Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
Fogarty International Center (FIC)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
National Institute of Environmental Health Sciences (NIEHS)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Research on Women's Health (ORWH)
U01 Research Project Cooperative Agreements
This Funding Opportunity Announcement (FOA) solicits applications for research projects in linked Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth). The overall objective of the GEOHealth program is to support the development of institutions in Low- or Middle-Income Countries (LMICs) that will serve as regional hubs for collaborative research, data management, research training, curricula and outreach material development, and policy support around high priority local, national, and regional environmental and occupational health threats. These hubs are expected to conduct the research and training needed to identify and design mitigation strategies for the adverse consequences of environmental exposures and inform relevant policy development in LMICs. The global network of hubs will serve as a platform for coordinated research and research training. GEOHealth Hubs are expected to provide leadership in environmental and occupational health research and in training a new generation of environmental and occupational health experts. Hubs are supported by two coordinated linked awards to 1) a LMIC institution for research and 2) a U.S. institution for research training. Both applications must demonstrate a commitment to extensive coordination between these two awards to meet goals of the GEOHealth program. An application submitted in response to this FOA for research must be harmonized with a linked application for research training under RFA-TW-21-002 Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research Training (Collaborative U2R Clinical Trial Optional) . This research FOA is intended to support collaborative research that contributes to the long-term goals of 1) building and strengthening sustainable research capacity in LMICs to address environmental and occupational health, and 2) developing a research foundation to inform evidence-based policy related to environmental and occupational health.
Clinical research (https://grants.nih.gov/grants/glossary.htm#ClinicalResearch), clinical trials (https://grants.nih.gov/grants/glossary.htm#ClinicalTrial), and human subjects research (https://humansubjects.nih.gov/) are allowed under this FOA. Examples of the types of NIH-defined clinical trials that could be proposed include (but are not limited to) technology interventions, behavioral interventions, etc. This FOA will NOT support studies whose purpose is to evaluate safety clinical efficacy, effectiveness, and management and/or implementation of new or established pharmacological agents. For the NIH definition of clinical research versus clinical trials, please see https://grants.nih.gov/policy/clinical-trials/definition.htm. Please use the clinical trial tool (https://grants.nih.gov/ct-decision/index.htm) to determine whether your proposed study is a clinical trial. For additional information please refer to the NIH Clinical Trials Requirements and Fogarty information on human subjects research and clinical trials. Applicants desiring to conduct NIH-defined clinical trials should contact the FIC prior to submission to review the scope of the proposed clinical trial with the program contact.
Applicants are strongly encouraged to review the NOT-OD-15-103 on enhancing the reproducibility of NIH-supported research through rigor and transparency and to incorporate appropriate features into the proposed research plans.
30 days before the application due date.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 08, 2021 | July 08, 2021 | Not Applicable | October 2021 | January 2022 | March 2022 |
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.
Purpose
This Funding Opportunity Announcement invites new and renewal applications from LMIC institutions for support of innovative multidisciplinary public health-relevant environmental and/or occupational health research projects that are likely to inform assessment and control of environmental and workplace hazards, and inform policy around priority local, national and regional environmental and occupational health threats.
The purpose of this FOA, as one of two linked FOAs comprising the GEOHealth Hub program, is to support research that will increase knowledge of how environmental exposures impact health and disease in LMICs.
Applicants may propose one focal research project and up to two pilot research projects that are aligned with the focal research project as described in Section IV.
The research must address priority LMIC environmental and occupational health issues and it must be integrated with research training activities proposed in the linked application. Therefore, applications in response to this FOA must be developed in close coordination with linked applications under RFA-TW-21-002 Cooperative Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research Training (Collaborative U2R Clinical Trial Optional) .
Background
The World Health Organization estimates that nearly a quarter of all deaths are attributed to living or working in an unhealthy environment, and environmental risk factors, such as air, water and soil pollution, chemical exposures, climate change, and ultraviolet radiation, contribute to more than 100 diseases and injuries (1). The burden is highest in Low- and Middle-Income Countries (LMICs), and environmental health risks especially affect women and children because they are more vulnerable socially and because exposures to environmental contaminants create greater risks for children’s developing bodies and cognitive functions (2).
Although LMICs suffer adverse and sometimes catastrophic health effects from environmental contamination and occupational hazards, in many cases inadequate capacity exists to study and mitigate these problems. Addressing these challenges requires a critical mass of scientists with expertise in large-scale environmental and occupational health analysis, complementary skills such as data management, and appropriate understanding of the socioeconomic and policy context that influences the effectiveness of interventions. Research partnerships can enhance access to expertise and resources to improve research capacity for environmental and occupational health in LMICs. Additionally, environmental health problems often cross national boundaries, as air and water pollutants travel thousands of miles impacting neighboring countries and locations around the world. Collaborative multi-country research on environmental and occupational health topics provides opportunities to address variation in exposure levels and inclusion of more extensive population genetic backgrounds that inform not only local health problems but also broader U.S. and international environmental and occupational health questions.
