Opportunity Information: Apply for RFA MH 15 800
Apply for RFA MH 15 800
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Oct 7, 2014 and posted on Sep 15, 2014.
- Applicants must submit their applications by Dec 10, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,525,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $5,250,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Independent school districts County 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 City or township governments Public and State controlled institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Private institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
This NIH funding opportunity (RFA-MH-15-800) supports the creation of a single, coordinated research Consortium focused on improving how social impairment in autism spectrum disorder (ASD) is measured in clinical trials. The main idea is to move beyond relying only on clinician ratings and caregiver questionnaires by developing and qualifying more objective, standardized tools that can detect meaningful change over the course of treatment studies, whether those treatments are behavioral interventions or medications. The mechanism is a U19 cooperative agreement, meaning NIH staff are expected to play an active partnership role in shaping and overseeing the project rather than acting only as a passive funder.
The funded Consortium is expected to run a multi-site study in school-age participants with ASD, collecting data at three key time points: baseline, 6 weeks, and 24 weeks. Across sites, the study must use a well-justified and standardized battery of lab-based measures that target specific domains of social impairment, alongside biological and behavioral measures that already show promise for ASD research. The FOA specifically emphasizes electrophysiology and attention-based metrics, calling for both resting-state and task-based EEG paradigms and eye-tracking measures. By gathering these measures repeatedly over time and in a consistent way across multiple locations, the project aims to determine which measures are reliable, sensitive to change, and feasible for broad use in clinical trials.
A central goal is to qualify a set of measures that can serve two major purposes in ASD trials. First, the measures may function as stratification biomarkers, meaning they could help identify subgroups of individuals with ASD who share underlying biological or behavioral profiles and who might respond differently to specific interventions. Second, the measures may serve as objective outcome measures, meaning they could be used to track whether a treatment actually improves social functioning in a way that is measurable, repeatable, and less dependent on subjective reporting. In practice, this is meant to strengthen ASD clinical trials by improving signal detection, reducing measurement noise, and making results easier to compare across studies.
The FOA lays out several specific evaluation questions the Consortium must address. One is whether the lab-based measures of distinct social domains are more sensitive indicators of clinical status and change than commonly used clinician- and caregiver-based assessments of social impairment, which are often the default endpoints in trials. Another is whether eye-tracking measures, EEG measures (resting and task-based), or a combined approach can serve as useful stratification biomarkers and/or as sensitive and reliable indicators of change over time. The Consortium must also analyze how these different measure types relate to one another, including correlations between lab-based social measures and the eye-tracking/EEG paradigms, as well as correlations between lab-based measures and traditional clinician/caregiver assessments. This cross-measure mapping matters because it helps clarify whether biological signals and performance-based measures are capturing the same underlying constructs as existing clinical scales, or whether they provide distinct and potentially more informative information.
Beyond the clinical and methodological aims, the FOA strongly emphasizes building a community resource through rapid, broad data sharing. All data generated by the Consortium, including processed and analyzed datasets (not just raw files), are expected to be deposited in the National Database for Autism Research (NDAR) on a timely basis. The expectation is that these data will be accessible to qualified investigators, enabling secondary analyses, replication, method development, and future trial planning across the wider autism research community. This requirement is not incidental; it is framed as a key goal of the project, reflecting NIH priorities around transparency, standardization, and maximizing the scientific return on large, multi-site investments.
The opportunity also includes an explicit biospecimen resource component. The Consortium is expected to collect blood samples for DNA from all subjects, and also from the parents of ASD participants, to support future genomic work. These samples are expected to be deposited in the NIMH Repository and Genomics Resource for broad future research use. In other words, even if the primary Consortium study is focused on measuring social impairment and related biomarkers over time, the FOA is designed to ensure the project also generates enduring genomic resources that can later be linked with behavioral, EEG, and eye-tracking phenotypes.
