Mind and Body Interventions to Restore Whole Person Health via Emotional Well-Being Mechanisms (R61/R33 Clinical Trial Required)

The National Center for Complementary and Integrative Health (NCCIH) announces this Notice of Funding Opportunity (NOFO) to solicit applications for research on how mind and body interventions through psychological and/or physical inputs (e.g., mindfulness meditation, yoga, acupuncture, massage, and other brain and/or body based interventions) impact mechanisms of emotional well-being (EWB) and their associations with whole person health (WPH), consistent with the NIH priority to address the health needs of the American people and improve their well-being. The NOFO will support rigorous and well-powered mechanistic research studies that are supported by strong preliminary data. The studies should examine the effects of mind and body interventions on innovative mechanisms of EWB (as the primary outcome), as well as the associated relationship with the Whole Person Health Index (WPHI, as a secondary outcome). To enhance research safety, rigor, and efficiency of NIH-funded mechanistic clinical trials, this initiative will use a two-phased award funding mechanism (R61/R33). The funding will support an initial phase (R61) to establish feasibility benchmarks for the proposed mechanistic clinical trial(s), followed by a second phase (R33) to complete the full-scale trials, which will be contingent upon successful completion of R61 milestones. Applications should provide preliminary data that are comparable in quality and quantity to those expected for an R01 proposal.

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 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 not allowed.

The major elements in evaluating proposals include assessments of: (1) the scientific merit innovation and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; (6) the relevance and importance to the announced program objectives and when applicable,and (7) the adequacy of assurances detailing the proposed means for safeguarding human or animal subjects. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed...