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Frequently Asked Questions for GEOHealth Hubs

Find below answers to frequently asked questions for applicants to Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research (Collaborative U01 Clinical Trial Optional) (RFA-TW-21-001) and Research Training (Collaborative U2R Clinical Trial Optional) (RFA-21-002).

Learn more about the Global Environmental and Occupational Health (GEOHealth) program.

Please check this page for updates.

Updated May 5, 2021

General

1. How can I find out more about the GEOHealth Program?

The Fogarty International Center (FIC) maintains a program webpage for the GEOHealth Program. This page includes information about the current Funding Opportunity Announcements, as well as information about past awards and GEOHealth-related news.

2. Where can I find more information on how to apply to NIH?

Potential applicants can find instructions for how to apply in the SF424 Application Guide. Carefully follow the specific guidelines/requirements found in both the SF424 Application Guide and the instructions in the Funding Opportunity Announcement (FOA). Be aware that the instructions in the FOA supersede those found in the SF424 application guide.

Additionally, tips for NIH applicants are provided in a video Grant Writing for Success NIH [Video via CUGH TV/YouTube] in which reviewers and staff at the NIH offer their insights to scientists seeking to improve their chances of getting a grant from the National Institutes of Health.

See the Annotated Forms for tips on how to fill in the SF424 forms.

3. I’m interested in the funding opportunities, but I need to find a new partner to develop a strong application. Where should I start?

You can find information about all funded NIH awards through the public database NIH RePORTER, which may be helpful in locating experts in specific scientific or geographic regions. Additionally, potential applicants may want to use World RePORT as a resource. This is an open-access, interactive mapping database project highlighting biomedical research investments and partnerships across many large funding organizations.

4. What is meant by linked applications/collaborative U01/collaborative U2R?

To be eligible for GEOHealth awards, both U01 and U2R applications in a collaborative set (pair) must be received by the NIH. Both applications in a collaborative set must be complete, compliant, and responsive. Applications received without an eligible linked application will be considered incomplete and will not be reviewed.

The two linked collaborative applications should be developed in close coordination and should cross reference each other carefully. Applicants should devote equal attention to both applications and should follow the application instructions closely.

Only U.S. institutions are eligible for U2R awards under RFA-TW-21-002. Only LMIC institutions are eligible for U01 awards under RFA-TW-21-001. FIC's Country Eligibility for Fogarty International Training Grants applies to this program (NOT-TW-12-011). This 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. For additional information see FIC's Country Eligibility.

5. What is difference between a partner institution and a “spoke” institution?

This terminology is used to provide a visual depiction of the hub model. The hub is based at the LMIC applicant institution and the hub is supported by paired awards to that LMIC institution and to the partner U.S. institution submitting the research training application. In addition, other institutions may participate as partners or spokes.

6. Are Multiple PDs/PIs required?

Yes. Multiple PDs/PIs are required on both linked collaborative (U01 and U2R) applications and a Leadership Plan must be included in the application. Each PD/PI on the U2R research training application (RFA-TW-21-002) must be designated as a multiple PD/PI on the linked U01 research application (RFA-TW-21-001), and each PD/PI on the U01 research application must be designated as multiple PD/PI on the linked U2R research training application. Exceptions require NIH prior approval from Program Officer. 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.

7. The FOAs state that applicants must have and maintain a System for Award Management (SAM) registration. Is this required for applications in response to both RFAs?

Yes, the submitting institution and all PDs/PIs are required to register in order to submit an application using the online systems. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations:

  • System for Award Management (SAM) – Applicants must complete and maintain an active entity registration (formerly CCR registration), which requires renewal at least annually. The renewal process may require as much time as the initial registration. Use the Sam.gov "Manage Entity" function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
  • Grants.gov
  • eRA Commons - Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Find detailed instructions about this multiple step process.

Your organization must be registered in SAM and your SAM credentials must be active at time of grant submission and time of grant award. A yearly renewal process is required to keep your credentials active. SAM uses the term "entity" to refer to your organization.

Purpose of SAM

Note that NIH requires electronic applications and it is critical that applicants complete all required registrations well in advance of the application deadline as the registration process can take several weeks or longer. Applications in response to these linked FOAs (RFA-TW-21-001 and RFA-TW-21-002) must BOTH be successfully submitted by the deadline. Applications received without a linked application will be considered incomplete.

