Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
U24 Resource-Related Research Projects Cooperative Agreements
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) will support a Coordinating Center to facilitate coordination across the consortium of multiple individual research project grants for the Metabolic Dysregulation and Cancer Risk Program (U24; RFA-CA-21-022) whose overarching goal is to enhance our knowledge of the dynamics, and underlying mechanisms, that link obesity, metabolic dysregulation, and increased cancer risk.
The Coordinating Center will have several responsibilities, including, but not limited to: provide administrative support to the Metabolic Dysregulation and Cancer Risk Program, facilitate and participate in collaborative research, coordinate the development of standard operating procedures and best practices to identify common measures/targets, collect core common data elements and biological samples (when appropriate), facilitate communication across researchers, provide meeting support, coordinate reviews of cross-consortium pilot project applications and/or activities, create and maintain the website, and facilitate deposition of data to NIH repositories (when appropriate).
September 6 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 06, 2021 | Not Applicable | Not Applicable | March 2022 | May 2022 | July 2022 |
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.
No late applications will be accepted for this Funding Opportunity Announcement
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
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) solicits applications for a Coordinating Center to facilitate coordination and collaborative research among multiple individual research project grants (see companion RFA-CA-21-021; U01) as part of a Consortium for the Metabolic Dysregulation and Cancer Risk Program.
Overall Goals of the Metabolic Dysregulation and Cancer Risk Program: to identify tangible mechanistic/etiologic pathway(s) that link obesity-related metabolic dysregulation with cancer risk to inform cancer prevention strategies.
Short-term goals of the Program include:
Applicants responding to this Coordinating Center FOA are expected to familiarize themselves with the companion FOA (RFA-CA-21-021; U01) and the features associated with the individual research project grants and the research objectives as well as the related activities and individual and joint responsibilities required for all Awardees of the Metabolic Dysregulation and Cancer Risk Program.
Key Terms and Definitions for this FOA
Background
The obesity-cancer link is a pressing concern due to the escalating prevalence of obesity. Obesity can be conceptually viewed as a disease-susceptible state and, of relevance, a metabolically dysregulated state. This state of disease predisposition has the potential to progress to cancer and other chronic pathologies. The Metabolic Dysregulation and Cancer Risk Program initiative seeks to support research projects to identify critical mechanistic/etiologic pathway(s) that link obesity-related metabolic dysregulation with cancer risk to inform cancer prevention strategies. The initiative intends to foster transdisciplinary research that cuts across different scientific domains to allow investigators from multiple disciplines to come together to advance discovery, translation of current knowledge or emerging findings, and ultimately extend our understanding on the mechanisms linking metabolic dysregulation and obesity-associated cancer risk. A Consortium (comprised of funded investigators for the individual research grants, the Coordinating Center, and NCI Program Staff) will be established and governed by a Steering Committee. Awardees of funded research project grants and the Coordinating Center will be expected to participate in this Consortium, engage in efforts to optimize synergy across projects, and to collaborate in pilot projects that may emerge within the Consortium.
This FOA seeks to support a Coordinating Center to facilitate communication, synergy, and integrate efforts across the individual research projects to facilitate cross-fertilization and transdisciplinary research. The Coordinating Center provides administrative, meeting, and scientific support to achieve the goals of the Metabolic Dysregulation and Cancer Risk Program as described below.
Specific Research Objectives and Requirements
General Requirements for the Coordinating Center
The Coordinating Center will have a central role in integrating the efforts of individual research project grants to be funded under its companion FOA (RFA-CA-21-021; U01).To fulfill this role, the Coordinating Center applicant team must demonstrate substantial experience in: (1) coordinating large multi-site programs, (ii) providing logistical infrastructure for such programs, and (iii) coordinating collaborative research that emerges from cross-fertilization of scientists across multiple disciplines.
The Coordinating Center will be expected to handle the operation logistics, contribute scientific inputs as participating member of the Consortium, and provide administrative and analytical support for individual research project grants. The Coordinating Center will work with Awardees of the individual research project grants and NCI Program Staff to bring together expertise and data relevant to the funded research and to meet the Consortium’s goals outlined above. The Coordinating Center should be able to connect available resources and serve as a research data management center.
The Coordinating Center will be expected to identify and support the integration of activities of the awarded individual research project grants to minimize resources/effort duplication and utilize existing resources available. The Coordinating Center will have substantial responsibility for the continued self-evaluation of research awardees and the evaluation of the entire Metabolic Dysregulation and Cancer Risk Program.
