EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Participant Engagement and Cancer Genome Sequencing (PE-CGS): Research Centers (U2C Clinical Trial Optional)
U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements
New
RFA-CA-19-045
RFA-CA-19-046, U24 Resource-Related Research Projects Cooperative Agreements
93.353, 93.396, 93.393
This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSMInitiative that is intended to accelerate cancer research. Specifically, this FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) as Recommendation A "Establish a Network for Direct Patient Engagement".
The National Cancer Institute (NCI) intends to support the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network, which will include:
The overall purpose of the PE-CGS Network is twofold:
In addition to conducting a Center-specific research program, PE-CGS U2C Research Centers will be expected to operate as a collaborative network. Various trans-network activities will be facilitated by the PE-CGS Network Coordinating Center (U24).
July 30, 2019
September 30, 2019
30 days prior to the application due date
October 30, 2019; October 30, 2020
All applicants 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.
July 2020; July 2021
New Date October 31, 2020 per issuance of NOT-CA-20-056. (Original Expiration Date: July 31, 2020)
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSMInitiative that is intended to accelerate cancer research. Specifically, this FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) as Recommendation A "Establish a Network for Direct Patient Engagement".
The National Cancer Institute (NCI) intends to support the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. The PE-CGS Network will include:
The overall purpose of the PE-CGS Network is twofold:
Each PE-CGS U2C Research Center to be proposed in response to this FOA must consist of the following components:
In addition to conducting a Center-specific research program, PE-CGS U2C Research Centers will be expected to operate as a collaborative network. Various trans-network activities will be facilitated by the PE-CGS Network Coordinating Center (U24).
Key Definitions for this FOA:
Beau Biden Cancer Moonshot Initiative. NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's goal of accelerating progress in cancer research, now called the Beau Biden Cancer MoonshotSM Initiative. The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation to Establish a Network for Direct Patient Engagement . The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer MoonshotSM Initiative, including support for this FOA.
In the recommendation to Establish a Network for Direct Patient Engagement , the BRP called for NCI to enlist direct patient engagement through a federated network where patients will be offered comprehensive tumor profiling . The panel further noted the importance of directly engaging with patients to facilitate participation in research and ensure patients are respected and have access to the research enterprise. Moreover, the panel stated that efforts to reach minority and underserved populations should be a high priority. This FOA is a step towards accomplishing the recommendation goals.
As appropriate for research proposed in response to this FOA, applicants are encouraged to engage a pool of scientists from diverse backgrounds, including those from underrepresented groups. In line with NIH-wide policies (NOT-OD-18-210), fostering diversity and addressing underrepresentation in the scientific research workforce are among the key components of the NCI strategy to facilitate scientific discovery and enhance innovation.
The Advances and Challenges in Cancer Genome Sequencing. Recent technological advances, in particular next-generation sequencing (NGS) technologies, have revolutionized our ability to conduct genomic characterization. For example, The Cancer Genome Atlas (TCGA) program generated a comprehensive molecular characterization of 33 tumor types, using biospecimens from over 11,000 patients. Notably, this comprehensive atlas of cancer genomic profiles allowed for the discovery of major cancer-associated genomic alterations, helping to generate novel insights into cancer biology that could be applied to develop new cancer therapies, diagnostic methods, and preventive strategies.
Currently, there are opportunities to address knowledge gaps which remain. For example, many of the hundreds of different forms of cancer have not been sufficiently characterized. Furthermore, for those cancers that have been well characterized molecularly, questions remain about the generalizability of those data due to underrepresentation of samples from specific cancer subsets and understudied populations such as racial or ethnic minorities. Finally, most current cancer genomics studies lack adequate clinical or epidemiologic data.
Addressing these gaps can be facilitated by innovative ways to directly engage participants in genomic characterization studies. Various strategies are possible for direct participant engagement (e.g., via the web, social media, collaborations with patient groups or organizations, or using other forms of outreach). Optimal approaches are likely to depend on the context of cancer/population subsets to be studied.
The Principle of Participant Engagement. The foundation for each of the proposed PE-CGS U2C Research Centers must be direct engagement of study participants (i.e., cancer patients and/or post-treatment cancer survivors). The direct participant engagement efforts must be in line with and serve the scientific goals outlined below.
Scientific Focus for PE-CGS U2C Research Centers
Knowledge Gaps and Priority Areas. Each proposed PE-CGS U2C Research Center should be centered on addressing a unique research knowledge gap in the genomic characterizations of tumors. Knowledge gaps proposed for characterization are expected to be mainly identified in several specific areas of interests (Interest Areas 1-5 below). Nonetheless, if compelling justification is available, knowledge gaps outside of these areas may also be proposed (as Interest Area 6 below).
