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Nutrition for Precision Health, powered by the All of Us Research Program: Research Coordinating Center (U24 Clinical Trial Not Allowed)
The purpose of this FOA is to invite applications for a Research Coordinating Center (RCC) to join the Nutrition for Precision Health consortium(https://commonfund.nih.gov/nutritionforprecisionhealth). The overall goals of the RCC are to provide administrative management and general coordination across the Nutrition for Precision Health consortium; facilitate the development and implementation of dietary intervention and assessment studies across the consortium; and manage relevant data. The RCC selected will work collaboratively, as part of the Nutrition for Precision Health consortium, to develop and implement research protocols and manage data sharing workflows. The RCC must also serve as a key partner with the All of Us Research Program, since it is anticipated that all participants enrolled in the Nutrition for Precision Health dietary studies will be participants in the All of Us Research Program, and all Nutrition for Precision Health data will be shared via the All of Us Researcher Workbench. The end products of the Nutrition for Precision Health consortium will be a rich data resource for research use and algorithms to improve the precision of nutrition advice for individuals.
- Letter of Intent: 30 days prior to the application due date
- Application: April 6, 2021
RFA-RM-21-006 Expiration Date April 7, 2021
Areas of Interest
Companion FOAs of the Nutrition for Precision Health Consortium
- RFA-RM-21-001: Nutrition for Precision Health, powered by the All of Us Research Program: Artificial Intelligence for Multimodal Data Modeling and Bioinformatics Center (U54 Clinical Trial Not Allowed). An Artificial Intelligence, Multimodal Data Modeling, and Bioinformatics Center will develop comprehensive dietary intervention algorithms that can predict biological responses.
- RFA-RM-21-002: Nutrition for Precision Health, powered by the All of Us Research Program: Metabolomics and Clinical Assay Center (U24 Clinical Trial Not Allowed). A Metabolomics and Clinical Assays Center will perform metabolomics analyses and other clinical assays on biospecimens.
- RFA-RM-21-003: Nutrition for Precision Health, powered by the All of Us Research Program: Microbiome and Metagenomics Center (U24 Clinical Trial Not Allowed). A Microbiome and Metagenomics Center will perform microbiome, metagenomics and metatranscriptomics analyses on stool samples for all participants.
- RFA-RM-21-004: Nutrition for Precision Health, powered by the All of Us Research Program: Dietary Assessment Center (U24 Clinical Trial Optional). A Dietary Assessment Center will support the application of innovative approaches to assess dietary intake.
- RFA-RM-21-005 : Nutrition for Precision Health, powered by the All of Us Research Program: Clinical Centers (UG1 Clinical Trial Required). Clinical Centers will engage, consent, and enroll participants from All of Us and conduct 3 diet modules (usual dietary assessment, a controlled feeding dietary intervention and a domiciled dietary intervention).
The set of six companion FOAs and existing All of Us Research Program components will establish the Nutrition for Precision Health consortium.
The PI/PD(s) must possess a doctoral degree and must have experience coordinating and leading large, multi-site clinical trials. Active participation of the PI(s) is expected during all phases of a clinical research study.
One individual must be designated as an Alternate PI(s), who is able to serve in the absence of the PI(s).
Together, the RCC PI(s) and staff should consist of a team of professionals with relevant expertise that must include biostatisticians and may include (as appropriate), but is not limited to: nutritional scientists, molecular biologists, bioinformaticians, dietitians, clinical trialists, as well as experts in study design and implementation. Together, the RCC PI(s) and staff should have the following minimum qualifications in terms of experience and expertise in:
- Planning, developing, and executing multi-site studies, and the special consent and IRB procedures needed for the conduct of dietary intervention research.
- A broad range of clinical trial study design and statistical expertise, particularly with nutrition-related research.
- Designing data collection systems, including distributed data entry, capabilities and experience with research performance and data quality control systems.
- Project management and knowledge of workflow and research team practices in implementation of clinical trials.
The NIH Common Fund intends to commit approximately $3,500,000 in FY2022, and $5,000,000 per year for years FY2023 through FY2026, which includes $2,500,000 per year for FY2023 through FY2026 for capitation costs.
Approximately one award is anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.