It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Funding Opportunity Purpose
This Funding Opportunity Announcement invites new and renewal applications from U.S. institutions for support of a collaborative research training program that will strengthen the capacity of institutions in LMICs to conduct collaborative research, data management, training, curriculum and outreach material development, practical approaches for assessment and control of environmental and workplace hazards, and policy support 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 training programs that address priority LMIC environmental and occupational health issues that are integrated with associated LMIC research activities. Therefore, applications in response to this FOA must be developed in close coordination with linked applications under RFA-TW-21-001 “Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) – Collaborative Research (U01 Clinical Trial Optional)”.
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 this FOA should propose research training activities and the LMIC institution responding to RFA-TW-21-001 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) – Collaborative Research Training (U2R Clinical Trial Optional)” are to:
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 training 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 area(s) in the linked U01 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 training that addresses the interactions between exposure factors is strongly encouraged. Research training 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 training program as described in Section VI (Research Training Program Plan. Background).
Attention should be given to recruiting and retaining women, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the LMIC context.
Applicants are encouraged to involve multiple U.S. and LMIC partner institutions in the proposed research training program, 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.
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.
Research must be conducted in World Bank designated LMICs in one of the following geographic regions:
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.
1) Prüss-Ustün A, Wolf J, Corvalán C, Bos R and Neira M. 2016. Preventing disease through healthy environments: A global assessment of the burden of disease from environmental risks. World Health Organization. ISBN 978 92 4 156519 6. https://www.who.int/quantifying_ehimpacts/publications/preventing-disease/en/ Accessed 18 June 2020.
2) Neira M, Fletcher E, Brune-Drisse.MN, Pfeiffer M, Adair-Rohani H and Dora C. 2017. Environmental health policies for women’s, children’s and adolescents’ health Bulletin of the World Health Organization 2017;95:604-606. doi: http://dx.doi.org/10.2471/BLT.16.171736. https://www.who.int/bulletin/volumes/95/8/16-171736/en/ Accessed 18 June 2020.
3) Rosenthal J, Jessup C, Felknor S, Humble M, Bader F, and Bridbord K. 2012. International Environmental and Occupational Health: From Individual Scientists to Networked Science Hubs. Am J Ind Med 55:1069-1077. http://onlinelibrary.wiley.com/doi/10.1002/ajim.22130/pdf. Accessed 18 June 2020.
See Frequently Asked Questions for the GEOHealth Hubs for more information.
Note: This Funding Opportunity Announcement (FOA) allows appointment of Trainees proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
Applications Not Responsive to this FOA
1. Applications submitted by an eligible U.S. institution without an eligible linked application in response to RFA-TW-21-001.
2. Applications that propose research training exclusively at the U.S. institution.
3. Applications that propose exclusively short-term training experiences of less than one month.
4. Applications that focus on tobacco use and cessation (but projects that address secondhand smoke exposure will be considered).
5. Applications that focus on HIV/AIDS research training (projects that address HIV comorbidities that are exacerbated by environmental exposures will be considered).
6. Applications that address occupational exposure to HIV.
7. Applications that focus on injury and trauma research training without direct relevance to environmental exposures.
See Section VIII. Other Information for award authorities and regulations.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applications must be submitted by eligible domestic (U.S.) institutions that demonstrate collaborations with eligible Low- and Middle-Income Country (LMIC) institutions named in their application by documented joint publications, grants or previous research training activities.
LMICs are defined by the World Bank classification (http://data.worldbank.org/about/country-classifications/country-and-lending-groups) 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.
Applications received without an eligible linked application in response to RFA-TW-21-001 will be considered incomplete and will not be reviewed.
The sponsoring institution must assure support for the
proposed program. Appropriate institutional commitment to the program includes
the provision of adequate staff, facilities, and educational resources that can
contribute to the planned program. The
letter should describe how the proposed research training will coordinate with
other research and research training programs at the institution.
The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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 must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with
the skills, knowledge, and resources necessary to carry out the proposed research training program as the
Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
Institutions/organizations must propose multiple PD(s)/PI(s) in response to this FOA. Each PD/PI on the linked U01 research application (RFA-TW-21-001) must be designated as a multiple PD/PI on this research training application, and each PD/PI on this U2R research training application must be designated as multiple PD/PI on the U01 research 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 Training PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
The PDs/PIs should have research and research training experience 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.
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.
Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.
Faculty should have research and/or research training experience in the LMIC which is the focus of the application.
Only individuals who are citizens of eligible LMICs (defined by the World Bank classification system; also refer to "Notice of Change in Country Eligibility for Fogarty International Training Grants" NOT-TW-12-011 for additional restrictions) are eligible for research training support or other training activities (as verified by the PDs/PIs).
Individuals who have dual citizenship or permanent residency in the U.S., other high income countries or ineligible countries described above are not eligible for support.
Research training may be offered to a wide range of scientists, including laboratory scientists, social scientists, clinicians and other health professionals, as well as technical and administrative staff in order to meet the needs for research capacity gaps at the LMIC institution.
Attention should be given to recruiting and retaining LMIC trainees from groups underrepresented in environmental and occupational health in the partnering country.
All medium- and long-term trainees (more than 1 month) are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.
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.
It is critical that applicants follow the Training (T) Instructions
in the SF424
(R&R) Application Guide except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.
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, PhD.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
Follow all instructions provided in the SF424 (R&R) Application Guide , with the following modifications:
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 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.
Follow all instructions provided in the SF424 (R&R) Application,? with the following modification:
Include the applicant institution and all of the collaborating institutions, both U.S. and foreign, as performance sites.