From an administrative and funding standpoint, the program is listed under NIH with activity aligned to health and mental health research (CFDA 93.242 and 93.865). It anticipated one award, with an estimated total funding level of $3,525,000 and an award ceiling of $5,250,000. No cost sharing or matching is required. The FOA was posted September 15, 2014, with an original and final closing date of December 10, 2014, and an archive date of January 10, 2015. Eligibility is broad and includes many U.S.-based organization types such as public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, school districts, special districts, small businesses and other for-profit organizations (other than small businesses), public housing authorities/Indian housing authorities, and a range of mission-specific institutions (for example HBCUs, Hispanic-serving institutions, AANAPISIS institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities). Non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply, though foreign components as defined by NIH policy are allowed.
Overall, this FOA is aimed at a practical bottleneck in ASD intervention research: many trials struggle because social outcomes are hard to measure objectively and consistently. By funding a coordinated, multi-site effort that combines standardized lab-based social measures with EEG and eye-tracking paradigms, and by requiring rapid NDAR data sharing plus DNA biobanking in the NIMH repository, the program is structured to produce tools and datasets that can improve trial design, participant stratification, and outcome measurement across the field.
Frequently Asked Questions (FAQs) - NIH RFA-MH-15-800 (U19 Consortium)
What is this funding opportunity (RFA-MH-15-800) trying to accomplish?
This NIH funding opportunity supports the creation of a single, coordinated research Consortium to improve how social impairment in autism spectrum disorder (ASD) is measured in clinical trials. The focus is on developing and qualifying more objective, standardized tools that can detect meaningful change during treatment studies, rather than relying mainly on clinician ratings and caregiver questionnaires.
How many awards does NIH anticipate making under this FOA?
The FOA anticipates one award to support a single, coordinated Consortium.
What funding mechanism is being used?
The mechanism is a U19 cooperative agreement. This means NIH staff are expected to have an active partnership role in shaping and overseeing the project, rather than serving only as a passive funder.
What is the main measurement problem this FOA is addressing in ASD trials?
The FOA targets a practical bottleneck in ASD intervention research: social outcomes can be difficult to measure objectively and consistently. Many trials depend on clinician and caregiver reports, which can be subjective and may not be sensitive enough to detect change. The program aims to strengthen trials by improving signal detection, reducing measurement noise, and making results more comparable across studies.
What kinds of outcome tools or measures is the Consortium expected to develop or qualify?
The Consortium is expected to use a well-justified, standardized battery of lab-based measures targeting specific domains of social impairment, alongside biological and behavioral measures that already show promise in ASD research.
Does the FOA emphasize any specific biological or behavioral technologies?
Yes. The FOA specifically emphasizes electrophysiology and attention-based metrics. It calls for both resting-state and task-based EEG paradigms, as well as eye-tracking measures.
What study design is the Consortium expected to run?
The funded Consortium is expected to conduct a multi-site study in school-age participants with ASD, collecting data at three time points: baseline, 6 weeks, and 24 weeks.
Who are the expected study participants?
The FOA specifies school-age participants with ASD for the multi-site study.
Why are there multiple data collection time points (baseline, 6 weeks, and 24 weeks)?
Repeated measurement over time is intended to help determine which measures are reliable, sensitive to change, and feasible for broad use in clinical trials.
What does it mean to "qualify" measures in the context of this FOA?
Based on the FOA description, qualifying measures refers to determining which tools perform well enough (for example, reliability and sensitivity to change) to be credible candidates for broad clinical trial use.
What are the two major intended uses for the qualified measures in ASD trials?
The FOA describes two major purposes:
- Stratification biomarkers: measures that could help identify subgroups of individuals with ASD who share underlying biological or behavioral profiles and may respond differently to specific interventions.
- Objective outcome measures: measures that could track whether a treatment improves social functioning in a measurable, repeatable way that is less dependent on subjective reporting.
Are both behavioral interventions and medications within scope?
Yes. The FOA frames the measurement goals as relevant to treatment studies whether the interventions are behavioral or pharmacological.
How does the FOA compare lab-based measures to traditional clinician/caregiver assessments?
A key evaluation question is whether lab-based measures of distinct social domains are more sensitive indicators of clinical status and change than commonly used clinician- and caregiver-based assessments, which are often the default endpoints in trials.
What does the FOA require regarding EEG measures?
The FOA calls for both resting-state and task-based EEG paradigms, collected repeatedly over time and consistently across multiple study locations.