Interest Area 1: Rare cancers or rare cancer subsets;
Interest Area 2: Highly lethal cancers;
Interest Area 3: Cancers with an early age of onset;
Interest Area 4: Cancers with high disparities in incidence and/or mortality;
Interest Area 5: Cancers in understudied populations; and
Interest Area 6: Other cancer and/or population subsets justified to be highly relevant to the goals of this FOA.
Irrespective of cancer and/or population subsets chosen, the specific gap in knowledge to address should be highly important in terms of general understanding of cancer and/or relevance to clinical oncology or public health.
Note on programmatic funding priority: The NCI intends to ensure a broad coverage across the listed priority areas. It is anticipated that no more than one application focused on a specific cancer type or cancer and/or population subset will be selected for funding. Applications relevant to Interest Area 5: "Cancers in understudied populations" may receive a particular funding preference.
Applications that address cancers diagnosed in children, adolescents, and/or young adults are encouraged (in line with the goals of the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2018, Public Law No: 115-180).
Optional Clinical Trials. Applicants may propose behavioral studies that meet the NIH definition of clinical trials. Note that any clinical trials that include clinical development or testing of interventions for therapeutic or diagnostic or preventive purposes, evaluation of intervention safety, efficacy, clinical management, etc. are beyond the scope of the FOA.
Required Attributes of the Genomic Characterizations Proposed for U2C Research Centers
Scale of Effort. It is expected that each PE-CGS U2C Research Centers will focus on at least one cancer or population subset. Multiple cancer types (or population subsets) may be selected, as long as a sufficient number of participants can be recruited to allow for meaningful interpretations of results.
In general, it is anticipated that the required genomic characterizations will be conducted on tumor specimens from hundreds of participants. However, the proposed minimal number of unique tumors to characterize (i.e., the proposed number of participants to engage) should be sufficiently high to ensure rigorous and interpretable results for the specific research proposed.
Required Characterizations. All genomic characterizations must be conducted in parallel on tumor and normal specimens in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (state-of-the-art methods are expected).
For each cancer or population subset, the characterizations must include, at a minimum:
Applicants may propose additional types of genomic characterizations, if appropriate for the study focus.
Biospecimens. It is anticipated that PE-CGS U2C Research Centers will collect and use formalin-fixed, paraffin-embedded (FFPE) or fresh frozen tissue samples for tumor genomic characterizations. However, an alternative biospecimen source may be proposed if appropriate (e.g., for hematologic tumors).
Blood specimens should be proposed as a source for normal DNA, however, in situations where it is not possible to collect blood specimens, an alternative source may be proposed if appropriate.
Research Team and Main Capabilities
The proposed PE-CGS U2C Research Centers must have the following expertise and requisite capabilities in place:
Team Composition. Given the above requirements, it is expected that the multidisciplinary team will include an appropriate combination of such specialties as:
Structure of the PE-CGS U2C Research Centers
Each proposed PE-CGS U2C Research Center must include the following administrative and functional components:
These components must adhere to the characteristics described below:
Administrative Core
The Administrative Core will provide the administrative support to the PE-CGS U2C Research Center leadership. The main roles of the leadership and the Administrative Core will include:
Participant Engagement Unit
This Unit will be responsible for a direct participant engagement for the purpose of performing genomic characterization. The participant engagement strategies proposed are expected to use current state-of-the-art, culturally sensitive approaches. In addition, this unit should be designed to ensure continuous improvements to the engagement process by interactions with and adapting research findings from the Engagement Optimization Unit.
Participant Engagement Unit should be able to perform such activities as:
Genome Characterization Unit
This Unit should be capable of completing all the steps required for the tumor characterizations (i.e., DNA and RNA sequencing, bioinformatic analyses and interpretations, etc.).
Specifically, the Genome Characterization Unit must be able to:
Engagement Optimization Unit
This Unit should be able to incorporate rigorous behavioral research on optimal approaches to participant engagement in various aspects ranging from recruitment, communication, to education about genomic characterization goals and discoveries. This unit should be also be able to examine and respond to participant preferences and needs in the context of taking part in cancer genome characterization efforts.
Specific interventions to be developed and tested should be designed to identify optimal approaches (appropriate for the cancer and/or population subset selected) for such aspects as:
As appropriate for the study, specific behavioral interventions proposed may constitute clinical trials as defined by NOT-OD-15-015.
All research activities/interventions to be developed by the Engagement Optimization Unit should be fully integrated with and serve the overall goals for the proposed U2C Research Center.
Required Trans-Network Collaborative Activities
All PE-CGS U2C Research Centers will be required to interact closely with the PE-CGS U24 Coordinating Center (to be supported under companion RFA-CA-19-046). Therefore, the prospective Research Center applicants are expected to read RFA-CA-19-046 and familiarize themselves with the scope and responsibilities of the PE-CGS U24 Coordinating Center.
