Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)

This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this NIDCD R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites grant applications for Education and Research Centers (ERCs) that are focused on occupational safety and health training. NIOSH is mandated to provide an adequate supply of qualified personnel to carry out the purposes of the Occupational Safety and Health Act, and the ERCs are one of the primary means for meeting this mandate. ERCs are academic institutions that provide high-quality interdisciplinary graduate and post-graduate training, research training, continuing education, and outreach in the core occupational safety and health disciplines of industrial hygiene, occupational health nursing, occupational medicine, and occupational safety, as well as allied disciplines. Research and research training are integral components of ERCs, with ERC faculty and NIOSH trainees conducting research on issues related to the NIOSH National Occupational Research Agenda (NORA) and emerging issues to advance the field of occupational safety and health. NIOSH ERCs have regional presence to further diversify the occupational safety and health profession through their core values, mission statements, and outputs. ERCs serve as resources for our nation's workforce through continuing education, outreach and strong collaboration with professional associations, worker advocacy groups, businesses, industries, and public health agencies. ERCs work with other institutions and organizations, including Minority Serving Institutions and other NIOSH supported training programs to have a positive impact on worker health, safety, and well-being.

The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD.

This notice of funding opportunity (NOFO) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this NOFO are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial. The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multisite clinical trial that has the potential to make a significant impact on public health.

The purpose of this NOFO is to enhance the capability of NCATS CTSA Program KL2 scholars and recipients of re-entry supplements supported by the CTSA Program to conduct research as they complete the transition to fully independent academic translational scientists. These R03 grants will support different clinical and translational science research projects, including pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Research proposed in the R03 application may or may not include patient-oriented research. The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that provide preliminary data to support submission of a subsequent R01, or equivalent, application.