Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Funding Opportunity Title

Limited Competition: Fogarty HIV Research Training Program for Low-and Middle-Income Country Institutions (D43)

Activity Code

D43 International Research Training Grants

Announcement Type

Reissue of PAR-12-068

Related Notices

  • 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.
  • July 12, 2013 - See Notice NOT-TW-13-008. Notice to Extend the 2013 Application Due Date and Provide Additional Instructions for Correct Application Package.
  • July 3, 2013 - See Notice NOT-TW-13-006 Instructions for Correct Application Package.

Funding Opportunity Announcement (FOA) Number

PAR-13-126

Companion Funding Opportunity

PAR-13-214, D71, International Research Training Planning Grant
PAR-13-215, G11, Extramural Associate Research Development Award (EARDA)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.989, 93.279, 93.242, 93.398

Funding Opportunity Purpose

The purpose of this FOA is to encourage applications for research training programs to develop and strengthen the scientific leadership and expertise needed for HIV-related research at eligible Low-and Middle-Income Country (LMIC) institutions.

This FOA can support training for a broad range of HIV research areas:

  • all basic, epidemiologic, clinical, behavioral, social science, implementation, operations, health services, and health systems research across HIV prevention, care and treatment;
  • research on HIV co-infections, AIDs-defining and HIV-related cancers, co-morbidities and other health conditions, both infectious and non-infectious, that contribute to HIV transmission or poor health in HIV-infected individuals;
  • research and research methodology for community-based research, complex and multi-component interventions, for structural interventions, for comparative effectiveness research, for impact evaluation or for health economics;
  • HIV-related research among vulnerable or under-researched LMIC populations, including women, children, substance users, men who have sex with men, transgendered populations, aging populations, orphans and vulnerable children;
  • training for clinical research team members to support clinical research and clinical trials;
  • bio-statistics for research design and methodology, data analysis, data management, and data quality assurance and control; and
  • laboratory capacity, bio-safety, and maintenance of lab quality assurance and control.

However, an application must focus the proposed training program to build or strengthen research capacity in a defined HIV-related scientific topic at one identified LMIC institution.

Key Dates
Posted Date

April 25, 2013

Open Date (Earliest Submission Date)

June 24, 2013

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

(Extended to July 31, 2013 per NOT-TW-13-008) July 24, 2013, July 24, 2014, July 30, 2015, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

July 24, 2013, July 24, 2014, July 30, 2015 by 5:00 PM local time of applicant organization.

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

Scientific Merit Review

October/November 2013, October/November 2014, October/November 2015

Advisory Council Review

January 2014, January 2015, January 2016

Earliest Start Date

April 2014, April 2015, April 2016

Expiration Date

July 31, 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 the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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.


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The overall goal of the Fogarty International Center (FIC) HIV Research Training Program is to strengthen the human capacity to contribute to the ability of institutions in eligible low- and middle-income countries (LMIC) to conduct HIV-related research on the evolving HIV-related epidemics in their country and to compete independently for research funding. See NOT-TW-12-011 to ascertain LMIC eligibility.

The Fogarty HIV Research Training Program encourages applications under three different Funding Opportunity Announcements (FOAs). This FOA (D43) encourages applications to support research training to develop and strengthen the scientific leadership and expertise needed for HIV-related research at eligible LMIC institutions. The second FOA (D71) (PAR-13-214) is to encourage planning grants to support eligible LMIC institutions to develop an application to submit under this FOA. The third FOA (G11) will support applications from U.S. institutions for training in defined research infrastructure areas at LMIC institutions (PAR-13-215). See Section III. Eligibility Information for eligibility information.

The FIC, with co-funding from other NIH Institutes and Centers, has provided 25 years of support to HIV research through two HIV research training programs, the AIDS International Training and Research Program (AITRP) and the International Clinical, Operations and Health Services Research Training Award for AIDS TB program (ICOHRTA AIDS TB). Awards under these two programs have supported research training of LMIC individuals who have participated in important HIV-related research conducted at LMIC institutions and in partnership with U.S. and other international scientists and scientific institutions. Over the years, some of the most important recent scientific advances in HIV/AIDS, including interventions to reduce mother-to-child HIV transmission, to address HIV/TB co-infection, and to prevent HIV infection through behavior change, microbicides, and antiretroviral drugs, have been facilitated through partnerships with LMIC scientists and supported by the FIC research training programs. Continued investment in training to strengthen research and research capacity at LMIC institutions is needed to address the on-going HIV epidemic in LMICs.