Applicants must have appropriate professional expertise and experience in the areas defined above. The applicant institution must have the necessary facilities to meet the special requirements mentioned in the FOA. The same institution may submit applications to this U24_RFA and its companion U01,RFA-CA-22-021, so long as there is no overlap regarding investigators and direct cost funding.
Strategic Goals for the Coordinating Center
The Coordinating Center applicant team should be cross-disciplinary with expertise aligning with the topic areas of the Metabolic Dysregulation and Cancer Risk Program. The Coordinating Center must address the following strategic objectives:
Required Structure and Main Components of the Coordinating Center
All applicants must address the following main features:
1a. Leadership and Administration. The Coordinating Center must be able to provide close coordination of transdisciplinary research efforts of the Metabolic Dysregulation and Cancer Risk Program. This role will require strong leadership, scientific insight, and capacity to bring diverse teams together.
Because of the central requirement for interactions across the Metabolic Dysregulation and Cancer Risk Program, the Coordination Center will be responsible for the following activities:
1b. Logistic and Administrative Responsibilities. In addition to scientific and leadership support of the Metabolic Dysregulation and Cancer Risk Program, the Coordinating Center must be able to provide logistic and administrative support to each research project grant funded under the companion RFA-CA-21-021, and other activities, including but not limited to:
2. Data and Bioinformatics. The Coordinating Center will be responsible to develop a Central Data Hub (Bioinformatics Core) and provide bioinformatic support as needed and in collaboration with research awardees. The main goal of this component is to facilitate data sharing and results dissemination across awardees and between awardees and NCI.
The Bioinformatics Core support must provide infrastructure for data collection and archiving to meet standards for common data systems and future data repositories. Specifically, informatics and data sharing approaches proposed for the Coordinating Center must be compliant to all NIH data sharing policies.
It is expected that this Core will strongly involve resources and personnel that will interact with the funded individual research project grants.The data management functions of the Coordinating Center may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site.
3. Outreach. The Coordinating Center must include an outreach program that is integrated across all individual research project grants. Plans for this component must include the following elements:
4. Collaboration Core. Awardees of the Metabolic Dysregulation and Cancer Risk Program are required to participate in cross-Consortium activities (see Section VI.2, Cooperative Agreement Terms, and Conditions of Award for further details). The Coordinating Center will be responsible for coordinating cross-Consortium activities (i.e. collaborative research to be developed and conducted by awardees post-award). Funding for cross-Consortium activities, including pilot projects, will be supported in part by restricted Collaborative Funds (See below and Section II.R&R and Modular Budget for further details). Specifically, plans for this Collaboration Core include the following, but are not limited to:
Collaborative Funds for Developmental/Pilot Projects
Collaborative Funds (see Section IV.2. R&R and Budget for further details) can be used to support the expansion or inclusion of an exploratory aim to incorporate identified common measures or targets, develop new methodologies that can be validated via multiple grants, or facilitating diverse study population. This restricted fund may be combined with other award recipients' Collaborative Fund. Collaborative Funds may also be used to fund cross-Consortium pilot projects or developmental ideas with one or more award recipients within the Consortium and may involve outside investigator(s) (not recipient within the Consortium). The outside investigator(s) must bring a desirable expertise that is not already part of the Consortium and must meet the purpose of the Metabolic Dysregulation and Cancer Risk Program. The inclusion of outside investigators will require appropriate justification and approval from the Steering Committee. Proposed pilot projects without the inclusion of other award recipients are considered ineligible for the use of Collaborative Funds. Collaborative Funds should not be used for activities that have been supported under the awards for individual research project grants and outside the scope of the outlined goals of the initiative. Usage of Collaborative Funds to enable conduct of multi-year cross-consortium pilot project or activities are allowable. The Coordinating Center may choose to use its Collaborative Fund to provide educational opportunities (e.g. travel awards) for early-stage investigators or students to the Consortium's meetings.
5. Integration and Self Evaluation Core. The Coordinating Center must have the capacity to enable timely self-evaluation mechanisms promoting effective self-correcting actions. In this area, the Coordinating Center will have to closely collaborate with the Steering Committee (see below) and possibly other members of the funded research project grants, and NCI program staff. An appropriate evaluation system is expected to be integrated into the Coordination Center’s design and operations.
This self-evaluation system should track the relevant performance benchmarks of the consortium, taking into consideration the individual accomplishment of each research project grant and any collaborative endeavors. The outcomes will help Steering Committee and individual awardees to take corrective steps and optimize their performance.
