Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01 Clinical Trial Optional) | PAR 18 220

FAQs: NIH PAR 18-220 (U01 Cooperative Agreement) - NIDA Standard Research E-Cigarette (SREC) Clinical Studies

What is PAR 18-220?

PAR 18-220 is a National Institutes of Health (NIH) funding opportunity for a cooperative agreement (U01 mechanism; clinical trial optional) intended to accelerate research on whether electronic cigarettes (also called ENDS) can meaningfully reduce harm for people who currently smoke combustible cigarettes.

What is the main purpose of this funding opportunity?

The main purpose is to produce credible, policy-relevant evidence about the potential benefits and risks of e-cigarette use among current smokers, using a standardized research product to make results easier to compare across studies and to support future research and regulatory discussions.

Why does this FOA require a single standardized e-cigarette product?

The FOA is designed to move beyond studies that use many different commercial vaping products. It requires investigators to use one newly developed research device, the NIDA Standard Research E-Cigarette (SREC), so study findings are easier to interpret across projects and can serve as a benchmark for comparison in future research and regulatory contexts.

What is the NIDA Standard Research E-Cigarette (SREC)?

The NIDA SREC is a newly developed, standardized research e-cigarette device required for use in studies funded under this opportunity. Its purpose is to standardize the product used across studies so findings can be compared more reliably.

Who is the target study population?

The FOA focuses on clinical studies in people who currently smoke combustible cigarettes (current tobacco smokers).

What types of studies are encouraged under this FOA?

The FOA emphasizes clinical studies that evaluate both potential benefits and potential risks of switching to, or using, the NIDA SREC. Studies are expected to assess multiple outcomes rather than relying on a single endpoint.

Are clinical trials allowed or required?

The mechanism is listed as U01 with "clinical trial optional," meaning clinical trials may be included but are not necessarily required based on the text provided.

What outcome domains are projects expected to measure?

Projects are expected to examine multiple outcomes, including behavioral measures, dependence-related outcomes, and health-related biomarkers. The FOA signals a preference for multi-endpoint approaches rather than a single primary endpoint only.

What kinds of behavioral outcomes are mentioned?

Examples listed include patterns of use, product appeal, and compensatory behavior.

What dependence-related outcomes are mentioned?

Examples listed include craving, withdrawal relief, nicotine exposure, and indicators of addiction potential.

What health-related outcomes are mentioned?

The FOA references health-related biomarkers and biologically relevant markers tied to disease risk, with the goal of assessing whether switching from combustible cigarettes to the standardized SREC reduces exposure to harmful constituents and whether those reductions translate into improvements in markers relevant to disease risk.

What does "harm reduction" mean in the context of this FOA?

In this FOA, harm reduction is framed as more than toxicant exposure reduction alone. It includes understanding how the product affects dependence, dual use (using e-cigarettes and combustible cigarettes), and the likelihood of sustained switching away from cigarettes.

How does the FOA connect research to tobacco regulation?

The FOA explicitly positions the work at the intersection of research and tobacco regulation. Funded studies are expected to generate standardized data that can inform tobacco control and e-cigarette policy, including risk communication and regulatory decision-making.

Is FDA review part of the funding process?

Yes. Funding is explicitly contingent on review by the FDA Center for Tobacco Products (CTP). Before an award can proceed, CTP must determine whether the proposed study falls under its regulatory jurisdiction.

What is required from FDA CTP regarding the SREC?

CTP must either accept the NIDA SREC for use as an Investigational Tobacco Product (ITP) in the proposed study or determine that an ITP submission is not required.

What is an Investigational Tobacco Product (ITP) in this context?

Based on the information provided, an ITP is a regulatory status/route through FDA CTP that may be necessary to allow the NIDA SREC to be used in the proposed human study. The FOA states CTP must accept the SREC for ITP use or decide that an ITP submission is not required.

What practical implication does FDA CTP involvement have for applicants?

Applicants need to anticipate regulatory coordination as part of study planning, because the ability to use the SREC in human research under this FOA depends on FDA CTP decisions about jurisdiction and ITP acceptance (or non-requirement).

What grant mechanism is used for this opportunity?

This is a cooperative agreement under the U01 mechanism.

What does it mean that this is a cooperative agreement (U01)?

The FOA is described as a cooperative agreement structure, which typically means there is substantial scientific or programmatic involvement from the funding institute compared to a standard research project grant.

What is the CFDA number and activity area listed for this opportunity?

The activity area is listed under education and health, and the CFDA number is 93.279.

When was this opportunity created and what closing date is shown?

The record indicates the opportunity was created on November 28, 2017, and the original closing date shown was April 24, 2019.

Is the award ceiling or number of expected awards provided?

No. The provided text does not specify an award ceiling or the expected number of awards.

Who is eligible to apply?

Eligibility is broad and includes many organization types and governmental entities, including (as listed): state, county, city or township governments; special district governments; independent school districts; public housing authorities; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses; and other categories.

Does the FOA specifically encourage applications from certain institution types?

Yes. The FOA explicitly highlights additional eligible groups such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, tribally controlled colleges and universities, and faith-based or community-based organizations.

Are federal agencies, U.S. territories, and regional organizations eligible?

Yes. The FOA includes eligible federal agencies, U.S. territories or possessions, and regional organizations among the highlighted eligible groups.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The FOA indicates that non-U.S. entities (foreign organizations) are eligible.

What is the public health rationale behind funding standardized SREC research?

The FOA states a two-part public health purpose: (1) rapidly increase scientifically credible evidence about the harm reduction potential of e-cigarettes for people who already smoke, including whether e-cigarettes may lower negative health impacts associated with continued combustible tobacco use; and (2) generate rigorous, standardized SREC-based data to inform tobacco control and e-cigarette policy, including risk communication and regulatory decision-making.

What does the FOA say about comparing results across studies?

It emphasizes that using one standardized device (the NIDA SREC) is intended to make results easier to interpret across studies and to establish a benchmark that other e-cigarettes can be compared against in future research and regulatory discussions.