Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov) on behalf of the NIH.
UG1 Clinical Research Cooperative Agreements - Single Project
The purpose of this FOA is to invite applications for Clinical Centers (CC)s to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will support CCs to recruit participants and implement complex, modular protocols for dietary interventions studies. The CCs selected will work collaboratively with each other and other participating components of the Nutrition for Precision Health consortium to develop and implement study protocols. It is anticipated that all participants enrolled by the CCs into the Nutrition for Precision Health dietary studies will be part of 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.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| April 06, 2021 | Not Applicable | Not Applicable | June 2021 | October 2021 | December 2021 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The purpose of this FOA is to invite applications for Clinical Centers (CC)s to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will support CCs to enroll participants and implement complex, modular protocols for dietary interventions studies. The CCs selected will work collaboratively with each other and other participating components of the Nutrition for Precision Health consortium to develop and implement study protocols. It is anticipated that all participants enrolled by the CCs into the Nutrition for Precision Health dietary studies will be part of 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.
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
Applicants responding to this FOA are expected to familiarize themselves with the five other companion FOAs listed below since the CCs will be expected to communicate, coordinate, and collaborate with the awarded components of these FOAs.
Companion FOAs of the Nutrition for Precision Health Consortium
The set of six companion FOAs and existing All of Us Research Program components will establish the Nutrition for Precision Health consortium.
Background
Strategic plan for NIH Nutrition Research
The 2020-2030 Strategic Plan for NIH Nutrition Research (https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/strategic-plan-nih-nutrition-research) was released in 2020 and will guide NIH-supported nutrition research over the next decade. The Plan was organized around a unifying vision of precision nutrition research.
Research is needed to provide more precise and dynamic nutritional recommendations than currently possible through population-wide guidance. This in turn will facilitate a deeper understanding of how human biological systems and molecular pathways interact with or mediate the relationships among dietary patterns, environmental, social, and behavioral factors to influence health status. Through advances in -omic technologies and mobile devices combined with the large and diverse participant sample and existing infrastructure of the All of Us Research Program, innovations in artificial intelligence, machine learning, computational and mathematical modeling of complex biological systems an unprecedented opportunity exists currently to predict dietary responses and to design targeted dietary interventions aimed at improving health and quality of life.
The goal of the Nutrition for Precision Health, powered by the All of Us Research Program consortium (referred to as Nutrition for Precision Health in this document) is to develop algorithms that predict individual responses to foods and dietary patterns.
Nutrition for Precision Health, powered by the All of Us Research Program - Primary Aims
Enrollment: Nutrition for Precision Health will enroll All of Us participants through targeted enrollment. Participation in Nutrition for Precision Health is voluntary, and a participant’s decision whether or not to enroll in Nutrition for Precision Health will not affect the participant’s status as an All of Us participant. Nutrition for Precision Health will use a separate consent process from the All of Us Research Program, and, in order for a participant to enroll in Nutrition for Precision Health, they must already be enrolled in All of Us. All All of Us participants are currently adults and therefore it is expected that all Nutrition for Precision Health participants will be adults.
Data Collection, Generation and Integration: All data from the Nutrition for Precision Health study will ultimately be deposited in the All of Us Researcher Workbench, where it will be integrated with All of Us-collected data and made available for use by the scientific community. Data will be generated and collected by the Clinical Centers, Dietary Assessment Center, Microbiome and Metagenomics Center, and Metabolomics and Clinical Assays Center. These Centers will transfer raw and processed data to the Research Coordinating Center for further curation and processing. The Research Coordinating Center will coordinate with the All of Us Data and Research Center to deposit the data into the Researcher Workbench. Nutrition for Precision Health investigators, including the Artificial Intelligence, Multimodal Data Modeling, and Bioinformatics Center, will access Nutrition for Precision Health data in the Researcher Workbench. By leveraging existing data collection approaches, metadata standards, APIs, and other tools compatible with the Common Fund Data Ecosystem (CFDE; https://commonfund.nih.gov/dataecosystem), the Nutrition for Precision Health consortium will facilitate interoperability of Nutrition for Precision Health data with other large NIH datasets and interrogation across datasets (e.g., by using the CFDE workspaces), as allowed by data protection status.
