National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) – Research Training (U2R)
U2R International Research Training Cooperative Agreements
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
93.989, 93.399, 93.262, 93.113
This Funding Opportunity Announcement (FOA) solicits applications for research training activities in linked Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth). The overall objective of the GEOHealth program is to support the development of institutions in the Low- or Middle-Income Countries (LMICs) that will serve as regional hubs for collaborative research, data management, training, curriculum and outreach material development and policy support around high priority local, national, and regional environmental and occupational health threats. Hubs are supported by two coordinated linked awards to 1) a LMIC institution for research and 2) a U.S. institution to coordinateresearch training. Together all regional hubs supported will form the GEOHealth Network, a platform for coordinated environmental and occupational health research and research training activities. An application submitted in response to this FOA for research training must be harmonized with a linked application for a related research project under RFA-TW-14-001 “Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) – Research”. This FOA is intended to support research and research training that can only be conducted primarily in and/or by scientists at LMIC institutions.
August 7, 2014
September 22, 2014
New Date October 19, 2014 per issuance of NOT-TW-14-011. (Original Date: September 22, 2014)
New Date November 19, 2014 per issuance of NOT-TW-14-011. (Original Date: October 22, 2014), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
New Date November 20, 2014 per issuance of NOT-TW-14-011. (Original Date: October 23, 2014)
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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 U.S. institutions to develop a collaborative research training program that will strengthen the capacity of institutions in Low- and Middle-Income Countries (LMIC) to conduct collaborative research, practical approaches for assessment and control of workplace hazards, data management, training, curriculum and outreach material development, 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-14-001 “Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) – Research”. Training programs may include a mix of short- (three months or less), medium- (over three months and up to six months), and long- (six months and longer, including degree) term training as appropriate to strengthen the capacity of the LMIC institution to conduct environmental and occupational health research.
The objectives of the “Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) – Research Training” are to:
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 (Prüss-Üstün and Corvalán, 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.
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 this FOA should propose research training activities and the LMIC institution responding to RFA-TW-14-001 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.
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 training 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 training 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 training 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.
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..
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 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. 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 Training Program Activities
The GEOHealth Hubs are expected to provide leadership in environmental and occupational health research and in training a new generation of environmental and occupational health experts. Responsive applications will include the following activities:
Research Training Program.
Applicants should propose a research training program that is based on a needs and opportunities assessment. The assessment of needs and opportunities should address the policy environment in the LMIC, and the public health and science needed to support relevant policy development. The research training should support and be informed by the research activities under the linked research application RFA-TW-14-001.
Note that the proposed research training can take place in the U.S. or a foreign country, but research carried out by the trainees should be carried out mainly in the LMIC.
The research training proposed should provide environmental and occupational health scientists from LMICs with the necessary skills for careers in research and public health in their home countries. The program application should incorporate an appropriate mix of short-, medium- and long-term training opportunities to address the environmental and occupational health research training capacity needs identified in the LMIC and clearly linked to the proposed research under the U01 FOA (RFA-TW-14-001).
Short term training should provide selected trainees a thorough exposure to the principles and skills of specific research methods or research related competencies to enable immediate incorporation into current trainee research or career development activities. Mentorship should be provided to ensure short term training meets these goals. Evaluation plans (see section below) should include specific assessments of the effectiveness of the short term training activities proposed. Short term training support is limited to:
Research training may be delivered by interactive distance learning technology, if appropriate and sustainable for the LMIC participants and institutions involved. Applicants are encouraged to maximize training in the use of information technology to facilitate trainee data management, access to online scientific information and collaborative interaction.
Applicants are also encouraged to include plans for strengthening associated skills and knowledge necessary for long-term scientific or public health research career sustainability, such as scientific writing and presentation, grant writing, partnership development, and expertise in bioinformatics, data management, policy support, bioethics, good clinical practice, good laboratory practice, biosafety, research administration and the management of intellectual property.
Applicants should identify and organize the appropriate network of partners to address the public health and science needs identified in an assessment. Trainee projects should be developed collaboratively or in consultation with these stakeholders so that trainees may develop relationships that will impact the implementation of their research throughout their careers.
GEOHealth Hubs should conduct policy-relevant research and research training and should involve appropriate governmental, subnational, private sector, and regulatory decision makers.
GEOHealth Hubs should serve scientific communities beyond the participating investigators and institutions, including end users of the knowledge and tools generated.
Research must be conducted in World Bank designated LMICs in one of the following geographic regions:
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 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.
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.