The self-evaluation of the Awardee (and the activities of this component) will be essential to facilitate and enhance the overall evaluation of the Consortium, to be determined by NCI. The Coordinating Center (and specifically this Integration and Self-Evaluation Core) will be expected to cooperate with NCI in the evaluation process. For example, this component includes evaluating the quality and innovativeness of the science conducted by the individual research project grant as well as assessing critical intermediate indicators of success such as infrastructure development and capacity building, cross-fertilization, linkages and resource sharing arrangements within and among the consortium, and the interdisciplinary and multilevel nature of the research. Evaluation variables may include items such as peer-reviewed publications, developed web sites, joint collaborative grants submitted for funding outside of the Consortium, or other new collaborations and partnerships.
Areas for the self-evaluation and desirable outcomes will include such aspects as:
Overall Structure of the Metabolic Dysregulation and Cancer Risk Program
The Metabolic Dysregulation and Cancer Risk Program will include Awardees of the individual research project grants (RFA-CA-21-021) with scientific expertise that cuts across basic science, metabolism, oncology, epidemiology, and intervention/prevention research and the Awardee of the Coordinating Center. Awardees should identify shared resources that can support needs across the Consortium and optimize synergy and facilitate the collaborative nature and impact.
Upon successful funding, members of the Consortium will be required to participate in a virtual kick-off meeting which will take place within 30 days of the release of the Notice of Award (NOA). Awardees will be required to attend a yearly face-to-face annual meeting and other topic-specific smaller meetings (as appropriate) for the exchange of scientific information across the Consortium. The Coordinating Center, in conjunction with NCI staff, will facilitate cross-Consortium collaborative activities among the individual research project grants and identified partners. The Metabolic Dysregulation and Cancer Risk Program will be governed by a Steering Committee comprised of representatives from the funded individual research grants, the Coordinating Center, and NCI Program Staff.
Governance
The Steering Committee will be comprised of the PI of each individual research grant, the PI of the Coordinating Center, and NCI Program Staff. Though the Steering Committee will make recommendations, NCI Program Staff will have final authority to approve or reject any proposed recommendations. All consortium-related activities must comply with NIH, DHHS, and Federal Guidelines.
Additional details on the composition and functions of Steering Committee are provided in Section VI.2, Cooperative Agreement Terms, and Conditions of Award.
Non-Responsive Applications
The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewe
NOTE: Applicants to this FOA or the companion RFA-CA-21-021 are strongly encouraged to attend at least one of two planned pre-application webinars sponsored by the NCI and contact the designated NCI Program staff as soon as possible in the development of the application (preferably no later than 12 weeks prior to the application due date) to discuss the details of their proposed study so that NCI staff can help the applicant understand whether the study is within the goals and mission of the Institute and is appropriate for this FOA.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIH intends to fund one award, corresponding to a total of $800K, for fiscal year 2022.
Application budget may not exceed $550,000 in Direct Costs per year and must reflect the actual needs of the proposed project .
The total project period may not exceed 5 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not 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.
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 NCI 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:
Tram Kim Lam, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6967
Email: [email protected]
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.
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.
Restricted Collaborative Fund for cross-Consortium activities: To facilitate synergy within the Consortium and to achieve unmet scientific priorities of the Metabolic Dysregulation and Cancer Risk Program, Awardees of the Metabolic Dysregulation and Cancer Risk Program must budget appropriate funds designated as "Collaborative Fund to facilitate cross-Consortium activities (see Section I.Collaboration Core and Section VI.2, Cooperative Agreement Terms and Conditions of Award). Specifically for the Coordinating Center, $25,000 in direct cost per year must be allocated as Collaborative Fund (and should be presented in the Other Expenses category under the heading "Collaborative Fund"). During Year 1 of the award, flexibility is allowable for modification of Specific Aims and associated milestones. Carryover of Year 1 Collaborative Fund is permitted with approval from NCI Program Staff. Collaborative Fund cannot be rebudget and unobligated fund, in any year, may be offset as per the recommendation from NCI Program Staff.
Travel Funds: The budget should include funds to support travel for Consortium-related activities, including but not limited to supporting the participation of PD(s)/PI(s) and other team members in annual meetings and/or ad hoc meetings related to the Consortium. Specifically, applicants will be required to budget for a key personnel and team members/ collaborators (in aggregate, up to three members) to attend one annual face-to-face investigator meeting.
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. Present the overall vision of the Coordinating Center to meet the needs of the Consortium and to advance the goals and objectives of the Metabolic Dysregulation and Cancer Risk Program. Specific aims should address the required structure and main components as described in Section I.2.
Research Strategy: Applicants must organize the Research Strategy to include the following subsection elements. Applicants may include other sub-sections as needed but must include the information requested below.
