NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 purpose of this Funding Opportunity Announcement (FOA) is to support inter-disciplinary research on HIV-associated malignancies in low-and middle-income countries (LMICs) to be conducted by collaborative consortia involving partnering institutions from both LMIC and the United States (U.S.). The FOA will also further provide the opportunity for enhancement of research capacity of LMIC institutions with the ultimate goal of such institutions developing progressively as independent competitive research centers. It is anticipated that this initiative will ultimately generate research collaborations, exchange knowledge and experiences within and across programs in these consortia and with Sub-Saharan African Collaborative HIV and Cancer Consortia funded under RFA-CA-13-010, so that they can potentially develop into a global collaborative network for HIV and cancer research.

Global cancer research, particularly in resource-constrained areas, is one of the priorities for the NCI. The NCI Office of HIV and AIDS Malignancy (OHAM) leads and coordinates efforts in the NCI on HIV-associated malignancies, and OHAM has as a priority the study of HIV-associated cancers in LMICs both in and outside of sub-Saharan Africa. In conducting international research on HIV-associated malignancies, OHAM works with the NCI Center for Global Health (CGH), which coordinates the overall NCI global cancer research efforts. This FOA contributes to both missions by building cancer research capacity in LMICs.

This FOA was developed in collaboration with the Fogarty International Center (FIC). The initiative addresses the NIH high priority area of HIV-co-morbidities and the goals of the strategic plans of NIH's Office of AIDS Research (OAR) Trans-NIH Plan for HIV-Related Research.

The FOA will be open to all qualified applicants from U.S. and LMIC institutions, i.e., an application can either be submitted by a U.S. institution or by an LMIC institution. LMICs are defined using 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). Each application must be based on collaborations between researchers in a U.S. institution and researchers in an LMIC institution(s). African countries i.e., Uganda, Tanzania, Malawi, Botswana, Kenya and Rwanda that house the institutions funded as part of the Sub-Saharan African Collaborative HIV and Cancer Consortia are not eligible to participate.

In recent years, HIV-associated cancers have been increasingly recognized as an important HIV comorbidity in LMICs. The prevalence and types of these cancers, however, vary considerably among different regions of the world. This diverse distribution is caused by a variety of factors, including different prevalence of viruses that cause most HIV-associated cancers, socio-economic and demographic differences, and access and quality of cancer prevention strategies and of health care systems.

The incidence of many HIV-associated cancers is substantially higher in many LMICs than in the United States, and these regions are thus the best places to study many of these tumors. In certain East African countries, for example, Kaposi sarcoma is the most common cancer. In addition, certain tumors (such as conjunctival cancers) are rarely seen outside of certain LMICs. Consequently, there are a number of important questions related to epidemiology, pathogenesis, and potential prevention approaches that can be optimally addressed by studying these cancers in LMICs. In addition, studies conducted at an LMIC institution that involve local investigators will strengthen the research capacity of the LMIC institution.

In the developed world, the incidence of HIV-associated malignancies is influenced by the widespread use of combination anti-retroviral therapy (cART). The impact of cART on cancer incidence in LMICs remains unclear. Nevertheless, based on trends in the developed world, it is quite possible that wider cART use will result in a decrease in AIDS-defining cancers with a concomitant increase in non-AIDS defining cancers, particularly those associated with viral infections (e.g. liver and anal cancers).

Given the diversity and scale of the HIV/AIDS epidemic and substantial incidence of HIV-associated malignancies in LMICs, it is critical to improve research capacity and to fund research that addresses loco-regional questions and strategies that will improve cancer prevention and care in LMICs. To attain these goals, NCI and FIC have focused efforts in developing research capacity in LMICs. NCI and FIC have previously supported research and research training through several initiatives including two initiatives (RFA-CA-09-016 and RFA-CA-13-010) that were focused on sub-Saharan Africa. The natural next step is to extend U.S collaborations with other LMICs beyond sub-Saharan Africa that address high priority questions that are relevant to both the LMIC and to the NIH HIV/AIDS research agenda.

The major goal of this FOA is to support highly meritorious, inter-disciplinary multi-project research efforts in the area of HIV-associated malignancies. These research efforts must be proposed and conducted jointly by U.S. investigators and investigators in LMICs and must be focused on the specific needs of a given LMIC. The proposed consortium should also enhance the ability of the partnering LMIC institutions to serve as a national/regional resource in research, training, and career development for new LMIC scientific leaders in HIV and cancer.