Prüss-Üstün, A. and C. Corvalán. 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.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Issuing agencies and partner components intend to commit an estimated total of $3 million for FY2015 for the combined linked (U01 and U2R) awards, corresponding to approximately five linked hub awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Anticipated budget total costs may not exceed $300,000 per year. The U2R application budget should be developed in close coordination with the linked U01 research application (RFA-TW-14-001) because the combined budget for both linked U01 and U2R applications cannot exceed $600,000 in total costs per year and at least 50% of the combined budget must be in the LMIC's U01 application.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
Awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience and contribute to the combined cost of tuition and fees at U.S. or foreign institutions. Trainees must be paid a stipend comparable to their professional experience.
Individuals designing, directing, and implementing the program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the U.S. Congressionally mandated cap.
Faculty mentors and other collaborating key personnel may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. The salary and fringe benefits requested for faculty and staff should not exceed 25 percent of total costs. If mentoring interactions and other activities with trainees are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.
Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. For institutions covered by OMB Circular A-21, this type of training program may qualify as a “major project” where administrative salaries are allowable as a direct cost. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.
Trainee travel to attend scientific meetings and workshops that the program determines to be necessary for the individual’s research training experience is an allowable trainee expense.
NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, small equipment, research supplies, and faculty/staff travel directly related to the research training program.
Faculty Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for the PD/PI to attend the annual program network meeting (meeting location may be in the U.S. or at a funded LMIC site). Funds may be requested for faculty to conduct well-justified training activities.
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
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.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.
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.
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 may be submitted by eligible domestic (U.S.) institutions that demonstrate collaborations with 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. 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 (http://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.Applications must be submitted with a linked research (U01) application in response to RFA-TW-14-001. Applications received without a linked application in response to RFA-TW-14-001 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 applicant institution should have a robust and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, students and postdoctorates (as applicable) and facilities on site and through proposed partnerships to conduct the proposed program. It is anticipated that program faculty will have active, funded research projects in which participating trainees gain relevant experiences consistent with their research interests and goals.
A GEOHealth Planning Grant (RFA-TW-12-001) is not required to be eligible for this FOA.
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.
International PDs/PIs may obtain more information on the registrations required for grants.gov and eRA Commons at:
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 https://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 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-14-001) must be designated as a multiple PD/PI on this research training application, and each PD/PI on this U2R 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 an established investigator in the scientific 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 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 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:
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:
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.
U.S. and other non-LMIC faculty mentors should have research and research training experience in the LMIC country that is the focus of the application.
Only individuals from LMICs (defined by the World Bank classification system and excluding individuals from upper-middle-income countries that are also members of the G20 major economies (http://www.g20.org/en/members), with the exception of individuals from Sub-Saharan Africa and individuals involved in applications submitted in follow up to a successful planning grant application that had been received prior to January 1, 2013) are eligible for pre-doctoral or postdoctoral training support.
Research training may be offered to a wide range of scientists, including laboratory scientists, clinicians, social scientists, and other health professionals, as well as technical and administrative staff.
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 NIH staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Christine Jessup, Ph.D.
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 for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) 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-US”). 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 each1) 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.
Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) 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 Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional 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, including the long-term goals and objectives of the program, key elements of the research training plan, coordination with the linked U01 application, and a brief description of the planned research training program. Include the title of the linked research application; the country and name of the LMIC institution submitting the linked application; the environmental and occupational health topic proposed; the rationale and design of the program; the expected increased research capacity; and the measures the applicant will use to demonstrate that increased capacity.
Project Narrative: Describe the public health relevance of the proposed research training to the LMIC, including the relevance of increased research capacity. Include the name of the LMIC institution submitting the linked application, the title of the linked research application, and the environmental and occupational health focus of the proposed research training 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.
Other Attachments: A plan must be provided for an Administrative Oversight Committee (AOC) that is responsible for the overall management, communication, coordination, oversight, monitoring, evaluation and supervision of the awards. 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 linked GEOHealth Hub awards and network of all funded GEOHealth Hubs will rely on collegial and cooperative interactions among its constituent members.
The AOC must include representation from participant U.S. and LMIC institutions. LMIC members should constitute a minimum of 50% of the committee. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the AOC, identifying the role and the desired expertise of members. Do not name potential members of the AOC in the application.
A plan for AOC approval and selection of training program participants should be included. Describe how the AOC will function in providing oversight of the development, implementation, and evaluation of trainee recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Please name the file “AdministrativeOversightCommittee.pdf". This attachement should not exceed 5 pages.
