GACD Pre-Application Technical Assistance Webinar

Would Canadian (or other non-LMIC) institutions be eligible to apply?

Canadian institutions, along with other high-income country (HIC) institutions, can be a partner but cannot serve as the administrative lead and the submitting organization. Partnership with researchers in the United States (US) or low- and middle-income countries (LMICs) is encouraged.

What is select pay within the NIH?

Select pay is a mechanism at NIH to selectively fund an application even if it is outside the funding payline, meant to fund work that is strategically aligned with NIH partner Institute, Center, and Office (ICO) scientific priorities.

Could you clarify the minimum eligibility requirements for researchers from India (or other LMICs)?

Minimum eligibility is in the FOA. Be reminded that this is an R01 so preliminary data of intervention effectiveness is required, and you should carefully review NIH partner ICO priorities, along with the NIH Application Guide and SF424 for additional requirements.

Would primary health care delivery models in cities be considered? Or this is only for healthy environments?

health care delivery models in cities would be within scope of this FOA.

Are individuals from LMICs eligible to apply?

Individual applicants from LMICs are eligible to apply, although we do encourage multi-disciplinary teams.

Can we adapt experimental models tried in rural areas for scaling up to urban areas?

Yes, you can propose adaptation of experimental models from one setting to another.

If our charity is based in Europe but has charity registered status and an office in an LMIC, are we able to apply if the primary applicant is in the LMIC?

If your charity has specific registrations in the LMIC, it would be allowable. Please contact NIH program staff to confirm.

If I am an investigator based in the U.S., would we be able to apply as primary applicant along with an institution in LMIC?

A U.S. institution can apply as primary with your LMIC partner. Please contact NIH program staff on additional eligibility requirements.

In the FOA it is described that 'cities' may include urban centers, informal settlements, slums, and periurban areas. Do refugee settlements also fall under these categories?

Refugee settlements would be included if you can adequately explain the connection to the city environment.

Will there be any organized events to network and connect with organizations in LMICs?

We have annual GACD meetings of all the GACD grantees around the world. Please check the GACD website for further meeting information and location.

Can more than one collaborator can apply to this FOA?

More than one collaborator can be involved.

Is there a maximum number of NIH Institutes to apply to for this FOA?

You can apply with one application and list up to three preferences for primary assignment using the PHS Assignment Request Form in the application packet.

Does an application have to propose intervention studies only?

The focus of this FOA is on implementation research, defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

Would implementation of an evidence-based prevention intervention among adolescents qualify for the current R01 mechanism?

You could tailor your research to focus on adolescents as long as the focus is still within city environments.

Who should be the primary applicant if the research is being conducted in an LMIC? The US based institution or the LMIC-based one?

Either the US or LMIC institution can be the primary. US-based institutions have greater familiarity with the NIH grants process, but please reach out to NIH program staff to discuss your specific situation.

How many projects is this opportunity looking to fund?

There is no specific number of projects planned for funding. These are funded based on IC-specific R01 paylines or select pay.

Do LMIC need to submit with HIC partner?

LMIC institutions do not require an HIC partner, although they are certainly allowed.

May institutions apply for this funding multiple times for different LMIC countries?

You can submit multiple applications with different LMICs if they are scientifically distinct.

Does the primary applicant need to be an LMIC institution?

The primary applicant can be the LMIC or US institution.

Can an international organization apply to implement the research in the LMIC, or would local registration be mandatory?

The applicant organization must be registered in the LMIC or in the US. International organizations in HICs outside of the US can serve as a research partner or multiple-PI through a subaward.

What is the definition of direct costs? Are partner and project management costs included?

Further information on direct and indirect costs can be found here.

Is the research limited to implementation in cities in LMICs? What about implementation to the rural areas in the LMIC?

This is focused only on implementation research in city environments.

Can you describe how we should coordinate or verify alignment with one or more of the participating organizations (for example, NIMH, NCI, etc.)? What should that outreach or coordination look like?

Please review the “NIH IC-Specific Priorities” in Section 1: Funding Opportunity Description. You can then reach out to the IC programmatic contact listed under Section VII. Agency Contacts to set up a meeting to discuss your proposed project.

Are there priority LMICs countries?

There are no specific priority LMIC countries. All are allowed (but be mindful of difficult governmental issues that may slow the award of a grant).

Can an institution in an LMIC partner with another LMIC institution?

