Section V. Application Review Information
Important Update: See NOT-OD-18-228 for updated review language
for due dates on or after January 25, 2019.
EXPIRED
Fogarty International Center (FIC)
National Eye Institute (NEI)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)
Research activities under this FOA are expected to inform the development of comprehensive research programs that contribute to the long-term goals of building sustainable research capacity in LMICs to address NCDs and injury throughout life and to lead to diagnostics, prevention, treatment and implementation strategies. The proposed work may also contribute to developing a base for research networking and evidence-based policy beyond the specific research project. For applications on any research topic related to the brain, nervous system, mental health and substance abuse please see the companion FOA: PAR-18-836 "Global Brain and Nervous System Disorders Research Across the Lifespan (R21)". Applications on those topics are not appropriate for this FOA.
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.
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.
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) invites exploratory applications for the development of innovative, collaborative biomedical or behavioral/social science research in the areas of non-communicable diseases (NCDs) and injury throughout life, relevant to low- and middle-income countries (LMICs). Basic to clinical and translational research including implementation science approaches and interdisciplinary research on the intersection of a number of NCDs, or of HIV- or other communicable diseases and non-communicable diseases, are encouraged in addition to specific NCD or injury focused areas.
Background
Globally, NCDs kill more than 36 million people each year with 80 percent of these deaths occurring in LMICs, where they contribute significantly to the overall burden of disease (http://www.who.int/about/structure/organigram/nmh/en/). Data published in the Global Burden of Disease 2010 (http://www.who.int/healthinfo/global_burden_disease/gbd/en/), show that NCDs are also rapidly becoming the dominant causes of poor health globally, including all LMIC regions, except sub-Saharan Africa where they are second only to the disease burden of HIV/AIDS.
Globally, a large proportion of reported NCD deaths and chronic illnesses are reported to be caused by cardiovascular disease, cancer, chronic respiratory diseases, and metabolic and digestive disorders such as diabetes although other conditions also contribute to the burden of disease and disability, are often under-researched, and may be of particular importance in certain populations. The chronic sequelae of injury and trauma add substantially to the burden of disability. Together the care and treatment of NCDs, and of injury and trauma consequences, strain existing health care systems and lead to lost economic productivity. Although neurological and neuropsychiatric disorders also contribute significantly to the global NCD disease burden these topics are eligible for the companion Global Brain R21.
At the same time, during the past several decades, improvements in health care have led to a decrease in mortality (including and especially among children) and an increase in life expectancy in LMICs. These positive trends have set the stage for a complex and paradoxical epidemiology of health and disease as more children survive into adulthood affected by the sequelae of combined early illness, environmental toxins, malnutrition and other adverse experiences. These exposures can advance the onset and severity of chronic diseases in later life. Similarly, socio-economic factors, such as poverty, conflict, stigma and gender inequalities, contribute to the initial causes of many chronic disorders.
Maternal, perinatal and nutritional conditions still contribute disproportionately to Disability Adjusted Life Years (DALYs, a measure of overall disease burden, expressed as the number of years lost due to ill-health and disability or early death) in LMICs as compared to high income countries. All of these conditions may also lead to or exacerbate chronic NCDs as common risk factors (http://www.who.int/healthinfo/global_burden_disease/gbd/en/).
Environmental exposures to toxins in air, water and food from before birth and throughout life in the home, public places and in the workplace are important, and often modifiable, factors contributing in different ways alone and in combination to the onset and course of different NCDs. Conversely the contribution of positive environmental exposures/changes in environment and nutrition for NCD disease prevention and NCD treatment as well as promoting good health remains an important research area especially for resource limited settings.
Infectious and parasitic diseases, such as HIV/AIDS, tuberculosis, malaria and other neglected tropical diseases, are a particular burden for LMICs, especially in sub-Saharan Africa. They continue to be important causes of DALYs by themselves and due to their long-term effects, particularly on children. However, very limited data are available on the epidemiology, natural history and pathogenesis of NCDs in the context of infectious diseases such as HIV-AIDS, or on prevention and treatment of associated opportunistic infections and NCD co-morbidities (and vice versa) in LMIC settings. For example, there is a scarcity of research on the drug-drug interactions in patients receiving various treatments for an NCD (for example chemotherapy) and ART for HIV/AIDS or treatments for other infectious diseases. Contribution of socioeconomic factors in the diagnosis, treatment and management of NCDs and HIV/AIDS and other infectious diseases as comorbid conditions in LMICs remains an imperative research area.