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 Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) with the following modifications:
Include all PD(s)/PI(s) on the linked U01 research application (RFA-TW-14-001 as PD(s)/PI(s). List all U.S. and LMIC faculty mentors as Senior/Key Personnel. In addition, include at least one person at all of the other U.S. and foreign participating institutions as Senior/Key Personnel and identify their role. List all members of the Administrative Oversight Committee (AOC) as Senior/Key Personnel, select "Other" and list their role as "AOC member". Attach biographical sketches for the Key Personnel, including Key Collaborators and AOC members. Current and pending support documentation should be included for all Key Personnel, but not for AOC members.
Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).
Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modifications:
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the following additional instructions:
Particular attention must be given to the required Training Data Tables. The instructions for the Training Data Tables required for this FOA have been adapted for the international focus of this FOA and are included in the sections below. Training Data Tables 1, 3, 4, 7a, 7b, 8a, 8b, 9a, 9b and 10 do not need to be completed. Table 11, 12A and 12B are not relevant for this FOA as only new applications are allowed. Training Data Tables 2, 5 and 6 need to be completed.
Scientific topic and rationale. Applications must identify an environmental and occupational health scientific focus directly supporting the research activities in the linked research application (RFA-TW-14-001) and directly relevant to the LMIC environmental and occupational health priorities. Applicants should explain in detail how the linked U01 research application (RFA-TW-14-001) and other relevant research grant support and activities are related to the proposed research training plan. 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 training activities at the end of the grant period. For scope of scientific area, methodologies and health problems, see Part 2. Section I. Funding Opportunity Description above.
LMIC participation. Applications should describe how the LMIC institutional leadership and relevant professional staff from the LMIC institution were involved in the planning, decision-making and development of the application.
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 LMIC institution, and other partners, including relationships at the appropriate decision making level for the topic addressed and region of focus. Describe how these collaborations will support the proposed training, as well as plans to expand these relationships. Inclusion of more than more than four LMIC or more than four non-LMIC institutions is likely to be very challenging and must be fully justified, including how such a complex partnership could be managed and supported. Applicants are strongly encouraged to use data, tools and resources available through other components of the U.S. government and other organizations
Policy Relevance. The policy relevance of the proposed training and linked research should be clearly described and based on the assessment of needs and opportunities. The depth and nature of collaboration with decision makers (such as government, sub-national, private sector, and regulatory) should be described.
Other training activities. Describe how the proposed program relates to prior and current environmental and occupational health training activities by both the U.S. and LMIC institutions, regardless of funding source, that are relevant to the specified scientific topic. Provide justification for more research training at the LMIC institution and describe how the proposed training will leverage and support, but not duplicate, other environmental and occupational health research training activities.
Other research activities. Include short descriptions of all relevant on-going environmental and occupational health research at the LMIC, regardless of funding source, and describe how the proposed training in the specified scientific topic will support this research.
Sustainability. Discussion of how the proposed GEOHealth Hub research training activities will affect public health and policy should be provided. Because retaining the benefits of the training program in-country is particularly important, career paths, including mentorship, placement and future research support for trainees must be considered. How the proposed program will balance research, training and infrastructure development should be addressed, as well as how the intended outcomes will be evaluated and sustained. Applicants should also outline plans for sustaining the GEOHealth Hub beyond the duration of an award through the GEOHealth program.
Specific Aims. The Specific Aims must include an Overview section that should be identical for both linked applications in the collaborative GEOHealth Hub. The Overview should provide an overall rationale for applying as a collaborative hub, the role of each site, and the approach to project management.
The proposed specific aims for training should define measurable increased research capacity that will result at the end of the proposed funding period. Applicants are encouraged to submit a timeline that includes proposed training activities.
Program Administration. Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Training PDs/PIs, including relevant scientific or professional background and research training experience in the specific LMIC. Relate these strengths to the proposed management of the training program , the development of partnerships, and coordination with the research activities under the linked U01 application.
Describe the planned strategy and administrative structure to be used to oversee and monitor the program. The plan for Program Administration is expected to synergize with the “Multiple PD/PI Leadership Plan” section of the application and the Administrative Oversight Committee attachment.
Indicate the level of effort and activities for which the PDs/PIs will be responsible. Describe the decision-making process.
Include a section in the Program Administration 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.
Program Faculty. The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s), in particular, those from the LMIC that is the focus of the application. For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.
Proposed Training. Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among trainees. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how trainees will be educated in the human health- and disease-related aspects of their research training.