In 2012, FIC launched the Global Environmental and Occupational Health (GEOHealth) Hub program in order to develop a handful of regional science hubs, based in LMICs, that would become internationally-recognized centers for the collection, management, synthesis and interpretation of data on environmental and occupational health, ideally serving the multinational regions in which they reside (3). GEOHealth Hubs are supported by two linked cooperative agreement awards: a research award to the LMIC institution and a research training award to the US institution. Additional information about the program can be found on the program webpage at https://www.fic.nih.gov/Programs/Pages/environmental-occupational.aspx.
New in this FOA
This FOA contains several updates to the previous GEOHealth FOAs, including the following:
Goals of the GEOHealth Program
The goals of the GEOHealth program are to strengthen environmental and occupational health-related research collaborations, enhance research training, create relevant advanced educational curricula and outreach material, support research needed to identify and design mitigation strategies for the adverse consequences of environmental and occupational exposures, and inform nationally-relevant policy development in LMICs. Each Hub will provide training and curricular resources to academic institutions in the region. Hubs are expected to have collaborative relationships with ministries of health and other key planning and operating agencies that oversee health-affecting activities, such as agriculture, labor and public works, to serve as a source of scientific evidence for policy formulation related to environmental and occupational health.
Together the GEOHealth Hubs form the GEOHealth Network which will serve as a platform for coordinated environmental and occupational health research and research training activities. It is anticipated that the GEOHealth Hubs will not only leverage the current investments of national governments and international research agencies and donors, but also become attractive for further investments in these institutions in the future. In doing so, the Hubs can also become magnets that attract, develop and retain the best environmental and occupational health scientists in LMICs, key collaborators for scientists from the U.S. and international partners, and among the most credible sources in the world for state-of-the-art knowledge on environmental and occupational health.
GEOHealth Hub Characteristics
A GEOHealth Hub is defined as a multidisciplinary group of researchers and their institutions based in a LMIC, who, with their collaborators, focus on a core set of common research and training topics that address environmental and/or occupational health priorities in the LMIC and/or the region. For the purposes of the GEOHealth Program linked FOAs (RFA-TW-21-001 and RFA-TW-21-002), a pair of institutions (one LMIC institution and one U.S. institution) should form a consortium to support the GEOHealth Hub with other collaborating institutions in the U.S. and LMIC linked as spokes . The GEOHealth Hub should serve as a focal point for all proposed research, research capacity-building, training, and collaborative activities, in which "spoke" institutions may participate. The U.S. applicant responding to RFA-TW-21-002 should propose a research training program, and the LMIC institution responding to this FOA should propose research activities based on a set of common environmental or occupational health topics. Both applications must demonstrate a commitment to extensive coordination between these two awards to meet goals of the GEOHealth program.
Funding Opportunity Objectives
The objectives of the Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research (Collaborative U01 Clinical Trial Optional) are to:
Scientific Area
GEOHealth Hubs are expected to bring together multiple disciplines to advance the pace of scientific discovery in environmental and/or occupational health. The environmental or occupational health-related research areas should be selected by the applicants, based upon expertise within the proposed consortium to address a priority public health need in the country and/or region and to closely align with the focal research training in the linked U2R application. Applicants are encouraged to develop a deliberate process that builds on demonstrated capacity and may increase in scientific scope over the life of the grant.
Research that addresses the interactions between exposure factors is strongly encouraged. Research that addresses vulnerable or under-researched LMIC populations, including women, children, and aging populations, is encouraged.
A needs assessment including relevant local and global burden of disease estimates for the proposed country or region of work, consideration of the policy environment in the LMIC, and assessment of the public health and science needed to support relevant policy development, should be provided in the rationale for the proposed research.
Partnerships
Applicants are encouraged to involve multiple U.S. and LMIC partner institutions in the proposed research project, as scientifically appropriate and justified. As with the scientific focus, applicants are encouraged to develop a deliberate process for adding partners over the life of the grant. Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions are encouraged.
Initial inclusion of more than four LMIC or four non-LMIC partner institutions in the overall hub structure for new applications is likely to be very challenging and should only be undertaken if there is strong justification, including how the partnership will be managed and how the support and responsibilities will be distributed. Renewal applications may expand their partnership network as appropriate and justified.
Although new data collection is allowed, applicants are encouraged to use secondary data, tools and resources available through other sources. Letters of support that include descriptions of such resources should be included in the application.
Applicants are encouraged to explore the potential for future partnerships that include additional investment in the GEOHealth Hub, particularly with national governments of Upper-Middle Income and High-Income Countries, international donors, and other organizations in order to leverage local institutional capacities and to increase prospects for sustainability of the Hub.
GEOHealth Research Project Activities
The GEOHealth Hubs are expected to provide leadership in environmental and occupational health research and in training a new generation of environmental and occupational health experts. Responsive applications will propose an innovative multidisciplinary public health-relevant research project that 1) focuses on an environmental or occupational health topic, 2) is based on a documented needs and opportunities assessment that addresses the policy environment in the LMIC, 3) involves appropriate governmental, subnational, private sector, and regulatory decision makers in order to maximize uptake of evidence in policy and practice, 4) informs and is supported by the research training activities under the linked research training application RFA-TW-21-002, and 4) includes a plan to disseminate research results to serve scientific and policy communities beyond the participating investigators and institutions.