Modular Discovery Science: Nutrition for Precision Health is a modular discovery science study.
Module 1 will follow approximately 10,000 participants for up to 14 days to examine baseline diet and physiological responses to the test meal challenge. Module 1 is anticipated to consist of two clinic visits approximately two weeks apart, with remote data collection during the study period.
Module 2 is expected to be a free-living controlled feeding study that will examine responses to three short-term (~14 days) intervention diets in approximately 1,500-2,000 Module 1 participants. Additionally, after each intervention diet, physiological responses to the test meal will be assessed.
Module 3 is expected to be a domiciled controlled feeding study that will examine responses to the same three short-term (~14 days) intervention diets in approximately 500-1,000 participants from Module 1. Additionally, after each intervention diet, physiological responses to the test meal will be assessed.
In all 3 modules, investigators will collect dietary, microbiome, physiological, metabolic, behavioral, cognitive, environmental, and contextual data, and leverage standard All of Us-collected genomic, electronic health, and survey data to model the impact of diet and dietary patterns on physiological responses.
Collaborative Aspect of the All of Us Research Program
All Nutrition for Precision Health awardees must work collaboratively to plan and execute a large precision nutrition study that will catalyze precision nutrition research in transforming the application of targeted dietary approaches to improve health and reduce chronic diseases. The product will be predictive algorithms that inform targeted dietary approaches.
This project will be embedded in the All of Us Research Program and will enroll All of Us participants. The All of Us Research Program is guided by a set of Core Values (https://allofus.nih.gov/about/core-values) that will also guide the Nutrition for Precision Health consortium.
Research Objectives and Requirements of this FOA: Clinical Centers (CC)s
Applicants responding to the CCs FOA are expected to familiarize themselves with the companion FOAs and the structure and functioning of the Nutrition for Precision Health Consortium outlined in the background section.
Timeline for the CCs: The first year of the Program represents an initial planning and coordination phase followed by a subsequent four-year implementation phase. During the planning phase, it is expected that the Program will reach consensus on plans for the implementation phase.
Functions of the CCs:
Formation and Governance of the Nutrition for Precision Health Consortium
The award(s) funded under this FOA will be a cooperative agreement(s). Close interactions amongst the awardee, awardees from the companion FOAs, awardees from existing All of Us components (Biobank, Data and Research Center, and Participant Technology Systems Center), and NIH staff will be required. Shortly after the award, the PDs/PIs and NIH program staff will form the Nutrition for Precision Health Steering Committee. Consortium governance rests with the Steering Committee and is subject to oversight by a trans-NIH Nutrition for Precision Health Working Group of the NIH Common Fund, which will include NIH representatives from the All of Us Research Program.
The NIH will appoint co-chairs of the Steering Committee from among the Nutrition for Precision Health PDs/PIs. The Steering Committee Co-Chairs will preside at all Steering Committee meetings and serve on an Executive Committee. The Executive Committee will assist as necessary with annual progress reports, and appoint and charge members of subcommittees. These subcommittees will facilitate development, implementation, and monitoring of specific Nutrition for Precision Health functions/activities as needed, such as recruitment and retention, participant engagement, biospecimen quality control, and publications and presentations. Representatives from various components of Nutrition for Precision Health consortium will be expected to serve on subcommittees as appropriate according to their expertise.
The Steering Committee will meet in person in Bethesda, Maryland twice during the first year and at least annually thereafter. Monthly teleconferences will be held for the Steering Committee and its subcommittees, and these may be more frequent at times to facilitate planning, etc. The RCC will be responsible for organizing and facilitating the meetings and teleconferences. Applicants should plan to attend an initial planning meeting of the Steering Committee in Bethesda, Maryland, to be held within 4 months of the initial award.
The Steering Committee will have responsibility for developing the overall scientific direction of the consortium, setting the policies and procedures for the governance of the consortium, assuring compliance with these consortium policies and procedures, designing study protocols, implementing studies, ensuring data quality and completeness, planning for analysis and interpretation of data, developing data sharing policies and reporting results in presentations and publications. The Steering Committee must work cooperatively and interactively during the first year to develop the final protocols and the materials necessary to begin the study twelve months after awards are issued. The final plan, with a study timeline and milestones, will be submitted for the consideration by the NIH Nutrition for Precision Health Working Group and the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) before the second year of funds will be awarded.