The contribution of NCDs and injuries to the global disease burden has been increasingly recognized. In 2013, the World Health Organization (WHO) endorsed a global action plan for the prevention and control of NCDs (2013-2020) that included the promotion and support of national capacity for high-quality research and health system development. In order to address the WHO goals, critical information is needed about the burden, causes, prevention, treatment and long-term care of NCDs and injuries within regional and local contexts. Advancing research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities is a key goal of the FIC 2014-2019 Strategic Plan.
Specific Objectives
These developmental/exploratory research grants are expected to prepare the foundation for more comprehensive research programs that enrich the knowledge base and contribute to the long-term goals of sustainably strengthening research capacity in LMICs. The specific objectives of this FOA are to:
1) Identify NCD and injury research questions and needs in the participating LMIC;
2) Support locally-relevant and catalytic pilot research addressing prevention or reduction of morbidity and mortality attributable to NCDs or injury, or improving quality of life of persons living with NCDs;
3) Support development of diagnostics, prevention, treatment and implementation strategies;
4) Provide research opportunities for LMIC investigators including former FIC program trainees and Fellows from LMICs; and
5) Lay the foundation for more comprehensive research proposals to NIH or other funders;
6) Support activities that develop a base for research networking and for evidence-based policy beyond the specific research projects.
Research Topics and Approaches
Relevant research topics for this FOA are related to NCDs and trauma/injury from birth to advanced age and across generations and must be relevant to the collaborating LMICs. Relevant topics include but are not limited to risk factors and epidemiology; etiology, prevention, and treatment; palliative care; the influence of sociocultural and environmental factors; co-morbidities, especially of people living with HIV/AIDS or other chronic infectious diseases; technology development or implementation for monitoring and rehabilitative interventions; and other conditions. Applicants are especially encouraged to propose research in cross-cutting areas at different life stages and across the lifespan.
Influences on chronic disease across the lifespan include, but are not limited to, factors affecting the immune system and development, function and disease of specific organ systems. Examples include the chronic sequelae of injury due to violence and accidents, genetic predispositions, epigenetic changes in response to pre-, peri- and post-natal trauma and environmental factors (such as maternal nutrition, in-utero chemical exposure, perinatal hypoxia, and nutritional deficiencies), and infection by viral and parasitic diseases (such as HIV/AIDS, malaria). Other factors affecting healthy physical and immunological development include access to appropriate health care and socioeconomic factors.
Examples of some cross-cutting areas for research are:
Relevant types of research for these applications are not limited and may range from basic science to epidemiological, demographic, clinical, health services, implementation and translational (e.g. translation of basic research to therapy and of clinical research to applications in the field). This FOA encourages development of multidisciplinary and interdisciplinary research. The research must be relevant to the needs and priorities of the LMIC and must improve the capacity in the LMIC to conduct such research.
For applications on any research topic related to the brain, nervous system, mental health and substance abuse, please see the companion FOA: PAR-TW-18-836, R21 Global Brain and Nervous System Disorders Research Across the Lifespan Exploratory/Developmental Grant (Clinical Trial Optional) ". These topics should not be the main focus of applications to this NCD and injury FOA.
Research Capacity Building
The proposed collaborative exploratory/developmental research is expected to help build the capacity for full research programs by improving the research environment and strengthening LMIC individual and institutional research capabilities in the proposed research areas. The proposed work and follow up research are expected to contribute to the long-term goals of building sustainable research capacity for chronic NCDs and injury in LMICs. The proposed project may also contribute to the development of research networks and evidence-based policy.
