Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
Fogarty International Center (FIC)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Cancer Institute (NCI)
National Institute on Aging ( NIA )
R21 Exploratory/Developmental Research Grant
See Notices of Special Interest associated with this funding opportunity
The goals of this program are to support locally relevant research in critical areas of HIV-associated non-communicable diseases (NCDs) at Low- and Middle-Income Country (LMIC) Institutions, to enhance research capacity, and to build a network of researchers both within and across LMICs to address this critical burden. This initiative is expected to stimulate new research on the interplay between HIV and development of NCDs in persons living with HIV (PLWH). This includes exploratory studies to uncover the extent to which HIV infection influences the etiopathogenesis of the NCDs; and to identify and develop appropriate approaches for effective diagnosis, prevention, therapeutic interventions and integrated clinical care for PLWH with the comorbid conditions. Applicants should develop their studies in keeping with the NIH HIV/AIDS Research Priorities
(https://www.oar.nih.gov/hiv-policy-and-research/research-priorities ;
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html) . Research teams should contain an appropriate mix of expertise to accomplish the proposed studies, including partnerships between HIV and NCD researchers who can initiate new ideas and determine feasibility of novel approaches to understand and reduce the long-term suffering from the comorbid disorders. Applicants will also be asked to address the needs of collaborating LMIC institutions to develop capacity for carrying out research in this field.
November 8, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | Not Applicable | December 08, 2021 | March 2022 | May 2022 | July 2022 |
| Not Applicable | Not Applicable | December 08, 2022 | March 2023 | May 2023 | July 2023 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
This Funding Opportunity Announcement (FOA), issued by the Fogarty International Center (FIC), seeks to stimulate innovative ideas and impactful research to better understand the complexities around developing, testing and implementing appropriate approaches for effective diagnosis, prevention, therapeutic interventions and integrated clinical care for HIV-associated non-communicable diseases (NCDs) in Low and Middle-Income Countries (LMICs). Specifically, this initiative will support research in the following areas: a) Basic sciences to address etiopathogenesis of NCDs in People Living with HIV (PLWH); b) Aging process in PLWH to understand the early onset of geriatric diseases; c) Diagnostics tools for early detection of NCDs in PLWH; d) Therapeutic interventions to explore optimal drug regimens for PLWH with NCDs; e) Behavioral studies for better quality of life of PLWH with NCDs; and f) Clinical studies for better patient centered care for PLWH with NCDs. The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development and assessing feasibility of the proposed studies (https://grants.nih.gov/grants/funding/r21.htm ). It is hoped that this preliminary research will lay the foundation for larger studies that can lead to applications to other organizations or NIH institutes that support HIV-associated NCD research.
Through this initiative FIC seeks to support exploratory research on the interplay between HIV and development of NCDs in PLWH and uncovering to what extent HIV infection influences the pathogenic effects of comorbid conditions. Applicants will also be expected to address the needs of collaborating LMIC institutions to develop capacity for carrying out research in this field. The FOA is intended to foster partnerships between HIV and NCD researchers to develop interdisciplinary collaborations that may also include basic and clinical researchers, policy makers, health economists, and health systems experts. Research teams should contain an appropriate mix of the relevant disciplines to accomplish the proposed studies. It is expected that this small research grant mechanism will initiate new ideas and determine feasibility of studies of novel approaches to understand and reduce the long-term suffering from the comorbid disorders.
Background/Rationale:
NCDs are responsible for over 70% of deaths globally representing 41 million lives, of which 15 million people die prematurely between the ages of 30 and 69. Eighty-five percent of such premature deaths occur in LMICs and exert a substantial toll on the socio-economic structure of these resource-challenged communities, impeding any progress towards targeted prevention strategies (https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases). NCDs include, among many others, cardiovascular diseases, diabetes, obesity, chronic kidney, liver and respiratory diseases, cancer, alcohol and substance abuse and mental disorders. NCDs share the common feature that they are not transmissible and are often chronic in nature. While NCDs might have been triggered by an infectious agent, the chronic disease is often not dependent on the presence of the infectious agent and rather is the result of a combination of genetic, physiological, environmental and behavioral factors. Tobacco and alcohol use dependency, physical inactivity and unhealthy diets all increase the risk of dying from an NCD. WHO also recognizes that air pollution is a critical risk factor for NCDs (http://www.euro.who.int/en/media-centre/events/events/2019/04/WHO-conference-NCDs-Ashgabat-2019/key-questions-on-the-agenda). Detection, screening and treatment of NCDs, as well as palliative care, are key components of the response to NCDs. In 1981 when AIDS cases were first reported, there was the general assumption that people diagnosed with HIV would live 1-2 years. With the prescribed use of highly effective antiretroviral drugs and potent combination drugs, the life expectancy of PLWH has dramatically increased, and this population is living longer and relatively healthier lives. However, routine clinical care of these patients has shown increased risk of NCDs and life-style disorders and a new spectrum of comorbidities that raise new questions (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm;https://www.amfar.org/Non-AIDS-Defining-Illnesses-Impact-Health/).
