National Center for Complementary and Integrative Health (NCCIH)
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NCCIH Clinical FOAs Required Application Elements—Mind and Body

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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)

PAR-18-322

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)

PAR-18-323

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)

PAR-18-114

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)

PAR-18-115

Period of Award: Up to 3 years 

Budget: A limit of $500,000 per year in direct costs is recommended

See More

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)

PAR-18-417

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)

PAR-18-118

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

See More

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)

PAR-18-662

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)

PAR-18-663

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 

 

This page last modified March 20, 2019