Regions
Research must be conducted in World Bank designated LMICs in one of the following geographic regions (GEOHealth hubs may involve institutions in different countries within the region):
To support a global network of GEOHealth Hubs, the FIC and partners aim to fund one Hub in most of the above regions, depending on merit, coordination with the linked application, and availability of funds. Grants will be prioritized to ensure appropriate geographic and scientific representation, and special consideration will be made regarding activities in countries and regions where environmental and occupational health conditions adversely impact public health and economic progress (see Section V.2 Review and Selection Process).
Interests of Participating Components
The Fogarty International Center (FIC) is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a focus on Low- and Middle-Income Countries. The GEOHealth program reflects FIC's Strategic Plan (http://www.fic.nih.gov/about/pages/strategic-plan.aspx).
The National Institute on Aging (NIA) mission is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA’s interest in this FOA is research and research training to understand the influences of environmental and occupational exposures on life course aging and health, including Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD), in Low and Middle Income Countries (LMIC). Specific areas of interest include, but are not limited to research and research training that integrate environmental and occupational risk factors into longitudinal cohort studies in high exposure areas; molecular epidemiologic methods that elucidate the sequence of events that ultimately lead to AD and ADRDs resulting from exposure to environment and/or occupational factors; studies that use animal models to understand environmental effects/exposures on aging, AD, ADRD; elucidating life course pathways via environmental and occupational circumstances leading to disparities in mid and later-life cognitive and health outcomes; international comparative research to further our understanding of how different social, familial, environmental, geographic, cultural and institutional contexts influence the aging process, cognition and health; the relationships between labor market change, participation and associated occupational exposures with health and disability at older age, the consequences of occupational and workplace policies (e.g. shift work, high-risk jobs, etc.) on health outcomes at older ages; how early life exposure to acute or chronic stress as well as differences in educational quality or attainment affect cognitive and health outcomes; how differences in social isolation or integration caused by the built environment, family structure, or occupational experiences serve as risk or protective for cognitive and health outcomes; how differences in built environmental are related to health and cognitive outcomes via changes in physical activity or access to higher quality educational or work opportunities; and translation of discoveries into policy and practice designed to reduce disability and/or prevent or slow additional decline among persons with cognitive, sensory, or motor disabilities as they continue to age.
The National Cancer Institute (NCI) coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. NCI’s interest in this FOA is in research and research training directed toward understanding the carcinogenic consequences of environmental or occupational exposures of regional importance in LMICs. Priorities for NCI include research and research training in the following areas: well-designed epidemiologic studies to assess short- and long-term carcinogenic effects of environmental or occupational exposures (including environmental and occupational components of cohort studies); population-based studies of cancer prevention and control interventions targeting environmental or occupations exposures; application of molecular epidemiologic methods that elucidate the sequence of events that lead to cancer resulting from exposure to chemical, biological, or physical exposures in the environment or occupational settings; the integration of environmental or occupational components in existing local and regional cancer registries or other surveillance efforts that are established or in development in LMICs; environmental and occupational exposure assessment; the application of technologies to investigate biological changes resulting from potentially adverse environmental or occupational exposures; and studies of the translation of environmental and occupational health and cancer scientific discoveries into policy and practice designed to prevent and control cancer.
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. The NIEHS is interested in supporting research and research training in LMICs that address or seek to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and activities that lead 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 industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources. Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders, children’s environmental health and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, climate change and human health, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease. NIEHS supports research examining health consequences due to the interplay between environmental exposures and cofactors such as infectious agents or social factors that contribute to environmental health disparities.
The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. Given the burden of environmental and occupational exposures on women’s health globally, ORWH is specifically interested in innovative and multidisciplinary research to understand sex and gender differences in global environmental health, and the importance of building a diverse research workforce in the field of global environmental and occupational health. ORWH encourages interdisciplinary approaches and partnerships to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women. For more information on ORWH and The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 2023, please visit ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.
Citations
See Frequently Asked Questions for the GEOHealth Hubs for more information.
Note: This FOA may support NIH-defined clinical trials (see NOT-OD-15-015). Examples of the types of clinical trials that could be proposed include (but are not limited to) technology interventions, behavioral interventions, and others. Research that is NOT responsive to this FOA includes studies whose purpose is to evaluate safety, clinical efficacy, effectiveness, or management of new or established pharmacological agents. Please use the clinical trial tool (https://grants.nih.gov/ct-decision/index.htm) to determine whether your proposed study is a clinical trial. For additional information please refer to the NIH Clinical Trials Requirements and Fogarty information on human subjects research and clinical trials.
Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
Applications Not Responsive to this FOA
1. Applications submitted by an eligible LMIC institution without an eligible linked application in response to RFA-TW-21-002.
2. Applications that focus on tobacco use and cessation (projects that address secondhand smoke exposure will be considered).
3. Applications that focus on HIV/AIDS (projects that address HIV comorbidities that are exacerbated by environmental exposures will be considered)
4. Applications that address occupational exposure to HIV.
5. Studies whose purpose is to evaluate safety, clinical efficacy, effectiveness, or management of new or established pharmacological agents.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
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?
