Required Application Instructions

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

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 Fogarty International Center (FIC) HIV Research Training Program is to strengthen the scientific capacity of institutions in low- and middle-income countries (LMIC) to conduct HIV research on the evolving HIV epidemic in their country.

The Fogarty HIV Research Training Program encourages applications for three different Funding Opportunity Announcements (FOAs). This FOA (D43) encourages applications to support research training to strengthen scientific expertise needed for HIV research at LMIC institutions. The second FOA (D71) (PAR-16-281) encourages planning grant applications from LMIC institutions to develop a training program and application to submit under this FOA. The third FOA (G11) encourages applications for infrastructure development training in six research infrastructure functions described in PAR-16-280.

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

• basic, epidemiologic, clinical, behavioral, and social science research across HIV prevention, care and treatment;
• pathophysiology and therapeutics research to address HIV infection, the effects of HIV on body systems, and HIV’s interaction with other co-morbidities and co-infections;
• implementation, operations, health services, and health systems research to improve the HIV prevention, care and treatment care continuum;
• research on integrated bio-behavioral HIV prevention, care and treatment among high risk populations, including polysubstance drug (injection and non-injection) and alcohol use;
• research on HIV co-infections, AIDs-defining and HIV-related cancers, neurological and neuro-psychiatric morbidities, and other co-morbidities and health conditions, both infectious and non-infectious, that contribute to HIV transmission or poor health in HIV-infected individuals, including HIV infected substance (drug and alcohol) users;
• community-based HIV research, HIV research on complex/multi-component interventions, structural interventions, and comparative effectiveness, and HIV research on impact evaluation or health economics;
• cross-disciplinary HIV research among vulnerable or under-researched LMIC populations, including women, substance (drug and alcohol) users, men who have sex with men, transgendered populations, aging populations, orphans, and children;
• clinical research for team members to support HIV clinical research and HIV clinical trials;
• bio-statistics for HIV research design and methodology
• bioinformatics, data analysis, data management, and data quality assurance and control to support HIV research;
• laboratory capacity, including bio-safety, and maintenance of lab quality assurance for HIV clinical research.

In previous competitions of this program, most LMIC institutions were not eligible to apply to the D43 FOA, but this restriction is now lifted. LMIC institutions now have the options to apply to the D43 FOA or to the D71 (planning grant) FOA. Another change is that the beneficiary of the training supported through this FOA is expanded to include LMIC sites in an established HIV research network.

FIC, with co-funding from other NIH Institutes, Centers and Offices (I/C/O), provided almost 30 years of support to enhance HIV research through HIV research training programs. Awards supported research training of LMIC scientists who participated in important HIV research conducted at LMIC institutions 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, address HIV/TB co-infection, and 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 at LMIC institutions is needed to address the on-going HIV epidemic and to achieve the goals of a "Cure" and an "AIDS-Free Generation."

Efforts to implement research findings in the context of increased HIV prevention, care and treatment services in LMICs over the past ten years led to the emergence of new issues, such as how to best combine HIV prevention interventions, link newly diagnosed individuals into care programs, and integrate HIV programs with other health services. As LMICs implement HIV prevention, care and treatment programs, these and other, yet undefined, issues will need evidence-based solutions.

The social context of an LMIC influences the design of research to answer many of these evolving HIV research questions, therefore, LMIC institutions and researchers are best positioned to conduct the most relevant HIV research, disseminate the results in-country, and influence policymakers, program managers and medical/public health practice.

In the Fogarty HIV Research Training Program, each research training award is expected to focus on strengthening specific high priority HIV research capacity at an identified LMIC institution or at LMIC sites within an established HIV research network. An established HIV Research Network (referred to as "the Network" in these FOAS) is defined as multiple research institutions, with a group of researchers from each institution that are collaboratively working towards a common HIV research agenda, that are formally organized and funded for such collaboration. This FOA will not support the establishment of a new HIV Research Network. The network sites located in LMICs for an established HIV research network are referred to as "LMIC Network sites" in these FOAs.