Efforts to implement research findings within the context of increased provision of HIV prevention, care and treatment services in LMICs over the past ten years have led to the emergence of new research issues, such as combination HIV prevention interventions, better linking of newly diagnosed individuals into care programs, and integration of HIV programs with other health services. As LMICs implement HIV prevention, care and treatment programs for their populations, these and other, yet undefined, research issues will need evidence-based solutions.

Because the social context of an LMIC will influence the research designed to answer these evolving research questions, LMIC institutions and their researchers, who intimately understand the social context of their country and with the research capacity to design and conduct the research, are best positioned to conduct the most relevant research, disseminate the results in-country, and influence policymakers, program managers and medical/public health practice.

FIC decided to consolidate the two FIC HIV research training programs in FY2013 into a new program, the Fogarty HIV Research Training Program. This new program is designed to focus each individual research training award on specific research capacity at an identified LMIC institution. The new program will move beyond simple output indicators (number and type of people trained) to outcome indicators (increased research capacity at an institutional level) for more meaningful monitoring and evaluating both of individual awards and of the program as a whole.

The new program will provide an opportunity for LMIC institutions and their U.S. partners to collaborate to fill a gap in research capacity and bring the LMIC institution to a higher level of research capacity in a particular HIV-related topic. This new program will allow applicants to design training programs to increase the research capacity at LMIC institutions to address the long-standing unanswered questions as well as the new and emerging questions that have arisen as a result of recent scientific advances. It is anticipated that this approach will allow applicants to be more responsive to an emerging need at an LMIC institution for research capacity, and will provide more opportunities for LMIC institutions to collaborate with NIH and other United States Government (U.S.G.) funded efforts.

This FOA, under the Fogarty HIV Research Training Program, can support training for a broad range of HIV research areas:

Each applicant will need to:

The selected topic or question may need expertise that crosses the research disciplines and methodologies (see HIV research areas listed above), and applicants are encouraged to develop research training programs in the various disciplines that are needed to address the specific scientific topic or question. The proposed training is expected to raise the LMIC institution to the next level of research capacity to be able to address the specific topic or question. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs relevant to the specific scientific topic or question occurring at the LMIC institution. The applicant should describe these other research training programs at the LMIC institution, regardless of the source of funding, and explain what distinguishes the proposed training program from the other training programs, how their program will synergize with the others, if applicable, and make it clear that the pool of training staff, potential trainees, and resources are robust enough to support additional research training programs.

Proposed programs can support a mix of short-(three months or less), medium- (over three months and up to six months) and long-(six months and longer, including degree) term training to support increased research capacity in the specified scientific topic at the identified LMIC institution. Part-time long-term training is permitted but should be described and justified in the application. Emphasis should be on training that provides the theoretical and applied depth needed by an individual or by a group of LMIC individuals in the LMIC institution so that the research capacity gained in the identified scientific topic would be maintained at a level of high quality (i.e., produce results publishable in international peer-reviewed journals, support independent research grants, etc.) after the five-year training period.

Over time, it is anticipated that the LMIC institution could serve as a training site in the defined scientific topic for other LMIC institutions, and existing faculty and staff at the LMIC institution are eligible for further training to achieve this goal. The applicant may propose advanced training to support the career development of former trainees under this or other FIC training programs, as long as the rationale describes how the training would contribute to increased and sustainable research and training capacity in the identified scientific topic at the LMIC institution. Training models can be innovative, but must be appropriate for the context of the LMIC institution. Applicants may propose advanced training models to engage former AITRP and ICOHRTA AIDS TB trainees, who are employed in non-research positions at the LMIC institution, in meaningful research in the specific topic.

Training should take place at the most appropriate site for the proposed training. The training site may include institutions other than the applicant or LMIC institution named in the application. Distance learning with sufficient mentoring and support at the LMIC institution can be an option.

