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
This Funding Opportunity Announcement (FOA) is associated with the U01 PDAC Stromal Reprogramming Consortium (PSRC) RFA-CA-21-041.The purpose of this FOA is to create a U24 Coordinating and Data Management Center (CDMC) that will support the overall coordination and research aims of the PSRC Research Projects. This FOA solicits U24 cooperative agreement applications from appropriate multidisciplinary groups that can assemble the appropriate infrastructure to facilitate and implement the administrative, outreach, collaborative and data management activities of the PSRC.
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 |
| November 01, 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
The purpose of this Funding Opportunity Announcement (FOA) is to create a U24 Coordinating and Data Management Center (CDMC) that will support the overall network coordination and advance multidisciplinary basic/mechanistic biology and preclinical/translational research of the U01 PDAC Stromal Reprogramming Consortium (PSRC) (RFA-CA-21-041). The U24 CDMC will help to integrate, manage, and coordinate the activities and basic/mechanistic and preclinical/translational research initiatives of the PSRC, as well as facilitate collaborations with closely aligned NCI-sponsored programs and resources.
The CDMC will be responsible for many administrative, outreach, collaborative, and data management activities as it optimizes the functionality of the PSRC (see Key Requirements of the PSRC CDMC ). The primary goal of the CDMC is to assist the PSRC to function as a thriving collaborative network by facilitating cross-network research efforts, coordinating pilot projects, and completing network-wide analyses and reports. The CDMC will facilitate the implementation of network-specific cross-cutting working groups dedicated to addressing trans-PSRC areas of importance in achieving its research goals. In conjunction with PSRC investigators, the CDMC will provide assistance with bi-directional bridging between basic, preclinical, and clinical science through collaborating with and leveraging closely aligned NCI-sponsored programs and resources. The CDMC will provide data management and analytical assistance to best support the needs of PSRC investigators and the network’s research aims. The CDMC will develop outreach opportunities to promote the exchange of scientific outcomes both within PSRC and between PSRC and the public through online portals, patient advocacy initiatives, sharing of PSRC data and resources, and feasible use of social media tools.
Background
The CDMC is intended to be in service to the PSRC. The overarching objectives of PSRC are to build upon and expand PDAC research to study tumor progression, recurrence and resistance to therapies through comprehensive tumor-tumor microenvironmental testing and evaluation of underrepresented, emerging, and non-classical mechanisms of PDAC progression and recurrence/resistance through a network of U01 Research Projects.
A primary goal of the PSRC (RFA-CA-21-041) is to develop a comprehensive understanding of PDAC tumor progression, its microenvironment (TME) as a tumor fate determinant and the reciprocal tumor-TME interactions that drive clinical outcomes. The information obtained through these comprehensive studies should expose new biology-backed vulnerabilities that will inform the development and preclinical testing of novel interventions in PDAC. Central to the PSRC structural organization is the implementation of multidisciplinary team science approaches that iteratively bridge basic and translational research across the tumor-TME continuum in each Research Project, in trans-PSRC activities, and in collaboration with other NCI-funded mechanisms and programs whenever possible.
It is anticipated that the research projects and resource cores of the individual PSRC U01 Research Projects will generate data, unique biospecimens, resources, models, and technologies that require a dedicated CDMC to centralize, integrate, and manage inter- and intra-network data, material, and know-how exchange. The PSRC CDMC will function as a coordinating intermediary across the network as a whole and facilitate liaisons between PSRC Research Projects, NCI staff, and the cancer research community.
The principal functions of the PSRC CDMC are to: 1) facilitate the integration of the multicomponent PSRC activities and communications; 2) support and enhance collective PSRC findings; and 3) accelerate iteration of discoveries between basic/mechanistic and preclinical/translational cancer research. It is envisioned that the PSRC CDMC will have national leadership and impact in addressing unmet needs to facilitate PDAC progression and therapy resistance research.
PSRC activities to be supported include, but are not limited to:
Key Requirements of the PSRC CDMC
The U24 PSRC CDMC will function as a crucial scientific and logistic infrastructure component of the PSRC. The main responsibilities of the CDMC will be to:
A. Provide a centralized administrative infrastructure to support and coordinate the activities of the U01 research projects, which includes administrative, organizational, analytical, and collaborative support for basic, preclinical, and clinical cancer research studies;
B. Facilitate and strengthen collaborations within the PSRC, and promote PSRC interaction and collaboration with NCI-sponsored programs and resources;
C. Provide multidisciplinary analytic expertise and application of statistical and computational tools in support of U01 research projects and collaborative research activities when appropriate;
D. Develop improved data integration and management methods to enhance PSRC research capacity;
E. Ensure PSRC compliance with NIH and NCI regulatory, data and resource sharing, and publication policies;
F. Assist the PSRC to identify and develop collaborative opportunities which encourage and promote bi-directional bridging between basic, preclinical, and clinical science;
G. Develop outreach activities to promote the exchange of scientific outcomes both within PSRC and between PSRC and the public; and
