Required Application Instructions

It is critical that applicants follow the 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

Purpose and Objectives of this FOA

This Funding Opportunity Announcement invites applications from Low- and Middle-Income Countries (LMIC) institutions for support of an innovative multidisciplinary public health-relevant research project that focuses on an environmental or public health topic.

The purpose of this FOA, as one of two linked FOAs comprising the GEOHealth Hub program, is to support research that addresses priority LMIC environmental and occupational health issues that are integrated with associated LMIC research training activities. Therefore, applications in response to this FOA must be developed in close coordination with linked applications under RFA-TW-14-002 Cooperative Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research Training .

Diseases related to environmental and occupational exposures are a growing public health concern. These exposures to human-caused and naturally occurring chemical and biological contaminants in air, water, soil and food cause hundreds of thousands of illnesses each year. The World Health Organization (WHO) estimates that environmental risk factors contribute to 24% of the global burden of disease from all causes, and to 23% of deaths, emphasizing that this is likely a conservative estimate because for many diseases, the associations are poorly understood (Pr ss- st n and Corval n, 2006). More recent WHO-led analyses indicate that air pollution alone (including ambient and household exposures) was responsible for approximately 7 million early deaths in 2012, primarily due to acute lower respiratory infections, chronic obstructive pulmonary disease (COPD), stroke, heart disease and lung cancer. The greatest burden is in Low- and Middle-Income Countries (LMICs), particularly in Africa, Southeast Asia and the Western Pacific.

While the occupational risks are not yet calculated and summarized separately by the WHO, the occupational contribution to death and disability associated with cancers, asthma, and injuries is significant. The International Labor Organization (ILO) reports that over 2 million workers around the world die every year due to occupational injury or illness at a global economic cost in the billions of dollars (ILO, 2002). In LMICs, workers often face unregulated and unprotected exposures and hazards, both known and unknown, and there is generally poor understanding of these exposures and their specific effects. In spite of advances in occupational health and safety, significant disparities persist and result in unsafe and unhealthy working conditions for many workers. Eighty percent of the world’s workers are in LMICs and they carry a disproportionate burden of occupational injury and illness worldwide.

The rapidly growing burden of chronic non-communicable diseases (NCDs) in LMICs is, in part, associated with these environmental and occupational exposures, but the causes and pathways are poorly understood for both chronic and disaster related vulnerabilities. There is increasing recognition that adverse environmental exposures play a substantial role in the initiation and/or progression of many NCDs including respiratory disease, heart disease, cancers, neurological disorders, mental disorders, obesity and Type 2 diabetes, among others. The problem is particularly acute in LMICs where pesticide exposure, radiation, water pollution, indoor air pollution from cooking and heating fuels, mining-related injuries and exposures, and climate change are associated with significant disease burdens.

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. Currently, few institutions outside of the United States and other High-Income Countries have sufficient research capacity to study toxic, carcinogenic, or occupational exposures or interactions with genetic, immune systems or population-based factors (Rosenthal et al. 2012). Addressing these challenges requires a critical mass of scientific experts 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.

For the purpose of this FOA, research capacity does not refer to building, enhancing, or maintaining infrastructure.

Based on this model, FIC, in partnership with National Institute of Environmental Health Sciences (NIEHS) and CDC’s National Institute for Occupational Safety and Health (NIOSH) launched a new program in 2012 to support the development of LMIC institutions to serve as regional hubs for environmental and occupational health (RFA-TW-12-001). Sixteen linked GEOHealth planning grants were awarded. Information on current GEOHealth activities, including the full list of planning awards, can be found on the GEOHealth website at: http://www.fic.nih.gov/programs/Pages/environmental-occupational.aspx. (Receipt of a planning grant is not required to be eligible for this FOA.)

Goals of the GEOHealth Program

The goals of the GEOHealth program are to strengthen environmental and occupational health-related research collaborations, accelerate scientific infrastructure development, enhance research training, create relevant advanced educational curricula and outreach material, and support research needed to identify and design mitigation strategies for the adverse consequences of environmental and occupational exposures and to inform nationally-relevant policy development in LMICs. FIC envisions that GEOHealth Hubs will become internationally recognized centers for the collection, management, synthesis and interpretation of data on environmental and occupational health, ideally serving the multi-national regions in which they reside. Each Hub will provide training and curricular resources to academic institutions in the region. Hubs will also be 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 these regional hubs will 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-14-001 and RFA-TW-14-002), 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-14-002 should propose research training activities 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.

