Opportunity Information: Apply for PAR 18 039

The National Institutes of Health (NIH) grant opportunity titled "Outcome Measures for Use in Treatment Trials of Individuals with Intellectual and Developmental Disabilities (R01 - Clinical Trial Optional)" (Funding Opportunity Number: PAR-18-039) supports research projects aimed at creating and improving outcome measures that can be used in clinical trials involving people with intellectual and developmental disabilities (IDD). The central idea is to strengthen how researchers measure whether a treatment is working in IDD populations, since weak, inappropriate, or insensitive outcome measures can slow down progress in both behavioral and especially pharmacological treatment development. In practical terms, the FOA is trying to fill a long-standing gap: even when promising therapies exist, trials can fail or produce unclear results if the endpoints do not capture meaningful change for individuals with IDD.

This FOA emphasizes the development of "informative outcome measures," meaning tools or metrics that are reliable, valid, and sensitive enough to detect clinically meaningful changes in this diverse group of conditions and functional profiles. The announcement frames this as a neglected but essential area within clinical and translational research. It also highlights that the need becomes especially obvious in medication development, where drug trials often require precise, standardized endpoints to demonstrate efficacy and safety across study sites and participants. While the funding mechanism is an R01 research project grant, clinical trials are optional under this announcement, so applicants may propose measure development and validation work that does not necessarily involve running a full clinical trial, as long as the work is clearly geared toward eventual use in treatment trials.

The opportunity sits within NIH's broader health and human services research portfolio (Funding Activity Category: Health, Income Security and Social Services; CFDA Number: 93.865). It is positioned as complementary to related efforts such as the NIH FOA "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)," which signals an interest in aligning preclinical and clinical approaches to treatment development. In other words, NIH is encouraging the field not only to test interventions but to build the measurement foundation needed to evaluate them well, bridging the gap between mechanistic discoveries and real-world clinical endpoints.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled and 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 (excluding institutions of higher education when relevant); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The FOA also explicitly names additional eligible groups 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); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; Indian/Native American tribal governments that are not federally recognized; and non-domestic (non-U.S.) entities/foreign organizations. This broad eligibility suggests NIH wants participation from a wide range of research, clinical, and community-connected organizations that can contribute to building measures that are both scientifically strong and practical for use in diverse settings.

From an administrative standpoint, the opportunity is categorized as a discretionary grant with an award ceiling of $499,999. The source data lists an original closing date of 2019-05-07 and a creation date of 2017-11-01. The expected number of awards is not specified in the provided details. Overall, the grant is designed to push the field toward better-defined, better-tested endpoints for IDD treatment trials, improving the quality of evidence that comes out of future intervention studies and ultimately supporting more effective therapies and medications for individuals with intellectual and developmental disabilities.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Outcome Measures for Use in Treatment Trials of Individuals with Intellectual and Developmental 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 2017-11-01.
  • Applicants must submit their applications by 2019-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $499,999.00 in funding.
  • 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 18 039

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Agency: National Institutes of Health
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Funding Number: PA 18 046
Agency: National Institutes of Health
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Funding Number: PA 18 343
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Research to Advance the Understanding and Management of the Multiple Organ Dysfunction Syndrome in Children (R01 Clinical Trial Optional) Apply for PAR 18 091

Funding Number: PAR 18 091
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Research to Advance the Understanding and Management of the Multiple Organ Dysfunction Syndrome in Children (R21 Clinical Trial Optional) Apply for PAR 18 094

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Funding Number: PA 18 089
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Funding Number: PA 18 096
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Funding Number: RFA HD 18 034
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Research to Advance the Understanding and Management of the Multiple Organ Dysfunction Syndrome in Children (R03 Clinical Trial Optional) Apply for PAR 18 095

Funding Number: PAR 18 095
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Advancing the Science of Multipurpose Technology for the Prevention of HIV and Unintended Pregnancy (R43/R44) Apply for RFA HD 18 033

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