In addition, each PE-CGS U2C Research Center will be expected to collaborate across the PE-CGS Network with other U2C Research Centers. These collaborations will be facilitated by special set-aside funds, included in the direct cost limit which may be requested, for Trans-Network collaborative projects. Such collaborative projects are intended to promote and facilitate sharing best practices, optimizing approaches, and addressing common issues across the program. For example, the Network awardees may work jointly to identify and address common challenges involved in participant recruitment, consistency of laboratory procedures (biospecimen handling, sequencing, etc.), data analysis and interpretation, as well as ethical, legal and social issues
To facilitate broader interactions, all PE-CGS awardees will be required to participate in two annual meetings, an annual Investigator Meeting and annual meeting for participants.
PE-CGS Network Governance
The Network will be governed by the PE-CGS Steering Committee. The Steering Committee will convene a PE-CGS External Advisory Panel as a sub-committee that will include a broad set of external experts and stakeholders. Details on the composition and responsibilities of the Steering Committee and External Advisory Panel are provided in Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.
Non-Responsive Applications
The following types of research activities are outside the scope of this FOA and will be considered non-responsive. (Non-responsive applications will not be reviewed.)
Trans-Network Activities
The PE-CGS Network will function as a collaborative network allowing PE-CGS U2C Research Centers to address common issues, share best practices and lessons learned, and utilize common methods where appropriate.
See Section VIII. Other Information/span> 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.
New
Resubmission of application submitted to the earlier round of 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.
Optional: Accepting applications that either propose or do not propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
NCI intends to commit $12 million (total costs) in FY2020 to fund up to three awards.
Application budgets are limited to no more than $2.5 million per year (direct costs) and need to reflect the actual needs of the proposed program.
The maximum project period is 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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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.
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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
Leah E. Mechanic, Ph.D.
Telephone: 240-276-6847
Fax: 240-276-7920
Email: [email protected]
Available Component Types |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core (use for Administrative Core) |
6 |
Functional Unit (Use for Participant Engagement Unit, Genome Characterization Unit, and Engagement Optimization Unit) |
12 |
Additional page limits 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 a multi-component application.
The application should consist of the following components:
When preparing your application, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Project Summary /Abstract: Succinctly describe the research gap to be addressed and methods of direct participant engagement. State the cancer or cancer and/or population subset selected for the study.
Project Narrative: State how the research findings and resources generated from the PE-CGS U2C Research Center are expected to further knowledge in the genomic characterization of cancer and the potential impact they may have on public health. Describe how studies performed will inform future research using direct participant engagement approaches.
Facilities & Other Resources: In addition to the information required in the standard instructions, list available facilities and/or services that can be leveraged for accomplishing the goals of the proposed U2C Center (e.g. Clinical Laboratory Improvement Amendments, or CLIA, certified laboratories, informatics/computational platforms, data storage resources, communication platforms). Specify on what basis such resources will be available to the PE-CGS U2C Research Center investigators (e.g., in-lab, freely available, fee-for-service, etc.). Provide details regarding CLIA certification for laboratories and genome characterization pipelines.
All aspects of Facilities and Other Resources should be covered here, under Overall component. Indicate, however, to which functional units the specific items listed here would be relevant (and group them accordingly).
Other Attachments: Applicants must provide the following additional materials in support of their application. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks). Each Attachment must not exceed 5 pages.
Attachment 1: A table listing of Available Partnerships and Infrastructures along with their main characteristics [use file name Partnerships and Infrastructure ].
Attachment 2: PE-CGS U2C Research Center Engagement Process [use file name Engagement Process ].
Attachment 3: Example draft consent form(s) [use file name Consent ]
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.
Specific Aims: Outline the overarching, high-level vision and goals for the proposed PE-CGS U2C Research Center for the funding period, distinct from the aims of the individual functional units.
Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the sub-sections defined below to present a concise overall vision and plan for the proposed PE-CGS U2C Research Center. However, applications should highlight aspects of the proposed activities of the Research Center that speak to the significance and innovation of the approach.
Sub-section A: Research Focus and Significance
Using the subheading "Knowledge Gap and Interest Area", address all of the following points:
o Document the lack (or substantial insufficiency) of genomic characterization data for the knowledge gap of focus [for this aspect, refer to the current status of relevant characterizations in the publicly available genomic databases, notably those of The Cancer Genome Atlas (TCGA) program or International Cancer Genome Consortium (ICGC)];
o As background information, describe the known challenges in addressing this research gap (e.g. difficult tumor to sequence, challenges in reaching or recruiting the population of interest).
o Outline the significance and anticipated benefits from the elimination of this knowledge gap in terms of general understanding of cancer and/or relevance to clinical oncology or public health (for example, explain how this genomic characterization study may lead to insights into cancer etiology, precision prevention and therapeutic intervention strategies);
o Outline rationale for and benefits from using a direct participant engagement approach to characterize the specific knowledge gap selected.