FIC and partner components intend to commit an estimated total of $4.2 million for FY2022 for the combined linked (U01 and U2R) awards, corresponding to approximately seven linked hub awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The application budget should be developed in close coordination with the linked U2R research training application (RFA-TW-21-002) because the combined budget for both linked applications cannot exceed $600,000 in total costs per year (including 8% F&A), and at least 50% of the combined budget must be in the LMIC's U01 application.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Applications must be submitted by eligible Low- and Middle-Income Country institutions that demonstrate collaborations with eligible domestic (U.S.) institutions named in their application by documented joint publications, grants or previous research training activities.
LMICs are defined by the World Bank classification and include low-income, lower-middle-income, and upper-middle-income countries. See Notice of Change in Country Eligibility for Fogarty International Training Grants (NOT-TW-12-011) and Country Eligibility for additional restrictions. High-Income Country (HIC) institutions are not eligible.
Applications received without an eligible linked application in response to RFA-TW-21-002 will be considered incomplete and will not be reviewed.
The following LMIC organizations/institutions are eligible to apply:
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at:
NIH Application Submission Tips for International Applicants
Electronic Submission: Quick Contact Support for International Applicants
Common Questions & Answers for International Applicants
Grants.gov - Organization Registration
Guidance for International Applicants Blocked from Registration Websites: NOT-OD-11-090.
An NIH supported webinar on Electronic Submission of Grant Applications for Foreign Institutions can be found at: http://grants.nih.gov/grants/webinar_docs/webinar_20120927.htm.
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.
Institutions/organizations must propose multiple PD(s)/PI(s) in response to this FOA. Each PD/PI on the linked U2R research training application (RFA-TW-21-002) must be designated as a multiple PD/PI on this research application, and each PD/PI on this U01 research application must be designated as multiple PD/PI on the U2R research training application. Visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PDs/PIs should be established investigators in the environmental and occupational health area on which the application is focused and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PDs/PIs should have experience conducting research and leading research training in the LMIC country that is the focus of the application.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
An institution,normally identified by having a unique DUNS number and NIH Institutional Profile File (IPF) number, can only submit one application in response to this FOA. The applicant institution may receive a sub-award through the linked research application. The applicant institution may also participate as a partner via a sub-award or associate program in one additional GEOHealth Hub through an application submitted by another institution.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
This FOA only accepts applications that are part of a collaborative set of multiple applications. A set must contain two applications: one U01 application in response to RFA-TW-21-001 and one U2R application in response to RFA-TW-21-002.
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.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Christine Jessup, Ph.D.
Telephone: 301-496-1653
Email: [email protected]
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, with the following modification:
Descriptive title of applicant's project: To allow NIH to identify linked applications as a related pair of collaborative applications, the titles for each application must have the following format: a N/2 indicator + Identical title + Country of Applicant Institution (e.g., "1/2", where 1/2 means that this is site 1 of 2 sites in the pair. The other site will be labeled as 2/2 and have the same descriptive title). For example, 1/2-GEOHealth Hub Descriptive title-Zambia and 2/2-GEOHealth Hub Descriptive title-U.S. . Titles may not exceed 200 characters in length, including the tag, e.g.,1/2, at the beginning of the title and the country at the end of the title.
Proposed Project Start and Ending Date: Use the "Earliest Anticipated Start Date" given in this FOA as the Proposed Project Start Date.
Cover Letter Attachment: The Cover Letter is one PDF file only. In addition to the instructions in the SF424 (R&R) Application Guide, the following collaborative information is required in the Cover Letter: a listing of both linked applications (U01 and U2R) in response to RFA-TW-21-001 and RFA-TW-21-002, including for each 1) the PDs/PIs names, 2) the Title (including the tag, e.g. 1/2 or "2/2", and the applicant's country), and 3) the Applicant Institution. Each linked application should submit an identical listing.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following modifications:
Include the applicant institution and all of the collaborating institutions, both U.S. and foreign, as performance sites.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional guidance:
Does this project involve activities outside of the United States or partnerships with international collaborators?: Check YES and list the foreign countries for all of the performance sites listed in the SF 424(R&R) Project/Performance Site Locations Form.
Project Summary/Abstract: Provide a succinct and accurate description of the proposed work, including a statement of objectives and a concise description of the research design and methods. Describe the long-term goals and objectives for the overall program, and coordination with the linked U2R research training application. Include the institution name of the partner U.S. institution submitting the linked U2R application; the environmental and occupational health topic proposed; and the rationale and design of the research.
Project Narrative: Describe the public health relevance of the proposed research to the LMIC and any other collaborating LMIC institutions, including the relevance of increased research capacity. Include the environmental and occupational health focus of the proposed research.
Facilities and Other Resources: Include descriptions of facilities and other resources to be used for research at all U.S. and foreign performance sites.
