Opportunity Information: Apply for RFA MH 20 325
This NIH funding opportunity (RFA-MH-20-325) is a limited-competition cooperative agreement (U19; clinical trial not allowed) focused on strengthening and extending objective biomarkers of social impairment in autism spectrum disorder (ASD) that emerged as especially promising in the Autism Biomarkers Consortium for Clinical Trials (ABC-CT). The central idea is to take specific EEG and eye-tracking paradigms that previously performed well and push them further along the path toward being qualified for use in ASD clinical trials, either to help sort participants into more biologically similar subgroups (reducing heterogeneity) or to provide sensitive, reliable measures of change over time that do not rely solely on subjective reporting.
The FOA supports a multi-site consortium study designed around three main scientific goals. First, the consortium will replicate and extend earlier findings on the most promising EEG and eye-tracking measures, with explicit attention to recommendations from the FDA Biomarkers Qualification Program (BQP). This reflects an emphasis not just on discovering interesting signals, but on generating the kind of evidence regulators and the broader field look for when deciding whether a measure is robust enough for trial use. Second, the project will test how well these biomarker readouts relate to established, validated clinical assessments, including standardized measures of social impairment. In practical terms, that means quantifying correlations between biomarker performance (from EEG, eye tracking, or combinations of both) and clinical phenotypes to understand what the biomarkers are actually capturing and how they might complement clinical endpoints. Third, the consortium will evaluate feasibility of collecting the same biomarker measures in a younger cohort, which addresses real-world constraints in ASD research where age, developmental stage, attention, and tolerance for procedures can strongly affect data quality and generalizability.
A defining feature of the opportunity is its strong commitment to data and resource sharing. The consortium is expected to function as a community resource by rapidly depositing all data generated into the National Database for Autism Research (NDAR). This expectation includes not only raw data but also processed and analyzed datasets, enabling other qualified investigators to reuse the materials for secondary analyses, method development, or replication efforts. In addition to behavioral and biomarker data, the FOA expects collection of blood samples for DNA, with deposition into the NIMH Repository and Genomics Resource so the samples can be leveraged for future genetics and genomics research that may not be part of the original consortium aims.
From an administrative standpoint, this is a discretionary NIH opportunity using a cooperative agreement mechanism, meaning NIH program staff are typically more actively involved than in a standard investigator-initiated grant. The activity category is aligned with health and related social services research, and the CFDA numbers listed include 93.173, 93.242, 93.853, and 93.865. Eligibility is restricted: public and state-controlled institutions of higher education are listed as eligible applicants, and non-U.S. (foreign) institutions are not eligible to apply directly. Non-domestic components of U.S. organizations are also not eligible to apply, though foreign components as defined by NIH policy are allowed, which generally means certain project elements may occur abroad under a U.S. applicant organization if they meet NIH requirements and are well justified.
The application window for the original announcement closed on December 23, 2019 (created November 6, 2019). While the listing does not provide an award ceiling or expected number of awards in the provided text, the overall structure signals NIH’s intent to fund a coordinated, multi-site effort aimed at producing biomarker evidence that is replicable, clinically meaningful, and broadly usable by the ASD research community, with particular attention to trial readiness and regulatory-aligned validation practices.Apply for RFA MH 20 325
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Limited Competition: Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.242, 93.853, 93.865.
- This funding opportunity was created on 2019-11-06.
- Applicants must submit their applications by 2019-12-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public and State controlled institutions of higher education.
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