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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website. In addition, some ICs support global health research and international career development activities for U.S. scientists.

Program Description

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

The objective of the IRSDA program is to prepare qualified advanced postdoctoral research scientists and recently-appointed junior faculty (see Eligible Individuals) for research careers that will have a significant impact on the health-related research needs of LMICs. The award will provide salary and research project support for a sustained period of protected time (three to five years) for intensive research career development, under the guidance of experienced U.S.-based and LMIC-based mentors, in any health-related discipline that is relevant to the health priorities of the LMIC.

Awardees must spend a minimum of 50% of the cumulative effort over the project period (all years) physically in-country conducting collaborative research at the LMIC institution. In addition, in each year of the award, the recipient must spend a minimum of three months in the LMIC (see In-country requirement under Eligible Individuals in Section III). Awardees are expected to gain increased capabilities in collaborative research (i.e. team science) skills in low-resource settings, advanced research methodology, analysis and data management, research administrative skills, responsible conduct of research, scientific presentation, and manuscript and grant writing. 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.

LMICs are defined by the World Bank classification system (according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups).

Interests of Participating NIH Institutes and Centers

The Fogarty International Center (FIC) is interested in applications from individuals 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 IRSDA is responsive to the FIC Strategic Plan to build research capacity through individuals, institutions and networks by building future research leaders in the U.S. and in LMICs.

The NCI's Center for Global Health (CGH) will support intensive, mentored research career development for early stage investigators committed to a cancer research career. CGH is particularly interested in applications that include well-designed epidemiology studies on common risk factors (social, biological, occupational, environmental) for cancer, clinical and translational research, detection and diagnosis, health surveillance including cancer registry development, knowledge sharing, implementation science, informatics, mHealth, or malignancies associated with chronic infection. The research activities should be specifically focused on cancer. The career development plan should include training in advanced scientific skills, research methodology, data management and analysis, grant and manuscript writing, and research administration skills that are appropriate for the LMIC. The proposed career development and mentoring must be focused on developing independent researchers in the field of cancer in a manner that increases the research capacity at the LMIC institution. Mentors should have a track record of research in cancer.

Additional Information

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

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

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

Individuals from LMICs (individuals who are not U.S. citizens, non-citizen nationals or permanent residents) are not eligible for the IRSDA but may apply for PAR-17-001 Fogarty Emerging Global Leader Award (K43).

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

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.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Mentors

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

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her primary 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

Current and former PDs/PIs supported by major NIH research grants, grants from the U.S. Government, or grants from other funding organizations are not eligible. This includes having been an independent PD/PI on NIH research project grants (e.g., R01, R03, R21, R34), research training grants (e.g., D43), resource grants (e.g., R24), research education grants (e.g., R25), SBIR/STTR grants (e.g., R41, R42, R43, R44), NIH career development awards (e.g., K01, K02, K07, K08, K23, K25), or other peer reviewed NIH or non-NIH multi-year research awards, or having been project leader on sub-projects of program project (P01) or center (P50) grants. Individuals supported by institutional K awards (K12 or KL2) remain eligible but cannot exceed 6 years of combined institutional K plus individual K01 funding. A candidate for this award may not concurrently apply for or have an award pending for any other NIH career development award.

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

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, 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. governement 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.

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

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the FIC Program Officer prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to FIC 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.

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

Before submitting the application, the candidate must identify a primary mentor at the U.S. applicant institution and a primary mentor at the collaborating LMIC institution who are accomplished investigators in the research area proposed and have experience in successful development of independent investigators. Together, the two primary mentors will supervise the proposed career development and research experience. The primary LMIC mentor should not be a U.S. citizen who holds a joint appointment at the LMIC institution. The primary mentors should be active investigators in the area of the proposed research and committed both to the career development of the candidate and direct supervision of the candidate’s research. The primary mentors must document the availability of sufficient research support and facilities for the candidate's research. Candidates are encouraged to identify additional co-mentors to form a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development plan. The candidate must work with all mentors (primary and co-mentors) in preparing the application. The mentors should describe in detail successful track records of mentoring individuals at the candidate’s career stage.

Institutional Environment

The U.S. and LMIC institutions where the proposed research will be conducted 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.

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.

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

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

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

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

Both the primary US and primary LMIC mentor must insert 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 research support in the Biographical Sketch, clarify PD/PI status (direct recipient) of awards.

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

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

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

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

Human Subjects Sections

Other Research Plan Sections

Appendix

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate's Background

• Describe the candidate's commitment to a global health-related research career.
• Describe prior training and research experience beyond doctoral training and how it relates to the objectives and long-term global health research career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent global health researcher (such as lead authorship of and/or significant contribution to research publications in peer-reviewed journals, presentations at international meetings, prior research interests and experience, research fellowships, and letters of reference).
• Justify the candidate's need for an additional mentored research experience to become an independent research scientist.
• Describe all the candidate's professional responsibilities at the grantee institution and elsewhere and show the relation of these responsibilities to the proposed activities on the career development award.
• For junior faculty, describe how this award will relieve the candidate of current duties so that a greater portion of the candidate’s effort (at least 9 person-months, equivalent to 75% full-time professional effort) may be devoted to research and related career development activities.
• For postdocs, describe how the award would provide additional research and career development opportunities beyond the standard postdoctoral experience.

