Pulmonary and Cardiovascular Consequences of Inhaled Nicotine (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the purpose of the Pulmonary and Cardiovascular Consequences of Inhaled Nicotine (R01) funding opportunity?

This NIH funding opportunity (RFA-HL-17-008) supports mechanistic, disease-focused research to explain how inhaled nicotine affects the lungs and the cardiovascular system. The emphasis is on identifying nicotine-responsive molecular and cellular pathways and linking those pathways to clinically meaningful outcomes in non-cancer heart and lung disease.

What makes this FOA different from studies that simply report associations?

The FOA is explicitly aiming for plausibly causal biological chains rather than broad descriptive observations. Projects are expected to move beyond correlation and instead demonstrate how nicotine triggers specific receptors, signaling cascades, inflammatory processes, vascular effects, airway changes, or tissue remodeling that produce measurable cardiopulmonary dysfunction.

What kinds of outcomes or endpoints are considered relevant under this FOA?

Relevant outcomes are non-cancer pulmonary and cardiovascular endpoints that reflect organ or whole-organism dysfunction. Examples mentioned include impaired endothelial-dependent vasodilation, heightened airway hyperreactivity, altered heart rate variability, pulmonary vascular remodeling, or exacerbation of existing cardiopulmonary disease processes.

Does the FOA require a multiscale research design?

Yes. A defining feature is a required multiscale approach. Applicants are expected to include experiments at the molecular or cellular level and also include experiments at the tissue, organ, or whole-animal level. The intent is to support integrated studies where mechanistic findings in isolated systems are validated and extended in more complex biological settings.

What does "multiscale" mean in practical terms for an application?

It means the project should connect what nicotine does in cells (for example, receptor activation, signaling pathways, inflammatory responses) to functional consequences at higher biological levels (for example, vascular bed function, airway physiology, intact organ behavior, animal-level physiology, or human physiologic measures). The expectation is that the mechanistic story holds across levels of biology.

Are in vitro studies alone sufficient to meet the FOA requirements?

Based on the stated requirement to include both molecular/cellular experiments and tissue/organ/whole-animal experiments, a design limited to in vitro work would not satisfy the multiscale expectation described in the opportunity summary.

What experimental platforms does the FOA encourage?

The FOA encourages the use of multiple experimental platforms, including cellular systems, animal models, and human studies. Applicants can tailor the platform mix to their hypothesis as long as the work remains mechanistic, nicotine-inhalation relevant, and tied to non-cancer pulmonary and cardiovascular disease outcomes.

Are human studies allowed or required?

Human studies are encouraged as one of the possible platforms, but the FOA description emphasizes flexibility across cellular systems, animal models, and human studies. The key requirement described is the multiscale approach, not that a specific platform (such as human studies) must be included.

What kinds of cellular systems are examples of interest in this FOA?

Examples mentioned include cultured airway epithelial cells, smooth muscle cells, endothelial cells, immune cells, and cardiomyocytes. These systems can be used to isolate nicotine-specific signaling effects and identify nicotine-responsive molecular or cellular pathways.

What kinds of higher-level (tissue/organ/whole-organism) systems are examples of interest?

Examples mentioned include lung tissue, vascular beds, intact organs, animal models, or human studies. These settings are meant to validate and extend cell-level mechanisms into physiological dysfunction that is clinically meaningful.

What is the required exposure focus of the FOA?

The research must be relevant to inhaled nicotine exposure. The opportunity description highlights nicotine exposure paradigms related to inhalation, rather than other routes, and it prioritizes studies that connect inhaled nicotine to cardiopulmonary harm through mechanistic experiments.

Is cancer research within scope for this FOA?

The scope is centered on non-cancer pulmonary and cardiovascular diseases and endpoints, rather than oncology outcomes. Applications should anchor their hypotheses and endpoints in heart and lung disease processes outside of cancer.

Does the FOA prioritize any particular disease framing?

The description implies strong interest in how inhaled nicotine may worsen existing disease or contribute to pathophysiology in susceptible populations. Regardless of the disease context, the project is expected to use clear mechanistic hypotheses and testable endpoints tied to cardiopulmonary dysfunction.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R01 mechanism, intended for substantial, hypothesis-driven research projects.

What agency is administering this grant competition?

The administering agency is within the U.S. Department of Health and Human Services through the National Institutes of Health (identified as HHS-NIH11 in the source data).

What are the CFDA numbers associated with this opportunity?

The opportunity is listed under CFDA numbers 93.837 and 93.838.

What is the award ceiling for this FOA?

The listed award ceiling is $300,000.

How many awards does NIH expect to make under this FOA?

The expected number of awards is six, indicating a limited number of funded projects.

When was this funding opportunity posted and when did it close?

The opportunity was posted and created on November 17, 2015, and the application closing date was May 7, 2016.

What types of organizations are eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as clarified in the full eligibility text.

Are for-profit organizations eligible?

Yes. The eligibility list includes for-profit organizations other than small businesses, as well as small businesses.

Are academic institutions eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicant types.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments and other tribal organizations are included among eligible applicants.

What does NIH appear to value in a competitive application for this FOA?

The description indicates that competitive applications should present a clear mechanistic hypothesis, use a nicotine-relevant inhalation exposure model, bridge molecular/cellular findings to organ-level or whole-organism outcomes, and include clinically relevant endpoints tied to non-cancer cardiovascular and pulmonary disease.

Is this opportunity categorized in a specific funding area?

It is categorized as a discretionary grant in the health funding area.