What does the FOA require regarding eye-tracking measures?
The FOA calls for eye-tracking measures, with an emphasis on attention-based metrics, and expects them to be part of the standardized, multi-site battery collected at baseline, 6 weeks, and 24 weeks.
Does the FOA allow using EEG alone, eye-tracking alone, or a combined approach?
The FOA explicitly raises the question of whether eye-tracking measures, EEG measures, or a combined approach can serve as useful stratification biomarkers and/or sensitive and reliable indicators of change over time.
Is the Consortium expected to examine relationships among different types of measures?
Yes. The Consortium must analyze how different measures relate to one another, including correlations between lab-based social measures and EEG/eye-tracking paradigms, as well as correlations between lab-based measures and traditional clinician/caregiver assessments.
Why does the FOA emphasize mapping across measures (correlations and relationships)?
The FOA frames this as important for clarifying whether biological signals and performance-based measures capture the same underlying constructs as existing clinical scales, or whether they provide distinct (and potentially more informative) information.
What are the FOA's expectations for data sharing?
The FOA strongly emphasizes rapid, broad data sharing as a community resource. All data generated by the Consortium, including processed and analyzed datasets (not just raw files), are expected to be deposited in the National Database for Autism Research (NDAR) on a timely basis, and made accessible to qualified investigators.
Does the data sharing requirement include processed data, or only raw data?
It includes processed and analyzed datasets, not only raw files.
What is the stated purpose of depositing data in NDAR?
The FOA describes NDAR deposition as enabling secondary analyses, replication, method development, and future trial planning across the wider autism research community, aligning with NIH priorities for transparency, standardization, and maximizing the scientific return of large multi-site investments.
Are biospecimens required as part of the Consortium?
Yes. The FOA includes an explicit biospecimen resource component.
What biospecimens are expected to be collected?
The Consortium is expected to collect blood samples for DNA from all subjects, and also from the parents of ASD participants, to support future genomic work.
Where are the DNA samples expected to be deposited?
The samples are expected to be deposited in the NIMH Repository and Genomics Resource for broad future research use.
What is the rationale for collecting DNA and parental samples in a study focused on social impairment measures?
The FOA is designed so that, in addition to improving measurement of social impairment and related biomarkers over time, the project generates enduring genomic resources that can later be linked with behavioral, EEG, and eye-tracking phenotypes.
What is the estimated funding level and the award ceiling?
The FOA lists an estimated total funding level of $3,525,000 and an award ceiling of $5,250,000.
Is cost sharing or matching required?
No. The FOA states that no cost sharing or matching is required.
Which NIH program areas or CFDA listings are associated with this opportunity?
The program is listed under NIH with activity aligned to health and mental health research, and references CFDA 93.242 and 93.865.
When was the FOA posted, and what were the due dates?
The FOA was posted on September 15, 2014. The original and final closing date was December 10, 2014. The archive date was January 10, 2015.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organization types, such as:
- Public and private institutions of higher education
- Nonprofits (with or without 501(c)(3) status)
- State and local governments
- Tribal governments, tribal organizations, and tribally controlled colleges/universities
- School districts and special districts
- Small businesses
- Other for-profit organizations (other than small businesses)
- Public housing authorities/Indian housing authorities
- Mission-specific institutions (including HBCUs, Hispanic-serving institutions, AANAPISIS institutions, Alaska Native and Native Hawaiian serving institutions)
Are non-U.S. entities eligible to apply?
No. Non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply.
Are foreign components allowed?
Yes. The FOA notes that foreign components, as defined by NIH policy, are allowed.
Is this opportunity focused on creating a one-off dataset or an ongoing community resource?
The FOA emphasizes both. It aims to improve measurement in ASD clinical trials through a coordinated study, while also requiring rapid NDAR data sharing and DNA biobanking in the NIMH repository to create lasting resources for the broader research community.
What does "multi-site" mean in the context of this FOA?
Based on the FOA description, the Consortium is expected to collect the same standardized battery repeatedly over time across multiple locations, with consistency across sites being central to assessing reliability, sensitivity to change, and feasibility for broad clinical trial use.
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