8. Do all PDs/PIs need to have an eRA Commons ID?

All PDs/PIs 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. For additional information, see the eRA Commons Registration FAQs.

9. Do applicants have to wait for a response from the NIH to their letter of intent before submitting an application?

No. Letters of intent inform the NIH of who may be planning to submit and what institutions are involved. Although letters of intent are not required nor binding, the NIH often uses the letters to better anticipate the volume of incoming applications and identify any unique expertise that needs to be included on a peer review panel.

The letter of intent has no effect on your score in peer review. Still, if you provide the correct information, program staff can further advise you on how to best direct your effort. Here are some additional details you could include:

  • Concise description of your proposed project/specific aims.
  • Whether your plans touch on special policy areas, such as human subjects, clinical trials, or animal research.

Applicants are strongly encouraged to communicate with NIH program staff prior to submitting an application. Applications will be screened for responsiveness prior to initial peer review, and non-responsive applications will be withdrawn before peer review. NIH staff can provide feedback to potential applicants on responsiveness and scientific content prior to submission.

10. What is the timeframe for submission of applications?

The application can be submitted any time between June 8, 2021 and July 8, 2021. Applicants and their institutions should familiarize themselves with the requirements of electronic submission through grants.gov, including registration of the applicant and the institution through NIH Commons (see above regarding registrations). It is strongly suggested that you submit your application electronically at least a few days BEFORE the actual deadline. Remember, you must check for error messages after submission to Grants.gov AND subsequently when the application is transferred automatically to eRA Commons (check your eRA Commons account).

You must correct any Grants.gov and eRA-identified errors BEFORE the submission deadline or your application will NOT be accepted by NIH. Verify that your application is viewable in your eRA Commons account. If you cannot view the application in eRA Commons, NIH has not yet accepted it! Do not wait until the last day.

Check your application for common errors before you submit, or see "Avoiding Common Errors."

11. How is a hub defined for the purposes of these RFAs?

A GEOHealth Hub is defined as a multidisciplinary group of researchers and their institutions based in a LMIC, who, with their collaborators, focus on a core set of common research and training topics that address environmental and/or occupational health priorities in the LMIC and/or the region. For the purposes of the GEOHealth Program linked FOAs (RFA-TW-21-001 and RFA-TW-21-002), a pair of institutions (one LMIC institution and one U.S. institution) should form a consortium to support the GEOHealth Hub with other collaborating institutions in the U.S. and LMIC linked as “spokes”. The GEOHealth Hub should serve as a focal point for all proposed research, research capacity-building, training, and collaborative activities, in which "spoke" institutions may participate. The U.S. applicant responding to RFA-TW-21-002 should propose research training activities, and the LMIC institution responding to RFA-TW-21-001 should propose research activities based on a set of common environmental or occupational health topics. Both applications must demonstrate a commitment to extensive coordination between these two awards to meet goals of the GEOHealth program.

12. How do I find out more about NIH Cooperative Agreements as related to these linked FOAs?

The Cooperative Agreement (U Series) mechanism is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. The Cooperative Agreement Terms and Conditions of Award in the FOAs describe the respective roles and responsibilities of PDs/PIs and U.S. Government staff, as well as areas of joint responsibility. U.S. Government Project Collaborators will be appointed at the time of award and will have substantial programmatic involvement by providing advisory input as described in the FOAs. The role of the U.S. Government Project Collaborators will be to facilitate and not to direct activities.

13. The instructions for the External Advisory Committee state that members should be named in the application if they have been invited to participate at the time the application is submitted and it also states that potential members should not be named in the application and should not be contacted. How should we handle the composition of the External Advisory Committee in the applications?

If individuals have already been identified to serve on this committee at the time the application is submitted, then they should be named in the application, named as key personnel, and their Biographical Sketches included. This is also true for applicants submitting renewal applications if experts are already serving in this advisory role.

On the other hand, if individuals have not yet been approached to serve on this committee, potential committee members should not be invited to participate in the application and should not be named in the application.

NIH considers confirmed members of an Advisory Committee as having Major Professional Roles on the application. Therefore, per NIH conflict rules, the Scientific Review Officer has to make sure that these individuals do not serve on the review panel.