Scientific Area

GEOHealth Hubs are expected to bring together multiple disciplines to advance the pace of scientific discovery initially in one focal environmental or occupational health area. The focal environmental or occupational health-related area 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. 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.

The scientific area of proposed research may include, but is not limited to: agricultural health, workplace safety, occupational health, informal work, outdoor and indoor air quality, electronic waste, extractive industries, food safety, water quality, toxic waste, and climate change health science, including disaster response, among others. Projects that focus on tobacco use and cessation and projects that address occupational exposure to HIV are beyond the scope of this program; projects that address secondhand smoke exposure will be considered. The scientific approach of the proposed research may include the following relevant disciplines and methodologies: epidemiology, surveillance, biostatistics, genetics, clinical research, environmental science, industrial hygiene, workplace risk assessment, systems science, toxicology, behavioral science, social science, environmental exposure assessment, biomarkers, hazardous waste assessment, implementation science, and other research areas that will inform environmental and occupational health disease prevention and control programs, including cost-benefit analyses. Health problems that may be addressed by the proposed research include cancers, developmental disorders, neurological disorders, mental disorders, heart disease, respiratory disease, trauma and injury, obesity, Type 2 diabetes, and infectious diseases (excluding HIV/AIDS), among others. Studies addressing the interactions between exposure factors are strongly encouraged. Applicants interested in HIV research training should apply to the Fogarty HIV Research Training Program funding opportunities see: PAR-13-126; PAR-13-214; and PAR-13-215.

Partnerships

Applicants are encouraged to involve multiple U.S. and LMIC partner institutions in the proposed research project, as scientifically appropriate and justified. 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 is likely to be very challenging and must be fully justified, including how the partnership will be managed and how the support and responsibilities will be distributed. Applicants are strongly encouraged to use secondary data, tools and resources available through other sources. LMIC 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, to leverage local institutional capacities and to increase prospects for sustainability of the Hub.

GEOHealth Research Project Activities

Research.

Applicants should propose an innovative multidisciplinary public health-relevant research project that focuses on an environmental or occupational health topic. The selected research project should be based on a documented needs and opportunities assessment that addressed the policy environment in the LMIC, and the public health and science needed to support relevant policy development. The research should inform and be supported by the research training activities under the linked research training application RFA-TW-14-002.

Dissemination.

Research results generated by GEOHealth Hubs are intended to serve scientific and policy communities beyond the participating investigators and institutions, including end users of the research evidence and tools generated.

Regions

Research must be conducted in World Bank-designated LMICs in one of the following geographic regions:

• East Asia and the Pacific (including Southeast Asia)
• Europe and Central Asia
• Latin America and the Caribbean
• Middle East and North Africa
• South Asia
• Sub-Saharan Africa

To develop a global network of GEOHealth Hubs, the NIH aims to fund one grant 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 NIH Institutes and Centers, and Centers for Disease Control and Prevention

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 may support activities in any therapeutic or scientific area related to those goals. To this end, FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular focus on Low- and Middle-Income Countries. The GEOHealth program reflects the Center's core principles: pioneering discovery and filling gaps, promoting international training and collaboration, generating data and concepts to guide national and international global health policy, and advancing global health research at the NIH and around the world.

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 is in this FOA is in research and research training directed toward understanding the carcinogenic consequences of environmental exposures of regional importance in LMICs. Of primary importance are population-based research and research training in cancer prevention and control, and molecular epidemiologic methods that elucidate the sequence of events that ultimately lead to cancer resulting from exposure to environmental contaminants. Also important are research and research training in: environmental exposure assessment; the application of technologies to investigate biological changes resulting from exposure to environmental contaminants; the integration of environmental and occupational components in existing local and regional cancer registries or other surveillance efforts that are established or in development in high exposure areas in LMICs; well-designed epidemiologic studies to assess short- and long-term health effects of environmental or occupational exposures (including environmental and occupational components of cohort studies); and the translation of environmental 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.

The National Institute for Occupational Safety and Health (NIOSH) has been a co-sponsor of the Fogarty International Center’s global work in occupational and environmental health since the 1990 s. NIOSH is the U.S. federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. The agency’s mission is to provide national and world leadership to prevent work-related illness, injury, disability and death. Our broad interests in this FOA align with NIOSH’s strategic goals (2010 - 2015): 1. Conduct research to reduce work-related illnesses and injuries; 2. Promote safe and healthy workplaces through interventions, recommendations and capacity building; and 3. Enhance international workplace safety and health through global collaborations. NIOSH's specific interests in this FOA are in the characterization or workplace risks for injury and illness, particularly in the informal sectors of national economies, and the development and testing of innovative and practical interventions that reduce occupational exposures, injury, illness and fatality. NIOSH is also interested in programs that incorporate Total Worker HealthTM strategies that integrate occupational safety and health protection with health promotion to prevent worker injury and illness and to advance health and well-being.

