Concept: NCCIH High Program Priority Initiatives for Basic and Mechanistic Studies of Complementary and Integrative Health Approaches

Project Concept Review

Council Date: September 20, 2019

Program Officer: Wen G. Chen, Ph.D.

Background

There are three key elements of basic and mechanistic research on complementary and integrative health approaches: 1) the approach itself: what components impact the biological system or subjective experience? 2) the biological system potentially targeted by the approach: what cellular systems or hormonal, genetic, or neural mediators, for example, are influenced by the intervention? 3) the mechanisms: what are the key processes (i.e., biological and/or behavioral) by which the approach exerts its effects?

In February 2017, the program directors within the Basic and Mechanistic Research Branch in the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH) developed an initial version of a research framework to summarize NCCIH’s ongoing high program priority initiatives within the Branch as well as to guide our future development of high-priority research initiatives. The framework includes four major categories of research. The first category is fundamental science of complementary and integrative health approaches, the second is optimization research, the third is translational research, and the fourth includes technology, method, and resource development. These four categories of research aim to support various key objectives outlined in the NCCIH 2016 Strategic Plan, including Objective 1: Advance Fundamental Science and Methods Development; Objective 2: Improve Care for Hard-to-Manage Symptoms; and Objective 3: Foster Health Promotion and Disease Prevention.

The Basic and Mechanistic Research Branch has supported fundamental science research primarily through either investigator-initiated funding opportunities such as program announcements (PAs) or special Requests for Applications (RFAs) with set-aside funds. Examples of the PAs include NCCIH-led funding opportunity announcements (FOAs) such as PA-18-322/PA-18-323 (Fundamental Science Research on Mind and Body Approaches), and NCCIH’s participation in many trans-NIH FOAs, such as PA-18-876 (Advancing Mechanistic Probiotic/Prebiotic and Human Microbiome Research) and PA-18-141, PA-18-159 (Mechanisms, Models, Measurement, & Management in Pain Research). NCCIH-issued RFAs to support fundamental science research are typically one-time events to stimulate special and/or unique research topics of high program priority to NCCIH. Every concept for these special topic RFAs is individually brought to the attention of the NCCIH Advisory Council for review and concurrence. Examples of some recent RFAs include RFA-AT-19-008 (Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes), RFA-AT-18-003 (Discovery and Biological Signatures of Diet-Derived Microbial Metabolites), and RFA-AT-15-001 (Center of Excellence for Natural Product Drug Interaction Research). After the initial stimulation with set-aside funds, research related to these high program priority topics will be continued through existing and ongoing funding opportunities such as the various PAs described earlier.

In contrast, optimization research, translational research, and research related to technology, methods, and resource development involve more complex grants, typically requiring special review criteria and processes. These research programs are often started with an FOA with set-aside funds through RFAs or PASs, and then continued with program announcements with special reviews (PARs) without any set-aside funds. For example, PAR-18-114 (Phased Innovation Award for Mechanistic Studies to Optimize Mind and Body Interventions in NCCIH High Priority Research Topics, R61/R33, Clinical Trial Required) and PAR-18-115 (Innovation Award for Mechanistic Studies to Optimize Mind and Body Interventions in NCCIH High Priority Research Topics, R33, Clinical Trial Required) have been the main funding opportunities to support optimization research on mind and body approaches involving mechanistic clinical trials. PAS-18-120 and PAS-18-121 (Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions) are recent initiatives to support technology development and validation for mind and body interventions via the small business funding mechanisms.

The Basic and Mechanistic Research Branch also uses PAR-18-113 (Center of Excellence for Research on Complementary and Integrative Health, P01, Clinical Trial Optional) to support highly innovative, synergistic, impactful, and complex program project grants for fundamental science, optimization research, translational research, and/or technology development for complementary and integrative health approaches.

Purpose of Proposed Program

The purpose of this concept proposal is to support the development and continuation of complex initiatives for optimization research, translational research, and technology, methodology, resources, or special fundamental science research on complementary and integrative health approaches requiring special reviews without set-aside funds.

Objectives

The objective of this concept is to ensure continuous development of complex basic and mechanistic research programs that would require special reviews but without the need to have set-aside funds.