The Fogarty HIV Research Training Program is designed to move beyond simple output indicators (number and type of people trained) to outcome indicators (increased research capacity at an LMIC institutional or at LMIC Network site(s) level) to provide more meaningful monitoring and evaluation of individual awards and the program as a whole. Applicants should design a training plan for individuals that will also demonstrate in an explicit and defined way how the training will contribute to a higher level of research capacity at the LMIC institution or LMIC network sites.

This program provides opportunities for U.S. and LMIC institutions to collaborate with their partners, including an established HIV Research Networks with LMIC sites, to fill gaps in a particular area to strengthen the HIV research capacity at the proposed LMIC institutions or Network sites. Applicants should design HIV research training programs for LMIC scientists and staff at LMIC institutions or Network sites so that they can address the long-standing and emerging HIV research questions. It is anticipated that this approach will allow applicants to be more responsive to research needs at an LMIC institution(s) and provide more opportunities for LMIC institutions to collaborate with NIH, U. S. Government, other donors and LMICs in their HIV/AIDS efforts.

The selected scientific area of the proposed research training may need expertise that crosses research disciplines, especially to reach underserved and vulnerable populations. Applicants are encouraged to develop research training programs that include all of the disciplines needed to address the selected scientific area and the populations of interest. The proposed training is expected to raise the LMIC institution or LMIC Network sites to the next level of research capacity in the selected scientific area. The research training should include training that incorporates research methods and processes that enhance research reproducibility, as recently highlighted by NIH. Research training proposed for LMIC Network sites should address research capacity in the selected scientific area that is broader than what is needed to address the current Network research agenda alone.

In many cases, it is anticipated that the proposed program will complement other ongoing research training programs relevant to the selected scientific area at the LMIC institution(s) or LMIC Network sites. Proposed research training should be designed to be synergistic and not duplicative of these other programs.

It is anticipated that some LMIC institutions could serve as training sites in the proposed HIV scientific area for other LMIC institutions or LMIC Network sites. Faculty and scientific staff from these more advanced LMIC institutions or LMIC Network sites may serve as training faculty. As a result, three different scenarios for applications may be proposed: a U.S. institution as the applicant with an LMIC institution or LMIC sites in a particular Network as beneficiary of the research training; a LMIC institution as applicant with their own institution as the beneficiary of the research training to further strengthen its own capacity; a LMIC institution as applicant with another LMIC institution or LMIC sites in a particular Network as the beneficiary of the research training.

Proposed programs can support a combination 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 selected scientific area at the identified LMIC institution or LMIC Network sites. Part-time long-term training is permitted but should be well described and justified in the application. Emphasis should be given to training that provides the theoretical and applied depth needed by an individual or by a group of individuals in the LMIC institution or Network sites to maintain the research capacity in the selected scientific area at the higher level after the five-year training period.

Short-term training should provide selected trainees with a thorough exposure to the principles and skills of specific research methods or research-related competencies that are needed to support their current research or career development activities. Mentorship should be provided to ensure short-term training achieves this expectation. Short-term training support is limited to:

• Training in specific research skills or methods directly applicable to trainee research projects.
• Research leadership, management or career development skills, such as expertise in research ethics and compliance issues, grant management and administration, grant and scientific manuscript writing, information technology and data management, technology transfer and intellectual property.

The applicant may propose advanced training to support the career development of former trainees from this or other FIC training programs, as long as the training contributes to increased and sustainable research and research training capacity in the selected scientific area at the LMIC institution or LMIC Network sites.

Training models can be innovative, but must be appropriate for the context of the LMIC institution or LMIC Network sites. Training should take place at the most appropriate site. The training site may include institutions other than the applicant or LMIC institution(s) or LMIC Network sites named in the application, including other high-income or "ineligible" middle-income countries (see http://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx). Distance learning with sufficient mentoring and support at the LMIC institution or LMIC Network site may be proposed.

Training-related research must be conducted in or use data from the country of the LMIC institution or from the Network as long as the data include data from LMIC Network sites. The training-related research must be designed to incorporate research methods and processes that enhance research reproducibility, and 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.

All mentored research projects under this award must receive independent scientific review through procedures established by the applicant and be in compliance with the federal requirements for the protection of human subjects and animals in medical research. If human subjects are involved, the trainee must receive education in the protection of human subjects, and the research must receive annual 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 conducted. If animals are involved, institutions where research is conducted need to have Animal Welfare Assurance.

