Dysregulation and Proximal Risk for Suicide (R21 Clinical Trial Optional) | RFA MH 20 326

FAQs: Dysregulation and Proximal Risk for Suicide (R21 Clinical Trial Optional) - RFA-MH-20-326

What is the main focus of this NIH funding opportunity?

This opportunity supports research aimed at improving near-term, practical understanding of suicide risk by studying how and when people move from suicidal thoughts to suicidal actions. A key point in the announcement is that suicide risk is not static; it can change quickly, often in response to acute stressors. The intent is to support studies that can capture these time-varying, short-window (proximal) risk changes and clarify the best moments to intervene.

What does "proximal risk" mean in the context of this FOA?

In this FOA, proximal risk refers to short time-scale predictors and mechanisms that signal heightened suicide risk in the near term (for example, short windows when risk escalates). The announcement emphasizes that attempts are frequently preceded by acute stressors and that risk can shift rapidly, so projects should be designed to measure and model those short-term fluctuations rather than only long-term or static risk factors.

Why does the FOA emphasize that suicide risk is not static?

The FOA highlights that suicide risk changes over time and can change rapidly. Because of this, the program interest is geared toward research that can detect and explain real-time or near-real-time changes in risk, including the periods right before suicidal behavior, and identify when intervention could be most effective.

What is meant by "dysregulation" in this funding announcement?

Dysregulation is used in a broad sense, not limited to emotion dysregulation. The FOA notes that prior research has often focused on emotion dysregulation, while fewer studies examine arousal and regulation more broadly, such as physiological or behavioral arousal systems and the ability to modulate them. The program interest is in understanding how these regulation problems dynamically influence or interact with emotional and cognitive functions in ways that may signal escalating risk over short periods.

Is this FOA only about emotion dysregulation?

No. The FOA explicitly states that many existing studies emphasize emotion dysregulation, but it encourages more work that also examines arousal and regulation systems (physiological or behavioral) and how the ability to modulate these systems may relate to short-term suicide risk.

What kinds of cognitive, emotional, or motivational functions are highlighted as examples?

The FOA specifically highlights areas such as response to reward, frustrative non-reward (responses when expected rewards do not occur), cognitive flexibility, cognitive control, and decision-making. The overall thrust is to connect dysregulation with measurable changes in cognition and motivational systems, including negative and positive valence processes, that could mark escalating risk in real time.

What research gap is NIMH trying to address with this announcement?

The announcement targets a gap in the NIMH suicide-risk portfolio: relatively little work has focused on proximal predictors and mechanisms. This FOA aims to fund projects that identify mechanisms explaining how dysregulation interacts with cognition and with positive and negative valence systems to produce fluctuating risk over short time scales.

What is NIMH looking for as a key deliverable from funded projects?

A major deliverable sought by NIMH is the identification of modifiable targets: factors that can realistically be changed and could serve as leverage points for timely interventions during high-risk periods. The FOA emphasizes mechanisms that can inform both when to intervene and what to intervene on, rather than only describing correlates of suicide risk.

Does the FOA require a clinical trial?

No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component, but a clinical trial is not required. Non-trial mechanistic studies and observational designs are also consistent with the announcement if they address the scientific goals around proximal risk and dysregulation-related mechanisms.

What kind of funding mechanism is this opportunity using?

This is an R21 funding opportunity, which is typically intended for exploratory, developmental, and potentially high-risk/high-reward projects. The FOA notes that projects without extensive preliminary data, or projects that leverage existing datasets in innovative ways, may be well suited to the R21 mechanism.

What if an applicant already has substantial preliminary data?

The FOA indicates that applicants who already have substantial preliminary data are pointed toward an R01 alternative referenced in the announcement as RFA-MH-19-327.

Can projects that use existing datasets be responsive to this FOA?

Yes. The FOA explicitly notes that projects leveraging existing datasets in innovative ways may be well suited for the R21 mechanism, particularly in the context of exploratory work on proximal risk and underlying mechanisms.

Which NIH organization is associated with this opportunity?

The opportunity is issued by the National Institutes of Health (NIH), and it is described as a targeted NIMH research investment aimed at stimulating new directions in understanding short-term risk processes related to suicide.

What is the CFDA number and activity category listed?

The activity category is listed as Health under CFDA 93.242.

What is the award ceiling listed in the provided information?

The listed award ceiling in the provided information is $200,000.

What are the key dates shown for this FOA?

The FOA creation date shown is 2019-11-08, and the original closing date shown is 2020-02-13.

Is the expected number of awards provided?

No. The provided information states that the expected number of awards is not specified.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. and non-U.S. organizations and government entities. The listed eligible applicants include state, county, city/township, and 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 Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses.

Are specific institution types and community organizations explicitly included as eligible?

Yes. The FOA explicitly calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (foreign) entities.

Does this FOA support non-U.S. (foreign) applicants?

Yes. The eligibility list explicitly includes non-domestic (foreign) entities.

What types of study designs are consistent with the stated goals?

Based on the "Clinical Trial Optional" description and the stated emphasis on mechanisms and proximal risk, designs can include clinical trials (optional), as well as non-trial mechanistic and observational studies, as long as they address the scientific goals of capturing time-varying short-window risk and clarifying mechanisms that relate dysregulation to transitions toward suicidal behavior.

What is the overall purpose of the FOA in plain terms?

The FOA is pushing the field beyond broad, long-term risk factors and toward research that measures and models how dysregulation in arousal and regulation systems interacts with cognition and reward/punishment processing to create short windows of heightened danger. The purpose is to explain near-term transitions to suicidal behavior and to identify actionable, modifiable targets that could guide timely intervention during high-risk periods.