The chronic nature of most NCDs has adverse health and economic consequences for the individual and the household, ultimately affecting the communities and nation as a whole, and that impact is more pronounced in resource limited settings such as LMICs. This concomitant presence of NCDs is more serious in PLWH where scientific evidence points to increased severity and compounded debilitating consequences of multimorbid conditions.
HIV infection results in a chronically inflamed physiological state and it is believed that monocyte activation likely is responsible for initiating the development of NCDs by promoting metabolic and cellular changes leading to early immune aging. The aging process itself is a risk factor for a number of NCDs and whether the presence of HIV infection compounds the risk factors is not well understood. In addition, HIV infection and the normal aging process share immune changes that result in the premature aging of HIV-positive subjects, which in turn increases their susceptibility to diseases associated with normal aging. Understanding these processes may help in the design of therapeutic interventions to stem the premature development of NCDs in HIV-infected subjects, especially in children, adolescents and young people. In addition, specific diagnostic markers to identify immune aging will be extremely useful in predicting the risk for developing a specific NCD.
There is a need for strong epidemiological, clinical and management related evidence that takes into consideration the differences in the disease epidemiology among different countries, the specific HIV-associated NCD and/or combinations of such diseases, and health system environment and types of services available towards developing a context specific integrated care model that is feasible, affordable, and effective in the specific LMIC.
The research priorities need to be adapted to comprehensively understand the role of HIV in causing or exacerbating a wide range of diseases and the clinical manifestations of these diseases. Clinicians caring for patients with HIV will likely require new tools for optimal detection to prevent and to monitor for early signs of developing NCDs. The long-term goals for the FOA are to support locally relevant and catalytic research at LMIC Institutions in critical areas of HIV-associated NCDs to enhance research capacity building efforts at the LMIC institutions, and to build a network of researchers both within and across LMICs to collaborate and complement unique resources and strengths to build the scientific workforce locally.
Definitions:
For the purposes of this FOA:
Objectives:
The objective of this FOA is to enhance understanding of the complex mechanisms leading to an increased susceptibility to NCDs, drug-induced metabolic disorders leading to a higher risk for developing NCDs, and an accelerated aging process in PLWH that may lead to better design of future interventions aimed at decreasing the effects of such co-morbidities. In vitro studies and use of applicable animal models are allowed; however, the relevance of these studies to human disease should be clear. The areas of focus under each topic area may include but are not limited to:
In keeping with the suggested research topics above of interest to FIC, the following lists some specific focus areas of interest to the partner ICs in HIV-associated NCDs.
NIAMS is interested in observational, translational, and basic/pre-clinical research focusing on how the presence or treatment of HIV/AIDS impacts systemic rheumatic, musculoskeletal and skin disease progression and pathogenesis with a focus on utilization of existing HIV cohorts and repositories. NIAMS will not accept clinical trials under this FOA. Applicants who wish to submit clinical trial applications for consideration by NIAMS should submit to one of the NIAMS FOAs specifically for clinical trials at http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp.
NCI is interested in research projects aimed at identifying specific contributions of HIV infection and its potential interaction with other pathogens towards the development and pathogenesis of cancer, or provide information on the clinical outcomes in PLWH and cancer.
Proposed studies must be consistent with the NIH Office of AIDS Research priorities for HIV research ( https://www.oar.nih.gov/hiv-policy-and-research/research-priorities;
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html).
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $150,000 may be requested in any single year. The budget request must reflect the actual needs of the proposed project.
Applicants may request a project period of up to two years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email: geetha.bansal@nih.gov
All page limitations 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 an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
This FOA provides an avenue for investigators in the LMICs and in the U.S. with interests in studying the intersection of HIV/AIDS with chronic NCDs to establish research collaborations and research capacity strengthening activities at the LMIC institution. It is expected that collaborating investigators will provide complementary expertise in proposing studies to investigate HIV-associated NCDs.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should budget funds for at least one PD/PI or designated co-Investigator to attend the annual program network meeting each year in Bethesda, MD.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The R21 grant will provide support to assess needs, to initiate preliminary studies and strengthen research capabilities at the LMIC institution, and to organize, plan, prepare, and assemble or solidify partnerships, additional expertise, information and data as needed for an application for a more comprehensive research grant (e.g. a R01). The application should define an exploratory research project and associated plan for assessing, developing and strengthening research capabilities .
Research Strategy:
Justify the relevance of the proposed research to the HIV-related health outcomes of people in the LMIC setting.