Other Attachments: A plan must be provided for an External Advisory Committee. External Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Potential members should not be named in the application and should not be contacted until after the review to avoid potential conflict situations in review; instead indicate the areas of expertise and anticipated input, as well as any critical considerations in the selection of members. Renewal applications with similar Advisory Committees should include the names of all committee members during the past project period. Please name your file "External_Advisory_Committee.pdf". This attachment should not exceed 5 pages.
The plan should include composition, roles, and responsibilities of committee members, frequency of committee meetings, and other relevant information should be included. The External Advisory Committee should be composed of experts and relevant professionals from the U.S., LMICs or other countries. LMIC members should constitute a minimum of 50% of the committee. Members should be external to participating Departments and at least one member should be external to participating Universities or Institutions. At least one member should have research expertise to provide input into the proposed research; at least one member should have relevant experience in research training in LMICs; and at least one member should be able to provide input into the translation of research to policy and practice. Committee members should not be directly involved in the research project(s), the research training program, or in mentoring trainees. Committee members should be included as key personnel as described in SF 424 (R&R) Senior/Key Person Profile Expanded Component.
Describe how the External Advisory Committee will contribute to the development, implementation and evaluation of the overall effectiveness of the linked research and research training programs, including translation to policy and practice and identification of additional partnership opportunities. The External Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research and research training, discuss future research and training goals, aims and ideas. It is expected that face-to-face meetings of the External Advisory Committee will be convened at least twice during the five-year grant period (once in years 1-2, and once in years 3-4).
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional guidance:
Include all PD(s)/PI(s) on the linked U2R research training application (RFA-TW-21-002) as PD(s)/PI(s). Include at least one person at all the other U.S. and foreign participating institutions and identify their role. Include biosketches for Key Personnel.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional guidance:
The budget justification should summarize the total direct and indirect costs for both linked applications. Do not include the detailed budget for the linked U2R application.
The budget should include costs for PDs/PIs and selected key personnel travel to attend meetings of their GEOHealth Hub at least annually.
The budget should also include costs for the PDs/PIs and selected key personnel travel to attend the annual network meeting of all funded GEOHealth Hubs.
The budget may include costs for program administration, including costs for LMIC PDs/PIs to participate in the administration of their GEOHealth Hub's Administrative Oversight Committee (described in Section VI.2.2. Cooperative Agreement Terms and Conditions of Award: Awardee and Principal Investigator Rights and Responsibilities). This may include travel, telephone and internet costs.
The budget may include costs related to program evaluation in order to review and determine the quality and effectiveness of the research and research capacity built.
The budget may include costs related to dissemination of research data, software, and other resources of the project, such as practical tools and materials.
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, with the following additional instructions:
Research Strategy:
Significance. Applications must identify an environmental and occupational health scientific focus directly relevant to the environmental and occupational health priorities of the LMIC(s) and research that will increase knowledge of how environmental exposures impact health and disease. For scope of scientific area, scientific approach and health status of disease area, see Part 2. Section I. Funding Opportunity Description above.
A needs assessment , including relevant local and global burden of disease estimates for the proposed country or region of work, consideration of the policy environment in the LMIC, and assessment of the public health and science needed to support relevant policy development, should be provided in the rationale for the proposed research project. The policy relevance of the proposed activities should be clearly described. The assessment of needs and opportunities should address the policy environment in the LMIC, and the public health and science needed to support relevant policy development. This may include documentation of: existing policies; implementation of multilateral agreements; existing funding allocations; health-relevant environmental monitoring systems and indicators; existing intersectoral assessments of the health implications of decisions in other sectors; existing advisory bodies with a mandate and capacity to direct research agendas and provide synthesis information to policy makers; societal awareness of health threats posed by environmental risks and potential solutions; and community engagement around environmental and occupational health research.
Applicants should propose a research plan that is directly coordinated with the research training activities in the linked research training application (RFA-TW-21-002).
Include short descriptions of all relevant ongoing environmental and occupational health research at the LMIC institution, regardless of funding source, and describe how the proposed research will complement these activities.
Innovation. Include a description of how the linked U01 and U2R applications provide an innovative and integrated model for addressing environmental and occupational health needs in the LMIC(s).
Approach. In addition to one main research project, applicants may propose pilot research in up to two additional areas that are aligned with the proposed research project. Although pilot activities do not need to be justified by preliminary data, they should be justified by the overall needs assessment and appropriate funds should be requested in the budget to support pilot activities.
If the proposed project leverages existing data, tools and resources available through other sources, these should be clearly described and relevant letters of support should be provided.
Plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use of research materials and data, or other means of distributing research and training materials to the wider community, and a means of arbitrating disagreements on publication and other issues should be included in the application.
Describe the prior and current environmental and occupational health collaborations among the applicant institution, the U.S. institution, and other partners. Describe how these collaborations will support the proposed research. Eligible institutions must demonstrate collaborations with U.S. institutions named in their application by documented joint publications, grants or previous research or research training activities.
Coordination. Include a section in the Research Strategy titled: "Coordination". The Coordination section should be identical in the linked applications. This section should describe the coordination of 1) the proposed research and research training activities, 2) the respective administration of the research and research training activities, 3) the monitoring and evaluation of progress of the overall GEOHealth Hub, 4) the roles of the External Advisory Committee, the Administrative Oversight Committee and other planned committees, 5) strategies that would involve both the research and research training awards in strengthening research capacity of the LMIC institutions and contribute to overall institutional excellence, 6) the dissemination research and research training outcomes to inform policy and practice, and 7) planning for new activities building on the Hub's strengths.