Training-related research must be conducted or use data from the country of the LMIC institution identified in the application. Where appropriate, the design of training-related research projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

Applicants are encouraged to review the FIC Strategic Plan at http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx and the NIH Plan for HIV-Related Research for the year they are applying, available at http://www.oar.nih.gov/strategicplan/. Applicants are also encouraged to explore research training in topics of interest to PEPFAR (http://www.pepfar.gov/) and the U.S. Global Health Initiative (http://www.ghi.gov/).

See Frequently Asked Questions for the Fogarty HIV Research Training for more information.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Resubmission

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

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

Application budgets are limited to $282,000 direct costs per year.

Award Project Period

Five years

Other Award Budget Information
Stipends, Tuition, and Fees

Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. Medium- and long-term trainees may be paid a stipend comparable to their professional experience and institutional policy, but stipend level should not exceed the NRSA levels (see NRSA Stipend levels at http://grants1.nih.gov/training/nrsa.htm#policy), or grantee institutional policies for trainees involved in medium- or long-term training. Partial stipends for part-time long-term trainees should reflect the amount of time they need to be supported for training in the budget and described in the budget justification

Living expense for short-term trainees should be covered by per diem and included under travel expenses

Funds for tuition and academic fees at the U.S. or a foreign institution may be requested. Note that health insurance is not included as part of this budget category, and is now included under the Training Related Expenses category.

Trainee Travel

Funds may be requested for round-trip economy class airfare on U.S. carriers (to the maximum extent possible).

Funds may be requested for lodging and per diem for short-term trainees.

Funds may be requested to support participation in international conferences and meetings in which current or former trainees will present training-related research results.

Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense.

Training Related Expenses

Applicants are encouraged to budget adequate professional development opportunities for trainees, including international scientific conference attendance. Training-related expenses (e.g., books, computers, and courses for software, English language proficiency, etc.) and limited costs for mentored research may be included but must be described in the budget justification. Funds for self-only or family medical insurance may be requested.

Applications may include costs for short- term courses and those costs should be described in budget justification.

Applicants may include costs to support mentored research projects conducted in his/her country for long-term trainees after they have completed their didactic training. Direct costs should be limited to up to $15,000 direct /project/trainee, and only one project allowed per trainee.

All training-related research projects under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, with documentation of education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is being conducted.

Other Program Related Expenses

Senior/Key Personnel Salary: The salary for the PD/PI, other key personnel, training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at http://grants.nih.gov/grants/policy/salcap_summary.htm. Collaborators may receive appropriate compensation for significant activities on the program, such as recruitment and selection activities, as well as other program-related roles. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described and justified.

Senior/Key Personnel Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for training responsibilities and to attend necessary meetings, including the annual program network meeting, normally in the U.S. Program Director/Principal Investigator (PD/PI) are expected to attend the network meeting, and may also budget for grant administrators, other faculty, collaborators and trainees to attend.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Other

Only foreign institutions in low-and middle income countries are eligible to apply to this FOA. See NOT-TW-12-011: Notice of Change in Country Eligibility for Fogarty International Training Grants to ascertain LMIC eligibility.

Current AITRP and Phase II ICOHRTA AIDS TB award institutions are not eligible to submit applications to this FOA until the last year of their current AITRP or Phase II ICOHRTA AIDS TB project period.

U.S. Institutions must have on-going HIV research collaborations with the eligible LMIC institution named in their application to be eligible to apply.

The applicant institution must assure support for the proposed program. The LMIC institution named in an application from a domestic institution must also demonstrate institutional commitment to the proposed training by identifying a tangible means of support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. Applicants are encouraged to maximize the number of trainees supported under the award by exploring institutional support for reduced tuition, trainee stipend, trainee research expenses, and key personnel salary and travel.

The applicant institution must have a strong and high quality HIV research program in the scientific topic proposed under this FOA and must have the requisite faculty and facilities committed for the proposed research training program. A substantial number of program faculty should have active HIV research projects in which participating trainees may gain relevant mentored research experiences consistent with their interests and goals. The proposed research training program should complement other ongoing research and research training programs at the LMIC institution.