14. What does Clinical Trial Optional mean?

The FOA accepts applications that either propose or do not propose clinical trial(s). You must determine whether your study meets the NIH definition of a clinical trial and include the appropriate forms within your application. You are strongly encouraged to use the NIH Clinical Trial Decision Tool as well as review NIH policy on clinical trials and case studies for reference.

15. Where can I find instructions for preparing my Biographical Sketch (Biosketch)?

Access Biosketch Format Pages, Instructions and Samples from the NIH Office of Extramural Research (OER).

Please also see the following NIH Guide notice for Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 (NOT-OD-21-073).

16. Where can I find more information about NIH’s guidelines for considering sex as a biological variable?

The following NIH Guide Notice (NOT-OD-15-102) focuses on NIH's expectation that scientists will account for the possible role of sex as a biological variable in vertebrate animal and human studies. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies.

17. Where can I find more information about NIH’s anti-harassment policy?

The following sites contain more information about NIH’s anti-harassment policy:

As stated in the FOAs, Institutional Letters of Support must describe the U.S. and LMIC institutional commitment to harassment and discrimination protections.

Eligibility

1. How do I find out what countries are classified as LMIC?

For a current listing of LMIC countries, please review World Bank Country Classifications information. The LMIC definition used in the GEOHealth RFAs includes "low income economies," "lower-middle income economies," and "upper-middle income economies." Not all LMICs are eligible. Please see Notice of Change in Country Eligibility for Fogarty International Training Grants (NOT-TW-12-011) to determine which LMICs are eligible.

2. Can I include high-income country (HIC) institutions as partners on an application?

Non-U.S. HIC institutions cannot be applicants, but may be partners on an application. The focus of the linked GEOHealth applications must be on research in an LMIC and training of individuals from an LMIC. Any proposed budgets that include institutions or individuals in high-income countries should be minimal and thoroughly justified. Such costs will be closely reviewed and potentially disallowed.

3. Are LMIC institutions eligible to apply to Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health GEOHealth – Research Training U2R?

No. Only U.S. institutions are eligible to apply for the U2R. LMIC institutions may be proposed as sub-awards on a U2R application but may not be the applicant institution.

4. Are U.S. institutions eligible to apply to Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health GEOHealth – Research U01?

No. Only LMIC institutions are eligible to apply to the U01. For further details on LMIC eligibility, see above. U.S. institutions may be proposed as sub-awards on a U01 application but may not be the applicant institution. U01 research funds diverted to a U.S. institution as a subaward need to be well justified.

5. Are non-governmental organizations (NGOs) in LMICs eligible to apply to the U01 FOA?

The GEOHealth program is designed to fund LMIC academic and research institutions. These institutions must have LMIC scientific leadership as well as stable administrative and research infrastructure so that research capacity investments would be sustained for the foreseeable future. An NGO that can demonstrate that it meets these criteria would be eligible to be considered an LMIC institution for these FOAs. U.S.-based NGOs operating in LMICs and most multinational NGOs are not considered LMIC institutions and would not be eligible to apply for the U01. If you have any doubts about your eligibility, contact the program officer.

6. Are LMIC government entities eligible to apply to the U01 FOA?

The GEOHealth program is designed to fund LMIC academic and research institutions. These institutions would be expected to have LMIC scientific leadership as well as research infrastructure so that research capacity investments would be sustained for the foreseeable future. A government entity that can demonstrate that it meets these criteria would be eligible to be considered an LMIC institution for these FOAs. If you have any doubts about your eligibility, contact the FIC Program Officer.

7. Can renewal applications expand their hub network to include more than four LMIC or four non-LMIC institutions?

Yes, renewal applications may expand their partnership network as appropriate and justified.   

A plan to manage the larger collaborative network should be addressed.

8. To what extent should a renewal application build upon or connect with the activities conducted in the previous project period? Can the renewal support using the results from the previous project to inform policy? Or should research aims be extended?

A renewal application is a request for funding to continue to pursue the same long-term goals you have been pursuing but with new Specific Aims. Your peer reviewers take into account what you have accomplished when assessing the merits of your new application. A renewal application that only focuses on using results from the previous application to inform policy is not likely to be reviewed favorably unless there are clear research questions and aims. General guidance related to Renewal Applications can be found at the following NIH/NIAID website: https://www.niaid.nih.gov/grants-contracts/apply-renewal.