Describe the importance and feasibility of the planned research center by addressing the following four aspects (use subheadings indicated below):
o Geographic Management of Cancer Health Disparities Program (GMaP),
o National Outreach Network (NON); and/or
o The Partnerships to Advance Cancer Health Equity (PACHE).
Note: Additional specific documentation relevant to this sub-section is requested in Other Attachments (Attachment 1).
Sub-section B: Research Center Organization and Team Integration
At a minimum, address the following aspects:
Sub-section C: Overall Approach and Structure of Research Units
Provide a biological and statistical justification for the cancer type or subset proposed by the PE-CGS U2C Research Center. The number of participants included in the tumor sequencing study needs to be justified by the frequency of the cancer or cancer and/or population subset and characteristics of the cancer type proposed to study. Applicants should discuss the overall statistical power of the proposed tumor characterization for use in answering biological and/or clinical questions.
Provide a succinct outline of the structure of each Research Unit; Participant Engagement Unit; Genome Characterization Unit; and Engagement Optimization Unit; based on the requirements described in the Research Objectives and Main Requirements section earlier. Describe the workflow from working with participants or participant groups in design of the study, recruiting participants, consenting participants, obtaining epidemiology and medical record data, maintaining regular communication with participants, sample acquisition (tumor and normal), pathology examination, molecular characterization, analysis and interpretation of molecular characterization data, integration of molecular data with epidemiology and clinical data, collecting follow up epidemiology and clinical data, reporting study findings and data back to participants, communication of study results, storing of data, and deposition of data to NCI Genomic Data Commons (GDC).
Sub-section D: Milestones and Timelines
In this sub-section, describe the following:
Overall PE-CGS U2C Research Center Milestones: Describe the timeline for the overall program with brief descriptions of how the goals of each of the proposed specific aims will be achieved annually. Milestones should include outcomes for individual participants and outcomes for research generally. The overall milestones must be well-described, specific, quantitative when appropriate, and scientifically justified. The overall milestones should be connected to the performance benchmarks or progress for each of the Research Units (see the Research Strategy section of the Participant Engagement Unit, Genome Characterization Unit, and Engagement Optimization Unit). Milestones should include clear indicators of a program's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration for funding of non-competing award years for awarded U2C Research Centers. Milestones may be revised at the time of the award with approval by NCI Program Officials.
Sub-section E: Network-wide Collaboration
PE-CGS U2C Research Centers should anticipate common issues across the network, outline potential strategies for future collaborations with other PE-CGS U2C Research Centers, and describe potential flexibility to adapt for collaborative activities. Describe how the PE-CGS U2C Research Center will plan to collaborate with other PE-CGS U2C Research Centers in the network, share best practices, and address common issues in the network. Provide details on what the U2C Research Center can contribute to the PE-CGS Network, such as unique skills or engagement strategies. In addition, describe how the PE-CGS Network could enhance the activities of the U2C Research Center. Discuss plans to work with NCI and the PE-CGS U24 Coordinating Center to facilitate any future pilot activities.
Sub-section F: Health Disparities
If applicable to the type of research being proposed, address how health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.
Letters of Support: In addition to standard items, applicants must provide letters from the respective leadership official(s) in the institution(s) of the proposed PE-CGS U2C Research Center documenting specific institutional commitments to the proposed PE-CGS U2C Research Center. Letters should also be included that reflect any additional resources and partnerships that will be employed to achieve the goals of the PE-CGS U2C Research Center. Letters should include those from partnering health care institutions and any other organizations that may be involved in the participant engagement (e.g. relevant cancer patient communities, health interest groups, or organizations), but not formally part of the center.
All letters of support for the entire application should be provided under Overall component.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Overall)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
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.
When preparing your application, use Component Type Administrative Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Leadership Effort Commitment: The PE-CGS U2C Research Center contact PD/PI must commit and maintain through the life of the award a minimum of 1.8 person-months of effort. For applications with multiple PDs/PIs, a minimum effort of 1.8 person-months is required for the Contact PD/PI and 1.2 person-months of effort per additional PD/PI is required. The required levels of effort may reflect an aggregate of the effort for the entire PE-CGS U2C Research Center (listed here under Administrative Core) and the efforts for other PE-CGS U2C Research Center units, as applicable.
PE-CGS U2C Research Center Administrator: Based on the complexity of the U2C Research Center, applicants may propose and budget for a PE-CGS U2C Research Center Administrator to manage day-to-day operations.
