Opportunity Information: Apply for PAR 21 316

The grant opportunity titled "Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)" (Funding Opportunity Number PAR-21-316) is a discretionary NIH grant led by the National Institutes of Health, aligned with NIMH priorities in mental health services research. It is a reissue of PAR-17-264 and is designed to fund R01-level research projects that do not include clinical trials. The central goal is to support innovative studies that generate practical knowledge about how to deliver high-quality mental health services in real-world settings, with an emphasis on approaches that can help the largest number of people, including individuals who currently have a mental illness and those at risk of developing one. The overall focus is on improving the delivery, quality, reach, and ongoing improvement of mental health services rather than testing clinical interventions in a trial format.

This announcement specifically targets mental health services research that can inform how systems, organizations, providers, and communities can improve the way care is delivered. In practice, that means projects are expected to connect to NIMH strategic priorities for services research and to emphasize service delivery questions such as access to care, quality improvement, implementation and sustainment of evidence-based practices in routine settings, service system organization and financing, workforce and service capacity, equity in service delivery, and strategies that improve outcomes at scale. Because the opportunity explicitly disallows clinical trials, applicants need to propose research designs that answer services-focused questions without assigning participants to intervention conditions in a way that meets the NIH definition of a clinical trial. Suitable projects may include observational studies, secondary data analyses, systems and policy evaluations, implementation research that does not involve a clinical trial design, methodological advances for services research, and other rigorous non-trial approaches aimed at improving mental health service delivery and continuous learning within service systems.

The funding mechanism is an R01 research project grant under the health activity category (CFDA 93.242). The opportunity is broadly open to a wide range of applicant organizations, reflecting the services research emphasis and the need to study care in diverse settings. Eligible applicants include state, county, city or 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types that are often central to community-based service delivery, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility is meant to encourage research that is embedded in the real service environments where people seek and receive mental health support.

Key administrative details included in the source information are that the opportunity was created on 2021-08-17, with an original closing date listed as 2023-01-06. The award ceiling and expected number of awards are not specified in the provided text, which typically means applicants would need to consult the full funding announcement and NIH policy guidance for budget expectations, project period norms, and any institute-specific constraints. Overall, the opportunity is best understood as an invitation to conduct rigorous, policy- and practice-relevant mental health services research at the R01 scale, focused on improving how mental health care is delivered and continuously improved in the settings where it actually happens, while staying clearly outside of clinical trial territory.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
  • This funding opportunity was created on 2021-08-17.
  • Applicants must submit their applications by 2023-01-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for PAR 21 316

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Frequently Asked Questions (FAQs)

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

The opportunity is titled "Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)" and the Funding Opportunity Number (FON) is PAR-21-316.

Which federal agency is offering this opportunity?

This is a discretionary National Institutes of Health (NIH) funding opportunity, aligned with National Institute of Mental Health (NIMH) priorities in mental health services research.

What type of grant mechanism does this opportunity use?

The funding mechanism is an R01 research project grant.

What is the main purpose of this funding opportunity?

The central goal is to support innovative mental health services research that generates practical knowledge about how to deliver high-quality mental health services in real-world settings, with an emphasis on approaches that can help the largest number of people.

Who is the research intended to benefit?

The opportunity emphasizes work that can help large populations, including individuals who currently have a mental illness and people who are at risk of developing one.

What is meant by "mental health services research" in this announcement?

In this context, mental health services research focuses on how systems, organizations, providers, and communities can improve the way mental health care is delivered. The emphasis is on service delivery and service systems rather than testing clinical interventions in a trial format.

What kinds of research questions are a good fit for this opportunity?

Projects are expected to address service delivery questions such as access to care, quality improvement, implementation and sustainment of evidence-based practices in routine settings, service system organization and financing, workforce and service capacity, equity in service delivery, and strategies that improve outcomes at scale.

Does this opportunity allow clinical trials?

No. This opportunity explicitly disallows clinical trials. Applicants must propose study designs that answer services-focused questions without assigning participants to intervention conditions in a way that meets the NIH definition of a clinical trial.

If clinical trials are not allowed, what types of study designs are appropriate?

Examples of suitable approaches mentioned include observational studies, secondary data analyses, systems and policy evaluations, implementation research that does not involve a clinical trial design, methodological advances for services research, and other rigorous non-trial approaches aimed at improving service delivery and continuous learning within service systems.

What is the main focus: testing treatments or improving service delivery?

The overall focus is on improving the delivery, quality, reach, and ongoing improvement of mental health services, rather than testing clinical interventions using a trial format.

Is this a new announcement or an update to a previous one?

This announcement is a reissue of PAR-17-264.

What is the CFDA number or health activity category listed for this opportunity?

The opportunity is listed under the health activity category with CFDA 93.242.

Which organizations are eligible to apply?

Eligible applicants include a wide range of organizations: state, county, city or 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.

Are community-based or faith-based organizations eligible?

Yes. The announcement highlights faith-based or community-based organizations as additional eligible applicant types.

Are minority-serving institutions specifically included as eligible applicants?

Yes. The announcement highlights Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs).

Can U.S. territories or possessions apply?

Yes. U.S. territories or possessions are listed among the additional eligible applicant types highlighted in the opportunity description.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are included among the additional eligible applicant types highlighted.

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

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

Why does this opportunity have such broad eligibility?

The wide eligibility is intended to encourage research that is embedded in real service environments, including diverse settings where people seek and receive mental health support.

What kinds of settings does this opportunity emphasize?

It emphasizes real-world settings where mental health services are delivered, and encourages research embedded in service systems, organizations, provider networks, and community contexts.

Is the award ceiling listed in the provided information?

No. The award ceiling is not specified in the provided text.

Is the expected number of awards listed in the provided information?

No. The expected number of awards is not specified in the provided text.

Where should applicants look for budget expectations or limits?

Based on the provided information, applicants would typically need to consult the full funding announcement and NIH policy guidance for budget expectations, typical project periods, and any institute-specific constraints.

When was this opportunity created?

The opportunity was created on 2021-08-17.

What closing date is listed in the provided information?

An original closing date of 2023-01-06 is listed in the provided information.

What is the big-picture outcome this opportunity is aiming for?

It aims to generate rigorous, policy- and practice-relevant knowledge that improves how mental health care is delivered, expands reach, strengthens quality, advances equity, and supports ongoing improvement at scale in routine service settings.

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