An HIC partner is not required. You can certainly have an LMIC/LMIC partnership alone. But make sure you are clear on the NIH expectations to increase the likelihood that your application is well received during peer review.

Is South Africa considered LMIC for this application? It is classified by the World Bank “upper middle.”

Yes, South Africa is classified as an upper-middle income country and accordingly does count as an applicable country for this funding opportunity.

Yes, South Africa is classified as an upper-middle income country and accordingly does count as an applicable country for this funding opportunity.

It does not have to be medical research but it must be health-related implementation research. Intervention development research does not meet the criteria of this FOA.

Can we use secondary data on our research?

You can use secondary data in the research if there is still an implementation research project proposed.

Can you please confirm that hybrid effectiveness/implementation designs are responsive to this call?

Hybrid-effectiveness applications are acceptable, but we prefer Hybrid Type II or III, with more focus on implementation.

Is preliminary data required for submission of an application to this FOA?

This is an R01 mechanism which typically needs preliminary data related to the research proposed. For example, this could be preliminary data on the effectiveness of the intervention if you proposed a hybrid effectiveness-implementation study (i.e., one that is focused on implementation research while also collecting additional data on the intervention effectiveness).

Does the grant applicant have to be a registered research institute, or associated researcher, or it can be any registered non-governmental organization?

Your institute does need to be registered with NIH and the US federal government to apply (www.sam.gov). Please ensure sufficient lead time prior to the application deadline as the registration process can be lengthy.

Does the evidence of the intervention's effectiveness need to be in the region of implementation?

You can propose a study where you are implementing an effective intervention developed in one setting (e.g., a HIC) and adapted for use in another setting (e.g., an LMIC). Hybrid effectiveness-implementation designs can be useful to allow you the ability to test both effectiveness of the adapted intervention and implementation strategies.

What is the standard for "evidence-based effectiveness?”

Unfortunately, there is no standard for “evidence-based.” Given the focus of this FOA on implementation research, reviewers will be looking for some effectiveness data (e.g., preliminary effectiveness studies), but what this looks like will vary depending on the intervention you have chosen. Please reach out to NIH program staff to discuss further.

If we are unable to meet with March 9th, 2023 deadline, will there be another cycle for this grant in the future?

The “cities” FOA only has one receipt date. However, the GACD initiative will release a new funding call on implementation research focused on integrating interventions in clinical, community, and public health settings for optimizing management and care for patients coping with multiple conditions. Please check the NIH Guide to Grants and Contracts later this year for more information.

Is there a reason for a trial to choose the R01 "clinical trial optional" mechanism as opposed to the R61/R33 clinical trial required mechanism?

It depends on assignment of your application. If you are proposing a study that meets the NIH definition of a clinical trial and you request assignment to NHLBI or NIMH, then you would choose the R61/R33 clinical trial required mechanism. If you are proposing a clinical trial and request assignment to one of the other NIH institutes (e.g., NIEHS, NIA, NIDA, NINDS, NIMHD, NCI), then you would choose the R01 clinical trial optional FOA and check “yes” to all four questions on the clinical trial questionnaire in the application packet and complete the required forms.

Is it ok to submit a project application with duration less than 5 years?

Yes, the FOA supports projects up to 5 years but you can propose less than 5.

Must the proposed interventions be validated in LMIC settings, or can it be validated and tested during the planning stage?

Please reach out to NIH program staff to discuss the specifics of your application. You could propose a hybrid-effectiveness implementation study where you could do additional effectiveness research to adapt the intervention to the LMIC setting while also testing the implementation strategies to promote adoption and uptake of the intervention.

Is it acceptable to propose a study which includes an aim geared at identifying adaptable interventions (based on contextual appropriateness, feasibility, acceptability, etc.)? Is it required to have one or more interventions fully identified for adaptation to an LMIC city setting?

All proposals must contain a plan to implement and/or scale up an intervention already proven to directly impact human health or address the social determinants of health.

Can the grant support research with refugees and internally displaced populations (who might be migratory)?

Yes, if the connection to city environments is made clear in the application.

Is there any cap or guideline for the amount that can be disbursed through sub-contracts?

The awards are capped at $500,000 direct costs/year disbursed to the submitting institution. If you need to request above the $500,000 cap, please contact NIH program staff to discuss your proposed budget and process for submitting these requests. These requests must be received at least six weeks before the March 9th deadline. There is no cap on the amount that can be disbursed to a sub-award.

Can one PI be involved in two different applications?

Yes, as long as those applications are scientifically distinct.