Set-Aside Funds for Collaborative Trans-Network Projects: Starting in budget period 2, a minimum of $200,000 per year (direct costs) must be allocated to a restricted fund for support of post-award collaborative projects between PE-CGS U2C Research Centers. These funds should be presented in the Other Direct Costs category under the heading "PE-CGS U2C Research Center Collaborative Project Fund". Funds will be released pending approval by NCI following discussion of proposed projects by the PE-CGS Network Steering Committee.
Travel Funds: Include funds to support travel to two annual meetings: an annual Investigator Meeting and annual meeting for participants, including for PD(s)/PI(s) and other PE-CGS U2C Research Center investigators (up to four persons).
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Outline specific aims for the Administrative Core.
Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the sub-sections defined below to describe the administrative and organizational responsibilities of the proposed Administrative Core. Applications should also highlight aspects of the proposed activities of the Administrative core that speak to the significance and innovation of the approaches.
Sub-section A. Leadership and Participant Engagement and Cancer Sequencing PE-CGS U2C Research Center Organization
Address the major responsibilities of the Administrative Core:
Outline the organization of the leadership structure and overall PE-CGS U2C Research Center structure (provide relevant organizational diagrams). Describe the lines of responsibilities, including, as applicable, the effort distribution across the participating institutions.
Sub-section B. Center Logistics and Communication
Describe the communication strategies to ensure bidirectional exchange of logistical information, findings and insights, including lessons learned and best practices between:
State who will be the lead for each level of communication.
Sub-section C: Research Oversight and Progress Evaluation
Explain how the leadership of the Administrative Core envisions the oversight of the U2C Research Center activities. Describe how the Administrative Core will support planning and evaluation activities for the U2C Research Center, including plans for the evaluation of progress on a regular basis. Describe how these evaluations will be used to prioritize activities to ensure that the main goals of the PE-CGS U2C Research Center will be achieved in collaboration with staff from the individual Units. Progress evaluation should include consideration of outcomes for individual participants and outcomes for research. Identify potential problems and alternative strategies to accomplish PE-CGS U2C Research Center goals. Describe what action will be taken if progress is insufficient, if an overall U2C Research Center milestone or Research Unit benchmark is not met or significantly delayed.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
Resource Sharing Plans should only be included in the Overall component.
Appendix:
Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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
Delayed Onset Study
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
When preparing your application, use Component Type Functional Unit.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Outline requested budget to accomplish activities in the Participant Engagement Unit, including the outreach, recruitment, and engagement of research participants, specimen acquisition/collection and tracking, sample validation by pathologist, data collection (including medical records data abstraction, survey administration, and collection of epidemiology data), developing patient-facing materials for results reporting, participant following-up, developing and reporting on participant-centered outcomes. The budget request may include funding for equipment, software and informatics resources. Capital equipment is generally not allowed but may be permissible with strong justification to be considered on a case-by-case basis.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Outline specific aims for the Participant Engagement Unit and provide a rationale and description of how each aim addresses the research gap in the molecular characterization of a specific cancer or cancer and/or population subset using a direct participant engagement strategy.
Research Strategy: In lieu of the standard Research Strategy subsections (Significance, Innovation, and Approach), describe the activities of the Participant Engagement Unit using the sub-sections listed below. However, applications should highlight aspects of the proposed activities of the Participant Engagement Unit that speak to the significance and innovation of the approach.
Sub-section A: Rationale
Justify the research gap in the molecular profile of a specific cancer or cancer and/or population subset to be addressed by the PE-CGS U2C Research Center and explain how the Participant Engagement Unit will reach and engage participants, inform them of the purpose of the PE-CGS U2C Research Center, and acquire tumor/normal specimens and associated data in order to fill the research gap. The description should address all expectations for the Participant Engagement Unit stated in Section I. Applicants should justify the use of a direct participant engagement strategy to facilitate addressing the research gap in the molecular characterization of the cancer or cancer and/or population subset selected for the Research Center.
Sub-section B: Direct Participant Engagement
Applicants must provide details for plans for direct participant engagement, in which participant and caregiver inputs are incorporated throughout the research process. Applicants should consult the Patient-Centered Outcomes Research Institute (PCORI) Engagement Rubric in developing their plans. Specifically, the PCORI Engagement Rubric illustrates how input from patient and stakeholder partners can be incorporated throughout the entire research process (planning, conduct and dissemination). Applicants should provide details for participant engagement including:
Note: Additional information is requested for this sub-section under Overall component, Other Attachments (Attachment 2 "PE-CGS U2C Research Center Engagement Process ).
Sub-section C: Tissue Acquisition and Data Collection.
Applicants should explain the details for acquiring tissue and collecting epidemiology and clinical data including:
Applicants must document their ability to engage and recruit participants, procure, process, track and store biospecimens and collect epidemiological and clinical data using previously developed CDEs.