Citations

International Labor Organization. 2002. Work-related fatalities reach 2 million annually. Two million workers die each year through work-related accidents and diseases and that is just the tip of the iceberg, the International Labor Organization (ILO) reported today. GENEVA (ILO News). Press release. 24 May 2002. Available at: http://www.ilo.org/global/about-the-ilo/media-centre/press-releases/WCMS_007789/lang--en/index.htm. Accessed 25 May 2014.

Pr ss- st n, A. and C. Corval n. 2006. Preventing disease through healthy environments: Towards an estimate of the environmental burden of disease. World Health Organization. ISBN 92 4 159382 2. http://www.who.int/entity/quantifying_ehimpacts/publications/preventingdisease.pdf.

Rosenthal, J., C. Jessup, S. Felknor, M. Humble, F. Bader and K. Bridbord. 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

See Frequently Asked Questions for the GEOHealth Hubs for more information.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Applications may be submitted by eligible non-domestic (non-U.S.) foreign institutions in World Bank defined Low- and Middle-Income Countries (LMICs) (http://data.worldbank.org/about/country-classifications/country-and-lending-groups), including low-income, lower-middle-income, and upper-middle-income countries. Applications must be submitted with an eligible linked research training (U2R) application in response to RFA-TW-14-002. Applications received without an eligible linked application in response to RFA-TW-14-002 will be considered incomplete. FIC's Country Eligibility Notice (NOT-TW-12-011) states that for competing and re-competing research training grant applications (including the U2R mechanism), with the exception of Sub-Saharan African countries, FIC will no longer accept applications from, or applications that involve training of scientists from upper-middle-income countries that are also members of the G20 major economies (https://www.g20.org/en/members). This policy does not apply to an application submitted in follow up to a successful planning grant application that had been received prior to January 1, 2013.

The following LMIC organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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 and facilities on site and through proposed partnerships to conduct the proposed research.

A GEOHealth Planning Grant (RFA-TW-12-001) is not required to be eligible for this FOA.

Only non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

International PDs/PIs may obtain more information on the registrations required for grants.gov and eRA Commons at:

http://grants.nih.gov/grants/ElectronicReceipt/files/Tips_for_International_Applicants.pdf.

http://grants.nih.gov/grants/ElectronicReceipt/files/international_support.pdf

http://grants.nih.gov/grants/ElectronicReceipt/files/international_qa.pdf

http://grants.nih.gov/grants/ElectronicReceipt/preparing_grantsgov_reg.htm

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.

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 PDs/PIs in response to this FOA. Each PD/PI on the linked U2R research training application (RFA-TW-14-002) 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 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 or NIH IPF number) can only submit one application in response to this FOA. That institution may also receive a sub-award through the linked research training application. That institution may also participate as 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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit via email a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PDs/PIs on linked application
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Christine Jessup, Ph.D.
Telephone: 301-496-1653
Fax: 301-402-0779
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 modifications:

Descriptive title of applicant's project: To allow NIH to identify linked applications as a related pair of collaborative U01s and U2Rs, the titles for each application must have the following format: a N/2 indicator + Identical title + Country of Applicant Institution (e.g., 1/2-GEOHealth Hub Descriptive title-Zambia and 2/2-GEOHealth HUB Descriptive title-U.S. ). Titles may not exceed 80 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-14-001 and RFA-TW-14-002, 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), 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 modification:

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 title of the linked research training application; the institution name for the linked U.S. institution; 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, including the relevance of increased research capacity. Include the name of the U.S. institution submitting the linked application, the title of the linked research training application, and environmental and occupational health focus of the proposed research in the Project Narrative.

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.

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-14-002) as PD(s)/PI(s). Include at least ONE person at all of the other U.S. and foreign participating institutions as Senior/Key Personnel and identify their role. Attach biographical sketches for the Key Personnel, including Key Collaborators. Current and pending support documentation should be included for all Key Personnel.

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. The detailed budget for the linked U2R application should not be provided in the U01 budget.