9. Can a renewal application extend the scope of the previous project period to address health impacts in other population groups?

A renewal application may address other health impacts and target other populations compared to the previous project period. It may be helpful to remember that a renewal application is usually for pursuing the same long-term goals but with new Specific Aims. General guidance related to Renewal Applications can be found at the following NIH/NIAID website: https://www.niaid.nih.gov/grants-contracts/apply-renewal.

10. For the progress report that renewal applications must have, do we prepare these reports to cover the last year or a summary of all years of the past project period?

Renewal applications should include descriptions of progress during the previous project period. The placement of the progress report is different for the two mechanisms and you should follow the SF424 Application Instructions for the respective mechanisms. U2R applications will include a Progress Report for Renewal Applications attachment. U01 renewal applications must include a description of progress within the Research Plan and include the Progress Report Publication List attachment.

Although your renewal applications describe your progress, you must separately submit progress reports for your existing grants. To determine whether to send an interim- or final-Research Performance Progress Report, see Research Performance Progress Report (RPPR).

Budget

1. How much total support is available to a Hub through the linked grants?

The combined budget for the two linked applications is limited to a maximum of $600,000 per year in total costs. This amount is to be divided between the budgets of the two applicant institutions as determined by the applicants, with at least half going to the LMIC institution.

2. The Budget sections in both FOAs state that the budget justification should summarize the total direct and indirect costs for both linked applications. What does this mean?

Each of the linked applications must have its own unique detailed budget pages and associated budget justification. In addition, the budget justification in each of the linked applications should include a short summary section (identical in both applications) that provides the total direct and indirect costs for both linked applications.

3. Are F&A costs 8% for both LMIC and U.S. applications?

Yes, F&A costs are capped at 8% for foreign institutions (U01) and at 8% for research training awards (U2R).

4. Can key personnel from U.S. participating institutions with effort on the U01 receive salary from the U01?

As stated in the FOAs, U.S. salaries on the U01 grant are expected to be minimal and well-justified. In general, U.S. salaries should be covered on the associated U2R application.

5. Are equipment purchases permitted under either U01 or U2R?

Yes, requests to purchase equipment must be reasonable and applicable to the research aims and will be reviewed accordingly. Authority to purchase equipment, no matter the type and/or cost must be defined and well-documented through established institutional policies.

6. Can the grant support building a lab facility to support laboratory analyses?

FIC grant funding does not have the authority to pay for construction of any permanent facility. If not a permanent facility, alteration and renovation (A&R) activities are considered as modernization activities and are typically supported under research grants where the primary purpose for the grant is other than construction or modernization. The determination of whether proposed A&R is major or minor is made by the NIH Program Official.

7. Are budgets for renewal applications prepared differently from budgets for new applications? Do we request budget for only the first year or should the budget request include subsequent years?

A renewal (Type 2) application is an initial request for additional funding for a period subsequent to that provided by a current award. Renewal applications must be developed fully as though the applicant is applying for the first time. The budget should be structured to reflect the entire project period (3-5 years for GEOHealth RFAs) and must include all annual budget periods.

8. RFA-TW-21-002 suggests that funds for mentored research projects for long-term trainees should not be used to support travel. Does this mean that these funds cannot be used for trainees to travel, even locally or in-country, to collect data or to visit a field site related to the funded research project?

No. GEOHealth research training awards can indeed support trainee travel, but it must be captured in the appropriate section of the Budget R&R form. Trainee travel needs to be budgeted in the Travel line of the Budget R&R form (Line D). The Training Related Expenses line should not include trainee travel budget.

9. Do partners or “spoke” institutions need to have a Dun and Bradstreet Universal Numbering System (DUNS) number and System for Award Management (SAM) registration or only the applicant institutions?

The applicant institutions must have both a DUNS number and SAM registrations. If an award is granted/funded, the recipient organization must notify potential subcontractors that no organization may receive a subaward under the grant unless the organization has provided their DUNS number to the recipient (parent) organization. Recipient Organizations must maintain an active SAM registration while they have an active award. Subcontractors are not required to register in SAM.

10. Can the applicant request assignment to any of the Institutes or Centers listed in the Components of Participating Organizations section of the FOAs?

No. Upon receipt, applications are assigned to the Fogarty International Center. Applicants should not request assignment to any other NIH component.

