Clinical High Risk for Psychosis Research Network (U01 Clinical Trial Not Allowed) | RFA MH 20 340

Frequently Asked Questions (FAQs)

What is the title and FOA number for this grant opportunity?

The opportunity is titled "Clinical High Risk for Psychosis Research Network (U01 Clinical Trial Not Allowed)" and the FOA number is RFA-MH-20-340.

What kind of funding mechanism is being used?

This is an NIH cooperative agreement using the U01 mechanism. A cooperative agreement typically involves substantial scientific or programmatic involvement from NIH staff compared to a standard research project grant.

What is the main purpose of this funding opportunity?

The central goal is to build one or more coordinated research networks focused on people who meet criteria for the clinical high risk for psychosis (CHR) syndrome. The networks are intended to rapidly recruit a large enough sample to analyze the wide variation within CHR and determine whether distinct subgroups follow different outcome paths.

What does "clinical high risk for psychosis (CHR) syndrome" refer to in this FOA?

In this announcement, CHR refers to people who meet criteria for the clinical high risk for psychosis syndrome and are the population that the proposed research network(s) will focus on recruiting, following longitudinally, and analyzing for differing outcomes and predictors.

Why does the FOA emphasize a network approach instead of individual projects?

The FOA emphasizes network-style science to speed enrollment, harmonize methods across sites, and generate datasets that are large enough for rigorous subgroup analyses and predictive modeling, rather than relying on isolated projects that may be underpowered for heterogeneity-focused questions.

What does the FOA mean by "dissecting heterogeneity" in CHR?

The FOA signals that applications are expected to go beyond average effects and instead map and explain variation within CHR by identifying separable profiles or subgroups and testing whether those subgroups have different clinical trajectories and outcomes.

What kinds of outcomes is this network expected to help predict?

The work is intended to improve the field's ability to predict who will develop psychosis, who will have other clinical trajectories, and what factors drive these differences across CHR participants.

What is the practical payoff expected from this research?

The expected payoff is clearer prediction of differential CHR outcomes and findings that can directly inform later intervention research, helping create a stronger evidence base for future treatment development and testing.

Are clinical trials allowed under this funding opportunity?

No. The FOA explicitly indicates "Clinical Trial Not Allowed" for this U01 award.

If clinical trials are not allowed, how is the research expected to support treatment development?

The supported work is framed as building the evidence base needed for later treatment development and testing by clarifying CHR subgroups, trajectories, and predictors. Any subsequent intervention testing would be expected to occur under separate funding mechanisms that allow clinical trials.

What NIH area and CFDA number are associated with this opportunity?

The activity category is Health, and the CFDA number listed is 93.242.

What are the key dates shown in the summary provided?

The FOA record shows a creation date of November 27, 2019, and the original application closing date listed is January 31, 2020.

Does the summary provide an award ceiling?

No. The summary information provided does not include an explicit award ceiling.

Does the summary specify the number of expected awards?

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

Who can apply (in general terms)?

Eligibility is broad and includes many types of U.S. domestic organizations and governments, reflecting the intent to enable large, multi-site recruitment and diverse community reach.

Which U.S. government entities are eligible applicants?

Eligible applicants include state governments, county governments, city or township governments, and special district governments.

Are public and private higher education institutions eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.

Are nonprofit organizations eligible?

Yes. Nonprofit organizations with or without 501(c)(3) status (other than higher education institutions) are listed as eligible.

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.

Are school districts eligible?

Yes. Independent school districts are included among eligible applicants.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations other than federally recognized tribal governments are also listed as eligible.

Are housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are highlighted as additional eligible applicant categories.

Are faith-based or community-based organizations eligible?

Yes. The FOA highlights faith-based or community-based organizations among additional eligible applicant categories.

Are minority-serving institutions specifically called out as eligible?

Yes. The FOA highlights additional eligible applicant categories that include Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs).

Are regional organizations eligible to apply?

Yes. Regional organizations are listed among the additional eligible applicant categories.

Are federal agencies eligible applicants?

Yes. The FOA includes eligible federal agencies among the additional eligible applicant categories.

Can non-U.S. (foreign) organizations apply?

Yes. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are eligible to apply.

Can a non-domestic component of a U.S. organization apply as part of the application?

No. The FOA states that non-domestic components of U.S. organizations are not eligible to apply as components.

Are foreign components allowed at all under this FOA?

Yes. The FOA states that foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means a U.S. awardee can include justified and compliant foreign elements, even though non-domestic components of U.S. organizations are not eligible to apply as components.

What kinds of activities does the FOA suggest the network should be able to do well?

Based on the framing provided, the opportunity is aimed at teams that can collaborate across sites and systems to enroll CHR participants quickly, follow them carefully over time, and analyze outcome differences with enough statistical power to identify meaningful subgroups and predictors.

What methodological priorities are implied by the FOA description?

The description implies priorities such as standardized ascertainment of CHR, consistent follow-up to capture divergent clinical outcomes, harmonized methods across sites, and analytic approaches capable of modeling complex, heterogeneous trajectories and supporting subgroup analyses and predictive modeling.

How does NIH involvement typically differ under a U01 compared to a standard grant?

Because this is a cooperative agreement (U01), NIH staff are generally expected to have substantial scientific or programmatic involvement in the supported work, compared to more investigator-directed mechanisms.