The budget should include costs for PDs/PIs and key personnel travel to attend meetings of their GEOHealth Hub at least annually.

The budget should also include costs for the PDs/PIs and key personnel travel to attend the annual network meeting of all funded GEOHealth Hubs. The venue for this meeting will alternate between U.S. and LMIC locations.

Costs associated with attending multiple Steering Committee meetings per year are allowed (travel, telephone and internet costs). It is anticipated that most GEOHealth Network Steering Committee meetings will be virtual meetings.

The budget may include costs for program administration, including costs for LMIC PDs/PIs to participate in the administration of their GEOHealth Hub the 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:

Specific Aims: The Specific Aims must include a section titled "Overview" that should be identical for both linked applications in the collaborative GEOHealth Hub. The Overview should provide an overall rationale for the collaborative hub, the role of each site, and the approach to project management.

Research Strategy:

Background

Scientific topic and rationale. Applications must identify an environmental and occupational health scientific focus directly coordinated with the research training activities in the linked research training application (RFA-TW-14-002) and directly relevant to the LMIC environmental and occupational health priorities. 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. Applications should document the existing research capacity in the chosen scientific focus and define measurable increased research capacity parameters expected as a result of the proposed research activities at the end of the grant period. Applicants should explain in detail how the linked U2R research training application (RFA-TW-14-002) and other relevant research grant support and activities are related to the proposed research strategy. For scope of scientific area, methodologies and health problems, see Part 2. Section I. Funding Opportunity Description above.

Prior planning grant. For applicant institutions who received support through a planning grant funded through the GEOHealth program, describe how the planning activities supported the development of the present application.

Partnerships. 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. Initial inclusion of more than four LMIC or four non-LMIC partner institutions is likely to be very challenging and must be fully justified, including how the partnership will be managed and how the support and responsibilities will be distributed.

Other research activities. Include short descriptions of all relevant on-going environmental and occupational health research at the LMIC institution, regardless of funding source, and describe how the proposed research will complement these 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, and 4) planning for new activities building on the Hub's strengths.

The Coordination section should describe a feasible mechanism for integration of managerial and administrative responsibilities, integration of research and research training activities in the linked applications. 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.

The coordination section should demonstrate a willingness to engage in research and capacity building activities across the network of funded GEOHealth Hubs.

Proposed Research

In addition to describing the research around the one scientific area following guidance in the SF424 (R&R) Application Guide, applicants should briefly describe a strategic plan for building upon the proposed research to develop a Hub that becomes the most credible source for state-of-the-art knowledge on environmental and occupationla health in the region. Applicants may propose pilot research in up to two additional areas that are alligned with the proposed research project.

If the proposed project leverages existing data, tools and resources available through other sources, these should be clearly described.

Letters of Support: Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions should be documented through letters of support.

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.

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. 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Consistent with achieving the goals of this program, applications are expected to include a statement that data will be shared across the network of funded GEOHealth Hubs in a timely manner and according to any terms developed by the GEOHealth Network Steering Committee.

Applicants should include plans for dissemination of research data, software, and other resources of the project, such as practical tools and materials. Applicants should also have a plan for contributing to public databases and/or developing their own (local) databases to meet their needs. Such databases should have the capability for collecting and rapidly disseminating the data that would be collected through the GEOHealth Hub.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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.

Part I. Overview Information contains information about Key Dates. 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 electronic submission.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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 Applying Electronically.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Scientific Review Branch by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the proposed research informed by an assessment of needs and opportunities that identifies health burdens and priority needs, addresses the policy environment in the LMIC, and the public health and science needed to support relevant policy development? Does the proposed research focus on one clearly-justified scientific area? Is the proposed research well-integrated with, informed by, and in support of the linked research training program (RFA-TW-14-002)? Does the proposed research take advantage of the LMIC institution’s research infrastructure and of previous and current research and research training support from FIC, NIH, and other organizations? Does the application demonstrate a willingness to engage in research and capacity building activities across the network of funded GEOHealth Hubs?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the research bring together the appropriate multidisciplinary team of investigators to match the topic addressed? Have the investigators sought to include appropriate partners to address the problem identified? Do the PDs/PIs have the scientific background, expertise, and LMIC experience to provide strong leadership, direction, management, and administration of the proposed research? Is a strong justification provided that the multiple PD/PI leadership approach will benefit the research and the linked research training program? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and integrated with the aims of the training program and with the complementary expertise of each of the PDs/PIs? Do the PDs/PIs have the experience to develop, direct and administer the proposed research?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Do the proposed linked awards provide an innovative and integrated model for addressing environmental and occupational health needs in the host country?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? If pilot research activities are proposed, are they clearly justified and aligned with the goals of the GEOHealth Hub and do they build upon the proposed research project? If the proposed program involves collaboration with more than four LMIC or more than four non-LMIC institutions, is the collaboration appropriate and is the rationale for the inclusion of additional institutions scientifically justified? 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? Does the project leverage existing secondary data, tools and resources available through other sources?