External Study Monitoring
Four to six External Program Consultants will provide input based on their individual areas of expertise as needed over the course of the program. They will assist the NIH Nutrition for Precision Health Working Group regarding processes and substantive issues that arise during the project and will help ensure that the resources to be delivered by the program are as useful as possible for the end users.
An independent Data and Safety Monitoring Board (DSMB) will be established to monitor and provide recommendations to the NIH regarding participant engagement/enrollment, safety, data quality, and other issues, as appropriate. The DSMB will also review the Steering Committee-approved common protocol, informed consent templates, milestones, and monitoring plans prior to the start of enrollment. A single central Institutional Review Board (IRB) should be used, per regulations at 45CFR 46.11, to streamline the protocol approval process and to standardize the monitoring of human subjects protection in Nutrition for Precision Health. The RCC will be responsible for developing and finalizing the Data and Safety Monitoring Plan and for managing DSMB and IRB logistics.
Common Fund Data Ecosystem
The NIH Common Fund (CF) programs are intended to provide resources that accelerate discovery across many different biomedical research fields. These resources include large data sets and associated digital tools needed to mine and analyze the data. To maximize their impact, data sets and tools generated by the CF programs must be usable together. Towards achieving this goal, the Common Fund created the Common Fund Data Ecosystem (CFDE), a data management infrastructure where the interconnected ecosystem facilitates scientific advances by ensuring CF data and digital objects are usable and useful both within a program and in combination with data from other programs. Aims of the CFDE are to enhance the ability to ask scientific questions; enable the uptake, reuse, and addition of data sets generated by the future, current and ended CF programs and support their sustainability; and educating the scientific community about available CF resources. The CFDE is composed of a CFDE Coordination Center (CFDE-CC) and the data coordinating centers (DCCs) of the participating CF Programs. CFDE teams will work towards standardizing the data deposition/structuring/handling to make data FAIR, adapting data and metadata standards to enable interoperability, and providing educational opportunities about the available CF resources to the scientific community.
New CF programs (e.g., Nutrition for Precision Health) are expected to engage in the CFDE from the start. This can be achieved by designing the program components such that they: i) construct a data infrastructure which ensures FAIRness of the data, and ii) adapt the appropriate data and metadata standards to enable interoperability of the generated data with other data sets. The Nutrition for Precision Health Research Coordinating Center will be the primary point of contact with the CFDE. Applicants are expected to discuss their plans for ensuring compatibility with the CFDE and other Common Fund datasets and resources (e.g., via the CFDE portal, Metabolomics Workbench and the MoTrPAC Data Hub) in their application.
Leveraging STRIDES for Cloud Computing Activities
The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) initiative has established partnerships with commercial cloud service providers (CSPs) Google and Amazon Web Services (AWS) to provide favorable pricing for cloud-based costs. The NIH Common Fund, managed by the Office of Strategic Coordination, is using the STRIDES partnerships to provide in-kind support for CSP costs. For more details, please see NOT-RM-20-009.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NIH Common Fund intends to commit approximately $7,000,000 in FY2022, and $9,500,000 per year for FY2023 through FY2026.
Approximately five-six awards are anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.
Application budgets must reflect the actual needs of the proposed project. It is anticipated projects proposing to participate in all three study modules and/or with higher participant capacities may require higher budgets than other applications.
The maximum project period is five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Eligible Agencies of the Federal Government, including the NIH Intramural Program
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PI/PD(s) must possess a doctoral degree in a relevant field such as nutrition, medicine or physiology. The PD/PI(s) must have experience in leading large dietary intervention studies, multi-site clinical trials and recruiting diverse populations. Active participation of the PD/PI(s) is expected during all phases of a clinical research study.
One individual must be designated as an Alternate PD/PI(s), who is able to serve in the absence of the PD/PI(s). The alternate PD/PI(s) must also possess a doctoral degree in a relevant field such as nutrition, medicine, or physiology.