The Coordination section also should demonstrate a willingness to engage in research and capacity building activities across the network of funded GEOHealth Hubs.
Plan for Partnership. Include a section titled "Plan for Partnership". This section should be identical in the linked applications. It should describe a plan that 1) identifies and organizes a network of partners and stakeholders, 2) describes how prior and current collaboration among partners will support both research and research training, 3) describes how trainee projects will be developed collaboratively with hub partners and in consultation with stakeholders so that trainees may develop relationships that will impact the implementation of their research throughout their careers, 4) describes a deliberative process for adding partners.
Progress Report for Renewal Applications. For renewal applications, in addition to the instructions in the SF424 (R&R) Application Guide, provide a detailed description of the progress made in the previous funding period to achieve proposed environmental and occupational health research, partnerships, and sustainable capacity building objectives, including, for example, the use of in-country laboratories for sample analysis, etc. Summarize contributions to translation of research into practice, practical approaches for interventions, and promotion of health and protection from environmental and occupational exposures. Describe plans to expand or network with additional departments, with other country institutions, and/or with institutions within the region, using the original institution/program as a hub and/or node for expanded and networked environmental and occupational health research, translation, and outreach.
Letters of Support: Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions should be documented through letters of support. Applicants are encouraged to include letters of support from officials at appropriate LMIC government entities that describe how they will support and collaborate with the proposed research and capacity building.
If the proposed project leverages existing data, tools and resources available through other sources, relevant letters of support should be provided.
The U.S. and LMIC institutions must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program. As part of the Letters of Support, include a signed letter, on institutional letterhead, signed by the president, the provost, a dean, or another key institutional leader with institution-wide responsibilities that contains a description of the U.S. and LMIC institution’s commitment to the planned program to ensure its success. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. The letter may also describe any support that is expected to be provided by the LMIC or LMIC institution to trainees upon completion of their training under the linked research training application.
In the same letters include descriptions of the U.S. and LMIC institutional commitment to harassment and discrimination protections that:
1) Ensures proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.
2) Responds appropriately to allegations of discriminatory practices.
3) Adopts and follows institutional procedure for requesting NIH prior approval of a change in the status of the program director/principal investigator (PD/PI) or other senior/key personnel if administrative or disciplinary action is taken that impacts the ability of the PD/PI or other key personnel to continue his or her role on the NIH award described in the grant application.
See https://grants.nih.gov/grants/policy/harassment/policy-requirement.htm for more information.
The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program. The application must include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. The letter should describe how the proposed research will coordinate with other research and research training programs at the institution.
All letters should be assembled as a single PDF.
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:
All applications, regardless of the amount of direct costs requested for any one year, must submit a Data Sharing Plan.
Include a Dissemination Plan section that includes a plan to construct and maintain a Hub website in coordination with the linked U2R application for dissemination of information about the Hubs and research outcomes. The plan should also include plans for dissemination of research data, software, and other resources of the project, such as practical tools and materials; and contributing to public databases and/or developing their own (local) databases to meet their needs. Such databases should have the capability for collecting, integrating, and rapidly disseminating the data that would be collected through the GEOHealth Hub.
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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Each application of a collaborative set must be complete, compliant, and responsive.
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.
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?
Does the assessment of needs and opportunities provide appropriate justification for the proposed research? Are the expected contributions of the proposed research likely to strengthen the ability of the LMIC institution to conduct ongoing research of importance to that country and serve as a regional hub?
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?
Do the PDs/PIs have the scientific background, expertise, and LMIC experience to provide strong leadership, direction, management, and administration of the proposed research? Do the PDs/PIs, collaborators and other researchers demonstrate a record of collaboration? Do the PDs/PIs, collaborators and other researchers demonstrate a willingness to engage in research and capacity building activities across the network of funded GEOHealth Hubs?
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 application provide an innovative and integrated model for addressing environmental and occupational health needs in the LMIC(s)?
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?
Does the proposed research take advantage of previous and current research and research training support from FIC, NIH, and other organizations? Does the proposed research project contain explicit strategies to strengthen capacity through the linked U2R research training application and does the proposed collaboration lead to sustainable enhancement of the LMIC institution's research capacity and contribute to overall institutional excellence? If pilot research activities are proposed, are they clearly justified and aligned with the goals of the GEOHealth Hub and with regional environmental and/or occupational priorities, and do they build upon the proposed research project? Does the proposed research provide a solid foundation for a hub structure, serving as a focal point for all research, research capacity-building, training, collaborative activities, data management and policy support in the country or region? If the project leverages existing secondary data, tools and resources available through other sources, are these well-described and appropriate, and do associated letters of support demonstrate appropriate commitment to the research? Is the required Data Sharing Plan reasonable and adequate?
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, 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?