Only eligible LMIC institutions with a previous planning grant award under the AIDS International Training and Research Program (AITRP), an award under the Phase II (U2R) International Clinical, Operations and Health Services Research Training Award for AIDS and TB Program (ICOHRTA AIDS TB), or a planning grant award under this program (Planning Grant for HIV Research Training for Low-and Middle-Income Country Institutions D71 Award) may apply to this FOA. Other eligible LMIC institutions should apply for a planning grant- see D71 FOA (PAR-13-214).

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

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

Required Registrations

Applicant Organizations

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

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at:

http://grants.nih.gov/grants/ElectronicReceipt/files/Tips_for_International_Applicants.pdf.

http://grants.nih.gov/grants/ElectronicReceipt/files/international_support.pdf

http://grants.nih.gov/grants/ElectronicReceipt/files/international_qa.pdf

http://grants.nih.gov/grants/ElectronicReceipt/preparing_grantsgov_reg.htm

Guidance for International Applicants Blocked from Registration Websites: NOT-OD-11-090.

An NIH supported webinar on Electronic Submission of Grant Applications for Foreign Institutions can be found at http://grants.nih.gov/grants/webinar_docs/webinar_20120927.htm.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed program as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

PD(s)/PI(s) on applications from U.S. institutions must demonstrate a history of relevant research collaboration with researchers or faculty at the LMIC institution.

The PD(s)/PI(s) on a D71 award under the Fogarty HIV Research Training Program is expected to be the PD(s)/PI(s) on the respective D43 application.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is programmatically and 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:

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award. Applications should include descriptions of the roles and bio-sketches for relevant faculty, mentors and other teaching staff expected to participate in the proposed research training program and contribute to its ability to bring the LMIC institution to the next level of capacity in the specified scientific topic.

Trainees

Only individuals from LMICs are eligible for training under this FOA.

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Jeanne McDermott
Program Officer
Division of International Training and Research
Fogarty International Center, NIH
Bldg 31 Rm B2 C39
31 Center Dr. MSC 2220
Bethesda MD 20892-2220 U.S.A
Telephone: 301-496-1492
Email: jeanne.mcdermott@nih.gov

Required and Optional Components

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.

Page Limitations

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

SF424(R&R) Cover Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following modifications:

Proposed Project Start and Ending Dates: Use the “Earliest Anticipated Start Dates” given in this FOA as the Proposed Project Start Date.

SF424(R&R) Project/Performance Site Locations Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Include the applicant institution, the identified LMIC institution in the application and any other participating institutions, both U.S. and foreign as performance sites.

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following modifications:

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the research training plan, and a brief description of the planned research training program. Include the country and name of the LMIC institution and the specified scientific topic for which research training is being proposed. Include the rationale and design of the program, the expected increased research capacity and the measures the applicant will use to demonstrate that increased capacity.

Project Narrative

Include the name of the LMIC and the LMIC institution, the specified scientific topic for which research training is being proposed, and describe the public health relevance of the increased research capacity to the LMIC institution.

Other Attachments

Advisory Committee: A plan must be provided for the appointment of a Training Advisory Committee (TAC) to monitor progress. Responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Training Advisory Committee, identifying the role and the desired expertise of members. The Training Advisory Committee should be composed of expert faculty and relevant professionals from the U.S. and the specific LMIC as well as other countries and who are not directly involved in the training program or in mentoring trainees. They should be included as key personnel as described in SF 424(R&R) Senior/Key Person Profile Expanded Component.

Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, scientific review of trainee projects, and the evaluation of the overall effectiveness of the program. Please name your file “Advisory_Committee.pdf”

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

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

Follow the directions in SF424 for whom to include as Senior or key personnel. In addition,

Training and Research & Related (R&R) Budget Component

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

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:

Particular attention must be given to the required Training Data Tables. The instructions for the Training Data Tables required for this FOA have been adapted for the international focus of this FOA and are included in the sections below. Training Data Tables 1, 3, 4, 5, 6, 7a, 7b, 8a, 8b, 9a, 9b and 10 do not need to be completed. Table 11, 12A and 12B are not relevant for this FOA as only new and resubmission applications are allowed. Training Data Table 2 does need to be completed. The requested Data Tables should be included in the application at the point indicated (PHS 398 Research Training Plan, 13. Data Tables) and should not be inserted in the narrative for Sections 8.9.2-8.9.5.