Together, the CC PD/PI(s) and staff should consist of a team of professionals with relevant expertise that may include (as appropriate), but is not limited to: nutritional scientists, biostatisticians, bioinformaticians, dietitians, physicians, as well as experts in study design and implementation. It is required than an All of Us Research Program Investigator (https://allofus.nih.gov/funding-and-program-partners/health-care-provider-organizations) and a Registered Dietitian be part of the research team, and applicants are encouraged to involve Early Stage Investigators as part of the research team, as appropriate. Together, the CC PD/PI(s) and staff should have the following minimum qualifications in terms of experience and expertise in:
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Email: nutrprechealth@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Facilities and Other Resources
The application must contain information on access to and capacity per week, month or year of any metabolic kitchen and/or domiciled feeding center, as appropriate to the study modules being proposed in the application.
Other Attachments: The following item should be included as attachments under Other Attachments.
Consortium Assurance: The filename "Consortium Assurance.pdf" should be used.
The PD/PI should provide a letter stating his/her willingness to participate in Consortium activities, including sharing the scientific portion of the application, participating in meetings at the NIH and regular conference calls and abiding by approved Consortium policies, following all common elements in the protocol agreed to during the planning phase, providing clinical data to the Research Coordinating Center (RCC) in approved formats, and submitting biospecimens for storage at the All of Us Biobank throughout the study. In the letter, the PD/PI may discuss past experiences participating in multi-center studies.
In addition, the PD/PI and an authorized Institutional Official must provide evidence that the Institution is willing to sign a standard reliance agreement and use the single IRB proposed by the RCC, if required, as part of its application, in accordance with NIH policy on the use of a single Institutional Review Board for multi-site research, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The budget for the first year will be for participation with the Steering Committee, in study planning activities, and preparation for the clinical study only. This should include minimal personnel costs and travel to one Steering Committee Meeting.
Applicants should budget based on their proposed protocols. However, it is understood that final budget numbers will reflect the common study protocol developed and approved by the Steering Committee that all Clinical Centers must implement.
Appropriate travel funds must be included in the proposed budget to support travel for at least one Clinical Center PD/PI to participate in an Annual Steering Committee Meeting.
Budgets should not include participant incentives (participant incentives will be provided via capitation from the Research Coordinating Center).
The CC’s F&A rates on the initial competitive awards will not be adjusted in future years due to changes in their negotiated rate agreements.
Applicants who anticipate requiring >$10,000 direct costs in commercial cloud services from either Google or AWS in any one year of the anticipated award are expected to request in-kind support via the Common Fund STRIDES partnerships rather than requesting direct cost support for these services. To request in-kind support for cloud services via STRIDES, applicants must outline the anticipated costs of commercial cloud services in the Budget Justification section, including, but not limited to, data storage, analysis, data movement/egress, professional services, scientific education and outreach, and related activities. Please review NOT-RM-20-009 for important details about how to provide this information in your application.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: The overall goal is to facilitate Nutrition for Precision Health, Powered by All of Us Research Program by enrolling All of Us Research Program participants and implementing Modules 1, 2 and/or 3 (described above). Applicant should describe how they will participate, or not, in each Module, and this will include capacity (participants per week, month or year). Applicants should describe how they plan to enroll participants and implement each module proposed. Applicants should also describe how the proposed CC will achieve the CC functions as described in Section I. Funding Opportunity Description.
Research Strategy: Applicants should describe how the proposed CC will fulfill the functions of the CC as described in Section I. Funding Opportunity Description, including enrollment of All of Us participants, the mixed-meal test challenge (Modules 1, 2 and 3) and three isocaloric dietary interventions proposed along with necessary washout periods (Modules 2 and 3), and collaboration with other components of the Nutrition for Precision Health consortium. Applicants should note that the applicant’s demonstrated capacity to perform the functions of a Clinical Center, the experience of applicants relevant to preforming the functions of the Clinical Center, and the proposed enrollment plan will be emphasized in review. The final common study protocol implemented by all CCs beginning in year two will be developed and decided upon by the Nutrition for Precision Health Steering Committee (SC), in which the CCs will have membership.
Applicants should address the following aspects of their proposed studies:
Letters of Support:
Include letters of support from partnering institutions, appropriate leaders of institutional component services, or outside collaborators with statement of roles/responsibilities. The application must include a statement from the applicant institution (senior institutional official) describing the commitment to the planned program, senior and junior investigators, research staff, and infrastructure needed.