Detailed biospecimen collection annotation is a requirement. The description should include information on the types of participants to be accrued, clinical and epidemiology information to be collected, and types of biospecimens to be collected.
Applicants should describe the quality assurance/quality control (QA/QC) procedures. The procedures and the documentation should include confirmation of pathology reports. The applicants must discuss their experience with relevant quality control metrics and other considerations that may arise in complex studies which may involve multiple institutions. All new biospecimen collections and storage should follow the guidelines provided in NCI Biorepositories and Biospecimen Research Branch's Best Practices.
Sub-section D: Informed Consent
In this sub-section provide details about the informed consent which will be obtained from participants. Since this study is a research study, where the molecular characterization is unlikely to provide clinical benefit to the participants in this study, careful design of consent forms is required to explain the research study to participants. In addition, consent forms must allow for broad data sharing as required by the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy. Initial informed consent form may be updated based on participant feedback.
Note: Additional information is requested for this sub-section under Other Attachments (Attachment 3 "Consent Form").
Sub-section E: Performance Benchmarks
Applicants should provide a clear set of benchmarks. These benchmarks should address the aims of the Participant Engagement Unit, i.e. directing participant engagement, recruiting participants, acquiring tissue, collecting appropriate data, and communicating with and returning information to participants. Outline benchmarks that will document progress towards the achievement of the Overall Research Center milestones. Benchmarks should include consideration of outcomes for individual participants and outcomes for research. Applicants should include plans for critically evaluating and revising these benchmarks on a regular basis. The inclusion of a proposed timeline for implementing components and processes of the Unit is encouraged. In addition, applicants should describe how they will prioritize their activities to ensure that the Overall Research Center milestones of the PE-CGS U2C Research Center will be achieved. Applicants should also describe what action will be taken, and when, if a benchmark is not met or significantly delayed. In addition, applicants should identify potential problems and alternative strategies to accomplish Participant Engagement Unit goals.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
Resource Sharing Plans should only be included in the Overall component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions, with the following modifications:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
Delayed Onset Study
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
When preparing your application, use Component Type Functional Unit.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Detail requested budget for Genome Characterization Unit, including costs for DNA/RNA isolation and library preparation, CLIA genomic characterization, quality control/assurance, data analysis and interpretation, development of summary report for participants, uploading data to the NCI GDC, expertise in informatics and data storage, and all associated materials. Capital equipment is generally not allowed but may be permissible with strong justification to be considered on a case-by-case basis.
Note that specimens should be batched to minimize costs for genomic characterization. This budget request may include funding for equipment, software, and computing resources.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Outline specific aims for the Genome Characterization Unit and provide description and rationale of how each aim addresses the research gap in the molecular profile of a specific cancer or cancer and/or population subset using a direct participant engagement strategy.
Research Strategy: In lieu of the standard Research Strategy subsections (Significance, Innovation, and Approach), describe the activities of the Genome Characterization Unit using the sub-sections listed below.
Sub-section A: Rationale
Explain how the Genome Characterization Unit will approach conducting genomic characterization for selected cancer or cancer and/or population subset using biospecimens procured by the Participant Engagement Unit and using state-of-the-art technologies. At a minimum, sites should plan on whole exome sequencing, RNA sequencing and low-pass whole genome sequencing (15X coverage) of tumor and normal specimens acquired by the Participant Engagement Unit. Provide rationale for any additional proposed molecular characterization of tissue.
The description should also address all the other expectations for the Genome Characterization Unit stated in Section I.
Applicants should highlight aspects of the proposed activities of the Genome Characterization Unit that demonstrate the significance and innovation of the approach.
Sub-section B: Molecular Characterization, Analysis and Interpretation
Address challenges and concerns about reproducibility with the molecular characterization of DNA and RNA extracted from FFPE tissues. It is expected that the applicants will take the necessary measures to address the potential challenges and a plan for addressing potential pitfalls in the approach must be provided.
The Genome Characterization Unit should plan to work closely with the Participant Engagement Unit regarding standardization, optimization and preservation of sample integrity submitted for molecular characterization. Appropriate controls must be used for all assays.