Is a significant level of U.S. and LMIC institutional commitment to the program evident and is the level of institutional commitment to the program sufficient to ensure success of the program? Are the resources necessary to perform the research available or obtainable at the LMIC institution? Has the LMIC institution made a convincing commitment to the program (e.g., provided research/academic appointment and salary support)? How successful is the history of institutional and individual collaborations among the faculty of the participating institutions? Does the applicant institution have sufficient capacity in human subjects protection, vertebrate animal care, biosafety, biomedical libraries, information technology, international research management and English as a second language, if needed, to support the research proposed? Do letters of support from officials in LMIC government entities and/or non-governmental organizations (NGOs) show evidence for collaborative relationships that will enable research findings to inform environmental and occupational health policy formulation and public health practice?
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.
Coordination and integration of linked applications
Do the linked applications show evidence of coordination, integration and mutual reinforcement between the research training and research? Is the proposed research well-integrated with, informed by, and in support of the linked research training program? Do the PDs/PIs demonstrate a commitment to extensive coordination with the linked application? Are sufficient and feasible mechanisms in place to ensure collaboration across sites to achieve integration of research, research training, overall managerial and administrative responsibilities, planning for data management, analysis and reporting of results? Are there adequate plans for shared decision making among PDs/PIs with regard to personnel, changes in study protocol, and authorship? Does the team demonstrate its willingness and capability to engage in collaborative research and capacity building activities across the network of funded GEOHealth Hubs to enhance the GEOHealth program's productivity?
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
Not Applicable
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Does the application describe accomplishments that reflect coordination and integration with the linked research training award? Does the application describe accomplishments that reflect coordinated activities with other GEOHealth Hubs in the GEOHealth network? Does the program demonstrate plans to continue to evolve and expand, reflecting changes in the research field, strengthening of existing partnerships and development of new partnerships?
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) Sharing Model Organisms; and (2) 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.
Application 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 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.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
1. Defining research objectives and approaches (plan, conduct, analyze, and publish results, interpretations, and conclusions of the research conducted); and defining research training objectives and approaches, the mentored research training projects, and other research training activities within the guidelines of the linked RFAs and in accordance with the terms and conditions of the award.
2. Establishing an Administrative Oversight Committee (AOC) to facilitate coordination between the research training (U2R) and research (U01) awards that comprise a GEOHealth Hub. The AOC is responsible for the overall management, communication, coordination, oversight, evaluation and supervision of the awards. The PDs/PIs on both linked awards will serve on the AOC. Other members may be included as appropriate and justified.
3. Establishing an External Advisory Committee (EAC) of experts not involved in the GEOHealth Hub awards to advise the PDs/PIs as described in the linked RFAs.
4. Implementing the research and research training proposed and reporting on all activities supported. The PDs/PIs must assure compliance with applicable host country regulations; and assure compliance with all applicable DHHS/NIH/FIC policies for conduct of research and research training.
5. Submitting interim progress reports, when requested, to the FIC Program Director. Such reports are in addition to the required annual noncompeting continuation progress report.
6. Holding face-to-face meetings at least annually for their GEOHealth Hub to be attended by all affiliated Hub award PDs/PIs, key personnel, program partners, in order to review progress, plan and design activities, and establish priorities. The FIC Program Official, U.S. Government Project Collaborator(s), and members of the Steering Committee may attend these meetings, when possible.
7. Attending the annual GEOHealth Program Network meeting. The venue for the annual GEOHealth Program Network meeting may vary between U.S. and LMIC sites. The PDs/PIs may be asked to organize one GEOHealth Program Network Meeting over the award project period.
8. Serving on a Steering Committee with other GEOHealth PDs/PIs, program and scientific staff from NIH, and funding partners, to collaborate and coordinate activities and assess priority needs and opportunities. PDs/PIs will participate in Steering Committee meetings and teleconferences and accept the participation and assistance of NIH and funding partner staff in accordance with the guidelines described in Section VI.2 Cooperative Agreement Terms and Conditions of Award: NIH and Funding Partner Staff Responsibilities.
9. Facilitating the formation of and participating in appropriate Working Groups to promote the exchange of information, experiences, protocols, and ideas across GEOHealth Hubs to enhance coordination and collaboration.
10. Ensuring that research, research training, and research capacity building activities conducted under this cooperative agreement employ an approach in which research and research training are driven by priority LMIC needs to provide the evidence base for environmental and occupational health interventions and policies in LMICs. The PDs/PIs will provide an ongoing process for assessing priority needs and a process for assessing ongoing research and research capacity building projects. They will modify, redirect, and/or curtail ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions within the geographic regions.
11. Regularly briefing the U.S. Government Project Collaborator(s) on activities of the hub and hub committees, including the AOC and the EOC.
12. Submitting all abstracts, manuscripts and reviews (co-)authored by members of the grant and supported in part or in total under these Cooperative Agreements. Manuscripts must comply with the NIH Public Access Policy (see http://publicaccess.nih.gov/). Publications or presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of support in language similar to the following: This investigation was supported by the Fogarty International Center [add other funding partners specified in the Notice of Grant Award] under the Global Environmental and Occupational Health program award [grant number(s)].
13. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards:
One or more U.S. Government staff, such as NIH Program Directors, will be substantially involved in each of the GEOHealth Hubs as U.S. Government Project Collaborators. The U.S. Government Project Collaborators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The role of the U.S. Government Project Collaborators will be to facilitate and not to direct the activities. It is anticipated that the Project Collaborators will provide advisory input.
The U.S. Government Project Collaborator(s) will be the appointed by FIC and will be primary Government contact with the PDs/PIs for scientific and technical issues. During performance of the award, the U.S. Government Project Collaborator(s) may provide appropriate assistance and advice in the design of activities, facilitate liaison activities for partnerships, and provide assistance in the identification of and access to NIH and other scientific resources. Other appropriate U.S. Government staff assistance may be coordinated by the U.S. Government Project Collaborator(s)as needed.
The U.S. Government Project Collaborator with substantial programmatic involvement may:
1. Provide input and support in the design, implementation and analysis of research and research training activities as agreed to by the PDs/PIs, and suggest studies and research training activities within the scope of the funded research and research training activities.
2. Provide programmatic support during the accomplishment of research and research training activities.
3. Advise in management and technical performance.
4. Participate in scheduled meetings and teleconferences to discuss program coordination and/or progress and encourage close coordination of activities under the linked research and research training awards.
5. Participate as a voting member in Steering Committee meetings as described in Section VI.2 Cooperative Agreement Terms and Conditions of Award: Areas of Joint Responsibility".
6. Facilitate collaboration with other NIH- and U.S. Government-supported researchers and research resources.
7. Serve as a resource for all major transitional changes that the awardees might propose (e.g., a change in partnership organization) and advise on their appropriateness prior to implementation to assure consistency with the goals of this FOA.
8. Assist in avoiding unwarranted duplication of effort with other NIH efforts.
9. Make recommendations to the Network Scientific Advisory Group (NSAG; described below) for continued funding based on: (a) overall research and research training progress; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and (c) maintenance of high-quality research and research training.
A Network Scientific Advisory Group (NSAG) will be appointed by the FIC and its U.S. Government partners to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA. The NSAG will be comprised of scientifically appropriate extramural and intramural staff, as well as other Federal and non-Federal experts selected by FIC and its U.S. Government partners to participate in NSAG activities in an advisory capacity when appropriate. The NSAG will meet at the annual Network Meeting of GEOHealth Hubs and may meet more frequently through virtual meetings. The FIC Program Official will serve as Secretariat for the NSAG. U.S. Government Project Collaborators will synthesize and present GEOHealth Hub progress to the NSAG. Members of the NSAG will be invited to attend all Steering Committee meetings described in Section VI.2 Cooperative Agreement Terms and Conditions of Award: Areas of Joint Responsibility".
The FIC Program Official will be responsible for the normal scientific and programmatic stewardship of the award. The FIC Program Official will be the primary U.S. Government contact for the PDs/PIs for issues relating to program administration, funding, and policy.
FIC and its U.S. Government partners may elect, following consultation with grantees, to publish summary results from program activities to fulfill its responsibility to disseminate lessons learned from the program.
FIC reserves the right to terminate or curtail an award in the event of substantial lack of planned program activity completion, shortfall in trainee recruitment, incomplete or delayed reporting, or other major NIH research or research training policy breach.
Areas of Joint Responsibility:
GEOHealth Steering Committee. PDs/PIs of each GEOHealth award, U.S. Government Project Collaborators, and funding partner staff will be active members of the GEOHealth Steering Committee. On voting matters, each funded project will have one vote and each funding partner will have a single vote. Other individuals may participate as non-voting members. U.S. Government voting membership will not exceed non-U.S. Government voting membership. The chairperson will be selected by the Steering Committee with years of service determined by the Committee. The chairperson is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to the Steering Committee members. The Steering Committee will develop Terms of Reference including details about meeting frequency (virtual meetings are appropriate), establishment of subcommittees as deemed appropriate, and development of any harmonized research and research training activities. The Steering Committee may develop a Data Sharing Policy that describes the sharing of methods, data, and information, including but not limited to protocols, questionnaire results, monitoring data, exposure data, and others, among network participants and collaborating organizations. GEOHealth awardees are expected to accept and implement the Policy developed by the Steering Committee.
Dispute Resolution
Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: one designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and DHHS regulation at 45 CFR Part 16.
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)
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Contact Center Telephone: 800-518-4726
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Christine Jessup, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]
Curt DellaValle, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7225
Email: [email protected]
Damali Martin, Ph.D., M.P.H.
Division of Neuroscience, National Institute on Aging (NIA)
Telephone: 301-402-8310
Email: [email protected]
John Phillips, Ph.D.
Division of Behavioral and Social Research, National Institute on Aging (NIA)
Telephone: 301-827-4137
Email: [email protected]
Michael C. Humble, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3272
Email: [email protected]
Regine A. Douthard, MD, MPH
Office of Research on Women's Health (ORWH)
Telephone: 301-451-2729
Email: [email protected]
Seetha Bhagavan, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: [email protected]
Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
Jeffrey Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: [email protected]
Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.