Advanced degree or non-degree research training may be supported at a U.S. or foreign institution. Training may be short-, medium, or long-term. New training projects that are identified during the course of the award should be independently peer-reviewed through scientific review procedures established by the applicant institution. Documentation of education in the protection of human subjects, compliance with the required federal regulations, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted is required. English as a second language training may be supported, if needed.
Describe how the proposed program will provide all trainees with additional professional development skills and career guidance including instruction and training in scientific writing and presentation in order to apply successfully for future fellowships and independent research support and lead to productive research and/or public health careers. All postdoctoral trainees should also be provided with instruction in laboratory and project management.
The proposed training programs may provide administrative staff with training in compliance issues, grant management and administration.
Describe how the proposed training activities directly support the research activities in the linked research application (RFA-TW-14-001) and are directly relevant to the LMIC environmental and occupational health priorities. In addition to describing the research training program around the one scientific area (the same area proposed in the linked U01 application), applicants should briefly describe a strategic plan for building upon the proposed activities to develop a Hub that becomes the most credible source for state-of-the-art knowledge on environmental and occupational health in the region.
Applicants should describe a plan to construct a Hub website for dissemination of research data, software, curricula, and other resources of the project, such as practical tools and materials. Applicants should also describe 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, integrating, and rapidly disseminating the data that would be collected through the GEOHealth Hub. Plans for dissemination should be closely coordinated with associated activities through the linked U01 application. Training associated with data management is appropriate.
For programs that propose short-term training, any didactic training must be well structured and appropriately justified for the duration of the training experience. Short-term mentored research trainees must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a research or public health career.
Program Evaluation. Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program. Applications should include a plan for evaluating the proposed training activities supported by the award as well as the overall success in building research capacity at the LMIC institution. The evaluation should also include evaluation of data management by trainees, policy support of trainee research, and ongoing integration of research training with the research proposed in response to the linked research FOA (RFA-TW-14-001).
Describe the roles of faculty and professional staff at the applicant and LMIC institutions and all other participating institutions and of the Administrative Unit in the evaluation process. Define measures that will be used to demonstrate increased research capacity at the end of the funding period in the specific scientific topic for which the training program is proposed. Describe how the data for those measures will be collected and how they will be monitored over the award period. Describe strategies that will be used to support the LMIC institution to achieve a level of research capacity for which it can serve as a regional hub and a research training center for the specified scientific topic. Include a plan for data entry of long-term trainee information into CareerTrac, the web-based Fogarty Trainee Tracking System (see Section VI.3 Other Reporting Requirements below).
Trainee Candidates. Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe specific plans to recruit candidates Explain how these plans will be implemented. Describe the selection process to be used to select candidates who would be offered admission to the program and criteria for trainees’ inclusion in each proposed training activity under the program.
Institutional Environment and Commitment to the Program.
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. This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful training program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed program from existing ones at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.
Recruitment and Retention Plan to Enhance Diversity
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 Chapter 8 of the SF424 (R&R) Application Guide. Applicants are strongly encouraged to develop courses in the responsible conduct of research adapted to the locally relevant scientific context at the LMIC institution that include LMIC faculty.
Do not complete Tables 1 and 3.
Table 2. Participating Faculty Members - Include information relevant to the proposed training program for faculty and professionals who will be involved as faculty or mentors from all participating performance sites.
Referring to the faculty and professionals listed in Table 2, provide a short description of their research or expertise for each that is relevant to their role in the proposed training plan in the narrative. Include relevant information for each on their past training records and the subsequent success of former trainees, especially those from LMICs, in pursuing further career development and in establishing productive research and public health careers.
Complete tables 5 and 6.
Do not complete Table 4.
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 that describe how they will support and collaborate with the proposed research and research training.
Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions should be documented through letters of support.
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in 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 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.
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.
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 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 Sally.Tilotta@nih.gov 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/priority 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))
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 U01 Research application? Will the proposed research and collaboration lead to enhancement of the LMIC institution(s) and contribute to overall institutional excellence? Are LMIC PDs/PIs and collaborators actively involved in all aspects of the research? Are the expected contributions of the proposed research training likely to strengthen the ability of the LMIC institution to conduct research and research training of importance to that country and serve as a regional hub?
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 Children
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.
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 & Retention 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 LMIC 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 U.S. and LMIC faculty will participate in the instruction? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction every four years? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (predoctoral, post-doctoral, and faculty levels) and at a frequency of no less than once every four years?
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
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).
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:
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:
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.
Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.
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:
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:
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.
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.
The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.
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 Progress Report 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. Evaluation results should be included as part of the final Progress Report.
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.
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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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