This department is offering a grant to further validate EEG and eye tracking measures as biomarkers for reducing heterogeneity and measuring social impairment in autism spectrum disorders (ASD) clinical trials. The grant aims to replicate and extend previous characterizations, incorporate FDA guidance, and provide a community resource for data sharing. The project will assess the potential utility of eye tracking and EEG paradigms in ASD trials, correlate clinical measures with biomarkers, and explore feasibility in collecting biomarker measures in a younger cohort. Data and DNA samples are expected to be deposited for future research access.
Opportunity ID: 322315
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-20-325 |
| Funding Opportunity Title: | 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) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.173 — Research Related to Deafness and Communication Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 07, 2019 |
| Last Updated Date: | Nov 07, 2019 |
| Original Closing Date for Applications: | Dec 23, 2019 |
| Current Closing Date for Applications: | Dec 23, 2019 |
| Archive Date: | Jan 28, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: 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. See the funding announcement for the eligibility details |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to further validate promising EEG and eye tracking measures that showed promising performance in the recently-completed Autism Biomarkers Consortium for Clinical Trials (ABC-CT) study. The intent of the FOA is to qualify a set of measures that can be used as biomarkers to reduce heterogeneity, and/or as sensitive and reliable objective measures of social impairment in autism spectrum disorders (ASD) clinical trials. The FOA will support a multi-site consortium to conduct a study with three primary aims to replicate and extend previous characterization of the most promising EEG and eye-tracking measures, incorporating suggestions and guidance from the FDA Biomarkers Qualification Program (BQP). A key goal of the Consortium project is to provide a community resource for broad sharing of all data generated including processed/analyzed data, with rapid and timely deposition of data into the National Database for Autism Research (NDAR). All data generated in this project are expected to be deposited in NDAR and will be accessible for use by all qualified investigators. In addition, blood (DNA) samples are expected to be deposited in the NIMH Repository and Genomics Resource for future research use. The Consortium project will assess the following: (1) whether eye-tracking, EEG paradigms, or a combination of the two, have potential utility as stratification biomarkers and/or as sensitive and reliable measures of change in ASD clinical trials; (2) the relationship (correlation) of validated clinical measures (including measures of social impairment) to eye tracking or EEG paradigms; and (3) the feasibility of collecting the same biomarker measures in a younger cohort. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-20-325.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-E | FORMS-E | PKG00256455 | Nov 23, 2019 | Dec 23, 2019 | View |
Package 1
Mandatory forms
322315 RR_SF424_2_0-2.0.pdf
322315 PHS398_CoverPageSupplement_4_0-4.0.pdf
322315 RR_OtherProjectInfo_1_4-1.4.pdf
322315 PerformanceSite_2_0-2.0.pdf
322315 RR_KeyPersonExpanded_2_0-2.0.pdf
322315 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
322315 PHS_Additional_IndirectCosts-1.0.pdf
322315 PHS_AssignmentRequestForm_2_0-2.0.pdf
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