Follow all instructions provided in the SF424 (R&R) Application, with the following modifications:
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 entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of training, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and expected increase in research capacity in the selected scientific areas at the end of the five-year award period. Include the name of the partner LMIC institution submitting the linked U01 application and any other collaborating institutions and include the environmental and occupational health focus of the proposed research training.
Project Narrative. Describe the public health relevance of the proposed environmental and occupational health research training to the LMIC.
Facilities and Other Resources. Include descriptions of facilities and other resources to be used for research training at all U.S. and foreign performance sites.
Other Attachments. A plan must be provided for an External Advisory Committee to advise the PDs/PIs. 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. 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 relevant research expertise to provide input into the proposed research training; 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 1) the development, implementation and evaluation of the overall effectiveness of the linked research and research training programs; 2) ensuring that the research and research training activities are relevant to policy and practice; and 3) the 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).
The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.
Follow all instructions provided in the SF424 (R&R) Application,with the following modifications:
Include all PD(s)/PI(s) on the linked U01 research application (RFA-TW-21-001) as PDs/PIs. Include at least one person at all the other U.S. and foreign participating institutions and identify their role. List all invited members (and, for renewal applications, all previously serving members) of the External Advisory Committee as Senior/Key Personnel, select "Other" and list their role as "EAC member". Include biosketches for all Senior/Key Personnel.
Follow all instructions provided in the SF424 (R&R) Application.
Follow all instructions provided in the SF424 (R&R) Application Guide
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
The PHS 398 Research Training Program Plan Form is comprised of the following sections:
Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:
The Background section for the research training application should address the following points:
Scientific topic and rationale
Other training activities
Other research activities
o Training in specific research skills or methods directly applicable to trainee research projects
o Research leadership, management or career development skills such as expertise in research ethics and compliance issues, grant management and administration, grant and scientific manuscripts writing, information technology and data management, technology transfer and intellectual property, and science policy and decision-making support.
o Provide a detailed description of the progress made in the previous funding period to achieve proposed environmental and occupational health research training and sustainable capacity building objectives (e.g., documenting that former trainees have obtained their own grants or have progressed in their careers, including assuming research leadership positions).
o Describe any plans to expand or network with additional departments of the partner LMIC institution (linked U01 applicant institution), with other country institutions and/or with institutions within the region, using the partner LMIC institution as a hub and/or node for expanded and networked environmental and occupational health research training, research opportunities for trainees and research training information.
Training Program Evaluation
Institutional Environment and Commitment to Training
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 signed letters, 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.
In the same letters include descriptions of the U.S. and LMIC institutional commitment to harassment and discrimination protections that:
1) Ensure proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.
2) Respond appropriately to allegations of discriminatory practices.
3) Adopt and follow 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.
Plan for Instruction in the Responsible Conduct of Research
Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.
Applicants are strongly encouraged to develop courses in the responsible conduct of research that are adapted to the locally-relevant scientific context at the LMIC institution and that include LMIC faculty.
Multiple PD/PI Leadership Plan
A Multiple PD/PI Leadership Plan is required. In addition to the instructions in the SF424 (R&R) Application Guide, the plan should address the Multiple PD/PI governance and roles of the U.S. and LMIC PDs/PIs on the linked U01 and U2R applications.
In addition to the instructions in the SF424 (R&R) Application Guide, the report should
Letters of Support
The application should include letters of institutional commitment from all partners. Applicants are encouraged to include letters of support from officials at appropriate LMIC government entities, non-governmental organizations (NGOs), and academic institutions that describe how they will support and collaborate with the proposed research and research training.
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:
Study Record: PHS Human Subjects and Clinical Trials Information
DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.
If you check the “Anticipated Clinical Trial” box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any trainee begins independent clinical trial research.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information
contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission. When a
submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next business
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. Each application of a collaborative set must be on-time. Considerations for late applications that are based on the institution or PD/PI apply only to his/her individual application.
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
Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.
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.
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the SF424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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.
In addition, for applications involving clinical trials:
Reviewers will consider the nature of the research experience proposed by the trainee(s) and the scope of proposal relative to the available resources, including the mentor's and/or co-mentor's research support.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Training Program and Environment
Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
In addition, for applications involving clinical trials training
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
Protections for Human Subjects
Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
For Renewals, the committee will consider the progress made in the last funding period, including on the Training in the Responsible Conduct of Research.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Recruitment Plan to Enhance Diversity
Training in the Responsible Conduct of Research
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?
For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
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).
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:
Appeals of initial peer review will not be accepted for applications submitted response to this FOA.
Applications will be assigned to the Fogarty International Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI
will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Refer to Part 1 for dates for peer review, advisory council review, and earliest
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as described
in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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: Grantee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights 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.
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.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
A final RPPR, the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final RPPR.
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.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding ASSIST, eRA
Commons, application errors and warnings, documenting system problems that
threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application
instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration
Contact Center Telephone: 800-518-4726
Christine Jessup, Ph.D.
Fogarty International Center (FIC)
Curt DellaValle, Ph.D., M.P.H.
National Cancer Institute (NCI)
Damali Martin, Ph.D., M.P.H.
Division of Neuroscience, National Institute on Aging (NIA)
John Phillips, Ph.D.
Division of Behavioral and Social Research, National Institute on Aging (NIA)
Michael C. Humble, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Regine A. Douthard, MD, MPH
Office of Research on Women's Health (ORWH)
Seetha Bhagavan, Ph.D.
Center for Scientific Review (CSR)
Fogarty International Center (FIC)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.
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