For purposes of the research capacity building and networking encouraged in this FOA, and for background, applicants are also encouraged to use as a resource the compilation of the past awards under the FIC NCD-Lifespan and NCoD research training programs (http://www.fic.nih.gov/Grants/Search/Pages/search-grants.aspx?program=chronb7h).
Specific Research Interests of the FOA Sponsors
Participating NIH institutes and Centers (ICs) provided specific statements of interest for this FOA, below. Applicants can obtain more information on research interests for each of the NIH participants in this FOA at their web sites and through their Scientific/Research contact listed in this announcement.
The Fogarty International Center (FIC) is interested in all eligible applications relevant to its mission. The FIC Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) states the following relevant goals: 1) Build research capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5) Build and strengthen partnerships to advance global health research and research capacity.
Complementary health interventions of interest to National Center for Complementary and Integrative Health (?NCCIH) include both mind-body and natural product approaches. Studies focusing on complementary health interventions and on the conditions for which they are most frequently used are particularly encouraged. These would include, but not be limited to, investigations of the impact of complementary health modalities in alleviating chronic pain syndromes and inflammatory processes and improving health and wellness. Applications to conduct new clinical trials with the goal of evaluating the efficacy or effectiveness of an intervention are not appropriate for this FOA. Applicants can propose mechanistic studies of complementary or integrative interventions as long as the study does not propose to be powered to measure clinical outcomes such as efficacy or effectiveness.
The National Institute on Minority Health and Health Disparities (NIMHD) leads scientific research to improve racial/ethnic minority health and eliminate health disparities in the United States. As noncommunicable diseases are rapidly becoming a dominant cause of poor health globally, NIMHD has an interest in funding exploratory research, including biological, environmental, sociocultural, clinical, and behavioral research in LMIC regions and countries that have significant immigration to the United States.
The National Institute of Mental Health s (NIMH) mission is to transform the understanding and treatment of mental illnesses through basic, clinical, and services research in order to pave the way for prevention, recovery, and cure. NIMH’s interest in this PAR is to grow the evidence base on contextually relevant, cost-effective interventions for addressing the mental health consequences of infectious disease outbreaks and for co-treating mental and chronic medical illnesses, including HIV/AIDS, in low- and middle-income countries (LMICs). NIMH seeks research that builds on existing health care platforms (e.g., emergency care, primary care, chronic disease care, school-based care, workplace-based care, jail/prison-based care, etc.) to incorporate management of mental illness, employs a multi-disease care management approach with high potential impact for improving patient- and system-level outcomes (e.g., patient morbidity and functioning; improved diagnosis and treatment of mental illness among patients with chronic medical illnesses; decreased cost and increased efficiency of the care system; improved care coordination), and establishes feasible methods for multi-disease management in LMICs.
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. The NIEHS is interested in supporting research on non-communicable diseases in low and middle-income countries that address or seek to understand how exposures to toxic environmental insults alter biologic processes and are linked to disease initiation, progression, or morbidity. In addition, NIEHS is interested in research that leads to the development of prevention and intervention strategies to reduce environmentally induced diseases. Examples of environmental exposures relevant to the mission of the NIEHS include, but are not limited to, industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources, climate variability and the environmental impacts of natural and man-made disasters. NIEHS is interested in exposures throughout life and disease outcomes than manifest throughout the lifespan. Early life exposures and their biological consequences are of particular interest and include exposures before and during pregnancy and children’s environmental health outcomes that may arise from these exposures. Understanding the risk of diseases that arise throughout adulthood is also of interest, such as respiratory and cardiovascular disease, reproductive and endocrine system disorders, neuro-degenerative diseases, many types of cancer, and kidney disease are of interest. Exploring the impact of environmental exposures on biological pathways and genetic determinants related susceptibility are also encouraged. NIEHS supports research examining health consequences due to the interplay between environmental exposures and co-factors such as infectious agents or social factors that contribute to environmental health disparities.
The National Eye Institute (NEI) is interested in applications relevant to its mission as stated on the NEI website: http://www.nei.nih.gov/about/mission.asp.
