Research and Training in Complementary and Integrative Health

NCCIH is the lead Federal agency for scientific research on the fundamental science, usefulness, and safety of complementary and integrative treatments and practices. NCCIH seeks to build knowledge across disciplines, focusing on the whole person, and taking a transdisciplinary approach that integrates the natural, social, and health sciences and transcends traditional boundaries. To address the need for objective evidence on the fundamental science, safety and efficacy of complementary and integrative health approaches, NCCIH supports rigorous scientific investigation to better understand how these interventions impact health, for whom, and the optimal methods of practice and delivery. By deepening our scientific understanding of the connections that exist across domains of human health, we can better understand how conditions interrelate, define multicomponent interventions that address these problems, and expand how we support patients through the full continuum of their health experience, including the return to health.
To evaluate complementary and integrative health approaches. The following objectives support this goal: (1) coordinate and facilitate the investigation of complementary and integrative health approaches through peer-reviewed grant solicitations; (2) interface with the NCCIH National Advisory Council; (3) conduct technology assessment conferences for the purpose of establishing areas of Clinical and Pre-clinical research that need to be further developed within complementary health approaches; and (4) maintain a comprehensive bibliographic data base in conjunction with the National Library of Medicine.

The National Center for Complementary and Integrative Health (NCCIH) regularly examines and redefines its research priorities. In setting research priorities, NCCIH considers its existing research portfolio, its 5-year strategic plan, the recommendations of the National Advisory Council for Complementary and Integrative Health, current scientific advances, the plans of other NIH institutes and centers, and input from expert panels and stakeholders. Research constituting a rigorous evidence base for complementary health approaches will be developed through a range of research strategies including basic and translational research, and clinical investigation. Priority setting also takes into account: 1)scientific promise, 2)amenability to rigorous scientific inquiry,3) potential to change health practices, and 4) relationship to use and practice.

Research Approaches
Basic, translational, efficacy/effectiveness, and implementation research for Complementary and Integrative Health approaches need to be studied across the research continuum. NCCIH continues to emphasize basic research that defines biological effects and mechanisms of action; this research is aimed at understanding the nature of complementary health approaches such as their biology, physiology, and physical, chemical and behavioral properties. NCCIH also supports the development of tools, models, and methodologies for studying these approaches. NCCIH continues to encourage efficacy studies to determine specific clinical effects of complementary health approaches under carefully controlled conditions that minimize nonspecific and contextual effects. There is also the need to strengthen translational and preliminary clinical research required to design and implement definitive clinical research and "real world" outcomes and effectiveness research that capitalizes on the reality that many complementary health approaches are in widespread public use.

NCCIH’s support of translational research addresses the need for valid, reliable and relevant research tools, outcome measures, and innovative methodology to enhance the rigor of complementary health approaches within clinical studies and to ensure that they are maximally informative. NCCIH emphasizes studies that inform the design of future trials such as those that will: develop and validate outcome measures; standardize treatment protocols or algorithms; validate treatment algorithms and/or; develop measures of quality control or treatment fidelity; assess effects of various doses or intervention durations; develop preliminary clinical evidence regarding efficacy and safety to support estimates of sample size; or establish feasibility of interventions or study designs in specific populations for future studies.

Universities, colleges, hospitals, laboratories, and other public or private nonprofit domestic institutions, including State and local units of government, and individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate. For-profit organizations are also eligible, with the exception of NRSA. Individual NRSA awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All NRSA awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral candidates must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (e.g., M.D., Ph.D., D.D.S., D.O., N.D., D.C., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is being proposed and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which researches proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Award Procedure: All accepted applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score ranging from the best (10) to worst (90) compete for available funds based on scientific merit, program relevance, and program balance and are made annually. Initial award provides funds for the first budget period (usually 12 months) and Notice of Grant Award (Form PHS 1533) indicates support recommended for remainder of project period, allocation of Federal funds by budget categories, and special conditions, if any. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Overall from 180 to 300 days. Research Grants and Cooperative Agreements: approximately 6-10 months; National Service Research Awards: 6-9 months; SBIR/STTR awards 6 - 7 months.