Scientific Scope

Central Research Theme. Each proposed Consortium is expected to identify a distinct research theme and focus its activities around that theme. The research theme for the proposed consortium may be in various areas relevant to HIV and cancer provided that it addresses issues that are among high-priority to the partnering LMIC and are high priority HIV/AIDS research (NOT-OD-15-137). In addition to these high priority areas, basic research on Kaposi sarcoma-associated herpesvirus (KSHV) will be permitted.

Cancer Categories. Each application should include research projects that either address a variety of topics for a single HIV-associated cancer category or one topic for a related group of HIV-associated cancer categories. Cancer categories to consider may include, for example, hematological malignancies, infection-related cancers, and other cancers that significantly affect HIV-infected people in LMICs.

Areas of studies may include but are not be limited to the following examples:

• Assessment of the epidemiology of HIV-associated cancers and risk factors that impact the cancer burden in the LMIC;
• Development of novel, low cost and technologically feasible approaches for the prevention, diagnosis, and treatment of HIV- cancers particularly those that can be implemented in the setting of a LMIC;
• Evaluation of optimal approaches that will guide strategies to improve the integration of cancer care with HIV care commonly available in the public health setting of a LMIC including those linked to outside funders;
• Identification of novel interactions of HIV with other endemic oncogenic co-factors such as malaria in the pathogenesis of HIV-associated cancers and in modulating risk to these cancers;
• Improving the understanding of the pathogenesis of cancers that are rare in the U.S., but more common in people with HIV in LMICs;
• Developing unique methods to capture and analyze outcomes of HIV-associated cancers in LMICs;
• Understanding variations in in the prevalence of certain HIV-associated malignancies in LMICs, examining, for example, if this may be related to co-factors or variations in the pathogenic viruses that cause these cancers;
• Exploration of the complexities associated with treating additional concurrent co-morbidities such as tuberculosis (TB) in HIV-positive persons with cancer; and
• Addressing the biological differences of HIV-associated tumors from LMICs, as compared to similar tumors arising in individuals without HIV.

The proposed research may either address several areas for a single cancer category or one area for a related group of cancers. A consortium whose research would be spread across multiple areas AND multiple cancer categories is strongly discouraged and is unlikely to be selected for funding.

Non-responsive applications

No clinical trials will be supported, including clinical trials of drugs, biologics, or diagnostics; see the NIH definition of clinical trials at "Notice of Revised NIH Definition of Clinical Trial . Applications proposing clinical trials will be considered non-responsive. Non-responsive applications will not be reviewed.

Consortium Organization

The proposed Consortium must include all the required components listed below.

• Research Projects (required). At least two but no more than three well defined research projects that support one or more NIH HIV high priority research topics are required. Since a secondary aim of this FOA is to build research capacity at the LMIC sites, and to support new ideas from LMIC investigators, preliminary data are not required but can be included. Nonetheless, the proposed projects must be conceptually well developed and supported by sound rationale based on data from all available sources.
• Administrative Core (required) will be responsible for the overall administration, coordination, and management of the consortium.
• Career Enhancement Core (required) should focus on research-related activities that will facilitate and enhance the professional development of investigators in LMIC countries, including aiding junior investigators on their path towards becoming independent investigators. These activities should include dedicated pilot research studies designed to enhance research leadership capabilities of LMIC investigators. Note: All the activities proposed should be structured so that they not only benefit professionally junior LMIC investigators but always support and contribute to the overarching research goals of the Consortium.  Self-standing institutional training/education/career development programs are NOT appropriate and must not be proposed. For example, activities towards a specific degree will not be supported. Applications proposing such activities will be considered non-responsive.
• Shared Resources Cores (optional). The consortium may include the technical/research shared resource cores necessary to conduct the proposed research (e.g., data management). No more than two shared resources cores can be proposed and any proposed core must support at least two of the research projects.

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

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)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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)

Additional Eligibility Requirements for Foreign Institutions

Only foreign institutions located in LMICs (with exceptions noted below) are eligible for support either as applicant institution or a partnering LMIC institution in an application from a U.S. institution.

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).

Non-U.S. High Income Country (HIC) institutions are not eligible to apply but may be named as partners and serve as training sites on applications submitted by any eligible institution (i.e., either LMIC or U.S. institution).