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? 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 research facilities and research environment in the U.S. and LMIC institutions conducive to the proposed research? Are the resources necessary to perform the research available or obtainable at the LMIC site? Has the LMIC institution made a convincing commitment (e.g., provided research/academic appointment and salary support)? Does the program include the appropriate network of partners to address the public health and science needs identified in an assessment of needs and opportunities? 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? Are the expected contributions of the proposed research likely to strengthen the ability of the LMIC institution to conduct research and research training of importance to that country? Do letters of support from officials in LMIC government show evidence for collaborative relationships that will enable research findings to inform environmental and occupational health policy formulation and public health practices?

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 research training both in support of and informed by the research activities? 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 work with other members of the GEOHealth Network to enhance the GEOHealth program's productivity?

Research Capacity Building

Does the proposed program contain explicit strategies to strengthen capacity through the linked U2R Research Training application? Will the proposed research and collaboration lead to enhancement of the LMIC institution(s) and contribute to overall institutional excellence? Are U.S. and LMIC PDs/PIs and collaborators actively involved in all aspects of the 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?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

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 National Institute of Environmental Health Sciences (NIEHS), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to the GEOHealth FOA, FIC priorities (FIC strategic plan http://www.fic.nih.gov/about/pages/strategic-plan.aspx) and the missions of other participating NIH and CDC components.
• Scientific content for program balance.
• Geographic balance.
• Extent of coordination and integration between linked applications and potential impact of the proposed research project on the linked proposed research training program.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

NIH support should be acknowledged in language similar to the following: This investigation was supported by the Fogarty International Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of the National Institutes of Health under the Global Environmental and Occupational Health (GEOHealth) program (grant number). Investigators must submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central immediately upon acceptance for publication. Guidance is provided in http://publicaccess.nih.gov/.

In addition, news releases and other documents about the project must acknowledge federal funding.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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:

The PDs/PIs of the GEOHealth Hubs will have primary responsibility for defining the research objectives, approaches and details of the research and research training projects within the guidelines of the FOA and retain primary responsibility for the performance of all U01/U2R-supported research and research training activities. The PDs/PIs will be responsible for:

• Planning, directing, and executing the proposed research and research training activities;
• Assuring compliance with applicable host country regulations;
• Assuring compliance with all applicable DHHS/NIH/FIC policies for conduct of research and research training.

All awardees are required to perform the duties of organizer for meetings of their GEOHealth Hub to be attended by all affiliated Hub award PDs/PIs, key personnel, program partners, at least once per year to review progress, plan and design activities, and establish priorities. The FIC Program Official, U.S. Government Project Collaborators, and members of the Steering Committee will attend these meetings, when possible. PDs/PIs should attempt to coordinate the timing of these meetings with the Governments representatives.

Awardees also are required to organize one GEOHealth Network Meeting to be attended by all GEOHealth PDs/PIs, key personnel, and NIH and CDC staff over the award project period. GEOHealth PDs/PIs are required to attend their annual GEOHealth Hub meetings and the annual GEOHealth Network meetings. The venue for the annual GEOHealth network meeting will alternate between U.S. and LMIC sites.

PDs/PIs agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIH and CDC staff in accordance with the guidelines described in Section VI.2.3 Cooperative Agreement Terms and Conditions of Award: NIH and CDC Staff Responsibilities.

All clinical research performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research. All awardees must oversee that all training requirements for the protection of human subjects are in compliance.

The PDs/PIs will ensure that on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant.

The PDs/PIs will ensure 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 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. PDs/PIs will ensure the development of research-based strategies for use by government agencies, non-governmental organizations, and health care institutions to reduce the burden of disease attributable to environmental and occupational factors.