Applicants are encouraged to review the NIH HIV/AIDS Research Priorities, the NIH Plan for HIV-Related Research for the year they are applying and the FIC Strategic Plan to inform their proposed training plan.

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

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.

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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions) in LMICs eligible for support under FIC International Training grants (See below for more information on country eligibility)

An application may be submitted by a foreign institution in an eligible low- or middle-income country (LMIC) or by a domestic (U.S.) institution that demonstrates collaboration with an LMIC institution or a particular Network and its sites in eligible low- or middle-income country(ies). Collaboration should be documented by joint publications, grants or previous research training activities.

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). See Country Eligibility for Fogarty International Training Grants for additional information. Other High Income Country (HIC) or ineligible LMIC Faculty and institutions may be named as partners and serve as training sites.

The applicant institution whether from the U.S. or eligible LMIC must assure 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. The applicant institution, partnering institutions, the particular HIV Research Network (if applicable), and the LMIC institution or LMIC Network sites that serve as beneficiaries of the training must also demonstrate institutional or Network commitment to the proposed training.

The applicant institution is expected to have robust and high-quality HIV research ongoing in the selected scientific area proposed and the requisite faculty and facilities on site or at partner institutions to contribute to the envisioned HIV research training program. It is anticipated that participating training program faculty will have active, funded HIV research projects in which potential trainees may gain relevant research training experiences consistent with their career interests and goals.

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

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at: https://grants.nih.gov/grants/ElectronicReceipt/files/Tips_for_International_Applicants.pdf.
https://grants.nih.gov/grants/ElectronicReceipt/files/international_support.pdf
https://grants.nih.gov/grants/ElectronicReceipt/files/international_qa.pdf
https://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 https://grants.nih.gov/grants/webinar_docs/webinar_20120927.htm.

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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD(s)/PI(s) should be an established HIV investigator capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.

PD(s)/PI(s) on applications from U.S. institutions are expected to demonstrate a history of relevant HIV research collaboration with researchers or faculty at the LMIC institution or the Network named in the application. The PD(s)/PI(s) will be responsible for the recruitment and selection of trainees to the research training program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) is responsible for appointing members of the Training Advisory Committee (TAC) and for establishing a structure to obtain regular feedback from the TAC.

Applicants are encouraged to include LMIC individuals who meet the eligibility requirement as a Multiple PD/PI (see https://grants.nih.gov/grants/multi_pi/ for more information).

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 programmatically and scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the 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).

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees from LMICs who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Only individuals from LMICs that meet the Country Eligibility requirement are eligible for training under this FOA. Individuals who also have citizenship or permanent residency in the U.S., other high income countries, or countries not eligible under the Country Eligibility are not eligible for support under this FOA. Applicants are encouraged to recruit scientists and staff at LMIC institutions or Network sites as trainees, to help prepare them to address the long-standing and emerging HIV research questions.

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

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

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Geetha Bansal
Telephone: 301-496-1492
Fax: 301-402-0779
Email: [email protected]

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

Instructions for Application Submission

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

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application. Include the applicant institution, the LMIC institution or LMIC Network sites, and any other participating institutions, both U.S. and foreign as performance sites.

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

Project Summary/Abstract: Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements and a brief description of the planned HIV research training program. Include the selected scientific area for which research training is proposed, and how this addresses the HIV research priorities identified by NIH as "high." Include the LMIC name(s) and the name of the in-country institution, or the name of the Network and the names of the LMIC Network sites. Include the rationale and design of the program, and the expected increased research capacity in the selected HIV scientific area at the end of the five-year grant period. Describe the key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels and intended trainee outcome.

Project Narrative: Include the selected scientific area for which HIV research training is proposed, and how this addresses the HIV research priorities identified by NIH as "high." Include the LMIC(s) and name of the in-country institution or the name of the Network and the names of the LMIC Network sites. Describe the public health relevance of the expected increased HIV research capacity to the LMIC institution or LMIC Network sites.

Other Attachments:

Advisory Committee: A plan must be provided for the appointment of a Training Advisory Committee (TAC) to monitor progress. Describe the composition of the TAC, identifying the role and the desired expertise of TAC members. The TAC should include research faculty and relevant professionals with expertise in the selected HIV scientific area or in research training and mentoring for LMIC scientists and who are not directly involved in the training program or in mentoring trainees. They can be from the U.S., LMICs, or other countries. They should be included as key personnel as described in SF 424(R&R) Senior/Key Person Profile Expanded Component.