11. How do you expect to weigh the benefits of renewing a strong existing hub versus diversifying with new topics and partners?

The GEOHealth FOAs invite both new and renewal applications. Section V.2 of the FOAs describes the review and selection process, and also includes a list of considerations in making funding decisions.

Research activities

1. How focused should the research question be? Is it an R01 like proposal focusing on a specific research question? Or can we focus on broader occupational and environmental health issues and multiple target populations?

The U01 is the cooperative agreement equivalent of an R01 research project grant. It should have clearly defined research aims. Multidisciplinary projects are invited, and the research can include multiple populations, but the project should be well-defined and cohesive. In addition to one primary research project, applicants may propose pilot research in up to two additional areas that are aligned with the proposed research projects. If you have concerns about the scope of your project, it is advised that you to read the review criteria carefully, as these capture how your application will be evaluated by reviewers.

2. The RFA refers to research that supports policy development. How do I demonstrate that?

At a minimum, the application should include one or more letters from government and other policy makers in the country that outline the value of the project's activities to government needs for scientific support. The application should also articulate how the research results and their presentation to policy makers will address those needs with sufficient clarity and understanding to create confidence in reviewers that the activities will make a difference in local policies and practices.

3. Once a project receives funding, may a research topic be added mid-project period?

Although the focus of the U01 FOA is on a single research project, it is expected that the funded GEOHealth Hubs will attract funding for additional activities in the future. Applicants may propose up to two additional pilot research projects in their U01 application. These pilot research projects should be clearly related to the main research project through shared methodologies, analytical approaches, etc.

4. The U01 requires a resource sharing section that includes sharing of data and other resources however, the U2R states that the GEOHealth Steering Committee may develop a data sharing policy all awardees must implement. Is it sufficient in the U01 to state that this GEOHealth wide resource sharing plan will be implemented?

A Resource Sharing Plan is required for the U01 application. This plan may include plans to implement any sharing plans developed for the network of awarded GEOHealth hubs, but it must also address other aspects of NIH Resource Sharing requirements that go beyond sharing with other awardees through the program. It would not be sufficient for the Resource Sharing Plan to only state that a GEOHealth resource sharing plan would be implemented. See additional information about Resource Sharing from NIH.

Training program

1. How broad or narrow should the training program's focus be?

The focus should be broad enough to cover multiple trainee research projects and multiple investigators. It should also be narrow enough to be scientifically coherent and compelling, clearly linked to the U01 application, and address a priority environmental and occupational health burden of relevance to the host country.

2. Once a project receives funding, may a research training topic be added mid-project period?

Although the focus of the U2R FOA is on research training associated with the research project proposed in the U01 application, it is expected that the funded GEOHealth Hubs will attract funding for additional activities in the future. Training in topics that support the research project and pilot research projects proposed in the linked U01 application is appropriate.

3. What types of training are allowed?

The types of training to be supported by the GEOHealth program can include short-, medium-, and long-term research training 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. The mode and duration of training(s) should be clearly justified based on the priority research and public health needs of the participating LMIC(s) and the academic goals of the host institution(s). Additional guidance for the training program is provided in the U2R FOA.

4. Who can be trained through the training program?

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, with the exception of individuals from Sub-Saharan Africa). See Notice of Change in Country Eligibility for Fogarty International Training Grants (NOT-TW-12-011). 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.

5. How tightly linked should training and research be? If training is in general scientific area and/or general scientific approaches of the research is that sufficient? Or does training need to be in specific topic of research? Can we propose training activities that are not referenced in the linked U01 application from the LMIC partner?

You do not need to cross reference each specific training activity with the linked U01, but you should make it clear how these support research goals of the U01 and the institutional capacity objectives of the host institution, as well as the long term goals of your program.

6. Can trainees complete training at non-LMIC, non-U.S. institutions as long as funds are disbursed to the trainee and not the institutions?

Trainees can receive training at high-income country institutions but any budgets that include institutions or individuals in high-income countries should be minimal and thoroughly justified. Such costs will be closely reviewed and potentially disallowed. The focus of the research training program should be on building both research capacity and capacity for advanced research training.

7. Do we have to submit all training tables?

Use the International Program Training Data Tables. Renewal applications must also include International Training Data Table 8I “Program Outcomes: International Trainees”.

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