LMIC Countries that are not eligible for this FOA. African countries that house the institutions funded as part of the Sub-Saharan African Collaborative HIV and Cancer Consortia (i.e. Uganda, Kenya, Tanzania, Rwanda, Botswana and Malawi) are not eligible for this FOA. Institutions located in these countries are neither eligible to apply nor be a partnering LMIC institution in an application from a U.S. institution.

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.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research 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. 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 SF424 (R&R) Application Guide.

U.S. applicants are encouraged to include LMIC individuals who meet the eligibility requirement as a Multiple PD/PI (see http://grants.nih.gov/grants/multi_pi/ for more information). Applicants are strongly encouraged to take advantage of the multiple PD/PI option so that both U.S. and LMIC investigators share responsibility for the consortium at the leadership level. If the multiple PD/PI option is used, the contact PD/PI should have their primary appointment at the institution submitting the application.

All individuals designated as PDs/PIs must have expertise in HIV/AIDS, oncology or implementation research and the appropriate level of authority and seniority to direct the consortium.

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

Applicant organizations may submit only one application in response to this FOA.

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).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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:

Geraldina Dominguez, Ph.D.
National Cancer Institute
Telephone: 301-496-3204
Fax: 301-480-4137
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core (use for Administrative Core)	6 pages
Project (use for Research Projects)	12 pages per project
Core (use for Shared Resources Core)	6 pages per core
Enhancement Core (use for Career Enhancement Core)	6 pages

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: Required
• Administrative Core: 1 Required
• Research Projects: Minimum of two required, no more than three allowed
• Shared Resources Core: Optional, no more than two allowed
• Career Enhancement Core: 1 Required

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form. The title of the application should reflect major theme of the consortium.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions. The following additional guidance applies.

Project Summary/Abstract: The Project Summary/Abstract should include the overall goals for the consortium and the selected research theme related to HIV-associated cancers. Also include a description how it addresses the HIV research priorities identified by NIH. The Project Narrative should summarize how the proposed research theme and career development activities will impact the HIV-associated cancer burden in the LMIC.

Facilities and Resources: Include any information about available unique resources and/or special capabilities that may be relevant for collaborative studies. List all available resources pertinent to the research and career development activities proposed in the application. Identify which partner is contributing which resources. Indicate which specific resources will be available to other partners in the consortium (e.g. specific reagents, patient samples, and access to populations or data for epidemiologic studies).

Other Attachments: Attachments listed below must be provided or the application will not be peer reviewed.

Upload all the items listed below in one pdf file named "Supplementary Documentation".

Provide the following:

• Details of the Consortium structure and organization (including an organizational chart of the consortium);
• Schemes for communication between investigators in LMIC institution(s) and the U.S. institution;
• Summary tables for responsibilities of U.S. and LMIC investigators; and,
• (If applicable) a summary table for the past collaborations between the partnering institutions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Describe the overall goals of the consortium, including the integration of its components.

Research Strategy: Instead of standard Research Strategy subsections, use the sub-sections A-C defined below.

Subsection A: Consortium Overview and Significance.

In this sub-section address the following aspects.

• Describe the overall vision for the consortium and explain the significance of the chosen research theme;
• Outline how the proposed research projects align with country-specific needs and how they address the NIH HIV/AIDS criteria for high priority research;
• Provide details on how the anticipated contributions of the consortium to scientific knowledge about HIV-associated malignancies, especially knowledge that will improve understanding, prevention, diagnosis, and treatment of these malignancies in LMICs;
• Address specifically how the outcomes of the proposed research may reduce the burden of HIV-associated cancers in the targeted country.

Sub-section B: Collaborative Experiences and Consortium Makeup.

The following elements must be addressed:

• Collaborative Experiences:
• Without repeating information in biosketches, explain the collective, collaborative experiences of the participating investigators in HIV/AIDS, cancer or other relevant research areas;
• Provide evidence that those collaborations have been productive and have substantially increased in-country research capacity; and
• Indicate how the collaborations among the partners involved have benefited the LMIC institution.
• Consortium Makeup:
• Describe the structure of the consortium, chain of command, and individual responsibilities for the Consortium leaders;
• Provide clear evidence of equal and shared partnership (it is encouraged that such partnership is reflected by a balanced distribution of responsibilities and leadership of research projects and cores); and
• Outline the roles and responsibilities of the U.S. and LMIC investigators in accomplishing the proposed research aims and career development activities, and in managing the consortium.