Describe how the TAC will provide feedback and advice to the PD(s)/PI(s) on trainee recruitment strategies, trainee selection and retention, monitoring of the progress of the training program, training-related research projects, and the overall effectiveness of the program. Responsibilities, frequency of meetings, and other relevant information should be included. 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.

Follow all instructions provided in the SF424 (R&R) Application. In addition,

• For applications from U.S. institutions, include the name of one person at the LMIC institution or at each LMIC Network site who will serve as the main collaborator(s), select Other, and list their role as Key Collaborator.
• Include at least ONE person at all of the other U.S. and foreign participating institutions as senior/Key Personnel and identify their role.
• List all members of the Training Advisory Committee (TAC) as Senior/Key Personnel, select Other and list their role as TAC member .

Follow all instructions provided in the SF424 (R&R) Application.

Follow all instructions provided in the SF424 (R&R) Application Guide.

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

• Use "Other Personnel section to submit costs for salary support for administrative staff.
• Use the "Travel section to submit costs for key personnel and faculty travel.
• Use the Participant/Trainee Support Costs section to submit costs for Trainees Tuition and Fees, Stipend and Trainee Travel. Do not use the Subsistence category. Use Other to submit costs for Training Related Expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance).
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification
• Provide details in the budget justification for expenses requested in each section, and identify, by name, any continuing trainees.

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees and Training Record
• Other Training Program Sections
• Appendix

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

Training Data tables are not required for this FOA.

Training Program

Program Plan

Background - In addition to the instructions in the SF424 (R&R) Application Guide:

• If applicable, identify the HIV Research Network and describe how it meets the definition of an established HIV Research Network. Include link to Network website, if available.
• Define the scientific area for which HIV research training is proposed and describe how it addresses HIV research that is considered "high priority" by the LMIC and NIH.
• Identify the LMIC institution or LMIC Network sites that will be the beneficiaries of the proposed training.
• Describe the current level of research capacity in the selected scientific area at the proposed training sites and justify the need for more research training.
• Describe how the leadership and professional staff from the LMIC institution or LMIC Network sites were involved in the planning, decision-making and development of the application.
• Describe prior and current HIV research collaborations among the applicant institution, LMIC institution or LMIC Network sites, and other proposed participating institution(s), and how they serve as a research foundation to support the proposed training.
• Indicate how the proposed program relates to prior and current HIV research training activities relevant to the selected scientific area by the applicant institution or others at the LMIC institution or LMIC Network sites, regardless of funding source. Provide justification for more research training in the selected area at the LMIC institution or LMIC Network sites.

Program Plan:

a. Program Administration - In addition to the instructions in the SF424 (R&R) Application Guide:

• Include the relevant scientific or professional background and research training experience of the key collaborators at the partner institutions and the LMIC institution or LMIC Network sites.
• Describe the role of the Key Collaborator(s) at the partner institutions and LMIC institution or LMIC Network sites in the on-going administration of the proposed research training program.
• Describe the decision-making process, including how the PD(s)/PI(s) will incorporate feedback from the TAC.
• Describe the processes that will be used to provide independent scientific review for trainee research projects, and document education in the protection of human subjects, compliance with federal requirements for the protection of human subjects and animals in medical research, and annual approval from relevant institutional (or ethical) review board(s) or committee(s).

b. Program Faculty- In addition to the instructions in the SF424 (R&R) Application Guide:

• Provide a short description of the training role for each faculty in the proposed training.
• For each faculty, include relevant scientific and research training experiences and information on the subsequent success of former LMIC trainees, to pursue further career development and productive research careers.
• Describe how the proposed faculty will contribute to the strengthening of the LMIC institution or LMIC Network sites to the next level of capacity in the selected scientific area.

c. Proposed Training- Substitute the following for instructions in the SF424 (R&R) Application Guide:

