Opportunity Information: Apply for PAR 18 766

The National Institutes of Health (NIH) grant opportunity titled "Identification and Management of Behavioral Symptoms and Mental Health Conditions in Individuals with Intellectual Disabilities (R01 - Clinical Trial Optional)" (Funding Opportunity Number PAR 18 766) supports research aimed at improving how behavioral symptoms and mental health conditions are recognized and treated in people with intellectual disabilities (ID). The FOA sits in the health-related assistance area (CFDA 93.865) and uses the R01 research project grant mechanism, with clinical trials allowed but not required. In practical terms, the program is looking for studies that can strengthen clinical decision-making by improving measurement and diagnosis, and by generating better evidence on medication use in this population.

A central goal of the FOA is to address longstanding gaps in the accurate identification of psychiatric disorders and clinically significant behavioral symptoms among individuals with ID. Because communication differences, atypical symptom presentation, and overlapping medical or developmental factors can complicate evaluation, the announcement highlights the need for assessment tools that are appropriate for this population. One major focus area is the development and validation of instruments that can reliably detect behavioral symptoms or support diagnosis of mental health conditions in individuals with ID. Competitive projects in this category would generally involve rigorous tool development steps such as establishing reliability (for example, inter-rater reliability and test-retest reliability), different forms of validity (content, construct, criterion, and predictive validity), sensitivity to change over time, and feasibility in real-world settings where individuals with ID receive care (clinical programs, community services, schools, residential settings, and similar environments). The underlying emphasis is on producing measures that are not only scientifically sound but also usable, interpretable, and robust across different levels of intellectual disability and communication ability.

The second major research emphasis is on psychotropic medication use for behavioral symptoms or co-occurring mental health conditions in people with ID, with particular interest in pharmacokinetics, safety, and efficacy. This reflects the reality that psychotropic medications are commonly prescribed in this population, sometimes with limited ID-specific evidence to guide dosing, monitoring, or risk-benefit decisions. The FOA encourages studies that clarify how specific medications are absorbed, distributed, metabolized, and excreted in individuals with ID, as well as studies that systematically evaluate therapeutic benefit and adverse effect profiles. Projects may include careful safety monitoring plans, consideration of medication side effects that can be more difficult to detect in individuals with limited communication, and designs that help clinicians understand who benefits, at what dose, and under what conditions. Because the FOA is "clinical trial optional," applicants can propose observational studies, tool validation studies, or clinical trials depending on what best fits the scientific question.

The opportunity is categorized as discretionary funding and uses the grant funding instrument type. Although the source summary does not list an award ceiling or expected number of awards, the R01 mechanism typically supports substantial multi-year research projects with clearly defined aims, strong methodology, and meaningful potential impact. The original closing date provided in the source data is 2021-09-07, and the creation date is 2018-04-27, which matters for applicants because it suggests the specific announcement as written may be historical; in practice, organizations usually confirm whether the FOA is still active, has been reissued, or has been replaced by a newer announcement before preparing an application.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations, reflecting NIH's interest in drawing strong interdisciplinary teams and diverse settings into this area of research. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly notes additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based and community-based organizations; Indian/Native American tribal governments that are not federally recognized; U.S. territories or possessions; regional organizations; and non-domestic (non-U.S.) entities, including foreign organizations. This wide eligibility supports research in varied populations and service systems, which is important given differences in care access, cultural context, and supports available to individuals with ID.

Overall, the grant opportunity is designed to move the field toward more precise, reliable identification of mental health needs in individuals with intellectual disabilities and toward safer, more evidence-based management strategies, especially regarding psychotropic medications. The intended outcome is practical: better tools for clinicians and researchers, clearer medication evidence where prescribing is common but data may be limited, and ultimately improved mental health and behavioral outcomes for individuals with ID across diverse communities and care settings.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Identification and Management of Behavioral Symptoms and Mental Health Conditions in Individuals with Intellectual Disabilities (R01 - Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
  • This funding opportunity was created on 2018-04-27.
  • Applicants must submit their applications by 2021-09-07. (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 18 766

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Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The funding opportunity is titled "Identification and Management of Behavioral Symptoms and Mental Health Conditions in Individuals with Intellectual Disabilities (R01 - Clinical Trial Optional)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is PAR 18 766.

Which agency is offering this grant?

This opportunity is offered by the National Institutes of Health (NIH).

What is the assistance listing (CFDA) number and area?

The opportunity sits in the health-related assistance area under CFDA 93.865.

What type of funding is this?

It is categorized as discretionary funding and uses a grant funding instrument type.

What grant mechanism does this FOA use?

This FOA uses the NIH R01 research project grant mechanism.

Are clinical trials required under this FOA?

No. The FOA is "clinical trial optional," meaning clinical trials are allowed but not required.