Applicants must provide a roadmap of plans for molecular characterization of tumors and normal specimens including, but not limited to the following:
Sub-section C: Preliminary Data
Use this sub-section to present preliminary data addressing, minimally, the following aspects of the Genome Characterization Unit:
Sub-section-D: Performance Benchmarks
Applicants should provide a clear set of benchmarks. These benchmarks should address the aims of the Genome Characterization Unit, i.e. tissue processing, genome characterization, analysis and interpretation, and uploading data to NCI GDC. Outline benchmarks that will document progress towards the achievement of the Overall Research Center milestones. Applicants should include plans for critically evaluating and revising these benchmarks on a regular basis. The inclusion of a proposed timeline for implementing components and processes of the Unit is encouraged. Applicants should describe how they will prioritize their activities to ensure that the Overall Research Center milestones of the PE-CGS U2C Research Center will be achieved. Applicants should also describe what action will be taken, and when, if a benchmark is not met or significantly delayed. In addition, applicants should identify potential problems and alternative strategies to accomplish Genome Characterization Unit goals.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
Resource Sharing Plans should only be included in the Overall component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
Delayed Onset Study
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
When preparing your application, use Component Type Functional Unit.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Outline requested budget for research activities for the Engagement Optimization Unit. Budget may include pilot data design and data collection, research protocol development and implementation, survey administration and other methods of gathering data on participant preferences and input, and communication and public relations expertise. This budget request may include funding for web development and design, social marketing strategies and tools, data analytics, equipment, software, and computing resources.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Outline specific aims for the Engagement Optimization Unit and provide a rationale and description of how each aim addresses the research gap in the molecular profile of a specific cancer or cancer and/or population subset using a direct participant engagement strategy.
Research Strategy: In lieu of the standard Research Strategy subsections (Significance, Innovation, and Approach), describe the activities of the Engagement Optimization Unit using the sub-sections listed below. However, applications should highlight aspects of the proposed activities of the Engagement Optimization Unit that speak to the significance and innovation of the approaches.
Sub-section A: Rationale
In this section, applicants should explain how the Engagement Optimization Unit will approach the performance of rigorous empirical research on participant engagement, recruitment, communication, and education about genomic characterization research goals and discoveries. Specifically, describe the empirical research problem, which will be examined by this unit. In addition, provide rationale for these studies in participant engagement and communication by addressing the following:
Sub-section B: Approach to Address Research Questions
In this sub-section, applicants should identify an initial set of empirical research questions in participant engagement and communication and provide plans to address these questions. Explain measures to ensure that plans are flexible and adaptable to ongoing research and implementation needs, including needs to modify initial questions or identify additional empirical questions. Plans should also include the following:
Since several empirical questions may be included in this unit, details about the approach should be provided for each question proposed in participant engagement and communication to be addressed.
Sub-section C: Plans for Integration with Participant Engagement Unit and Genome Characterization Unit
In this section, applications should outline plans for how results from the Engagement Optimization Unit will be used to inform the protocols developed by the Participant Engagement (e.g. design of consent, recruitment procedures) and Genome Characterization Unit (e.g. informing the generation of the genetic data report for participants).
Sub-section-D: Progress Evaluation
Applicants should provide a clear set of benchmarks. Outline benchmarks that will facilitate progress towards the achievement of the Overall Research Center milestones. Benchmarks should include consideration of outcomes for individual participants and outcomes for research. Applicants should include plans for evaluating research progress on a regular basis. Applicants should describe how they will prioritize their activities to ensure that the Overall Research Center milestones of the PE-CGS U2C Research Center will be achieved. The inclusion of a proposed timeline for implementing components and processes of the Unit is encouraged. Applicants should also describe what action will be taken if research progress is insufficient or significantly delayed. In addition, applicants should identify potential problems and alternative strategies to accomplish research studies planned for the Engagement Optimization Unit.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
Resource Sharing Plans should only be included in the Overall component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
Delayed Onset Study
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.
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) using ASSIST or other electronic submission systems. 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.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
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) and component Project Leads 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.
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 (SAM). 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 the NCI, 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.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the PE-CGS U2C Research Center 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 PE-CGS U2C Research Center 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 PE-CGS U2C Research Center that by its nature is not innovative may be essential to advance a field.