Establish Research Collaboration
1. The purpose of this grant is to foster initial development of collaborative work focused on HIV-associated NCDs relevant to LMICs;
2. The role of each key personnel and institution and the plans for the coordination of the research activities should be noted.
3. In the case of a collaboration between researchers in an LMIC and a U.S.-based institution, the application should include plans for coordination of research (and activities to strengthen LMIC research capabilities) between the partner institutions, which should be described and should include regular meetings (virtual and/or physical).
4. Collaborations between two or more LMIC investigators can be at the same or different LMIC Institutions, and the application must describe plans to build research capacity in their proposed research area.
Develop Research Networks
1. Applicants are encouraged to identify and interact with other relevant research and research training being conducted at the LMIC institution, and more widely within the country and region as feasible.
2. Applicants can discuss the potential to take advantage of synergies for networking and collaboration for research and for activities to strengthen research capabilities. Such activities may include but are not limited to:
Promote Research Capacity Building
1. Applicants should show evidence of institutional support for capacity building in the specific research area by providing letters of support from Institutional leadership.
2. Such support may take many forms, such as by encouraging networking seminars and symposia, by facilitating communications and partnership with other Institutional leaders to consider joint funding opportunities, and other similar avenues.
Letters of Support: Letters of support should be provided by each consultant, collaborator and collaborating institution. Letters of support are not required from those identified as key personnel or co-Investigator.
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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
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. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
In addition, specific for this FOA, note the following:
The R21 exploratory/developmental grant mechanism will support established partnerships as well as new partnerships between HIV researchers and NCD researchers that have not previously collaborated on joint projects. Thus, investigators are not required to demonstrate in the application any history of prior collaboration. However, factors in the investigators' background and/or institutional circumstances that will facilitate success in such collaboration should be assessed. The role of each key personnel and institution and the plans for the coordination of the research activities should be evaluated. It is expected that the new partnership will foster interdisciplinary collaboration to answer unaddressed questions in HIV-associated NCDs and develop appropriate integrated strategies for prevention, treatment and care for PLWH.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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 field?
In addition, specific for this FOA: Does the application clearly identify the nature of the HIV-associated NCD affecting the specific LMIC population, and justify the need for the proposed work?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
In addition, specific for this FOA: Do the PD(s)/PI(s) with HIV and NCD research expertise have experience working in the LMIC to provide strong leadership, direction, management, and administration of the proposed research? Are appropriate LMIC investigators included in key roles on the project with clearly defined roles on the project to plan coordination of the research activities? While prior history of collaboration is not required, will investigators' background and/or institutional circumstances facilitate success of interdisciplinary new collaboration to answer unaddressed questions in HIV-associated NCDs, and to develop appropriate integrated strategies for prevention, treatment, and care for PLWH? Is there an appropriate mix of HIV and NCD researchers from the LMIC whose combined expertise will provide an integrated approach to working on the proposed project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, specific for this FOA: Will the proposed study be able to strengthen and sustain HIV-associated NCD research capabilities at the LMIC institution?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, specific for this FOA: Does the proposed approach integrate the role of HIV in the investigation of the NCD related research in the study?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
In addition, specific for this FOA: Is there evidence of Institutional support to PD/PI(s) to build research capacity in HIV-associated NCDs at the LMIC Institution(s)? Is there evidence of support for interdisciplinary activities related to HIV-associted NCD research?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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 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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) 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.
Vertebrate Animals
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.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Allowed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the response to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
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.
Applications will be assigned to the Fogarty International 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 Fogarty International Center's Advisory Board. The following will be considered in making funding decisions:
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 recipient'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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
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.
Not Applicable
A final RPPR, 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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Geetha P. Bansal, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: geetha.bansal@nih.gov
Heiyoung Park, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: heiyoung.park@nih.gov
Peter Perrin, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3759
Email: peter.perrin@nih.gov
Anais Stenson, Ph.D.
National Institute of Mental Health (NIMH)
Email: anais.stenson@nih.gov
Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-781-3420
Email: domingug@mail.nih.gov
Raul Mandler, M.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-2541
Email: mandlerr@nida.nih.gov
Basil Eldadah, M.D., Ph.D.
National Institute on Aging (NIA)
Phone: 301-496-6761
Email: eldadahb@nia.nih.gov
Peer
Center for Scientific Review (CSR)
Email:
Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: Satabdi.Raychowdhury@nih.gov
Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-7760
Email: erik.edgerton@nih.gov
Sunshine Wilson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-827-4670
E-mail: wilsonsa2@nih.gov
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov
Alania Foster
National Cancer Institute (NCI)
Phone: 240-276-5375
E-mail: alania.foster@nih
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov
Maurice Koo
National Institute on Aging (NIA)
Phone: 301-827-6372
Email: koom@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.