentors, it should not duplicate the mentors' research.
  • Provide a detailed description of proposed career development activities, including plans to obtain the necessary research skills and experience to launch an independent global health research career. The description of the career development plan should include items such as advanced level courses, seminars, and opportunities for interaction with other scientists. 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.
  • Describe how the candidate plans to fulfill the requirement that he/she spend at least nine person months of effort conducting research or participating in research career development activities during each year proposed. A timeline that includes activities and time spent in the LMIC and in the U.S., if proposed, is 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

 

  • Provide a sound research project that is consistent with the candidate’s level of research development and the objectives of his/her career development plan.
  • The description of the proposed research project should indicate the extent to which the research will be conducted in the LMIC.
  • 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.
  • Candidates should provide a detailed explanation of the relevance of the proposed research to the health priorities of the LMIC and, where applicable, the relationship of the proposed research to any ongoing NIH or U.S. government research initiatives in the LMIC.
  • If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

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.

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 LMIC primary mentor based at the applicant institution, and one U.S. mentor) who, together with the candidate, are responsible for planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
  • Signed letters from the primary LMIC mentor, the primary U.S. mentor, as well as any co-mentors, are expected to provide an assessment of the candidate’s qualifications and potential for an independent research career. Mentor letters should describe relevant research expertise in the proposed applicant research area and document a record of success in training LMIC researchers, in particular, those who have gone on to become independent researchers in the LMIC that is the focus of the application.
  • Mentor statements should describe the career development plan for the candidate (coordinated with the candidate's research strategy) and explain how they will participate in this plan. Mentors should clearly describe how they will coordinate mentoring of the candidate with other proposed mentors, both primary and secondary co-mentors. The statement should describe a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and a plan for monitoring the candidate’s research, publications, and progression towards independence.
  • 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.
  • The primary LMIC mentor statement should 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.
  • 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. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
  • Both primary mentors (U.S. and LMIC) must agree to each provide annual evaluations of the candidate’s progress as required in the annual progress report.
  • Both primary mentors (U.S. and LMIC) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in any proposed clinical trials research experience.

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. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent researcher.
  • 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.

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

  • Describe the scientific environment at the LMIC institution, resources and facilities that will be available to the candidate, research and career development programs related to the candidate's area of interest and key faculty members and researchers capable of productive collaboration with the candidate. If the candidate plans activities at the collaborating U.S. institution, a description of the relevant U.S. institutional environment must also be provided.

Institutional Commitment to the Candidate’s Research Career Development

  • Appropriate officials at the LMIC institution (and the U.S. institution if activities are proposed there) must provide statements of commitment to the candidate's development into a productive, independent global health researcher.
  • A letter of support confirming the applicant's ongoing position, start date, the amount of release time for proposed research and the commitment to retain the candidate in his/her current position by the appropriate institutional official should be submitted.  
  • The LMIC institution must provide commitment to at least nine person months (75% full-time professional effort) for the award recipient.
  • The LMIC institution (and the U.S. institution if activities are proposed there) must provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
  • The institution must provide assurance that the candidate will have appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
  • The LMIC and U.S. Institutional Commitment letters (if activities are proposed at the U.S. institution) should be included in this section as a single PDF and must not exceed two pages.

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.

  • For FOAs that do not allow independent clinical trials, do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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 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. See Section III of this FOA for information on registration requirements.

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. 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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.

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.

Scored Review Criteria

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.

  Candidate

  • Does the candidate have the potential to develop as an independent and productive researcher addressing scientifically significant topics that reflect the health priorities of the LMIC?
  • Are the candidate's prior training and research experiences appropriate for this award?  
  • Does the candidate have the research experience and skills needed to carry out the proposed research?
  • Is the candidate’s academic, clinical (if relevant), and research record of high quality?
  • Do the reference letters from at least three well-established scientists address the candidate’s potential for becoming an independent researcher?
  • Is there evidence of the candidate's commitment to meeting the program objectives to become an independent researcher?
  • Does the candidate justify the need for three to five years of mentored research experience in order to become an independent scientist?

Career Development Plan

  • What is the likelihood that the career development plan will contribute substantially to the scientific development of the candidate and lead to research independence?
  • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated career development and research objectives for achieving research independence?
  • Are there adequate plans for mentors to monitor and evaluate the candidate's research and career development progress?
  • Does the career development plan demonstrate a clear commitment to a research career in the LMIC setting?

  • If proposed, will the clinical trial experience contribute to the applicant’s research career development?