Sub-section A: Background and Significance
The applicant should describe:
Sub-section B: Innovation
Critical to the success of the Consortium is optimizing synergy across members and to identify cross-Consortium activities, including pilot/developmental project(s) and/or integration of common measures/targets, which could not be pursued by individual U01 research sites. Describe how the proposed application works to facilitate and optimize this opportunity.
Sub-section C: Approach
Provide a detailed overview of the proposed Coordinating Center. Description of the administrative and scientific responsibilities should include, but not be limited to, the following features:
Inclusion of the following components is recommended.
Developmental Cross-Consortium Coordination
The applicant should describe, though not be limited to:
Resource and Data Sharing and Bioinformatics
The applicant should describe, though be not limited to:
Education and Outreach
The applicant should describe, though not be limited to,:
Internal Evaluation
The applicant should describe:
Letters of Support: Applicants must include letters of support from collaborating entities that are essential to the mission of the work proposed.
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:
Note: NCI Program Staff may negotiate modifications to these plans prior to funding or post-award.
Intellectual Property Policy: Consistent with achieving the goals of this program and maximizing the benefit of all research funded as part of the Consortium for the improvement of public health through discoveries of the scientific community, the Data Sharing and Data Release policies expect a broad freedom-to-operate for all users of data generated by members and/or collaborators of the Consortium (e.g., by rapidly making data and results available in the public domain).
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.
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.
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.
For this particular announcement, note the following:
In determining the merit of applications, reviewers will emphasize the applicants' capabilities and plans in terms of the stated scientific, technological, and organizational requirements.
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?
Specific to this FOA: How well does the proposed application address the needs of the Consortium that it will coordinate? How well does the scope of the application's proposed approaches meet those needs? Do the proposed aims sufficiently advance the operations of the Consortium to meet the goals and objectives of the Metabolic Dysregulation and Cancer Risk Program?
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?
Specific to this FOA: Are the Coordinating Center investigators and key personnel well-qualified for participating and managing multi-site collaborations and facilitatingg interactions and communication among investigators and staff from multiple institutions to optimize synergy? Are the backgrounds, diverse expertise, and commitments of the PDs/PIs and other key personnel sufficient for the proposed scope of activities and in line with the goals and objectives for the 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?
Specific to this FOA: How innovative are the proposed approaches and scope of activities to optimize communication and synergy within the Consortium? Are the proposed approaches innovative to facilitate cross-Consortium activities, including identifying common measures/targets between the diverse research projects or pilot projects, and advance the goals and objectives of the initiative?
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?
Specific to this FOA:
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?
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.
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
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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 NCI, 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.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NCI. 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 the National Cancer Advisory Board. 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.
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 the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 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 recipients 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.
The PD(s)/PI(s) will have primary responsibility for:
The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the proposed research in accordance with terms and conditions of the award.
All PD(s)/PI(s) of the Metabolic Dysregulation and Cancer Risk Program (Coordinating Center and individual research projects) will have primary responsibility for:
The PD/PI responsible for the Coordinating Center will have the following additional responsibilities:
The Consortium will be subject to periodic internal evaluation (coordinated by the Coordinating Center and NCI Program staff). Awardees will be expected to participate in such evaluations.
All Consortium awardee institutions/organizations will be expected to share with other awardees knowledge, data, research materials, and any other resources necessary and relevant to the Consortium.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
One or more NCI Program Directors will be substantially involved in the Consortium as NCI Project Scientists/Collaborators. NIH Project Scientists/Collaborators will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards.
NCI Project Scientist/Collaborator(s) will have the following, though not limited to, responsibilities to all Consortium recipients:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to those recipients' institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NIH Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.
Areas of Joint Responsibility include
A Steering Committee will serve as the governing board for the Consortium. The Steering Committee will have primary responsibility for:
The Steering Committee will be comprised of the following voting and non-voting members:
Other relevant details, including:
Cross-consortium Activities:To facilitate synergy within the Consortium to achieve unmet scientific priorities of the Metabolic Dysregulation and Cancer Risk Program, recipients are required to participate in cross-Consortium activities and identified pilot projects as recommended by the Steering Committee. The cross-Consortium activities (see Section 1. Collaborative Funds for Developmental/Pilot Projects for further details) will be developed and conducted by recipients at post-award as part of the Collaboration Core coordinated by the Coordinating Center. Funding for the cross-Consortium activities will be supported in part by set-aside Collaborative Funds.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to Dispute Resolution. The Dispute Resolution Panel will have three members: one NCI designee and two designees with expertise in the relevant area, chosen by the Steering Committee. 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: [email protected] (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: [email protected]
Tram Kim Lam, PhD, MPH
Division of Cancer Control and Population Sciences, NCI
Telephone: 240-276-6967
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]
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.