A letter of assurance of cooperation with the policy for capitation of research costs as outlined below should be provided from the departmental and institutional offices of sponsored research programs.
To receive per participant capitation for participant incentive costs, a funded CC must set up an agreement with the Nutrition for Precision Health Research Coordinating Center.
The CC PD/PI or designee will be required to help the Research Coordinating Center manage protocol costs. The PD/PI or designee should propose estimates of enrollment efforts for each protocol to the Research Coordinating Center and update these at least annually.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed,
with the following additional instructions:
Section 2 - Study Population Characteristics
2.5 Recruitment and Retention Plan
A detailed explanation of how enrollment plans achieve All of Us Research Program diversity and inclusion goals (https://allofus.nih.gov/about/diversity-and-inclusion) and how the CC will interact with of Us Research Program. Plans for participant retention and anticipated dropout rate should also be addressed.
Section 4 - Protocol Synopsis
4.3 Statistical Design and Power
The applicants should describe the study designs for Module 1, Module 2, and Module 3 (if proposed). This should include details on washout periods and randomization for Modules 2 and 3 which are both cross-over dietary intervention studies (if proposed). This should also include expected dropout rates at pivotal points for each Module, for example between Module 1 and each of 2 or 3, and during washout periods between dietary interventions in Modules 2 and 3. Further, applicants should describe plans to account for participant drop-out and other forms of missing data.
There are special considerations when addressing Statistical Design and Power for this FOA because Nutrition for Precision Health is a first of its kind, modular discovery science effort in precision nutrition. Applicants will have proposed baseline measures, dietary interventions, and outcomes which will include measures and physiological response to a test meal using scientific justification elsewhere in the application. Ultimately the exact baseline measures, dietary interventions, and outcomes measured will be decided upon by the SC and may vary from those proposed by the applicant. Further, the desired result of Nutrition for Precision Health is that there will be responders (defined as a change in some proposed measure) and non-responders (no change to a proposed measure) to each dietary intervention, that responders and non-responders will vary by baseline characteristics, dietary intervention and across outcome measures, and that this discovery data will be used to build an a yet-to-be-determined Artificial Intelligence-driven algorithm for predicting dietary response. Therefore, traditional power analysis approaches to determining a targeted sample size would not be appropriate in this context. The application should instead focus on quantifying detectable differences between intervention groups respective responders and non-responders, assuming a range of values for the variability in proposed measures supported in part by prior publications or data.
For Module 1 the applicants should describe important subgroups of participants (ex., those with low microbiome diversity, poor diets and poor diets or obesity at baseline) that are anticipated to have a differential response to the proposed mixed-meal test based on the expected distribution of these subgroups for participants enrolled at their CC. For the proposed primary outcomes, applicants should then provide power estimates for detecting differences between these important subgroups assuming a total sample size of 10,000 participants (Note: a CC will not be expected to enroll all 10,000 participants, this is just guidance for ease of calculating power; a CC will be expected to characterize their own enrolled cohort’s expected distribution of baseline subgroups). Expected minimally-detectable differences and how such differences may vary by baseline subgroups should be justified by the literature and/or historical data from an applicant’s experience, and sufficient detail should be included so that peer reviewers can confirm these calculations independently.
For Modules 2 and/or 3 (if proposed) the applicants should describe important subgroups of participants (ex., those with low microbiome diversity, poor diets or obesity at baseline) that are anticipated to have a differential response to the proposed three dietary interventions on the expected distribution of these subgroups for participants enrolled at their CC. For the proposed primary outcomes (which can include measures and measures of physiological response to the mixed-meal test), applicants should then provide power estimates for detecting differences between these important subgroups assuming a total sample size of 1,500 for Module 2 and 500 for Module 3 participants (Note: the specified total sample sizes should just serve as a guide for ease of calculating power, and how it may be impacted by an applicant’s expected distribution of baseline subgroups). Expected minimally-detectable differences per baseline subgroup should be justified by the literature and/or historical data from an applicant’s experience and sufficient detail should be included so that peer reviewers can confirm these calculations independently.