Research Plan

  • Is the prior research that serves as the key support for the proposed project rigorous?
  • Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?
  • Does the information in the literature or knowledge of biological mechanisms or preliminary data provide adequate rigor in prior research to support the proposed project? If not, has the candidate included plans to address weaknesses in rigor of prior research?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Are the proposed research question, design, and methodology novel, scientifically significant, creative, and of technical merit
  • Is the research plan relevant to the candidate’s research career objectives? 
  • Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?
  • Does the research plan address an area of health priority and scientific importance to the LMIC?
  • If proposed, will the clinical trial experience contribute to the research project?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

  • Are the primary U.S. mentor's and the primary LMIC mentor's research qualifications in the area of the proposed research appropriate, and is there evidence of previous research productivity and peer-reviewed support?
  • Do the primary mentors and any co-mentors adequately address the candidate’s potential and his/her strengths and areas needing improvement? 
  • Is there adequate description of the quality and extent of the primary U.S. mentor's and the primary LMIC mentor's proposed role in providing guidance and advice to the candidate? 
  • Are the mentors' descriptions of the elements of the research career development activities adequate? 
  • Is there evidence of the primary U.S. mentor's and the primary LMIC mentor's, any secondary co-mentors, consultant’s, collaborator’s previous experience in fostering the development of independent researchers in the LMIC proposed? 
  • Is active/pending support relevant to the candidate's proposed research project appropriate and adequate?
  • Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
  • If a Mentoring Team is proposed, are the qualifications of the members, the quality of the planned roles for advice, and scheduled meeting frequency of the Mentoring Team with the candidate adequate?
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Environment & Institutional Commitment to the Candidate

  • Is there clear commitment of the applicant LMIC institution to ensure that a minimum of 9 person-months (75% of the candidate's full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
  • Are the institutional commitments (U.S. and LMIC) to the career development of the candidate and for the mentors appropriately strong?
  • Are the research facilities, resources and training opportunities at the U.S. and LMIC institutions, including faculty capable of productive collaboration with the candidate adequate and appropriate?
  • Is the environment for scientific and professional development of the candidate of high quality?
  • Is there assurance that the LMIC institution intends the candidate to be an integral part of its research program?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Revisions

Not Applicable
Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

    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 level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

    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).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review 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 will receive a written critique.

    • 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.

    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
    • Geographic balance considerations.
    • Relevance to the interests of co-funding partners.
    • Potential to contribute 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 VI. Award Administration Information

    1. Award Notices

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

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

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

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

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

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

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

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

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

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

    3. Reporting

    When multiple years are involved, awardees 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. 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.

    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. 

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

    4. Evaluation

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

    Section VII. Agency Contacts

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

    .

    Application Submission Contacts

    eRA 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: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

    Scientific/Research Contact(s)

    Pre-application questions should be directed to the FIC Scientific/Research Contact

    Christine Jessup, PhD
    Fogarty International Center (FIC)
    Telephone: 301-496-1653
    Email:Christine.Jessup@nih.gov

    Sudha Sivaram, PhD
    National Cancer Institute (NCI)
    Telephone: 240-276-5804
    Email:sivarams@mail.nih.gov

    Jennifer L Troyer, PhD
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-402-2852
    Email:troyerj@mail.nih.gov

    Lynn King, PhD
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-5006
    Email:Lynn.King@nih.gov

    Carol Shreffler, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 919-541-1445
    Email:shreffl1@niehs.nih.gov

    Susannah Allison, PhD
    National Institute of Mental Health (NIMH)
    Telephone: 240-627-3861
    Email:allisonsu@mail.nih.gov

    Stacey D. Chambers, MS
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-0690
    E-mail: stacey.chambers@nih.gov

    Maria Carranza, Ph.D.
    NIA Training Officer
    National Institute on Aging (NIA)
    Email: NIATraining@mail.nih.gov

    Regine A. Douthard, MD, MPH
    Office of Research on Women's Health (ORWH)
    Telephone: 301-451-2729
    Email: douthardr@mail.nih.gov

    Peer Review Contact(s)

    Center for Scientific Review (CSR)

    Email:  FOA_ReviewContact@csr.nih.gov

    Financial/Grants Management Contact(s)

    Mollie Shea
    Fogarty International Center (FIC) 
    Telephone: 301-496-9750  
    Email: Mollie.Shea@.nih.gov

    Dianne Patterson
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-435-7861
    Email: pattersond@mail.nih.gov

    Barbara J. Gittleman
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 919-541-0585
    Email: gittlemanbj@mail.nih.gov

    Tamara A. Kees
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-8811
    Email: tkees@mail.nih.gov

    Diana Rutberg
    National Institute on Dental and Craniofacial Research (NIDCR)
    Telephone: 301-504-4798
    Email: rutbergd@mail.nih.gov

    Chief Grants Management Officer
    National Institute of Neurological Disorders and Stroke (NINDS)
    Email: ChiefGrantsManagementOfficer@ninds.nih.gov

    Jessi Perez
    National Institute on Aging (NIA)
    Telephone: 301-402-7739
    Email Address: jessi.perez@nih.gov

    Sean Hine
    National Cancer Institute (NCI)
    Telephone: 240-276-6291
    Email: hines@mail.nih.gov

    Section VIII. Other Information

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

    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.

    Authority and Regulations

    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. .


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