Background (Component of Program Plan)

Program Administration (Component of Program Plan)

Describe the strengths, leadership and administrative skills, and scientific expertise of the Training PD(s)/PI(s) including relevant scientific or professional background and research training experience in the specific LMIC and, if relevant, other LMICs PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program.

Indicate the level of effort and activities for which the PD(s)/PI(s) will be responsible. Describe the decision-making process, including how the PD(s)/PI(s) will obtain continuing advice from the TAC. For U.S. applicants, describe the role of the LMIC Key Collaborator in the development and administration of the proposed research training program.

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Do not complete Tables 1 and 3.

Table 2. Participating Faculty Members -Include information relevant to the proposed training program for faculty and professionals who will be involved as faculty or mentors from all participating performance sites.

Referring to the faculty and professionals listed in Table 2, provide a short description of their research or expertise for each that is relevant to their role in the proposed training plan in the narrative. Include relevant information for each on their past training record and the subsequent success of former trainees, especially those from LMICs, in pursuing further career development and in establishing productive research careers.

Do not complete Tables 4, 5 and 6.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Provide a five-year training implementation plan that provides the rationale for the balance of training options (degree-related and non-degree, long-, medium- and short-term training), the areas/disciplines selected for training and the training sites selected for the training. Describe courses and research opportunities that will be available to trainees at each of the participating institutions or other identified training sites. Describe a plan for mentorship that will support trainees while in formal coursework and while conducting training-related research relevant to the specified scientific topic. Describe the plans for the integration of the proposed training with other relevant capacity building activities at the LMIC institution. Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers. Programs should provide all trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future fellowships as eligible and career development and independent research support. All postdoctoral trainees should also be provided with instruction in laboratory and project management.

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements. Describe the mechanism to be used to annually review the capacity measures, the progress of your trainees and other indications of the effectiveness of your training program. Describe the roles of the faculty and professional staff at the applicant and LMIC institution, if U.S. applicant, and all other participating institutions, of current and former trainees, and of the TAC in the review process. Specified evaluation metrics should be tied to the goals of the program. Define measures that will be used to demonstrate increased research capacity at the end of the five-year funding period in the specific scientific topic for which the training program is proposed. Describe how the data for those measures will be collected and how they will be monitored over the five-year period. Describe strategies that will be used to support the LMIC institution to achieve a level of research capacity for which it can become a research training center for the specified scientific topic. Include a plan for data entry of long-term trainee information into CareerTrac, the web-based Fogarty Trainee Tracking System (see Section VI.3. Other Reporting Requirements below). Evaluation results should be included in future renewal applications and in the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. It is not necessary to name prospective trainees. Describe plans to recruit candidates and explain how these plans will be implemented. Describe the role of the LMIC institution faculty and the TAC in the recruitment and selection process. Describe the evaluation criteria to be used in the selection of trainees. Criteria should include a list of standards that will be used to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and are likely to contribute to the increased capacity of the LMIC institution in the specified scientific area. Describe recruitment efforts to attract women and other populations who are under-represented in sciences in that LMIC to apply for training opportunities. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences. Describe a plan for retaining students in the program until completion. Describe strategies that will be used to encourage and prepare trainees to pursue further research opportunities in their LMIC.

Institutional Environment and Commitment to the Program (Component of Program Plan)

Describe the institutional support and commitment to the goals of the training program by the LMIC institution, and for U.S. applicants, also by the U.S institution. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD(s)/PI(s) and/or participating faculty, support for additional trainees in the program, or any other innovative approaches to improve the climate for the establishment and growth of the training program. Include support provided by the LMIC to trainees upon completion of their training experiences.

Do not complete Tables 7A, 7B, 8A, 8B, 9A, 9B and 10.

Recruitment and Retention Plan to Enhance Diversity

Do not complete this section of the application.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Letters of Support

The application should include letters of support that describe how the proposed training program will collaborate with other training programs and relevant on-going HIV research at the institution. The application should include letters of support from officials at LMIC government that describe how they will support and collaborate with the proposed training program, as well as letters of institutional commitment.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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. 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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.

