This grant aims to establish a Consortium focusing on Biomarkers and Outcome Measures of Social Impairment in Autism Spectrum Disorder (ASD). The project intends to develop objective tools for use in clinical trials of interventions by conducting a multi-site study to assess standardized lab-based measures and biological indicators in individuals with ASD. The goal is to qualify these measures as stratification biomarkers and reliable outcome measures for social impairment in ASD trials. Data generated will be shared in a community resource and deposited in the National Database for Autism Research, with blood samples for genomic analyses. Application deadline is December 10, 2014.
Opportunity ID: 265108
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-15-800 |
| Funding Opportunity Title: | Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19) |
| 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: | 1 |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Sep 15, 2014 |
| Last Updated Date: | Oct 07, 2014 |
| Original Closing Date for Applications: | Dec 10, 2014 |
| Current Closing Date for Applications: | Dec 10, 2014 |
| Archive Date: | Jan 10, 2015 |
| Estimated Total Program Funding: | $3,525,000 |
| Award Ceiling: | $5,250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Small businesses State governments Independent school districts Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Private institutions of higher education Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for the Consortium on Biomarkers and Outcome Measures of Social Impairment in Autism Spectrum Disorder (ASD) in order to generate objective tools for use in clinical trials of behavioral or pharmacologic interventions. The FOA will support a Consortium project to conduct a multi-site study to assess a well-justified set of standardized lab-based measures of domains of social impairment and biological measures (resting state and task-based EEG as well as eye tracking measures) that show promise in school age individuals with ASD at baseline, 6 and 24 week time points. The intent of the FOA is to qualify a set of measures that can be used as stratification biomarkers and/or as sensitive and reliable objective measures of social impairment in ASD clinical trials. A key goal of the Consortium projectis 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 lab-based measures of specific domains of social impairment in ASD are more sensitive indicators of clinical status compared to commonly used clinician and caregiver assessments of social impairment for their potential use as outcome measures in clinical trials; (2) whether eye-tracking, electrophysiological (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; (3) the relationship (correlation) of lab-based measures of domains of social impairment to eye tracking or EEG (resting state and task-based) paradigms; and (4) the relationship (correlation) of lab-based measures of domains of social impairment to commonly used clinician and caregiver assessments of social impairment. In addition, the FOA includes a resource aim for the collection of blood (DNA) samples from all subjects, including the parents of ASD subjects, for future genomic analyses. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-800.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 |
|---|---|---|
| This funding opportunity has had its award ceiling updated per NOT-MH-14-034. | Oct 07, 2014 | |
| Oct 07, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-15-800 |
| Funding Opportunity Title: | Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19) |
| 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: | 1 |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Sep 15, 2014 |
| Last Updated Date: | Oct 07, 2014 |
| Original Closing Date for Applications: | Dec 10, 2014 |
| Current Closing Date for Applications: | Dec 10, 2014 |
| Archive Date: | Jan 10, 2015 |
| Estimated Total Program Funding: | $3,525,000 |
| Award Ceiling: | $5,250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Small businesses State governments Independent school districts Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Private institutions of higher education Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for the Consortium on Biomarkers and Outcome Measures of Social Impairment in Autism Spectrum Disorder (ASD) in order to generate objective tools for use in clinical trials of behavioral or pharmacologic interventions. The FOA will support a Consortium project to conduct a multi-site study to assess a well-justified set of standardized lab-based measures of domains of social impairment and biological measures (resting state and task-based EEG as well as eye tracking measures) that show promise in school age individuals with ASD at baseline, 6 and 24 week time points. The intent of the FOA is to qualify a set of measures that can be used as stratification biomarkers and/or as sensitive and reliable objective measures of social impairment in ASD clinical trials. A key goal of the Consortium projectis 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 lab-based measures of specific domains of social impairment in ASD are more sensitive indicators of clinical status compared to commonly used clinician and caregiver assessments of social impairment for their potential use as outcome measures in clinical trials; (2) whether eye-tracking, electrophysiological (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; (3) the relationship (correlation) of lab-based measures of domains of social impairment to eye tracking or EEG (resting state and task-based) paradigms; and (4) the relationship (correlation) of lab-based measures of domains of social impairment to commonly used clinician and caregiver assessments of social impairment. In addition, the FOA includes a resource aim for the collection of blood (DNA) samples from all subjects, including the parents of ASD subjects, for future genomic analyses. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-800.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-15-800 |
| Funding Opportunity Title: | Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19) |
| 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: | 1 |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 07, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Dec 10, 2014 |
| Archive Date: | Jan 10, 2015 |
| Estimated Total Program Funding: | $3,525,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education Small businesses County governments Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) State governments |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for the Consortium on Biomarkers and Outcome Measures of Social Impairment in Autism Spectrum Disorder (ASD) in order to generate objective tools for use in clinical trials of behavioral or pharmacologic interventions.
The FOA will support a Consortium project to conduct a multi-site study to assess a well-justified set of standardized lab-based measures of domains of social impairment and biological measures (resting state and task-based EEG as well as eye tracking measures) that show promise in school age individuals with ASD at baseline, 6 and 24 week time points. The intent of the FOA is to qualify a set of measures that can be used as stratification biomarkers and/or as sensitive and reliable objective measures of social impairment in ASD clinical trials. A key goal of the Consortium projectis 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 lab-based measures of specific domains of social impairment in ASD are more sensitive indicators of clinical status compared to commonly used clinician and caregiver assessments of social impairment for their potential use as outcome measures in clinical trials; (2) whether eye-tracking, electrophysiological (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; (3) the relationship (correlation) of lab-based measures of domains of social impairment to eye tracking or EEG (resting state and task-based) paradigms; and (4) the relationship (correlation) of lab-based measures of domains of social impairment to commonly used clinician and caregiver assessments of social impairment. In addition, the FOA includes a resource aim for the collection of blood (DNA) samples from all subjects, including the parents of ASD subjects, for future genomic analyses. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-800.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 |
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-C | FORMS-C | PKG00205843 | Nov 10, 2014 | Dec 10, 2014 | View |
Package 1
Mandatory forms
265108 PHS398_ResearchPlan_2_0-2.0.pdf
265108 PHS398_CoverPageSupplement_2_0-2.0.pdf
265108 RR_KeyPersonExpanded_2_0-2.0.pdf
265108 RR_OtherProjectInfo_1_3-1.3.pdf
265108 PerformanceSite_2_0-2.0.pdf
265108 RR_SF424_2_0-2.0.pdf
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