Note: Project leaders and core directors can be either from the U.S. or LMIC institutions (if appropriate, some components may be jointly led).

Sub-section C: Overall Strategy for Scientific Integration.

The following elements must be addressed:

• Explain how the scientific aims and goals of the consortium will synergize;
• Outline how projects and cores will integrate scientifically;
• Provide expectations on how the consortium will accelerate research in the LMIC;
• Explain the consortium potential to increase research capacity and develop new scientific leadership in the LMIC country;
• Indicate (as appropriate) how the consortium may enhance research experiences within the consortium and/or collaborations across other consortia that can serve to form a global collaborative network for HIV and cancer research;
• Mention other relevant existing research programs that the consortium may consider interacting/partnering with; and
• Mention other NIH programs (e.g., FIC's HIV Research Training Program for Low-and Middle-Income Country Institutions) as well as non-NIH programs that may be beneficial to the proposed consortium in terms of training and/or career development opportunities.

Letters of Support: Letters of support must be provided that detail the institutional and leadership commitment from the participating institutions. All letters of support for the Overall application should be included here.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Resource Sharing Plan should be provided only under the 'Overall' component but it should cover all the activities proposed for the entire consortium.

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.

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• If multiple PDs/PIs are designated, it is expected the contact PD/PI will lead the Administrative Core.
• If multiple PDs/PIs are NOT designated, indicate clearly a senior investigator in the partnering institution who will serve as the main collaborator (select Other, and list their role as Key Collaborator".)

Budget forms appropriate for the specific component will be included in the application package. Include budgets for the following items in the Administrative Core budget.

PDs/PIs Effort. All PDs/PIs (both from the U.S. and the LMIC) will be expected to have a significant effort commitment of at least 1.2 person-months. Salary support for faculty and research staff from LMIC institutions must follow salary guidelines of the institute and letters for such be provided by a senior institutional officer.

Consortia Meeting: Each application is required to budget for supporting travel to the annual meeting of the consortia investigators. It is anticipated that every meeting will be attended by the PDs/PIs and selected project and core leaders (up to four leaders). Applicants must plan that at least one of the Consortia Meetings during the project period will be held in the United States.

Travel costs: Travel by PD/PI to the collaborating institution, Consortia Meeting travel, scholar travel to scientific meetings or research training workshops, and any additional travel relevant to the goals of the consortium should not exceed $25,000 direct costs annually.

Enhancing administrative capabilities in LMIC institution: Budget allocation for enhancing administrative capabilities in the partnering LMIC institution should generally not exceed 5% of the direct costs for the entire Administrative Core; if a higher percentage is proposed, it should be particularly strongly justified. Costs associated with research administration may include, but are not limited to, the following activities: hiring new sponsored program staff, coursework on fiscal and grants management, purchasing new computers to ensure proper administrative and fiscal management to meet U.S. Federal requirements, developing improved institutional policies and procedures, and hiring staff for Institutional Review Board (IRB) and ethics staff.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Provide the strategies and goals for managing the consortium.

Research Strategy: The Administrative Core is expected to oversee the overall administration, coordination and management of the consortium. Use sub-sections A-B defined below to describe the following elements:

Sub-Section A: Administration Structure:

Applicants should articulate the process for communicating with members of the consortium, decision making, and conflict resolution. It should include contingency plans addressing solutions to setbacks and delays including those related to logistics, sub-contracting, ethical approvals, travel/visa issues and other possible hurdles in developing the U.S.-LMIC consortium. As part of the proposed structure, applicants must address the following aspects:

• The administrative infrastructure serving all consortium components. Provide details on how the Administrative Core will coordinate, supervise and manage all administrative activities.
• The partnerships that the consortium will develop with other existing programs.
• The contributions of trainees from other NIH programs (e.g., FIC's HIV Research Training Program for Low-and Middle-Income Country Institutions) as well as non-NIH programs to the aims of the proposed consortium.
• Where such expertise (e.g., grants administration, etc.) is not completely developed at the LMIC site, a description of the plans to help develop these capacities may be included, such that the LMIC institution will progress towards self-sufficiency in this area in the near future. If appropriate, describe other ongoing efforts to enhance research administration at the institution and how the funds budgeted for the core may help fill previously identified gaps at the institutional level.
• Articulate the process for communicating with members of the consortium, decision making, and conflict resolution. It should include contingency plans addressing solutions to setbacks and delays including those related to logistics, ethical approvals, travel/visa issues and other possible hurdles in developing the U.S.-LMIC consortium.