Applicants should also discuss using sets of outcomes (e.g., microbiome and physio-metabolic phenotyping measures) for which controlling a false-discovery rate might be appropriate, and be explicit on plans for handling incompletely-assessed sets of outcomes using principled missing-data methods. If applicants propose to elicit subgroups or latent classes (including latent transitions or growth curve / trajectory groupings) from post-baseline measures, some approach that considers false discovery rates and/or power to delineate subgroups should be specified AND supported by citation(s) from the peer-reviewed literature.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applications Involving the NIH Intramural Research Program
Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, the requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above and as described in the NIH Intramural Source Book.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
For this particular announcement, note the following:
The Clinical Center will participate in a multi-center, dietary intervention study called Nutrition for Precision Health, Powered by the All of Us Research Program (NPH).
The common study protocol will be developed in coordination with the other Clinical Centers, the Research Coordinating Center, and other members of the NPH Steering Committee during the first year of the award and implemented by all Centers beginning in year 2.
The first year will serve as a planning year.
Every Clinical Center is expected to participate in Module 1. Applicants will also propose how they would participate and conduct Module 2 or Module 3 (or both). The proposed budgets should reflect the proposed studies.
Importantly, the capacity of applicants to perform the functions of a Clinical Center, the experience of applicants relevant to preforming the functions of the Clinical Center, and the proposed enrollment plan should be emphasized in review.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition:
Do PD(s)/PI(s), collaborators, and other researchers have appropriate time planned to execute their roles? Do they have demonstrated experience in conducting dietary intervention studies? Do they have demonstrated experience in being part of a multi-center, multi-component, collaborative study where a common protocol was developed and implemented? If domiciled feeding studies (Module 3) are proposed, do they have demonstrated experience in conducting domiciled feeding studies? Do they have experience enrolling diverse participants? Does the applicant demonstrate the ability to collaborate with the All of Us Research Program?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition:
Is the plan to enroll participants from the All of Us Research Program, including how applicants will interact with the All of Us Research Program to do so, adequate? Is the enrollment strategy feasible and aligned with the All of Us Research Program? Are plans for participant retention and anticipated dropout rates appropriate? Reviewers will comment on whether the Data Sharing Plan is reasonable.
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
In addition: Is the mixed-meal challenge for Modules 1, 2 and 3 appropriate? Does the applicant provide a strong rationale for the three isocaloric dietary interventions with washout periods for Modules 2 and 3 (as applicable), and proposed measures and outcomes? Applications that include animal models will be considered non-responsive.
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
If proposing to conduct Modules 2 and/or 3, how appropriate are the food service resources, including metabolic kitchens? If proposing Module 3, how appropriate are the dedicated resources for domiciled feeding?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Consortium Activities
Have the investigators stated their willingness to collaborate with NIH scientists and staff, and with investigators and staff from other components of the Nutrition for Precision Health consortium, including the All of Us Research Program? Have the investigators stated a willingness to participate in planning the study and to implement common study protocols? Have the investigators agreed to uphold to the All of Us Research Program Core Values (https://allofus.nih.gov/about/core-values), and Privacy and Trust Principles (https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles)?
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIH Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by National Advisory Child Health and Human Development Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the \\"responsible party\\" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below
Roles and Responsibilities & Management Strategy
1. PD(s)/PI(s) Responsibilities
The PD(s)/PI(s) will have the primary responsibility for:
2. NIH Staff Involvement
Definitions
For each individual award, NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH will designate program staff, including a Program Officer and a Grants Management Specialist to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer and Grants Management Specialist will be named in the Notice of Grant Award. NIH staff may have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
3. Areas of Joint Responsibility
Close interaction among the participating investigators will be required, as well as significant involvement from the NIH during each phase of the program. The awardees, the PSs, and other designated NIH Staff will participate in the annual in-person investigator meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as data and preliminary results. PDs/PIs, key co-investigators and students and postdoctorates, including those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings. EPCs will attend the annual in person meetings. Other government staff may also attend the annual investigators meetings.
The SC will serve as the main scientific body of the consortium, with the following roles:
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. The panel will have three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Ashley Vargas, PhD, MPH, RDN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-6030
Email: ashley.vargas@nih.gov
Elaine Sierra-Rivera, Ph.D.
Center for Scientific Review (CSR)
301-435-1043
Email: riverase@mail.nih.gov
Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.