H. Facilitate the implementation, management, and coordination of PSRC Steering Committee and specific working groups.
The PSRC CDMC must have expertise and capabilities in information technology, study design, data management, protocol development, and logistical support. CDMC activities include (but are not limited to):
I. Network coordination and collaboration
II. Data Management and Analytical support. The PSRC CDMC, under the direction of the PSRC and NCI program staff will work to:
III. Basic and translational and clinical research expertise. The PSRC should traverse the bridge between basic, preclinical, and clinical science in a bi-directional manner to address PDAC tumor-TME dynamics that impact clinical outcomes. In support of this goal, the CDMC should:
Coordination of the PSRC
Given the complex nature and structure of the multi-PI (U01s) and CDMC (U24), NCI program staff will be substantially involved in the PSRC and CDMC. NCI program staff will monitor the scientific progress of PSRC Research Projects, participate in monthly steering committee meetings for sharing pre-published data, provide direction in data management activities, and ensure that restricted funds are effectively used for productive trans-U01 collaborative projects. NCI program staff will assist in identifying and prioritizing areas of common interests and/or challenges across the PSRC, and with the CDMC, facilitate the implementation of network-specific cross-cutting working groups.
The CDMC will coordinate with the PSRC Steering Committee and Co-Chairs to provide leadership and be actively involved in decisions regarding the Consortium. Details on the Administrative and National Policy Requirements and Cooperative Agreement Terms and Conditions of Award are provided in Section VI.2.
The PSRC CDMC will be responsible for developing an overarching PSRC progress report that highlights the U01 Research Projects and trans-PSRC activities for the entire Consortium starting in year 2 of the award’s project period, and then cumulatively updated in years 3, 4, and 5.
NCI Resources to Support the PSRC
The PSRC is encouraged to collaborate with and leverage closely aligned NCI-sponsored programs and resources to help in the bi-directional bridging between basic, preclinical, and clinical science. The CDMC will assist the PSRC in identifying and facilitating collaborations with NCI-sponsored programs and resources, including but not limited to the Experimental Therapeutics Clinical Trials Network (ETCTN), National Clinical Trials Network (NCTN), NCI Cancer Therapy Evaluation Program (CTEP) agents, Pharmacodynamic Assay Development and Implementation Section (PADIS), Patient-Derived Xenograft Development and Trial Centers Research Network (PDXNet), Cancer Systems Biology Consortium (CSBC), Physical Sciences Oncology Centers Network (PSON), Patient -Derived Models of Cancer (PDMC), Radiation Oncology Biology Integration Network (ROBIN), Acquired Resistance to Therapy Network (ARTNet), Human Tumor Atlases Network (HTAN) and Specialized Programs of Research Excellence (SPOREs).
Further NCI resources include investigational agents in NCI’s IND agents portfolio or the NCI Formulary agents portfolio for preclinical studies available with a Material Transfer Agreement (MTA); patient-derived xenograft models developed by NCI investigators at the Frederick National Laboratory for Cancer Research; and in some cases patient bio-specimens acquired before and/or after drug treatment in NCI clinical trials. Biomarker assay procedures developed by the PADIS laboratories may also be leveraged.
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?
NCI intends to fund one (1) Coordinating and Data Management Center award, not to exceed a total cost of $990,000 for fiscal year 2022. Future year amounts will depend on annual appropriations.
Application budgets must reflect the actual needs of the proposed project but must not exceed $600,000 per year in direct costs.
Applicants may request up to 5 years of support.
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 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:
Peter Ujhazy, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5686
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.
Each individual designated as a PD/PI must commit a minimum of 1.8 person-months of effort per year. This minimal effort level must be maintained throughout the entire project period.
Funds for travel. The PSRC CDMC PD(s)/PI(s) are required to travel to face-to-face PSRC meetings per year (one or two). Include travel funds for two to four representatives from the PSRC CDMC (at least one of whom must be the PSRC CDMC PD/PI). Travel costs for one to two presenters for one major national meeting may be included in the budget.
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: List Specific Aims for the proposed Coordinating Data and Management Center (CDMC)
Research Strategy: Instead of standard sub-sections, the Research Strategy must consist of the following sub-sections A through D. In these sub-sections, provide a narrative describing plans to meet the following CDMC requirements:
Sub-section A. Overall Vision of the Proposed CDMC
The description must include the following specific aspects:
Sub-section B. Leadership and Administration Unit
The description must include the following specific aspects:
Sub-section C. Virtual Resource Repository Unit
Sub-Section D. Data Management and Analytical Support
The description must include the following specific aspects:
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.
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.
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: Are the available research infrastructure, programs, scientific expertise, and collaborations adequate to support the PSRC Research Projects?
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: Does the applicant team have experience overseeing selection and management of sub-awards, if needed? Does the CDMC team have the appropriate capabilities to support proposed projects and data sharing among all PSRC participating sites? Are plans to facilitate data and resource sharing across the Network compatible with the PSRC Research Projects capabilities? Does the administration infrastructure demonstrate the capacity of the PSRC CDMC to collaborate with the PSRC Research Projects and NCI program staff on scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships? Is there adequate evidence of the managerial and collaborative capabilities of the proposed CDMC leadership? Is the leadership structure of the proposed Coordinating Center in terms of (a) the overall goals of the PSRC program; (b) the coordination of multiple institutions participating in the PSRC Research Projects; and (c) understanding and familiarity with the state of the science in this field of research appropriate?