Does the PE-CGS U2C Research Center 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 PE-CGS U2C Research Center 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 PE-CGS U2C Research Center address a knowledge gap, defined as performing genomic characterizations of tumors that are currently not well-covered (i.e. characterized with a sufficient number of cases for meaningful interpretation of sequencing results by prior efforts such as TCGA or ICGC)? How well is the proposed research aligned with the areas of interest and goals defined for this FOA? Will the proposed participant engagement strategy result in participants feeling respected, empowered, and motivated to participate in this research program? Will study accomplishments lead to insights into optimal approaches to participant engagement, outreach, and communication in genomic characterization studies?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the PE-CGS U2C Research Center? 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: Do the PE-CGS U2C Research Center PD(s)/PI(s) and other key personnel have the necessary expertise, experience, and understanding of the design, administration, and analysis of the multi-disciplinary research program? How well do the proposed collaborations between the PE-CGS U2C Research Center PD(s)/PI(s), Unit Leads, and other key personnel integrate the components and advance genomic characterization? Do the investigators demonstrate relevant experience with participant engagement in diverse, minority and understudied populations and settings as appropriate? Do the PD(s)/PI(s) have experience with collecting, analyzing, and publishing phenotypic and genomic data, and with returning genomic results to participants?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the program, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the plan for participant engagement, education and communication employ novel concepts, approaches, methods, and/or platforms?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the PE-CGS U2C Research Center? Have 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 PE-CGS U2C Research Center 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: Does the application include adequate plans to recruit and retain the proposed numbers of diverse participants, minority, or understudied populations, as appropriate for the cancer type or subset selected for study? Are the participant engagement plans feasible for the selected cancer or cancer and/or population subset? Does the research center include adequate plans for reporting back data and study information to participants? How are the Overall PE-CGS U2C Research Center milestones designed to ensure successful completion of the proposed genomic characterization using direct participant engagement approach? Does the application include adequate plans for integration across units and for collaborating across the network? How acceptable are the plans for addressing the NCI Cancer Moonshot Public Access and Data Sharing Policy?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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: Are appropriate resources available to engage diverse participants and populations, as appropriate?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Reviewers will provide only one overall adjectival rating for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:
Reviewers will provide only one overall numerical score for the Participant Engagement Unit (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:
Reviewers will provide only one overall numerical score for the Genome Characterization Unit (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:
Reviewers will provide only one overall numerical score for the Engagement Optimization Unit (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:
As applicable for the PE-CGS U2C Research Center 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.
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the program incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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.
When the proposed PE-CGS U2C Research Center 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.
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.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the program.
Not Applicable
Not Applicable
As applicable for the U2C Research Center 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.
Not Applicable
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).
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 .
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.
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:
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:
o To ensure a broad coverage across the listed areas of interest, it is anticipated that no more than one application focused on a specific cancer type or cancer and/or population subset will be selected for funding. In addition, applications focused on cancers in understudied populations may receive a particular funding preference.
o Compliance with Beau Biden Cancer Moonshot Open Access and Data Sharing Policy
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
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 grantee’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: Grantee 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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.
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, Grantees, 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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.
Cooperative Agreement Terms and Conditions of Award
The following special terms of 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.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the program 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 the primary responsibility for:
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.
PE-CGS U2C Research Center investigators will also be encouraged to participate, as appropriate, in other PE-CGS meetings and workshops, collaborative activities, and/or scientific and programmatic working groups.
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
One or more designated NCI Program staff members will have substantial involvement as Project Scientist(s) for the PE-CGS U2C Research Center.
Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Program Officials may also have substantial programmatic involvement (as Project Scientists).
The specific roles of the substantially involved NCI staff members include the following activities:
In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act.
Areas of Joint Responsibility include:
PE-CGS Network Steering Committee. The PE-CGS Network Steering Committee will be the main governing body for the PE-CGS Network. The PE-CGS Network Steering Committee will be composed of one representative (contact PD/PI or other designated senior level investigator) from each PE-CGS awardee, i.e., from the PE-CGS U2C Research Centers and the PE-CGS U24 Coordinating Center who will have one vote each and a Project Scientist, who will have one vote for NCI.
If needed, other NIH staff members may also participate in PE-CGS Network Steering Committee meetings as non-voting members.
Two PD(s)/PI(s), representing two different PE-CGS U2C Research Centers, will be selected to serve as chairpersons of the PE-CGS Network Steering Committee starting at the first meeting of the PE-CGS Network Steering Committee following award issuance. All PE-CGS Network Steering Committee decisions and recommendations that require voting will be based on a majority vote.
The PE-CGS Network Steering Committee will meet quarterly by videoconference and in-person at the PE-CGS annual network meeting, annual participant meeting, and as needed.
The PE-CGS Network Steering Committee will:
The Steering Committee may form sub-committees as needed, including the External Advisory Panel (see below).
PE-CGS Network External Advisory Panel. An External Advisory Panel (EAP) will be convened as a sub-committee to the PE-CGS Steering Committee. EAP will evaluate the progress of the PE-CGS Network and advise the Steering Committee and PE-CGC awardees regarding the scientific directions of the program. The panel will be logistically supported by the PE-CGS U24 Coordinating Center.
The PE-CGS Network EAP will be composed of nine individuals (selected by the PE-CGS Network Steering Committee), including established scientific leaders in oncological sciences, individuals with a history of cancer diagnosis, cancer advocates, and other stakeholders with relevant expertise. If needed, EAP membership may be enlarged permanently or on an ad hoc basis. The EAP will meet at least once a year, either in person with the Steering Committee meeting or by telephone conference.
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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees 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 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]
Leah E. Mechanic, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6847
Email: [email protected]
Elizabeth M. Gillanders, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6764
Email: [email protected]
Wen-Ying Sylvia Chou, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6954
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
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.