Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Fogarty International Center (FIC)
Funding Opportunity Title	International Research Scientist Development Award (IRSDA) (K01)
Activity Code	K01 Research Scientist Development Award - Research & Training
Announcement Type	Reissue of PAR-10-066
Related Notices	July 7, 2015 - This PA has been reissued as PAR-15-291. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
Funding Opportunity Announcement (FOA) Number	PAR-13-072
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.989
Funding Opportunity Purpose	The purpose of the Fogarty International Center (FIC) International Research Scientist Development Award (IRSDA) is to provide support and protected time (three to five years) to advanced postdoctoral (at least two years beyond conferral of doctoral degree) U.S. research scientists for an intensive, mentored research career development experience in a low- or middle-income country (LMIC) 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) leading to an independent research career focused on global health. FIC invites K01 applications from biomedical, epidemiological, clinical, biostatistical, social and behavioral scientists in the formative stages of their research careers.

Posted Date	January 4, 2013
Open Date (Earliest Submission Date)	February 4, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	March 4, 2013; March 4, 2014; March 4, 2015, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July 2013; July 2014; July 2015
Advisory Council Review	October 2013; October 2014; October 2015
Earliest Start Date	December 2013; December 2014; December 2015
Expiration Date	March 5, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

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

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. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the International Research Scientist Development Award (IRSDA) (K01) is to prepare qualified individuals for research careers that will have a significant impact on the health-related research needs of low- and middle-income countries (LMICs) as defined by the World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups). The IRSDA will provide salary and research support for a sustained period of protected time (three to five years) for intensive research career development, under the guidance of U.S.-based and LMIC-based mentors, in the biomedical, epidemiological, clinical, biostatistical, social and behavioral sciences leading to research independence. Awardees must spend a minimum of 50% of the total grant period (and at least three months per year) physically in-country conducting research at the LMIC institution or at research sites in the LMIC. The expectation is that through this sustained period of research career development, 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. The IRSDA is part of the FIC strategy (http://www.fic.nih.gov/about/pages/strategic-plan.aspx) to expand the number of overseas research experiences available for early-career U.S. scientists in order to encourage them to pursue research careers in global health.

The FIC invites K01 applications from advanced postdoctoral research scientists (at least two years beyond conferral of doctoral degree, including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees) in biomedical, epidemiological, clinical, biostatistical, social and behavioral sciences who are pursuing research careers in global health.

Applicants are encouraged to review answers to frequently asked questions about the IRSDA K01 program at http://www.fic.nih.gov/Programs/Info/Pages/irsda-faqs.aspx, which will be updated on a regular basis.

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.
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 may not exceed 5 years.

Salary	NIH will contribute up to $75,000 per year toward the salary of the career award recipient, plus applicable fringe benefits. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the IRSDA award.
Other Program-Related Expenses	NIH will contribute up to $30,000 per year toward the research development costs of the award recipient. These funds may be used for expenses such as: (a) tuition and fees related to career development; (b) research expenses such as supplies, equipment and technical personnel; (c) statistical and computational services, including personnel and computer time; and (d) travel to developing country research site for research, research meetings, or training. Salary for mentors, secretarial staff, and administrative assistants 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 grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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 mentors (one U.S.-based and one LMIC-based) 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. 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).

Former and current PDs/PIs on major research grants supported by the NIH, the Federal Government, or other funding organizations are not eligible. This includes NIH research project grants (R01, R03, R34), program project grants (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), research training grants (D43), resources grants (R24), research education grants (R25), exploratory/developmental grants (R21), SBIR/STTR grants (R41, R42, R43, R44), other individual career development awards (K awards), or the equivalent. Individuals on institutional K awards (K12 or KL2) remain eligible, but cannot exceed 6 years of combined institutional K plus individual K01 funding. A candidate for the K01 may not concurrently apply for or have an award pending for any other NIH career development award. Candidates are strongly encouraged to contact the FIC staff person listed under Section VII of this FOA prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.

Candidates for this award must hold 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. The candidate must clearly demonstrate that he/she already has research experience beyond his/her doctoral training (length of time may vary), show that he/she is committed to developing into an independent investigator in global health research relevant to the mission of the FIC, and must justify the need for up to five years of mentored research experience in order to become an independent research scientist. Evidence of research experience includes lead authorship of and/or significant contribution to research publications in peer-reviewed journals, presentations at international meetings, and research fellowships. Candidates must clearly describe how the activities proposed in the application will enable them to progress to a research career as an independent scientist in global health.

The award will enable suitable candidates to undertake special study and supervised research under mentors (one U.S.-based mentor and one LMIC-based mentor) who are accomplished investigators in the research area proposed and have experience in developing independent investigators. Awardees must spend a minimum of 50% of the total grant period (and at least three months per year) physically in-country conducting research at the LMIC institution.

Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) to conducting research and career development activities associated with this award. The remaining 3 person-months (25% effort) can be divided among other research, teaching, administrative, and clinical activities, as appropriate to the candidate's career development.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of 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 during or after their K award funding as described in NOT-OD-08-065.

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have U.S. Department of Veterans Affairs (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. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Before submitting the application, the candidate must identify both a U.S.-based and a LMIC-based mentor who will supervise the proposed career development and research experience. The mentors should be active investigators in the area of the proposed research and be committed both to the research career development of the candidate and to the direct supervision of the candidate’s research. The mentors must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. One individual must be identified as the principal mentor who will coordinate the candidate’s research. The mentors, or a member of the mentoring team, should have a successful track record of mentoring. The candidate must work with the mentors in preparing the application.