For this particular announcement, note the following:

The research training proposed should be evaluated for its expected impact on bringing the identified LMIC institution to the next level of capacity in the scientific topic proposed in the application. The applicant should provide a clear rationale for the selection of the particular scientific topic as critical to the research capacity of the LMIC institution. The applicant should describe how the proposed training will build or strengthen the LMIC institutional capacity in that scientific topic. While the applicant can and should collaborate and leverage other efforts at the designated LMIC institution, regardless of funding source, the application will need to demonstrate that the proposed training is “distinct” and not duplicative of other efforts at the LMIC institution in that specific scientific topic.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the HIV- research capacity in LMIC institutions, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Training Program and Environment

Will the proposed training fill a gap that is critical to the HIV-related research capacity of the LMIC institution? Will the proposed training contribute to bringing the LMIC to the next level of research capacity in the specified scientific topic? Do the objectives, design, direction and mix of short-, medium- and long- term training in the defined research areas proposed for the training program ensure effective research training in the specified scientific topic?

To what extent does the proposed training program take advantage of the LMIC institution’s research infrastructure and of previous and current investments and support from FIC, NIH, and other organizations? Is it duplicative of research training in the specified scientific topic that has been or is currently being provided by others at the LMIC institution? Has the applicant proposed a training plan that includes components to enhance sustainability of the research capacity and will support high quality research?

Is there evidence of a significant level of institutional commitment to support the program from both applicant and LMIC institutions? Have the LMIC and/or the participating institutions committed additional resources that will strengthen the ability of the proposed research training to increase the research capacity at the LMIC institution? Are the strategies for trainees to be engaged in the HIV-related research relevant to the specified scientific topic at the LMIC institution sufficient? How strong is the history of collaborations among the faculty/mentors at the participating institutions? How well will these collaborations serve as a platform for the proposed training?

Is the Training Advisory Committee constructed to achieve the functions defined in this FOA? Are the plans adequate for review of training-related research for scientific review and compliance with federal requirements for protection of human subjects in research and animal care and use in research?

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

Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration of the proposed research training program? Does the Training PD(s)/PI(s) plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program?

For applications designating multiple PD/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PDs/PIs?

Mentors

Are sufficient numbers of experienced mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application? Do they have experience with training for LMIC trainees? Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? How successful have the proposed faculty and mentors been in providing training in the specified scientific topic? Have their previous trainees been successful in completing their training and applying the new knowledge and skills?

Trainees

Is a recruitment plan proposed with strategies to attract high quality trainees? Are there well-defined and justified selection criteria and retention strategies? Is a competitive applicant pool in sufficient numbers to warrant the proposed size and levels of the training program in evidence?

Training Record

How well has the applicant defined measures that can be used to demonstrate increased capacity in the specified scientific area at the end of the five-year funding period? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training over the five-year period? How adequate is the proposed method to monitor the long-term impact of the training experience on the subsequent research capacity at the LMIC institution and the careers of trainees?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

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

Additional Review Considerations

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

Applications from Foreign Organizations

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

Recruitment & Retention Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the training program, level of trainee experience, and the particular circumstances of the trainees, 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, and laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? If this is a renewal, is there a report describing past instruction in the five components described above? 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

Not Applicable

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 training.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

2. Administrative and National Policy Requirements

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

Inventions and Copyrights

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Other Reporting Requirements

Grantees will be requested to enter information annually concerning long- term trainees into FIC’s CareerTrac, a database to track the training history and accomplishments of trainees over time. The database will be made available to grantees after the award is made.

A final Progress Report 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. Evaluation results should be included as part of the final Progress Report.

4. Evaluation

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 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)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Dr. Jeanne McDermott
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: jeanne.mcdermott@nih.gov

Dr. Geraldina Dominguez
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov

Dr. Richard Jenkins
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email: jenkinsri@nida.nih.gov

Dr. Willo Pequegnat
National Institute of Mental Health (NIMH)
Telephone: 301-443-1187
Email: wpequegn@mail.nih.gov

Peer Review Contact(s)

Hilary D. Sigmon, Ph.D., R.N.
Center for Scientific Review (CSR)
Telephone: 301-357-9236
Email: hilary.sigmon@nih.gov

Financial/Grants Management Contact(s)

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: Kasima.Brown@nih.gov

Shane Woodward
National Cancer Institute (NCI)
Telephone: 301 496-8791
Email: Shane.Woodward@nih.gov

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: mconnell@nida.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.


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