NCCIH Clinical FOAs Required Application Elements—Mind and Body
Applicants should follow instructions in the application package and use the PHS Human Subjects and Clinical Trial Information form to provide details about their clinical trial (see Annotated FORMS-E). NIH policy has eliminated most Appendix materials related to clinical trials (NOT-OD-18-126); however, investigators should follow instructions within the FOA and outlined below to provide additional attachments when required by the FOA. Please be sure to check the “Related Notices” section of the FOA for any changes to the required elements.
Fundamental Science Research on Mind and Body Approaches (R21)
Period of Award: Up to 2 years
Budget: Combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 6 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trial Information
- Complete all required elements
Required Other Clinical Trial-related Attachments
- None
Fundamental Science Research on Mind and Body Approaches (R01)
Period of Award: Up to 5 years
Budget: Should reflect needs of the proposed project. For applications requesting more than $500,000, please see, NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trial Information
- Complete all required elements
Required Other Clinical Trial-related Attachments
- None
Phased Innovation Award for Mechanistic Studies To Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R61/R33)
Period of Award: Up to 2 years for R61 phase; Up to 3 years for R33 phase (R61/R33 combined up to 5 years)
Budget: R61 phase: a limit of $300,000 per year in direct costs is recommended; R33 phase: a limit of $500,000 per year in direct costs is recommended
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Page Limits
- Specific Aims: 1 page (for both R61 and R33 phases together)
- Research Strategy: 12 pages (for both R61 and R33 phases together)
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trial Information
- Complete all required elements
- Specific instructions for sections 3.3, 4.2, 4.3, and 4.4 provided in the FOA
Required Other Clinical Trial-related Attachments
- None
Research Plan
- Go/No-Go Criteria: Yes, include within the 12-page Research Plan as a section titled, “Go/No-Go Criteria for R61”
Innovation Award for Mechanistic Studies To Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R33)
Period of Award: Up to 3 years
Budget: A limit of $500,000 per year in direct costs is recommended
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trial Information
- Complete all required elements
- Specific instructions for sections 3.3, 4.2, 4.3, and 4.4 provided in the FOA
Required Other Clinical Trial-related Attachments
- None
Research Plan
- Go/No-Go Criteria: No
Exploratory Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34)
Period of Award: Up to 3 years (includes the optional administrative period)
Budget: Up to $450,000 total (includes optional administrative period budget of up to $100,000; and limited to $225,000 in direct costs per year)
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trial Information
- Complete all required elements
Required Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
Research Plan
- Go/No-Go Criteria or Milestones: No
NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01)
Period of Award: Up to 5 years
Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
PHS Human Subjects and Clinical Trials Information
- Complete all required elements
- Specific instructions for sections 2.5, 2.7, and 3.3 provided in the FOA
Required Other Clinical Trial-related Attachments
- Regulatory Communication Plan (up to 3 pages): Yes
- Clinical Trial Experience (up to 3 pages): Yes
Research Plan
- Milestone Plan: Brief summary to be included in the Research Plan
Clinical Coordinating Center for NCCIH Multisite Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3)
Period of Award: UG3 phase: 1 year planning; UH3 phase: up to 4 years implementation (up to 6 years with strong justification)
Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year
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Page Limits
- Specific Aims: 1 page (for both UG3 and UH3 phases together)
- Research Strategy: 12 pages (for both UG3 and UH3 phases together)
- Introduction (for Resubmission applications): 1 page
Cover letter: Yes
PHS Human Subjects and Clinical Trials Information
- Complete all required elements
- Specific instructions provided for sections 2.4, 2.5, 3.3, 3.5, 4.6, and 4.7 in the FOA
Required Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
- Milestone Plan (up to 5 pages): Yes
Other Attachments
- Project Management Plan (up to 3 pages): Yes
Research Plan
- Milestones: Brief summary to be included in the Research Plan
Mind and Body Intervention Multisite Clinical Trial Data Coordinating Center (U24)
Period of Award: Up to 5 years (up to 7 years with strong justification)
Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year. The combined budgets of the Clinical Coordinating Center and Data Coordinating Center will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied.
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Yes
PHS Human Subjects and Clinical Trials Information
- Complete all required elements
- Specific instructions provided for sections 2.4, 2.5, 3.3, 3.5, 4.6, and 4.7 in the FOA
Required Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
- Milestone Plan (up to 5 pages): Yes
Other Attachments
- Project Management Plan (up to 3 pages): Yes
Research Plan
- Statistical Analysis Plan: Yes