What is the overall purpose of this FOA?

The FOA supports research aimed at improving how behavioral symptoms and mental health conditions are recognized and treated in individuals with intellectual disabilities (ID), with an emphasis on strengthening clinical decision-making.

What main problems or gaps is the FOA trying to address?

A central goal is to address longstanding gaps in accurate identification of psychiatric disorders and clinically significant behavioral symptoms among individuals with ID, especially where evaluation is complicated by communication differences, atypical symptom presentation, and overlapping medical or developmental factors.

What are the two major research emphasis areas described in the FOA?

The FOA highlights two major emphases: (1) development and validation of assessment instruments to detect behavioral symptoms and support diagnosis of mental health conditions in individuals with ID, and (2) research on psychotropic medication use in this population, particularly pharmacokinetics, safety, and efficacy.

What kinds of projects are encouraged related to measurement and diagnosis?

The FOA encourages the development and validation of instruments that can reliably detect behavioral symptoms or support diagnosis of mental health conditions in individuals with ID, with attention to scientific rigor and real-world usability.

What measurement properties does the FOA suggest are important for tool development and validation?

The announcement emphasizes rigorous steps such as establishing reliability (including inter-rater reliability and test-retest reliability), multiple forms of validity (content, construct, criterion, and predictive validity), sensitivity to change over time, and feasibility in real-world settings.

In what settings should proposed assessment tools be feasible to use?

The FOA highlights real-world settings where individuals with ID receive care, including clinical programs, community services, schools, residential settings, and similar environments.

Does the FOA emphasize usability across different levels of intellectual disability and communication ability?

Yes. The FOA emphasizes measures that are usable, interpretable, and robust across different levels of intellectual disability and communication ability.

What kinds of medication-focused research does the FOA encourage?

The FOA encourages studies focused on psychotropic medication use for behavioral symptoms or co-occurring mental health conditions in people with ID, with particular interest in pharmacokinetics, safety, and efficacy.

What does the FOA mean by pharmacokinetics in this context?

It refers to clarifying how specific medications are absorbed, distributed, metabolized, and excreted in individuals with intellectual disabilities.

Why is there a focus on psychotropic medications in individuals with ID?

The FOA notes that psychotropic medications are commonly prescribed in this population, sometimes with limited ID-specific evidence to guide dosing, monitoring, and risk-benefit decisions.

What safety considerations are highlighted for medication studies?

The FOA mentions careful safety monitoring plans and consideration of medication side effects that may be more difficult to detect in individuals with limited communication.

What kinds of study designs fit within "clinical trial optional"?

Applicants may propose observational studies, tool validation studies, or clinical trials, depending on what best fits the scientific question.

Is there an award ceiling or expected number of awards listed in the provided information?

No. The source summary described does not list an award ceiling or expected number of awards.

What does the R01 mechanism typically support?

Based on the description provided, the R01 mechanism typically supports substantial multi-year research projects with clearly defined aims, strong methodology, and meaningful potential impact.

What is the creation date of this FOA?

The creation date provided is 2018-04-27.

What is the original closing date listed for this FOA?

The original closing date provided in the source data is 2021-09-07.

Does the provided information suggest the FOA may be historical?

Yes. The dates suggest the specific announcement as written may be historical, and applicants are advised (based on the provided description) to confirm whether it is still active, has been reissued, or has been replaced before preparing an application.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. and non-U.S. organizations, including various government entities, institutions of higher education, nonprofit and for-profit organizations, small businesses, and other entities described in the FOA information provided.

Are U.S. state and local government entities eligible?

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

Are school districts eligible?

Yes. Independent school districts are listed as eligible applicants.

Are colleges and universities eligible?

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

Are nonprofit organizations eligible?

Yes. Nonprofit organizations with or without 501(c)(3) status are listed as eligible (excluding higher education institutions in those categories, as described in the provided eligibility text).

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible.

Are federally recognized tribal governments the only tribal entities mentioned?

No. The FOA information provided explicitly includes Indian/Native American tribal governments that are not federally recognized among eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed as eligible applicants.

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

Yes. The FOA explicitly includes non-domestic (non-U.S.) entities, including foreign organizations.

Are faith-based and community-based organizations eligible?

Yes. Faith-based and community-based organizations are explicitly listed as eligible.

Are eligible federal agencies included in the eligibility list?

Yes. Eligible federal agencies are explicitly listed among eligible applicants.

Which types of minority-serving institutions are explicitly mentioned as eligible?

The FOA information provided explicitly mentions Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs).

What kinds of outcomes is the FOA ultimately aiming for?

The intended outcome described is practical improvement: better tools for clinicians and researchers, clearer evidence to guide psychotropic medication use, and improved mental health and behavioral outcomes for individuals with intellectual disabilities across diverse communities and care settings.

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