Sub-Section B: External Advisory Group.

Address how the consortium will convene and organize the required External Advisory Group to advise the Consortium leadership. The External Advisory Group is suggested to include, policy makers, health education specialists, institutional and government leaders, key opinion leaders and community advocates from the LMIC. Explain how the External Advisory Group will serve as the bridge between the research projects and the community at large and help identify research outcomes that might inform health policy changes. In this section, provide details on the process the core will follow in assembling the External Advisory Group and for gathering input and feedback. When discussing the potential members of the group, do not mention any specific names; rather just indicate the desirable member's expertise/profiles.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans should only be provided in the Overall component of the application.

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.

PHS Inclusion Enrollment Report (Administrative Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Project.

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

Complete only the following fields:

• Applicant Information;
• Type of Applicant (optional);
• Descriptive Title of Applicant’s Project (start each title, as appropriate, with "Research Project 1:" or "Research Project 2:" or "Research Project 3:");
• Proposed Project Start/Ending Dates.

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Summary/Abstract: Provide a Project Summary/Abstract narrative for the proposed research project that includes the project goals, how it addresses the selected research theme of the application and the HIV research priorities identified by NIH as "high" priority. Include the LMIC and LMIC institution(s) from the proposed consortium.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Budgets for individual research projects are not restricted but the combined budget for all research projects must not exceed 60% of direct costs for the entire application.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims: Outline the specific aims of the proposed Research Project and explain how it fits into the overall research theme of the consortium.

Research Strategy: Use Sub-Sections A-D defined below to describe research project. Explain clearly in relevant sub-sections how each project conforms to the general requirements outlined in Section I, including the NIH criteria for high priority research on HIV/AIDS defined in NOT-OD-15-137.

• A research project may be proposed for research in a variety of areas of studies relevant to the theme and goals of the consortium.
• Research projects can be a balance of hypothesis driven, hypothesis generating and implementation research.
• All projects are expected to be supported by a strong rationale that is based on integrating to the extent possible the available relevant information from various sources.
• When describing the plans for a given research project, indicate where specific activities will be executed (e.g., specific aims will be conducted LMIC vs. U.S. institution). Applicants should attempt, whenever feasible, to maximize the scope of research activities to be conducted in LMIC institutions.
• For laboratory experiments and/or data analyses that are not feasible at the LMIC site, explain the reasons and, if appropriate, provide the timeline for the transfer to the LMIC site of the requisite expertise/skills/technology etc.
• The studies proposed are expected to address the chosen research theme through collaborative efforts involving investigators representing different disciplines as appropriate.
• The proposed research projects may span (and integrate) basic, translational, behavioral, and/or clinical research (but no clinical trials).
• All projects must address a question of the proposed theme of the consortium.

In addition to the standard items covered by applicable instructions in the SF424 (R&R) Application Guide, address the following aspects in sub-sections A-D:

• Sub-Section A: Significance. Describe the central problem/hypothesis to address and describe how the proposed research will contribute to meeting the goals and objectives of the consortium and its primary theme. Indicate the project's relevance to the specific situation of the partnering LMIC and how it will leverage and strengthen existing research capacity at the LMIC institution(s).
• Sub-Section B: Rationale. Include any data and rationale supporting the proposed hypothesis and/or focal point of the research project. Original research preliminary data are not required but encouraged if available. Regardless of the availability of applicants-generated preliminary data, the concepts for the proposed projects must be well developed and rigorous. All projects are expected to be supported by a strong rationale that is based on integrating to the extent possible the available relevant information from various sources.
• Sub-Section C: Innovation. Describe how the research project may provide a novel or innovative approach that could have the potential to reduce the burden of HIV-associated cancers in the partnering LMIC or improve the outcomes of patients with HIV-associated malignancies. Include any novel concepts, approaches, tools or technologies for the proposed studies.
• Sub-Section D: Approach. This section should focus on the specific strategies that are being proposed. Explain the rationale for selecting the methods to accomplish the specific aims of the project. Describe the research design, conceptual procedures, and analyses to be used. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans should only be provided in the Overall component of the application.

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.

PHS Inclusion Enrollment Report (Research Project Name)

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

When preparing your application in ASSIST, use Component Type Shared Resource Core.