The PDs/PIs will be responsible for coordination between the research training (U2R) and research (U01) awards that comprise a GEOHealth Hub. An Administrative Oversight Committee (AOC) (detailed in RFA-TW-14-002) is responsible for the overall management, communication, coordination, oversight, evaluation and supervision of the awards. PDs/PIs on both linked awards will serve on the AOC. The AOC will 1) ensure that research training activities are supporting the research activities, 2) ensure that the research activities include full collaboration from investigators on the research training grant, 3) coordinate data management through identifying, developing or enhancing tools to facilitate data sharing, integration, management and interpretation within and across the network of GEOHealth Hubs, 4) coordinate communications and outreach with policy and decision makers to ensure more direct and relevant scientific inquiry and to inform policies, incentives and regulations, and 5) identify and develop additional partnerships relevant to the core areas of the GEOHealth Hub. The PDs/PIs agree to work closely with and brief the U.S. Government Project Collaborator(s) on activities of the AOC. The U.S. Government Project Collaborator(s) will work closely with linked award PDs/PIs and members of the AOC to encourage close coordination of activities under the research and research training awards and across the GEOHealth Network.

The PD/PI will be responsible for the timely submission of 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 oral 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 for the grant as specified in the Notice of Grant Award] under the Global Environmental and Occupational Health program award [grant number]. Timely publication of major findings is encouraged.

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

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 primary Government contact with the PDs/PIs for scientific and technical issues. The Project Collaborator(s) will be appointed by the U.S. Government. During performance of the award, the 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 NIH and CDC staff assistance will be coordinated by the Project Collaborator(s), which may include Medical Officer(s), clinical operations, and other expertise as required. The U.S. Government Project Collaborator with substantial programmatic involvement may:

• Provide input and support in the design of research activities as agreed to by the PDs/PIs
• Serve as a resource for protocol design and development
• Provide programmatic support during the accomplishment of research and research training
• Advise in the selection of sources or resources
• Advise in management and technical performance
• Participate in scheduled meetings and teleconferences to discuss program coordination and/or progress
• Participate as a voting member in Steering Committee meetings
• Facilitate collaboration with other NIH- and CDC-supported research resources
• 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
• Assist in avoiding unwarranted duplication of effort with other NIH efforts
• Participate in the analysis of results
• Suggest studies and research training activities within the scope of the funded research and research training activities
• Work closely with linked award PDs/PIs and members of the AOC to encourage close coordination of activities under the research and research training awards.
• 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/or (c) maintenance of high quality research and research training.
• A Network Scientific Advisory Group (NSAG) will be appointed by the NIH 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 program and intramural staff from NIH and CDC, as well as other Federal and non-Federal experts selected by NIH and CDC to participate in NSAG activities in an advisory capacity when appropriate. The NSAG will meet annually at the annual meeting of the Network of awardee 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.2.4 Cooperative Agreement Terms and Conditions of Award: Collaborative Responsibilities".

Additionally, an FIC Program Official will be responsible for the normal scientific and programmatic stewardship of the award. The FIC Program Official will be named in the award notice. The FIC Program Official will interact with the PDs/PIs on a regular basis to monitor progress. Monitoring may include: regular communications with the PDs/PIs and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee and NSAG meetings. The FIC Program Official will be the primary Government contact with the PDs/PIs for issues relating to program administration, funding, and policy.

The U.S. Government will have access to all data generated under this Cooperative Agreement and will periodically review the data for program and management purposes. The U.S. Government 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 the study (or an individual award) in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol.

Areas of Joint Responsibility include:

A Steering Committee, composed of the PDs/PIs of each GEOHealth award and the U.S. Government Project Collaborators, will be the main governing board of the GEOHealth Hub network. The PDs/PIs from each GEOHealth award and the U.S. Government Project Collaborator will have one vote on the Steering Committee. 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 is expected to 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-programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A dispute resolution panel will be composed of three members -- one selected by the Steering Committee (with the U.S. Government member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIH, and the third member selected by the two prior selected members. 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 HHS regulation at 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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Christine M. Jessup, Ph.D.
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Gary Ellison, Ph.D., M.P.H.
National Cancer Institute (NCI)
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Michael C. Humble, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
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Sarah Felknor, DrP.H.
National Institute for Occupational Safety and Health (NIOSH), CDC
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Sally E. Tilotta, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: [email protected]

Elizabeth C. Whittington
Fogarty International Center (FIC)
Telephone: 301-451-6830
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-287-4324
Email: [email protected]

Angie B. Tuttle
Centers for Disease Control and Prevention
Telephone: 770-488-2863
Blackberry: 770-568-8762
Email: [email protected]

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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 Parts 74 and 92.

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