Mechanism for Time-Sensitive Drug Abuse Research (R21 Clinical Trial Optional) | PAR 18 064

FAQs: Mechanism for Time-Sensitive Drug Abuse Research (R21 Clinical Trial Optional) - PAR-18-064

What is this funding opportunity?

This is an NIH discretionary grant opportunity called the Mechanism for Time-Sensitive Drug Abuse Research (R21 Clinical Trial Optional), FOA PAR-18-064. It is designed to support rapid research when new, urgent substance use problems emerge and data must be captured before the opportunity passes.

What is the main purpose of this FOA?

The main purpose is to enable quick research responses to fast-changing substance use issues, policy shifts, system changes, or outbreaks of harm where waiting for a standard research cycle would mean missing a critical window to learn from the event.

What makes a research question "time-sensitive" under this program?

A research question is considered time-sensitive when the relevant conditions are changing quickly or the event is short-lived, and the data needed to answer the question could be lost or become less meaningful if the study starts later. The FOA expects applicants to clearly justify why rapid review and an expedited funding decision are necessary.

What grant mechanism does this opportunity use?

It uses the NIH R21 mechanism, which is typically intended for early-stage, pilot, feasibility, or exploratory studies rather than large, long-term projects.

Is this opportunity meant for large, long-term research projects?

No. As an R21, it is oriented toward smaller, exploratory projects that generate actionable evidence quickly, often to inform follow-on studies or near-term decision-making.

What does "Clinical Trial Optional" mean?

"Clinical trial optional" means you may propose a study that includes a clinical trial if it is appropriate for the question being asked, but a clinical trial is not required for this FOA.

What kinds of research does this FOA emphasize?

The FOA emphasizes responsiveness and quick evidence generation in substance use epidemiology and health services research, especially in situations where the chance to measure impacts or collect data is temporary.

What types of projects are a good fit for an R21 under this FOA?

Examples described include pilot testing of measures, rapid analyses of emerging datasets, feasibility studies of interventions or service models, and natural experiment designs created by sudden policy or system shifts.

What are the priority research areas supported by this FOA?

The FOA targets five priority areas within substance use epidemiology and health services research: (1) rapid responses to sudden and severe emerging drug issues, (2) studies responding to emerging marijuana trends as laws and policies evolve, (3) time-sensitive opportunities in prescription drug abuse research tied to new initiatives or regulations, (4) unexpected and time-sensitive developments within medical and health care systems, and (5) criminal or juvenile justice system changes affecting drug use patterns or access to prevention and treatment.

Does the FOA support research on sudden overdose spikes or poisonings?

Yes. One of the priority areas is rapid research responses to sudden and severe emerging drug issues, such as abrupt spikes in overdoses or poisonings linked to a specific substance in a particular community (an example provided is synthetic cannabinoids).

Does the FOA support marijuana-related research?

Yes. It supports studies that respond to emerging marijuana trends, particularly as laws and policies evolve and create new patterns of use, risk, availability, and health outcomes.

Does the FOA support research on prescription drug abuse and policy changes?

Yes. It supports time-sensitive prescription drug abuse research opportunities, including those created by new state or local initiatives, regulations, or program rollouts that can best be evaluated during implementation or soon after.

Does the FOA support studies related to changes in health care systems?

Yes. It encourages research that takes advantage of unexpected and time-sensitive developments in medical and health care systems, such as changes in coverage, delivery models, or integration of addiction services, where understanding real-time effects can inform future practice and policy.

Does the FOA support research tied to justice system changes?

Yes. It supports research tied to criminal or juvenile justice system changes that affect drug use patterns or access to prevention and treatment, including structural reforms or new programs where impacts are best measured during early implementation.

What is the award ceiling for this opportunity?

The award ceiling listed is $200,000, consistent with the smaller, exploratory nature of R21 projects.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

What is the CFDA number associated with this opportunity?

The CFDA number provided is 93.279.

What activity category is associated with this opportunity?

The activity category is listed under education and health.

When was this FOA created and what was the original closing date?

The FOA creation date shown is 2017-11-08, and the original closing date shown is 2018-11-08. These dates indicate the opportunity was framed to address urgent developments during that period.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city or township 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; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses; and additional categories listed as "others."

Are community-connected and mission-driven institutions explicitly included?

Yes. The FOA explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Are foreign organizations eligible to apply?

No. The FOA restricts foreign participation: non-U.S. entities cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed.

What is the overall theme or expectation for applications?

The central theme is rapid responsiveness. Applicants are expected to show that the project can answer a pressing question that cannot wait and that the information to be collected is perishable if the study is delayed.

How might NIH expect the results to be used?

Based on the FOA description, the intent is to generate actionable evidence quickly to inform immediate decision-making and/or support the design of follow-on studies.