Opportunity Information: Apply for PAR 16 216
Apply for PAR 16 216
- The HHS-NIH11 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)" 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 Apr 26, 2016 and posted on Apr 26, 2016.
- Applicants must submit their applications by May 07, 2019. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The grant opportunity titled "Outcome Measures for Use in Treatment Trials of Individuals with Intellectual and Developmental Disabilities (R01)" (Funding Opportunity Number PAR 16-216) was issued by the U.S. Department of Health and Human Services through the National Institutes of Health (NIH). It is a discretionary, NIH R01 research project grant aimed at improving how clinical trials measure whether treatments actually help people with intellectual and developmental disabilities (IDD). The core idea is straightforward: progress in therapies, especially medications, is being held back because researchers often lack outcome measures that are sensitive, reliable, and meaningful for IDD populations. This FOA is meant to push the field toward better tools for evaluating treatment benefits in real-world, clinically relevant ways.
The primary purpose of the announcement is to encourage institutions and organizations to develop "informative outcome measures" that can be used in treatment trials involving individuals with IDD. In practice, that means creating or refining endpoints that can detect change over time, distinguish true treatment effects from noise, and reflect outcomes that matter to individuals with IDD and their families. Because many standard clinical trial measures were designed for the general population, they may not translate well to people with developmental differences, communication challenges, varied cognitive profiles, or co-occurring conditions. This funding opportunity is positioned as filling a neglected but essential gap in clinical and translational research: without strong, appropriate measures of change, even promising interventions can fail in trials simply because the study cannot accurately capture improvements.
A major emphasis is on enabling therapy and pharmacological treatment development. The FOA highlights that the need is "especially apparent" for drug development, where regulators, clinicians, and researchers require solid evidence of benefit based on credible endpoints. Better outcome measures can improve trial design, reduce the risk of false negative results, allow smaller or more efficient studies, and make it easier to compare findings across studies. In other words, this opportunity is not just about creating measurement tools as an academic exercise; it is about building the infrastructure that makes treatment development feasible and convincing for IDD populations.
The award mechanism is an R01 grant, which typically supports substantial, hypothesis-driven research projects led by a principal investigator and a research team. The posted award ceiling for this opportunity is $499,999, indicating an upper limit on funding amounts under the terms of the FOA as summarized in the source data. The opportunity was created and posted on April 26, 2016, with an application closing date of May 7, 2019 (both the original and current closing date listed as May 7, 2019). The CFDA program numbers associated with the opportunity are 93.865 (as listed in the source data), which corresponds to an NIH research assistance area.
Eligibility is broad and includes many types of organizations, reflecting NIH's general approach to supporting research across sectors. 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; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The listing also includes an "Others" category with a note to consult additional eligibility information in the full announcement for clarification, which is typical when NIH allows certain additional applicant types or special cases.
Finally, the announcement flags a related research direction that potential applicants might consider: a separate FOA titled "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)." That mention signals a broader, coordinated interest in strengthening the pipeline from basic and preclinical work to clinical trials in IDD, with this particular opportunity focusing specifically on the clinical trial measurement problem.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The grant opportunity is titled "Outcome Measures for Use in Treatment Trials of Individuals with Intellectual and Developmental Disabilities (R01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 16-216.
Which agency issued this funding opportunity?
This opportunity was issued by the U.S. Department of Health and Human Services through the National Institutes of Health (NIH).
What type of grant mechanism is being used?
The award mechanism is an NIH R01 Research Project Grant, which typically supports substantial, investigator-led research projects.
What is the main purpose of this FOA?
The primary purpose is to encourage development or refinement of informative outcome measures for use in treatment trials involving individuals with intellectual and developmental disabilities (IDD).
What problem is this grant trying to solve in IDD clinical research?
The FOA addresses a key barrier in IDD treatment development: many trials struggle to show whether an intervention truly helps because outcome measures are often not sensitive, reliable, or meaningful for IDD populations. Without strong measures of change, even promising therapies can appear ineffective in trials.
What does NIH mean here by "informative outcome measures"?
In this context, "informative outcome measures" are endpoints that can detect change over time, distinguish real treatment effects from measurement noise, and reflect outcomes that matter to individuals with IDD and their families in clinically relevant, real-world terms.
Why might standard clinical trial measures not work well for people with IDD?
Many common measures were designed for the general population and may not translate well to people with developmental differences, communication challenges, varied cognitive profiles, or co-occurring conditions. This can make it harder to capture meaningful improvement or decline accurately.
How does this FOA connect to treatment development (including medications)?
A major emphasis is enabling therapy and pharmacological treatment development. The FOA notes the need is especially apparent for drug development, where credible endpoints are important for demonstrating benefit in a way that regulators, clinicians, and researchers can rely on.
How can better outcome measures improve clinical trials in IDD?
According to the FOA description, better measures can strengthen trial design, reduce the risk of false negative results, support smaller or more efficient studies, and make it easier to compare findings across different studies by improving consistency and interpretability of endpoints.
Is this FOA focused on building measurement tools as an academic exercise, or on clinical impact?
The FOA is positioned as practical infrastructure for treatment development in IDD populations. The intent is not just to create measures in isolation, but to make treatment trials more feasible and convincing by improving how benefits are evaluated.
What is the maximum funding amount listed for this opportunity?
The posted award ceiling for this opportunity is $499,999.
When was this funding opportunity posted?
The opportunity was created and posted on April 26, 2016.
What is the application closing date?
The application closing date listed is May 7, 2019 (both the original and current closing date are shown as May 7, 2019).
What CFDA program number is associated with this opportunity?
The CFDA program number listed is 93.865.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including:
- State governments
- County governments
- City or township governments
- 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
- Nonprofit organizations with 501(c)(3) status (other than institutions of higher education)
- Nonprofit organizations without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
What does the "Others" eligibility category mean?
The listing includes an "Others" category with a note to consult additional eligibility information in the full announcement. This typically indicates NIH may allow additional applicant types or special cases that are clarified in the official FOA text.
Does this FOA mention any related funding opportunities?
Yes. It flags a related research direction via a separate FOA: "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)." This suggests broader interest in strengthening the pipeline from preclinical work to clinical trials, while PAR 16-216 focuses specifically on the clinical trial measurement gap.
Is this opportunity specifically about conducting a treatment trial, or about the measures used in trials?
Based on the description provided, the focus is on developing or refining outcome measures intended for use in treatment trials involving individuals with IDD, rather than being centered on testing a specific treatment itself.
What kinds of outcomes are emphasized as meaningful?
The FOA emphasizes outcomes that are sensitive to change, reliable, clinically relevant, and meaningful to individuals with IDD and their families, reflecting benefits that matter in real-world settings.
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