The mentors must provide letters of support that describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged. The mentors are also expected to provide an assessment of the candidate s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

IRSDA recipients must spend a minimum of 50% of the total grant period (and at least three months per year) physically in-country conducting research at a LMIC institution 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).

Time planned to conduct research at the LMIC institution should be noted in a timeline for career development and research activities included in the application. This timeline must meet the minimum in-country time requirements described above.

The applicant institution and LMIC institution where the proposed research will be conducted must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to serve as mentors. The applicant institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the candidate. The candidate, mentors, and institutions must describe a research career development program that will maximize the use of U.S. and LMIC research institutional environments, including available facilities and resources.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed, with the following additional requirements:

• Description of LMIC Institutional Environment: limited to 1 page (attached via "Other Attachments" in the R&R Other Project Information component)

LMIC Institutional Commitment to Candidate's Research Career Development: limited to 1 page (attached via "Other Attachments" in the R&R Other Project Information component)

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

Candidate’s Background (Component of Candidate Information)

• Describe the candidate's commitment to a global health-related research career.
• Describe prior training and research efforts, and how they relate 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 investigator. Usually this is evident from lead authorship of and/or significant contribution to research publications in peer-reviewed journals, presentations at international meetings, prior research interests and experience, research fellowships, international experiences, and letters of reference.
• Include a description of all the candidate's professional responsibilities at the grantee institution and elsewhere and show their relation 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 global health research career.

Career Goals and Objectives (Component of Candidate Information)

• Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and research career development activities that will occur; (2) justifies the need for further research career development to become an independent investigator; and (3) utilizes the relevant research and educational resources of the U.S. and LMIC institutions.

Career Development/Training Activities During Award Period (Component of Candidate Information)

• The candidate and the mentors are jointly responsible for the preparation of the career development plan. The candidate and sponsor may propose a Mentoring Team (or an Advisory Committee).
• Describe how the candidate plans to fulfill the requirement that he/she spend at least 50% of the total grant period at the LMIC institution. A timeline is recommended.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent global health research career.
• 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 the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the proposed research career development and research activities.

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.

Statements by Mentors, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

• The candidate must name two primary mentors (one U.S.-based mentor and one LMIC-based mentor), who, together with the candidate, are responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentors should be recognized as accomplished investigators in the proposed research area and have track records of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• 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 of the mentors and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors 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 personal meetings.
• Signed statements must be provided by all consultants/collaborators confirming their participation in the project and describing their specific roles. Collaborators and consultants generally 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 investigator.
• The U.S.-based and LMIC-based mentors must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe the sponsoring institution’s and the LMIC institution's scientific environment including the resources and facilities that will be available to the candidate.
• LMIC Description of Institutioanl Environment should be provided under "Other Attachments".

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

• Both the sponsoring U.S. institution and the LMIC institution must provide 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 development award.
• The U.S. and LMIC institution 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.
• LMIC Institutional Commitment should be provided under "Other Attachments".

Research Strategy (Component of Research Plan)

• A sound research project that 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 not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• The application must also 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 research strategy may be related to the research activities of the mentors, it should not be a duplication of the mentor's research strategy.

Appendix

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

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). 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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, 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.

Candidate

Does the candidate have the potential to develop as an independent and productive global health researcher? Is the candidate s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in global health research? Do the letters of reference from at least three well-established scientists address the candidate’s potential for becoming an independent global health investigator? Does the candidate justify the need for three to five years of mentored research experience in order to become an independent global health scientist.

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

What is the likelihood that the career development plan will contribute substantially to the scientific development of the candidate leading to research independence? Are the candidate's prior training and research experience appropriate for this award? 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 training and research objectives for achieving research independence? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress? Does the career development plan address an area of scientific importance to the LMIC? Is there a clear commitment to a research career in global health? Is there a commitment to spend a minimum of 50% of the total grant period (and at least three months per year) physically in-country conducting research at a LMIC institution?

Research Plan

Are the proposed research question, design, and methodology of significant scientific and 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? If applicable, are there adequate plans for data and safety monitoring of clinical trials? Does the research plan address an area of scientific importance to the LMIC?

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

Are the U.S.-based and LMIC-based mentor's research qualifications in the area of the proposed research appropriate? Do the 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 U.S.-based and LMIC-based 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, including formal course work adequate? Is there evidence of the U.S.-based and LMIC-based mentor's, consultant s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is active/pending support for the 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 or Advisory Committee is proposed, what are the qualifications of the members, what is the quality of the planned roles for advice and what is the adequacy of scheduled meeting frequency of the Advisory Committee with the Candidate?

Environment & Institutional Commitment to the Candidate

Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate 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 institution intends the candidate to be an integral part of its research program?

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 six 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 six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Renewals

Not Applicable

Revisions

Not Applicable

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

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned 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 FIC Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Relevance of the proposed career development program, prior training, and commitment of the candidate to becoming and independent global health research scientist.
• Geographic balance considerations.
• Relevance to the interests of co-funding organizations.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress by both the U.S.-based and LMIC-based mentors.

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Christine Jessup, Ph.D.
Program Officer, Division of International Training and Research
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]

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

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

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

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