• Describe the immediate and long-term objectives of the program.
• Include information about planned courses, curricula, seminars, workshops, or tutorials and mentored research experiences and activities.
• Describe courses and research opportunities that will be available to trainees at each of the participating institutions or other identified training sites.
• Provide a five-year training implementation plan that elucidates the rationale for the proposed 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.
• Provide a rationale for proposed short term training experiences and describe how this training will contribute to long term objectives of the program.
• Describe a plan for trainee mentorship during formal coursework and research relevant to the selected scientific area.
• Describe how training plans will be tailored to the needs of the selected trainees, accounting for their past experiences and competences.
• Describe the professional research career development skills and career guidance that will be provided, including the use of Individual Development Plans, if appropriate.
• Include a plan for retaining students in the program until completion, and describe strategies to encourage and prepare trainees to pursue further research opportunities in their LMIC.
• Describe the plans for the integration of the proposed training with other relevant capacity building activities at the LMIC institution and or within the Network. The applicant should describe these other research training programs, regardless of the source of funding, and explain what distinguishes the proposed training from these other research training programs, how their program will synergize with these other training programs, and demonstrate that the pool of training staff, potential trainees, and resources are robust enough to support an additional research training program.
• If relevant, describe strategies that will be used to support the LMIC institution or LMIC Network sites to achieve a level of research capacity to become future research training sites for the selected scientific area.
• For renewal applications, highlight how the training program evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the training program.

d. Training Program Evaluation - In addition to the instructions in the SF424 (R&R) Application Guide:

• Describe the roles of all faculty, professional staff at the applicant, LMIC institution or LMIC Network sites, and other participating institutions, and current and former trainees in the evaluation process.
• Describe how the PD(s)/PI(s) will incorporate feedback from the TAC into the evaluation process.
• Describe the increased research capacity expected at the end of the five-year funding period.
• Define measures that will be used to assess increased research capacity in the selected scientific area at the end of and beyond the five-year funding period. Describe how the data will be collected and monitored over time.
• If short term training is proposed, include specific assessments of the effectiveness of the short term training activities in the evaluation plan.

e. Training Candidates- In addition to the instructions in the SF424 (R&R) Application Guide:

• Describe the role of the LMIC institution faculty in the recruitment and selection process.
• Describe the criteria that will be used to recruit and select trainees to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and likely to contribute to the increased capacity of the LMIC institution in the selected scientific area, as scientists and staff.
• Describe recruitment efforts to attract women and other populations who are under-represented in sciences in the LMIC to apply for training opportunities.
• Describe how the TAC will provide feedback and advice to these processes.

f. Institutional Environment and Commitment to the Program- In addition to the instructions in the SF424 (R&R) Application Guide:

• Describe the institutional support and commitment to the goals of the training program by the eligible LMIC institution or eligible LMIC Network site, by the U.S. institution for U.S. applicants, and by the Network for applications to support LMIC Network sites.
• Describe any support that is expected to be provided by the LMIC or LMIC institution to trainees upon completion of their training.

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 the SF424 (R&R) Application Guide.

Progress report

In addition to the instructions in the SF424 (R&R) Application Guide,

• Provide information about current position, including country and responsibilities for individual trainees.

Summarize the major contributions to HIV research capacity at the LMIC institution made by the research training program in the previous grant period. Include significant publications and research grants in which current or former trainees contributed and which were supported by the research training award in the previous project.

Participating Faculty Biosketches

Participating faculty and mentors should include a Personal Statement in their Biosketch that reflects their contribution and role in the proposed training and their willingness to participate.

Letters of Support

The application should include letters of support from institutional leaders of partner institutions and, if relevant, from Network Leadership, that describe how the proposed training program will collaborate with other research training programs, intersect with relevant on-going HIV research at the institution or, if relevant, within the Network and provide future research and career development opportunities for trainees.

The Personal Statements from key personnel and participating faculty members and mentors will be used in place of individual letters of support to confirm their roles.

Data Tables

No Data Tables are required

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.

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

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). 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.

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.

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 will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, and on the HIV research capacity in LMIC institutions or LMIC Network sites in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

Does the proposed training address an HIV area that is of high priority to the LMICs involved?

Will the proposed training fill a gap that is critical to the HIV research capacity of the LMIC institution or LMIC Network sites? Will the proposed training contribute to bringing the LMIC institution or LMIC Network sites to the next level of research capacity in the selected scientific area? For LMIC Network sites, will the training strengthen the research capacity at the sites beyond the current research agenda of the Network?