The Office of Research on Women's Health (ORWH) is interested in funding applications that address the significant role of sex and gender in the onset, prognosis, treatment, and prevention of NCDs. ORWH is also interested in funding applications focused on investigating the contribution of sex and gender in injury, including but not limited to those injuries associated with intimate partner violence, domestic violence, and violence against women. Information about the ORWH mission and strategic plan can be found at: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf.
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.
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.
To determine country income categories, please see: http://data.worldbank.org/country
Note that Hong Kong-based institutions are not eligible as applicant due to its high-income status. Institutions on mainland China remain eligible as long as China remains an LMIC.
For-profit (small business and other for-profit) entities based in the LMICs are not eligible to apply for this FOA.
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.
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.
Non-U.S. High Income Country (HIC) investigators are not eligible as multiple PD/PIs.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
Marya Levintova, Ph.D.
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Supplemental Budget Information:
Networking meetings (3 days) involving grantees of these awards will be held at a site in the U.S. or elsewhere each year. A meeting focusing on evidence based dissemination and implementation policy, but in a regional context, may also be convened.
Funds should be budgeted for travel to at least one three day networking meeting per year (in the U.S.. or other country to be determined annually) by the PDs/PIs, their collaborator(s), and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award.
Applicants should describe how they will:
Applicants should propose specific milestones and a timeline to meet these goals.
Meetings, workshops and small conferences may be conducted as necessary to develop research plans and collaborations or for assessment of needs. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed.
The relevance of the proposed research to the health of the LMIC should be justified. Describe how the proposed research is relevant to NCD or injury related issues or priorities in the LMIC and to the stated NCD or injury related interests (including co-morbid conditions) of one or more of the participating NIH Institutes, Centers or Offices.
In addition, the role of this research and planned involvement of the LMIC institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.
Collaboration
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).
Networking
All applicants are encouraged to become familiar with other relevant research and research training being conducted at the LMIC institution, and more widely within the country and region as feasible. Applicants may 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:
- leveraging NIH or other funder investments already in place in specific foreign countries,
- using common measures/data elements across research studies in a country/region,
- sharing or pooling data or creating data repositories,
- making efficient use of local/regional oversight bodies such as IRBs, DSMBs
- sharing education platforms to develop expertise across programs.
Letters of Support: Letters of support should be provided by each collaborator and collaborating institution.
The following modifications also apply:
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.
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.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. 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.
Important Update: See NOT-OD-18-228 for updated review language
for due dates on or after January 25, 2019.
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.
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, 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.
Does the project 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 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?
Is the research on a problem of particular relevance and importance for the LMIC involved?
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?
If planning for a larger mission-centered research network is proposed, are investigators identified who can function as hubs and nodes in that network?
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?
Does the project make use of unique or special expertise, resources, circumstances or environment of the LMIC site to frame or address the research question? Does the project incorporate innovative strategies for strengthening research capabilities in the research proposed?
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 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?
In addition, for applications involving clinical trials
For all CT FOAs, add the following questions, after the standard questions for the Approach review criterion.
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?
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 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?
Does the application include a feasible and relevant plan to assess specific resource and research capacity strengths, needs, and gaps for research on NCDs and/or injury at the LMIC site(s) and to follow up to use the strengths and address the needs in the proposed pilot (and future) 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?
?Specific for applications proposing 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)?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not applicable.
No applicable.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
Information regarding the disposition of applications is available 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.
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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as 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).
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.
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.
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 processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Marya Levintova, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]
Cindy D. Davis, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-496-0168
Email: [email protected]
Andrea Horvath Marques
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: [email protected]
Emile (Pim) Brouwers
National Institute of Mental Health (NIMH)
Telephone: 240-627-3863
Email: [email protected]
Katrina Jane Serrano Ph.D
Office of Research on Women's Health (ORWH)
Telephone: 301-496-8931
Email: ?[email protected]
Rick Berzon DrPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: [email protected]
Abee Boyles Ph.D
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3241
Email: [email protected]
Lisa Neuhold Ph.D
National Eye Institute(NEI)
Telephone: 301-451-2020
Email: [email protected]
Lanay Mudd Ph.D
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: [email protected]
Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: [email protected]
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]