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.
• Explain how the career development award will contribute to career goals, and further the candidate’s global health research career.

Candidate s Plan for Career Development

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development activities proposed; (2) that justifies the need for further research career development to become an independent researcher; and (3) utilizes the relevant field, clinical, research and educational resources of the U.S. and LMIC institutions. The candidate and the mentors are jointly responsible for the preparation of the career development plan.
• 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.
• Provide a detailed description of the career development activities, including plans to obtain the necessary research skills and experience to launch an independent global health research career. The description of the career development plan should include items such as advanced level courses, seminars, and opportunities for collaboration and interaction with other scientists, especially in the proposed LMIC. Training in career skills such as grant-writing and making effective scientific presentations, is strongly encouraged. The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher.
• Describe a career develeopment plan that will maximize use of U.S. and LMIC research institutional environments, including available facilities and resources.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• Describe how the candidate plans to fulfill the requirement that he/she spend at least 50% of cumulative effort over the total project period (all years) physically in-country conducting research at the LMIC site AND in each year of the grant, the candidate will meet the requirement to spend a minimum of three months in the LMIC. A timeline outlining time in country is strongly recommended.
• Applicants are encouraged to describe plans for outreach and dissemination of research findings both in the LMIC and in the U.S.

Research Plan Section

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

Research Strategy

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

Training in the Responsible Conduct of Research

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

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

• Statements from the primary U.S. mentor at the applicant institution, the primary LMIC mentor, as well as any co-mentors, are expected to provide 1) an assessment of the candidate’s qualifications and potential for an independent global health research career; 2) information on the mentor's research qualifications and previous experience as a research supervisor; 3) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 4) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 5) a plan for monitoring and evaluating the candidate’s research, publications, and progression towards independence.
• Together, the mentors should provide evidence of 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.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The primary U.S. 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.
• Mentor statements should include a statement that the candidate will meet the time-in-country requirement (50% of requested effort over the entire award period).
• Mentor statements should clearly describe how they will coordinate mentoring of the candidate with other proposed mentors, both primary and secondary co-mentors.
• Mentor statements should describe 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 provide annual evaluations of the candidate’s progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all additional collaborators and/or consultants 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 researcher.
• The LMIC Institutional Commitment letter should also be included in this section, following page limit requirements for this section. It should provide a statement of commitment to the candidate's development into a productive, independent researcher and provide assurances that appropriate time and support for the proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
• All letters should be combined and submitted as a single PDF.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

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

Institutional Commitment to the Candidate’s Research Career Development

• Both the applicant 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 applicant U.S. institution must provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist, e.g. clinic responsibilities, teaching and administration, and/or additional research activities.
• The U.S. institution should provide assurance that the candidate will be able to spend at least 50% of the cumulative effort over the project period at the LMIC site, conducting research and career development activities.
• 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.
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.
• The LMIC Institutional Commitment letter should be submitted via "Letters of Support from Collaborators, Contributors, and Consultants", following page limit requirements. The U.S. Institutional Commitment letter should be submitted here.

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.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

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 a 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 with the following additional instructions:

• 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.

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

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference 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.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow our Post Submission Application Materials policy.

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

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

Candidate

• Does the candidate have the potential to develop as an independent and productive global health researcher addressing scientifically significant topics that reflect the health priorities of the LMIC?
• Are the candidate's prior training and research experience appropriate for this award?
• 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 global health researcher?
• Do the letters of reference address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent global health investigator?
• Does the candidate have the research experience and skills needed to carry out the proposed research?
• 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 plan will contribute substantially to the scientific development of the candidate, leading 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 training 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 global health research career in LMIC settings?

Research Plan

• Is there a strong scientific premise for the project?
• 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 candidate's 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 health priority and scientific importance to the LMIC?

Primary 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?
• 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 mentor’s descriptions of the elements of the research career development activities, including formal course work, adequate?
• Is there evidence of the mentors', consultant s, and/or collaborator’s previous experience in fostering the development of independent researchers in the LMIC proposed?
• Is there evidence of previous research productivity and peer-reviewed support?
• 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?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the applicant U.S. 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?
• Is there clear commitment of the applicant U.S. institution to ensure that the candidate will be able to spend the required time at the LMIC site (a minimum of 50% of the requested effort over the award period with a minimum of 3 months each year)?
• 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 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.

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 Guidelines for the Review of Human Subjects.

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 children 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.

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.

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.

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.

Not Applicable

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.

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.

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).

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).

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.

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

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

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

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

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

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

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

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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. Both primary mentors are required to provide evaluation statement of the candidate’s progress.

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 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.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-945-7573

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

For inquiries related to the career development aspects, contact:

Susan Lim, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: lims@mail.nih.gov

For inquiries related to research aspects, contact:
Shannon Silkensen, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5810
Email: shannon.silkensen@nih.gov

Seetha Bhagavan, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: bhagavas@csr.nih.gov

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

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

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 Part 75.