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

Optional Shared Resources Cores (not to exceed two) may be proposed as required for the proposed research projects (e.g. Clinical/Translational, Epidemiology, Biostatistics, or Laboratory Core).

SF424 (R&R) Cover (Shared Resources Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of the Core (starting with "Core 1:" or "Core 2:")
• Proposed Core Start/Ending Dates

PHS 398 Cover Page Supplement (Shared Resources Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resources Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Summary/Abstract: Provide a project narrative/abstract for the proposed Shared Resources Core, including which research projects will be supported by the Core.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Resource: Provide a description of the space and facilities that will be available to the core. Describe how the proposed core will either augment existing capabilities or constitute entirely new resources at the LMIC partner institution. Resources can be located in either of the partner institutions (or in both institutions) but must be available to both partners. These resources are expected to augment the LMIC partner research capability and the collaborative research of the partner institutions.

Project /Performance Site Location(s) (Shared Resources Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Shared Resources Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch should be included in the Overall component and in the Personal Statement state role in the core.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Shared Resources Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Shared Resource Core)

Specific Aims: Provide the specific aims for the particular core outlining which projects it will serve (must be a minimum of two projects).

Research Strategy: The Shared Resource Core can be a virtual (e.g. data management) or physical (e.g. biorepository) infrastructure that provides support to the research projects. Describe the intended function and rationale for the proposed core. The description of the core must contain the following information:

• Explanation how the proposed Core matches the research needs of Consortium;
• The scope of expertise available, including the level of skills of technical personnel, if applicable, who will be responsible for the day-to-day operation (and who may not be included under Senior/Key Persons);
• The key characteristics of the proposed Shared Resource Core (including approaches to ensure rigor and proper quality control) and anticipated benefits for the projects to be served; and
• The justification for the location of the Shared Resources Core.

A Shared Resources Core must support at least two of the research projects and must not duplicate an existing resource.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans should only be provided in the Overall component of the application.

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.

PHS Inclusion Enrollment Report (Shared Resource Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Enhancement Core.

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

SF424 (R&R) Cover (Career Enhancement Core)

• Complete only the following fields:
• Applicant Information
• Type of Applicant (optional)
• Title of the Core ("Career Enhancement Core")
• Proposed Core Start/Ending Dates

PHS 398 Cover Page Supplement (Career Enhancement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Career Enhancement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Summary/Abstract: Provide a project narrative/abstract for the proposed Career Enhancement Core.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Resource: Provide a description of the space and facilities that will be available to the core. Resources can be located in either of the partner institutions (or in both institutions) provided that the intended use will be to enhance professionally investigators from LMIC institutions.

Project /Performance Site Location(s) (Career Enhancement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Career Enhancement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch should be included in the Overall component and in the Personal Statement state role in the core.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Career Enhancement Core)

Budget forms appropriate for the specific component will be included in the application package.

The budget may include funds to support research pilot projects led by LMIC junior scientists participating in the career enhancement activities (up to $40,000 per year to fund up to three pilot projects; the requested amount should be commensurate with the number of projects planned) and up to $10,000 per year to cover expenses for other relevant activities to enhance research leadership capabilities of LMIC investigators.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional

entries. All other SF424 (R&R) instructions apply.

Specific Aims: Provide the specific aims for the core that will facilitate and enhance the professional development of investigators in LMIC countries.

Research Strategy:

Describe how this Core will support research-related activities that will facilitate and enhance the professional development of investigators in LMIC countries, including aiding junior investigators on their path towards becoming independent investigators. 

Address (at a minimum) the following aspects, explaining clearly how specific activities proposed will contribute to the professional development and career enhancement of junior investigators in LMIC institution(s):

• Collaborative development (jointly by the U.S. and LMIC institutions) of plans for mentored research activities for junior investigators at the LMIC that will enhance their research future leadership capabilities.
• The proposed career/research leadership enhancement activities are expected to include mentored research pilot studies. Such studies may either fall within the overall theme of the consortium (i.e., connecting to Consortium regular research projects) or be conducted as inter-consortia joint studies. For either scenario:
• Justify how these pilot projects will enhance professionally junior LMIC investigators involved;
• Explain how the mentored pilot studies to be led by LMIC junior investigators will be solicited/developed and the mechanism for their approval; and
• Define various specific requirements to be met when seeking approval for such a pilot study, including, as applicable, documentation of education in the protection of human subjects for the study leader, compliance with the required regulations, and approval from an institutional (or ethical) review board or committee at the LMIC investigator institution or, if different, at the institution in which the research will be conducted, etc.
• Other relevant strategies and activities to enhance research leadership capabilities of LMIC investigators may also be described, especially those that may help these investigators obtain independent research funding to sustain their future research.  Examples of such activities include  acquiring specific scientific skills or generally needed skills (like grants writing skills, manuscript writing) or any other aspects viewed as beneficial for personal career enhancement.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans should only be provided in the Overall component of the application.

