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Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)

ID: PAR-24-084 • Type: Posted
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Description

Posted: Dec. 20, 2023, 12:00 a.m. EST
The goal of this notice of funding opportunity (NOFO) is to support feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions that have been identified by NCCIH as high-priority research topics. This funding opportunity is intended to support feasibility clinical trials that provide new information that are scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent competitive full-scale clinical trial. Under this R34, the data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including, but not limited to the following: examining feasibility and acceptability of interventions lacking published data; tailoring or adapting the content or structure of an intervention to a specific population, modality, or setting; refining the intervention to determine the most appropriate frequency or duration; determining feasibility of recruitment, retention, and data collection procedures; refining and assessing the feasibility of protocolized multi-component interventions; or examining acceptability and adherence of control conditions. The subsequent full-scale clinical trial should have the potential to make a significant impact on public health. Prior to submitting to this NOFO, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP).
Posted: Dec. 20, 2023, 12:00 a.m. EST
Posted: Dec. 20, 2023, 12:00 a.m. EST
Posted: Oct. 23, 2023, 12:00 a.m. EDT
Posted: Oct. 23, 2023, 12:00 a.m. EDT
Background
The National Center for Complementary and Integrative Health (NCCIH) aims to support feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions identified as high-priority research topics. These approaches are increasingly recognized as nonpharmacologic approaches to symptom management and can be complementary to conventional health care. NCCIH encourages rigorous investigation of promising mind and body interventions.

Grant Details
This funding opportunity supports feasibility clinical trials that provide new information scientifically necessary for the planning and conduct of subsequent clinical efficacy or effectiveness studies, pragmatic trials, or dissemination and implementation trials within NCCIH's mission. The subsequent full-scale clinical trial should have the potential to make a significant impact on public health. Feasibility clinical trials can fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including examining feasibility and acceptability of interventions lacking published data, tailoring or adapting the content or structure of an intervention to a specific population, modality, or setting, refining the intervention to determine the most appropriate frequency or duration, determining feasibility of recruitment, retention, and data collection procedures, refining and assessing the feasibility of protocolized multi-component interventions, or examining acceptability and adherence of control conditions.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), U.S. Territory or Possession entities, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations, regional organizations. Foreign organizations are not eligible to apply.

Period of Performance
The maximum project period is 3 years. Applications are due by 5:00 PM local time of the applicant organization. The earliest start date is February 20, 2024.

Grant Value
This R34 grant is limited to direct costs requests of up to $450,000 over the entire project period. In no case may any year be more than $225,000 in direct costs.

Overview

Category of Funding
Health
Funding Instruments
Grant
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 12/20/23 the National Institutes of Health posted grant opportunity PAR-24-084 for Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required). The grant will be issued under grant program 93.213 Research and Training in Complementary and Integrative Health.

Timing

Posted Date
Dec. 20, 2023, 12:00 a.m. EST
Closing Date
Nov. 21, 2024, 12:00 a.m. EST Past Due
Last Updated
Nov. 21, 2024, 2:08 p.m. EST
Version
3
Archive Date
Dec. 21, 2024

Eligibility

Eligible Applicants
Public housing authorities/Indian housing authorities
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
State governments
County governments
Nonprofits having 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
Native American tribal organizations (other than Federally recognized tribal governments)
Small businesses
Private institutions of higher education
For profit organizations other than small businesses
Special district governments
Independent school districts
Native American tribal governments (Federally recognized)
Additional Info
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 Organizations) 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.

Award Sizing

Ceiling
$450,000
Floor
Not Listed
Estimated Program Funding
Not Provided
Estimated Number of Grants
Not Listed

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-24-084.html

Documents

Posted documents for PAR-24-084

Grant Awards

Grants awarded through PAR-24-084

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