Key Dates

Related Announcements

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to describe NCCIH priorities in innovative basic and mechanistic research or technology/method development research relevant to complementary and integrative health approaches.

Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care. Complementary approaches can be classified by their primary therapeutic input, which may be dietary (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, some forms of art therapies). The dietary approaches include what have been previously categorized as natural products, whereas psychological and/or physical approaches encompass what have been commonly referred to as mind and body interventions. Integrative health brings conventional and complementary approaches together in a coordinated way. Integrative health also emphasizes multimodal interventions that aim to improve health in multiple interconnected domains social, psychological, and physical, including multiple organs and systems.

Basic and mechanistic research on complementary and integrative health approaches should investigate the following key aspects. The first is the approach (also called intervention) itself, the second is the biological, behavioral, psychological, and/or social systems potentially targeted by the approach or intervention, and the third is the platform in which they will be studied (e.g., cell cultures, animal models, human subjects, or a computational model/in silico system). In the context of complementary and integrative health approaches, mechanistic research often refers to studies examining the interactions between the approach and the systems (e.g., biological, behavioral, psychological, and/or social), whereas basic research may investigate either the approach or intervention itself, the systems without the interactions, or the associated technologies. When basic research is pursued, applicants are encouraged to articulate the relevance of their basic or technological/method development research to a complementary or integrative health approach if the approach is not to be directly studied.

Although the areas of research submitted under this NOSI can be very broad, the following topics are high program priorities for NCCIH:

Basic research (Please specify the potential relevance of the proposed study to a complementary or integrative health approach if no interventions are to be studied directly.)

• Investigate the connections and interactions of multiple systems (e.g., any two or more physiological systems including neural, respiratory, musculoskeletal, cardiovascular, digestive, reproductive, endocrine, metabolic, immune, and lymphatic, and/or host/microbiome systems) in animal models or human participants.
• Uncover and evaluate innovative or unique mechanisms or multisystem effects that are modulated by a complementary or integrative health approach in the context of health outcomes such as resilience, well-being, and health restoration, or in the context of ameliorating pain, sleep disturbances, stress, anxiety, mild to moderate depression, eating disorders, menopause, fatigue, and other related disorders, or in the context of disease prevention with appropriate animal models or with research participants.
• Assess unique mechanisms, factors, or therapeutic targets, particularly of complementary or integrative health approaches in underserved populations.

Research on mechanisms of complementary or integrative interventions

• Elucidate the mechanistic effects of a complementary or integrative health approach on multiple systems (e.g., myofascial and immune systems, neural and lymphatic systems, microbial system and central nervous system, endocrine and digestive systems, central nervous system and cardiovascular system or respiratory system) and the interactions among multiple systems in animal models or research participants.
• Explore the mechanistic effects of multimodal interventions or integrative health approaches (e.g., meditation and a dietary supplement, acupuncture and cannabinoids, yoga and vagal stimulation) on one or more physiological systems and their interactions in animal models or research participants.
• Examine the effects of complementary or integrative health approaches on novel interoceptive processes in appropriate animal models or research participants.
• Investigate real-time mechanistic processes in the central nervous system and/or other physiological systems during meditation or other mind and body approaches in research participants.
• Identify innovative mechanisms of approaches in appropriate animal models or other preclinical models.
• Ascertain the interactions of physiological (e.g., neural, musculoskeletal, immune) and psychological systems in response to force-based interventions (e.g., acupuncture, massage therapy, osteopathic manipulation, chiropractic manipulation) in animal models or research participants.
• Identify and evaluate potential biomarkers that predict the therapeutic response to a complementary or integrative health approach.

Technology or Method Development Research

• Develop and evaluate innovative (1) humanized cellular or organ systems or (2) genetically modified or preclinical animal models suitable for mechanistic studies of complementary or integrative health approaches.
• Develop and evaluate innovative quantitative assessments of interoception processes, myofascial tissues, or lymphatic systems in animal models or with research participants.
• Develop and validate innovative technologies or methods to enhance and/or monitor the mechanistic effect of a complementary or integrative approach with research participants or animal models.
• Develop targeted and untargeted bioinformatic approaches to identify active components in a natural product mixture.
• Develop phenotypic models capable of illuminating mechanisms of action for natural products.
• Develop and validate prognostic and diagnostic systems in combination with biosensor and artificial intelligence for precision probiotic treatment.
• Develop and evaluate innovative approaches to explore biological activities of probiotics in the gastrointestinal tract.
• Validate the scientific basis of diagnostic systems commonly used in complementary and integrative health approaches.

Applications Not Responsive to this NOSI

• Studies exclusively focused on synthetic pharmaceuticals.
• Feasibility, efficacy, or effectiveness studies to analyze the effect size of an intervention(s) on clinical outcomes as the primary outcomes. Applicants for such studies should consult with the NCCIH Clinical Research Branch.
• Studies with a primary objective on disease treatments or pathophysiology (e.g., diabetes, arthritis, cardiovascular disease), rather than using disease models to explore innovative mechanisms of action or therapeutic biomarkers for complementary or integrative health approaches.
• Studies focusing on cancer therapeutics, treatments, or pathophysiology.
• Studies of diets, macronutrients, or micronutrients for nutritional benefits.
• Studies of the same or similar mechanistic effects of a complementary or integrative health approach as those already published in the literature in a different clinical population or using similar or related interventions are deprioritized at NCCIH.

Application and Submission Information

This notice follows standard receipt dates and applies to due dates on or after June 5, 2021 and subsequent receipt dates through September 7, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-AT-21-006 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Although NCCIH is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Scientific/Research Contact(s)

For general inquiries or studies related to acupuncture or art-based interventions, please contact:

Wen Chen, M.M.Sc., Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-3989
Email: chenw@mail.nih.gov

For studies related to non-acupuncture manual therapies or physical input-based approaches such as massage, spinal manipulation, and other force-based manipulations, please contact:

Merav Sabri, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: merav.sabri@nih.gov

For studies related to approaches involving both psychological and physical input, such as tai chi, yoga, qi gong, or other meditative movement therapies, please contact:

Inna Belfer, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-435-1573
Email: inna.belfer@nih.gov

For studies related to approaches involving predominantly psychological input, such as meditation and hypnosis, please contact:

Erin Quinlan, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-0636
Email: erin.quinlan@nih.gov

For studies related to technology or method development on botanicals or herbal medicine, please contact:

Craig Hopp, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-5825
Email: hoppdc@mail.nih.gov

For studies related to probiotics or microbial-based therapies, as well as basic and mechanistic research on dietary supplements and herbal medicine, please contact:

Hye-Sook Kim, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-827-6910
Email: hye-sook.kim@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears 2 weeks after the submission due date).

Financial/Grants Management Contact(s)

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: CarowS@MAIL.NIH.GOV