Not Applicable

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.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 emphasis of this FOA is on highly meritorious research efforts in the area of HIV-associated malignancies conducted jointly by U.S. investigators and investigators in LMICs. These research efforts must be focused on the specific needs of a given LMIC country but are expected to advance the general understanding of HIV-associated malignancies. To be viewed as highly meritorious, the proposed consortium must also have sufficient emphasis on career development efforts targeting specifically investigators/scholars in partnering LMIC institutions.

Scoring. Reviewers will provide an overall impact score for the entire Consortium (Overall). In addition, assigned reviewers will provide individual "criterion scores" for the Overall application but not for the other components.

Other components of the Consortium [i.e., Administrative Core, each individual Research Project, Career Enhancement Core, and optional Other Shared Resource Core(s)] will be evaluated but each will receive only one overall adjectival (not numerical) rating.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the consortium to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Administrative Core, Research Projects, Shared Resource Core(s) and the Career Enhancement Core proposed).

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. For example, a consortium that by its nature is not innovative may be essential to advance a field.

Does the consortium address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the consortium are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: How suitable are the consortium's choices of research projects and plans for cores for the goal of advancing the LMIC institution as an independent research center for HIV-related malignancies in the region? What is the likelihood that the consortium's research will advance the field of HIV-associated malignancies? Will such advancements in the areas corresponding to consortium research theme have meaningful clinically-relevant implications (in terms of prevention and/or diagnosis and/or treatment of HIV-associated malignancies)? How significant will the proposed activities of the consortium be on advancing research independence of LMIC institution(s) and their investigators? How does the proposed consortium enhance the partnering LMIC institution's ability to be a resource in research, training and career development for new LMIC scientists?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the consortium? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Are the expertise and backgrounds of investigators from the partnering institutions in LMIC and the U.S. complementary and appropriately balanced for the goals of the consortium and the goals of the entire initiative? Are the leadership responsibilities optimally divided between the LMIC and U.S. investigators?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the consortium? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the research involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: Based on the letters of Institutional and National commitment and other information provided, what is the likelihood that the distributed environment will be conducive to sustain the proposed goals of the consortium?

Consortium Integration

How well do the proposed research projects fit into the overall goals of the consortium? Are the career development activities properly integrated with the proposed research? Are the contributions of all components to the consortium clearly articulated and well integrated?

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

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

As applicable for the consortium 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.

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.

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

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

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

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

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Research Projects but will give only one adjectival rating for the entire project (criterion scoring is not used for this component). A project does not need to be strong in all categories to have major scientific impact. For example, a Research Project that by its nature is not innovative may be essential to advance the field.

Significance

Do the research projects address an important problem or a critical barrier to progress in the LMIC setting? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this in the LMIC setting?

Investigator(s)

Are the Project Leads, collaborators, and other researchers well suited for the projects proposed? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the research project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Reviewers will provide only one overall adjectival impact rating for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:

• Is the proposed Administrative Core well matched to the needs of the overall consortium? Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, and personnel management?
• Are the plans for establishing the External Advisory Group appropriate? Is its role in the consortium clearly defined?
• If appropriate, how well do the proposed activities for strengthening research administration address the needs of the LMIC institution?

Reviewers will provide only one overall adjectival impact rating for each Shared Resource Core (criterion scoring is not used for this component). Reviewers will consider each of the aspects below in the determination of the merit of a Shared Resources Core.

• How well is the proposed Shared Resource Core matched to the needs of the research being proposed by the consortium?
• How strong is the justification of the proposed Shared Resources Core in terms of providing essential services for two or more research projects?
• What is the overall quality of the proposed core services? Are adequate quality control processes proposed for the facilities or services provided by the Shared Resource Cores (including procedures, techniques, and quality control)?
• How strong are the qualifications, experience, and commitment of the Shared Resource Core Director(s) and other Core personnel adequate in the context of their ability to provide the proposed services?
• How does the core strengthen existing or add new capabilities at the LMIC partner institution?
• Is the environment for the shared resource core adequate to support the program as proposed?

Reviewers will provide only one overall adjectival impact rating for this Core (criterion scoring is not used for this component). Reviewers will consider each of the review aspects below in the determination of the merit of a Shared Resources Core.

• What is the likelihood that the proposed career enhancement activities will meaningfully aid junior LMIC investigators on their way towards research leadership?
• To what degree will these activities facilitate building HIV-associated malignancy research capacity at the LMIC institutions?
• Are the U.S. and LMIC institutional commitments to facilitate professional enhancements of LMIC junior investigators appropriate and sufficient for the needs at LMIC institution(s)?
• How reasonable and realistic are the plans for pilot research studies to be led by LMIC junior investigators?
• How well are other strategies and activities proposed to enhance research leadership capabilities of LMIC investigators matched to the needs of these investigators?

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 NCI 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer 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.
• Geographical balance and the relevance to the NIH HIV/AIDS research agenda will be among factors used in selection decisions.

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.

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining the overall research objectives and approaches of the consortium;
• Overseeing and coordinating the efforts of individual consortium components and ensuring their optimal integration;
• Overseeing the conduct of consortium research projects and ensuring their scientific rigor;
• Ensuring compliance with the applicable mandatory regulations (including protection of human subjects);
• Overseeing establishment and maintenance of appropriate quality control procedures;
• Overseeing final data analysis and interpretation and preparation of publications;
• Participating as voting members in the Consortia Steering Committee;
• Overseeing the Administration of the consortium and logistical support for joint activities; and
• Overseeing the preparation of required reports and informing, as needed, the NIH Program staff members concerning consortium progress in research projects and other activities.

All PDs/PIs will be expected to maintain significant effort commitment not smaller than that stated in the application (at least 1.2 person-months throughout the entire project period).

Participation in Consortia Meetings: Investigators from all the individual consortia should meet annually at one of the consortium sites to present updates on progress, to exchange ideas, to develop inter regional collaboration and to discuss problems encountered. It is required that at least PDs/PIs, project and core leaders will attend these meetings. Meetings of the Consortia awardees supported under this FOA may be combined with analogous meetings for the Sub-Saharan African Collaborative HIV and Cancer Consortia awardees funded under RFA-CA-13-010.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A designated NCI Program Director, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NCI Project Scientist will be the main NCI contact for all facets of the scientific interaction with the awardees and will provide advice to the awardee on specific scientific and/or analytic issues in addition to programmatic issues. As needed, additional NCI scientific staff members with relevant expertise may also become substantially involved in the Consortia activities as Projects Scientists. The responsibilities of substantially involved NCI Program Staff members will include the following aspects.

• Providing technical assistance, scientific input, and assistance in effort coordination across the U.S.-LMIC Consortia;
• Promoting collaborations across the different consortia;
• Facilitating interactions of the U.S.-LMIC Consortia with other ongoing programs and studies supported throughout the NIH to avoid duplication of effort and encourage sharing and collaboration among the different programs;
• Recommending additional research endeavors within the constraints of the approved research and negotiated budget of the consortium;
• Convening and facilitating the annual Consortia Meeting; and
• Participating as a voting member of the Consortia Steering Committee.

The FIC Program staff member(s) will support the NCI Program staff members by providing technical assistance and advice, by participating as a non-voting member of the Consortia Steering Committee, and by serving as a liaison among the awardees and other relevant FIC-supported programs.

In addition, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice.

Areas of Joint Responsibility include:

Consortia Steering Committee. The Consortia Steering Committee will be responsible for guiding the overall scientific directions of the consortia and promoting collaborations across the consortia.

The Steering Committee will be composed of the following voting members:

• PDs/PIs (or PD/PI plus a designated senior investigators) so that that each consortium is represented by one representative of the U.S. side and one of the LMIC side; and
• The NCI Project Scientist(s) (who will collectively have one vote for the NCI).

In addition, Program Official and other NIH staff members may participate in Steering Committee meetings as non-voting members.

The Consortia Steering Committee will be in charge of evaluating and proposing for approval the inter-consortia mentored research pilot projects.

The Consortia Steering Committee will meet three times a year; twice by teleconference and once at the annual Consortia Meeting.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Geraldina Dominguez, Ph.D.
National Cancer Institute
Telephone: 301-496-3204
Email: [email protected]

Jeanne McDermott, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

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

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.