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: Does the applicant propose novel organizational concepts in coordinating and supporting the PSRC? Are the tools proposed to undertake trans-Consortium analyses of data appropriate? Will the applicant’s proposal to facilitate meetings between basic scientists and clinical research investigators identify and address major challenges in basic and translational research that may inform and impact patient treatment effectively? Will the proposed CDMC identify and develop research/data project(s) and/or analyses that it can accomplish? Will the proposed CDMC facilitate the identification of Consortium-wide and/or cross-cutting analyses to uncover commonalities in science, approach, or proof of concept?
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: How adequate are the Resource Sharing Plans for the sharing and dissemination of data, model organisms, human and non-human specimens, tools, reagents, therapeutics, genomic data, intellectual property, know-how and proprietary techniques and inventions within and outside the institution, especially with other members of the PSRC? How much freedom to operate is granted to PSRC members to utilize, without restrictions other than by law(s) or regulation(s) said Resources for non-commercial purposes directly related to the PSRC activities and goals?
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?
Specific to this FOA:
Coordinating Data and Management Center (CDMC)
Are the environment and associated capabilities of the proposed CDMC conducive for the implementation of the overall strategy, operational plan, and organizational structure? Is the plan well-reasoned and appropriate to accomplish the goals of the PSRC? Does the level of translational experience of the proposed CDMC demonstrate the ability to traverse the bridge between basic, preclinical, and clinical science?
Is the proposed CDMC’s approach to integrate and harmonize data adequate? Is the plan to disseminate tools/resources to the greater NIH community and public appropriate? Will the CDMC be able to effectively facilitate and promote collaborations within PSRC and between PSRC and NCI resources/programs using the plan proposed? Is the plan to coordinate PSRC pilot projects reasonable and have the potential to be successful? Are the CDMC’s plans to facilitate meetings adequate?
Virtual Resource Repository Unit
How appropriate and well justified are the proposed plans to create the Virtual Resource Repository? Does the CDMC have the capacity for establishing a database that collects information on all available analytic and technological tools, procedures, protocols and patient samples to be used in the studies conducted by the PSRC and all participating sites? How appropriate are safeguards for privacy and confidentiality protections of identifiable data? How adequate and efficient is the plan to support the sharing of unique tools, technologies, specimens and information across the PSRC and with extramural collaborating investigators? How adequate is the plan to enable the tracking and distribution of available non-standard materials, protocols, technologies, reagents and new and/or archived specimens to investigators?
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 Resource Sharing Plans are reasonable.
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.
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 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.
Recipients 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 recipient 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, 2 CFR 200, 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 reside with the recipients for the project, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The following additional responsibilities will apply for the CDMC recipient:
Recipients will retain custody of and have primary rights to the data and software developed under these awards, within the limits of any accepted binding NCI/NIH collaborative agreements with biotechnology and pharmaceutical partners and as governed by NCI-approved Data Sharing Plans and NCI-approved review for use of biospecimens collected in association with PSRC. Custody of and primary rights to the data and software developed under these awards is subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. They may have primary rights in data but there may be restrictions based on binding collaborative agreements that provided specimens.
The CTEP Intellectual Property (IP) Option applies to all PSRC Research Projects and PSRC CDMC projects, regardless of the sponsor. Inventions conceived, as defined under United States patent law, or actually reduced to practice in performance of the Research Project under the applicable HMTA shall be managed in accordance with the terms of the CTEP IP Option, which can be found at:
The Terms and Conditions of Award for all the Cooperative Agreements under the PSRC define the operational principles under which the recipients must function to ensure the independence of the research conducted regardless of whether program income is or is not available for any of the awards. All key components of the PSRC must report Program Income to the NCI on an annual basis (in the non-competitive Type 5 application (Research Performance Progress Report (RPPR)) and must indicate the research study that the funds are being used to support (or other functional component if the funds are not provided to support specific studies).
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NCI Program staff member(s) acting as a Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement.
Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Some Program Officials may also have substantial programmatic involvement (as Project Scientists/Coordinators).
The specific roles of the substantially involved NCI staff members include the following activities:
Areas of Joint Responsibilities include:
The CDMC will facilitate PSRC Steering Committee activities in conjunction with NCI Program staff. The PSRC Steering Committee will serve as the main governing board of the PSRC.
The committee will consist of the following voting members:
Additional non-voting members who can serve in an advisory capacity may be added to the PSRC Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies.
The PSRC Steering Committee, CDMC, and NCI Program staff will have the following primary responsibilities:
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 composed of three members will be convened. It will have three members: a designee of the Steering Committee 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 recipient. This special dispute resolution procedure does not alter the recipient'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.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
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 recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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]
Peter Ujhazy, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5686
Email: [email protected]
Jeffrey Hildesheim, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6213
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
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, 45 CFR Part 75, and 2 CFR 200.