This NCCIH grant supports investigator-initiated, multi-site feasibility clinical trials of complementary and integrative mind and body interventions in high-priority research areas. The purpose of this grant is to assess intervention fidelity and demonstrate feasibility of recruitment, accrual, randomization, participant adherence, and retention across multiple sites. It also covers data collection feasibility. This grant is for preparing for future fully powered multi-site trials by filling scientific knowledge gaps, requiring preliminary data from prior single-site studies. It does not support efficacy or effectiveness trials. The aim is to enable the development of competitive trials with significant public health impact.
Opportunity ID: 334147
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-241 |
| Funding Opportunity Title: | NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 14, 2021 |
| Last Updated Date: | Dec 21, 2023 |
| Original Closing Date for Applications: | Mar 11, 2024 |
| Current Closing Date for Applications: | Dec 21, 2023 |
| Archive Date: | Jan 20, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments State governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities 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 For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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); 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: |
This Funding Opportunity Announcement (FOA) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a multi-site clinical trial to assess whether the intervention can be delivered with fidelity across sites; demonstrate feasibility of recruitment, accrual, and randomization of participants across sites; demonstrate participant adherence to the intervention, as well as retention of participants throughout the study across sites; and/or demonstrate feasibility of data collection across sites in preparation for a future multi-site trial. The need for multi-site feasibility trials are expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s)or the published literature. This FOA will not support randomized clinical trials to determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive fully powered multi-site clinical trial that has the potential to make a significant impact on public health Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-241.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Closing for reissue | Dec 21, 2023 | |
| Jun 14, 2021 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-241 |
| Funding Opportunity Title: | NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 14, 2021 |
| Last Updated Date: | Dec 21, 2023 |
| Original Closing Date for Applications: | Mar 11, 2024 |
| Current Closing Date for Applications: | Dec 21, 2023 |
| Archive Date: | Jan 20, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments State governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities 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 For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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); 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: |
This Funding Opportunity Announcement (FOA) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a multi-site clinical trial to assess whether the intervention can be delivered with fidelity across sites; demonstrate feasibility of recruitment, accrual, and randomization of participants across sites; demonstrate participant adherence to the intervention, as well as retention of participants throughout the study across sites; and/or demonstrate feasibility of data collection across sites in preparation for a future multi-site trial. The need for multi-site feasibility trials are expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s)or the published literature. This FOA will not support randomized clinical trials to determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive fully powered multi-site clinical trial that has the potential to make a significant impact on public health Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-241.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-241 |
| Funding Opportunity Title: | NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 14, 2021 |
| Last Updated Date: | Jun 14, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Mar 11, 2024 |
| Archive Date: | Apr 16, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Special district governments Private institutions of higher education For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments 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); 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: | This Funding Opportunity Announcement (FOA) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a multi-site clinical trial to assess whether the intervention can be delivered with fidelity across sites; demonstrate feasibility of recruitment, accrual, and randomization of participants across sites; demonstrate participant adherence to the intervention, as well as retention of participants throughout the study across sites; and/or demonstrate feasibility of data collection across sites in preparation for a future multi-site trial. The need for multi-site feasibility trials are expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s)or the published literature. This FOA will not support randomized clinical trials to determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive fully powered multi-site clinical trial that has the potential to make a significant impact on public health Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-241.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Related Documents
Folder 334147 Full Announcement-PAR-21-241 -> PAR-21-241-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00267725 | Jun 21, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00269804 | Oct 28, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277756 | Nov 01, 2022 | Dec 22, 2023 | View |
Package 1
Mandatory forms
334147 RR_SF424_2_0-2.0.pdf
334147 PHS398_CoverPageSupplement_5_0-5.0.pdf
334147 RR_OtherProjectInfo_1_4-1.4.pdf
334147 PerformanceSite_2_0-2.0.pdf
334147 RR_KeyPersonExpanded_2_0-2.0.pdf
334147 PHS398_ResearchPlan_4_0-4.0.pdf
334147 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
334147 RR_Budget_1_4-1.4.pdf
334147 RR_SubawardBudget30_1_4-1.4.pdf
334147 PHS398_ModularBudget_1_2-1.2.pdf
334147 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
334147 RR_SF424_5_0-5.0.pdf
334147 PHS398_CoverPageSupplement_5_0-5.0.pdf
334147 RR_OtherProjectInfo_1_4-1.4.pdf
334147 PerformanceSite_4_0-4.0.pdf
334147 RR_KeyPersonExpanded_4_0-4.0.pdf
334147 PHS398_ResearchPlan_4_0-4.0.pdf
334147 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
334147 RR_Budget_3_0-3.0.pdf
334147 RR_SubawardBudget30_3_0-3.0.pdf
334147 PHS398_ModularBudget_1_2-1.2.pdf
334147 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
334147 RR_SF424_5_0-5.0.pdf
334147 PHS398_CoverPageSupplement_5_0-5.0.pdf
334147 RR_OtherProjectInfo_1_4-1.4.pdf
334147 PerformanceSite_4_0-4.0.pdf
334147 RR_KeyPersonExpanded_4_0-4.0.pdf
334147 PHS398_ResearchPlan_5_0-5.0.pdf
334147 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
334147 RR_Budget_3_0-3.0.pdf
334147 RR_SubawardBudget30_3_0-3.0.pdf
334147 PHS398_ModularBudget_1_2-1.2.pdf
334147 PHS_AssignmentRequestForm_3_0-3.0.pdf
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