Do the objectives, design, direction and mix of short-, medium- and long- term training proposed for the training program ensure effective research training in the selected HIV scientific area?

Does the program provide appropriate inter- or multidisciplinary research training opportunities?

To what extent does the proposed training program take advantage of the existing research infrastructure, investments and support from FIC, NIH, and other organizations to the LMIC institution or LMIC network sites? Is the proposed training duplicative of existing research training provided by others at the LMIC institution or within the Network? Does the applicant propose a training plan that will enhance sustainability of research capacity and support high quality research?

Is there evidence of a significant level of institutional commitment to support the program from applicant and LMIC institutions or from applicant institution and Network and LMIC Network sites?

Will the LMIC and/or participating institutions or Network commit additional resources to strengthen the proposed research training to increase research capacity at the LMIC institution or LMIC Network sites?

Is the history of research collaborations among the PD(s)/PI(s)/faculty/mentors at the participating institutions or within the Network sufficiently strong to 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 for implementing mentored research projects adequate to provide independent, scientific review and ensure compliance with federal requirements for protection of human subjects and animals in medical research?

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

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

For applications designating multiple PDs/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? Are the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

Mentors

Are sufficient numbers of experienced faculty and mentors with appropriate HIV expertise and funding available to support the number of trainees and level of training proposed in the application?

Do the proposed faculty and mentors have strong records as HIV researchers, including research support in areas directly related to the proposed research training program?

How successful were the proposed faculty and mentors in providing training in the selected scientific area? Do they have experience training LMIC trainees? Were their previous trainees successful in completing their training and applying the new knowledge and skills?

Are appropriate plans in place to ensure that mentors lacking sufficient research training or mentoring experience for LMIC trainees are likely to provide strong and successful mentoring?

Trainees

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

Training Record

How successful are the LMIC trainees (or, for new applications, other past LMIC trainees in similar training) in completing their training? Did the training program ensure that trainees are productive (or, for new applications, other past trainees in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments, fellowship, career development or research awards?

How successful is the training program (or, for new applications, other past training efforts with LMIC institutions) in strengthening the HIV research capacity of the LMIC institution?

How successful is the training program in retaining trainees in positions conducting HIV research at the LMIC institution or, if relevant, LMIC Network sites?

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training over the five-year period? How well did the applicant define measures to demonstrate increased capacity in the selected scientific area at the end of and beyond the five-year funding 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 or LMIC Network sites?

If short term training is proposed, does the evaluation plan include specific assessments of the effectiveness of the short term training activities to increased capacity in the selected scientific area?

Are effective mechanisms in place for obtaining feedback from current and former trainees?

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

For Renewals, the committee will consider the progress made in the last funding period, including the Training in the Responsible Conduct of Research. Does the application describe the program s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Did the program evaluate the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees were used to strengthen the program? Are proposed changes likely to improve the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area of the proposed training?

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

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.

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:

• 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. ,as articulated in the NIH HIV/AIDS Research Priorities, the NIH Plan for HIV-Related Research for the year they are applying, and the FIC Strategic Plan.
• Consideration of programmatic and geographic distribution.
• Interests of participating organizations and components

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.

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.

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.

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.

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Chapters 1-6 and Chapter 7.5 of the Research Performance Progress Report (RPPR) Instruction Guide and additional guidance provided by FIC, must be followed.

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.

• Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. For each journal publication that results from a trainee s research, NIH support should be acknowledged in language similar to the following: This investigation was supported by the Fogarty International Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of the National Institutes of Health under the Fogarty HIV Research Training Program (grant number). In addition, news releases and other documents about the project must acknowledge federal funding as provided in Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.

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

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

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)
Finding Help Online: https://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
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Dr. Geetha Bansal
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: [email protected]

Shoshana Kahana
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2261
Email: [email protected]

Joan Romaine
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6230
Email: [email protected]

David Stoff
National Institute of Mental Health (NIMH)
Telephone: 240-627-3876
Email: [email protected]

Geraldina Dominquez
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: [email protected]

Robert Freund PH.D
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email:[email protected]

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]

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

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