HEAL Initiative: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional) | RFA NS 22 016

FAQs: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional) (RFA-NS-22-016)

What is this funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity under the HEAL (Helping to End Addiction Long-term) Initiative titled "Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional)" (RFA-NS-22-016). It supports research intended to improve chronic pain treatment in the United States by advancing safer, non-addictive, device-based pain relief approaches.

What problem is the program trying to address?

The program is grounded in the public health reality that more than 25 million Americans experience daily chronic pain. It also responds to how pain care has been shaped by widespread opioid prescribing, despite opioids often failing to restore function and carrying significant risks such as dependence, addiction, and overdose. The HEAL Initiative aims to accelerate solutions that reduce reliance on opioids.

What is the main purpose of this grant?

The main purpose is to support interdisciplinary, highly collaborative research teams focused on explaining how device-based pain relief technologies work, with an emphasis on mechanisms of action. The intent is not only to observe whether a device reduces pain, but to understand the biological, neural, physiological, and potentially behavioral processes that drive therapeutic effects.

What does "mechanisms of action" mean in the context of this FOA?

In this context, mechanisms of action refers to the underlying processes that produce pain relief, such as neural circuitry changes, physiological responses, biological pathways, and other measurable signals and effects that explain why and how a device produces therapeutic benefit.

Is the FOA focused on proving that devices work, or on understanding how they work?

The FOA is oriented toward understanding how device-based pain relief works. It prioritizes mechanistic understanding over simple outcome testing and aims to move device use beyond trial-and-error toward evidence-driven optimization.

What kinds of devices are in scope?

The FOA targets pain-relief devices that are already FDA approved or FDA cleared, with the goal of using mechanistic knowledge to optimize therapeutic outcomes for these existing technologies.

How might mechanistic knowledge be used to improve device-based pain relief?

The FOA describes practical ways mechanistic knowledge could improve outcomes, including refining stimulation targets, dosing parameters, biomarker development, patient selection strategies, and other factors that can make device-based therapies more reliable and effective.

What research approach does NIH expect from applicants?

NIH expects true "team science" with interdisciplinary, highly collaborative research teams. Projects should rely on synergy, frequent collaborative interactions, and shared experimental and analytical frameworks rather than loosely connected subprojects.

Does the funding opportunity require multiple Program Directors/Principal Investigators (PDs/PIs)?

Applications are intended to be led by multiple PDs/PIs, reflecting the multidisciplinary nature of device-based pain relief research and the FOA's emphasis on integrated team science.

What disciplines are relevant for these interdisciplinary teams?

The FOA notes that device-based pain relief spans multiple domains, including neuroscience, biomedical engineering, clinical pain medicine, rehabilitation, computational modeling, signal processing, physiology, and data science.

Are clinical trials allowed under this grant mechanism?

Yes. Clinical trials are optional under this RM1 mechanism. Teams may propose mechanistic clinical studies when appropriate, but the core emphasis remains on explaining and optimizing how device-based interventions produce pain relief.

What does "Clinical Trial Optional" mean here?

It means applicants can include clinical trials if they are appropriate for answering mechanistic questions, but a clinical trial is not required. The central focus remains mechanistic understanding and optimization of device-based pain relief.

What types of advances is NIH looking for (incremental or field-shaping)?

NIH is looking for advances that are intended to be field-shaping rather than incremental. Teams are expected to develop or integrate new principles, tools, and methods for experimentation, analysis, and interpretation.

Who is eligible to apply?

Eligibility is broad and includes state, county, city/township, and special district governments; public and private institutions of higher education; independent school districts; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in that category); for-profit organizations other than small businesses; and small businesses.

Are organizations serving specific communities specifically included?

Yes. The FOA highlights inclusion of organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, tribal governments that are not federally recognized, and U.S. territories or possessions.

Can non-U.S. entities apply?

No. The announcement states that non-U.S. entities are not eligible to apply.

Can non-U.S. components of U.S. organizations apply as the applicant?

No. Non-U.S. institutional components of U.S. organizations are not eligible to apply.

Are foreign components allowed at all?

Yes. Foreign components (as defined by NIH policy) are allowed. This typically means a U.S.-based applicant can include certain well-justified international elements within the overall project structure under NIH rules.

What is the funding instrument and activity area?

The opportunity is listed as a grant funding instrument within the health activity category.

Are there CFDA numbers associated with this opportunity?

Yes. The opportunity is associated with multiple CFDA numbers: 93.121, 93.213, 93.350, and 93.853, reflecting cross-institute collaboration at NIH.

When was the FOA created and when did it close?

The FOA was created on August 31, 2021. The original closing date was November 3, 2021.

How does this FOA connect to the broader HEAL Initiative?

This FOA supports HEAL's mission by accelerating scientific knowledge and medical solutions that can reduce reliance on opioids, specifically by strengthening mechanistic evidence for device-based therapies and translating that understanding into better, more consistent pain-relief outcomes with minimal addiction liability.