Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions in the Context of SPORE

1. Translational Research: Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer. 

2. Early detection, Prevention, or Population Science (EPPS) Research Projects: 

Early Detection: An early detection Research Project is one that is focused on the discovery of early detection biomarkers and/or on the development of an assay that determines the presence of precancerous lesions or early cancer. For either type of Research Project, there would need to be an already established or experimental subsequent intervention for treating the detected lesions. Qualified Research Projects may include early detection of a new primary tumor that appears as a result of a cancer field effect . Testing for metastases or recurrence of the primary tumor is not early detection. 

Prevention: A prevention Research Project investigates a medical, surgical, or lifestyle intervention that aims to reduce cancer incidence in individuals at risk. A Research Project that addresses the prevention of a second primary tumor is also appropriate. A Research Project that addresses the prevention of cancer recurrence or develops a therapeutic vaccine in a no-evidence-of-disease state in treated cancer is not acceptable as an EPPS Research Project.  However,  vaccines targeting "at-risk" lesions (e.g., pancreatic cysts, Barrett's esophagus, or ductal carcinoma in situ (DCIS)) are appropriate. 

Population Science: Population science aims to understand the causes and distribution of cancer across all populations, supports the development of effective interventions to reduce cancer risk, mortality, and morbidity, as well as the social cost of cancer, and monitors and explains cancer trends . A population science Research Project specifically in the SPORE may focus on study participants selected from sampling frames drawn from the general population, individuals at risk for cancer, or cancer patients. Unlike clinical trials with their specific inclusion criteria, population science studies should be sufficiently representational to allow for substantial external validity, i.e., generalized inferences to the target populations in the studies. Likewise, population science studies that focus on biomarker discovery and/or validation may not draw on specimens from convenience samples, such as a case series of highly selected patients, but instead must be drawn from a sampling frame that represents the target population under study and must be based on samples that allow for inferences to the target populations. 

3. Scientific Collaborations: 

Horizontal Collaboration: Collaboration with others outside the SPORE grant to complete the research aims and/or goals of a SPORE Research Project. These collaborations may be done in the laboratory, at the clinical trial stage, or as a part of a population science study. Examples of these collaborations include Research Projects with other SPOREs or the use of industry-provided agents. Interactions between Research Projects and Cores within a SPORE grant do not meet the definition of Horizontal Collaboration.

Vertical Collaboration: Collaboration with an entity outside the SPORE grant that extends SPORE translational research beyond the specific aims of Research Projects along the translational continuum (e.g., from discovery to pre-clinical development, to Phase I trials or studies, to later phase studies, and possibly to a final hand-off to a commercial company).

SPORE Features and Objectives

All SPOREs include the following common features:

1. Translational Research Focus: All SPOREs are focused on translational research that meets the definition provided above (see key definitions section). SPOREs are dedicated to capitalizing on research opportunities that have the potential to change the current paradigm in the prevention, detection, diagnosis, and/or treatment of human cancer. SPORE Research Projects may investigate basic science objectives if those objectives are relevant to human cancer and will lead to a human endpoint within the 5-year period of the grant.

2. Flexibility to Change Research Direction/Team Approach: The flexibility of the SPORE program allows PD(s)/PI(s) to replace projects that are completed ahead of schedule or projects that are making little or no translational progress with new translational projects. .  The team of scientists that participate in SPORE Research Projects may or may not remain the same, and the roles of co-leaders may change throughout the funding period. Review and approval by the External Advisory Board (EAB) and NCI Program Staff are required. The flexibility option is available only after the first year of the funding period. This option may not be used to add full scientific Research Projects over and above the number of Research Projects that were peer-reviewed, even if no new funds are requested.

3. SPOREs support Specialized Research Infrastructure by:

• Establishing critical research infrastructure needed to sustain the translational Research Projects proposed within the SPORE;
• Facilitating the complex research objectives inherent in studying human cancer;
• Having robust mechanisms in place for making SPORE generated shared resource data readily accessible to research and clinical investigators in the broader scientific community;
• Supporting the establishment of translational research cores that fill broad institutional infrastructure gaps;
• Utilizing and augment existing cores within Cancer Centers and other institutional facilities wherever feasible; and
• Preventing duplication of existing institutional cores or other resources.

4. Fostering Translational Research Careers: SPOREs provide a unique environment for translational research that can be used to prepare new scientists for careers in this evolving field or provide the opportunity for established scientists to re-orient their research careers toward translational research.

5. Research Collaborations, Networks, and Consortia: SPOREs are aimed to identify research questions that can only be accomplished through collaborations, networks, and consortia and take full advantage of SPORE's scientific expertise and infrastructure.

6. Participation in NCI-Sponsored SPORE-related Meetings, Workshops, and other Activities: Key personnel share expertise and research results with other translational research grantees in NCI-sponsored meetings, workshops, and working groups. The goals of these meetings may include the identification of consensus data standards, sharing of materials and data, assessing progress, and identification of new collaborative opportunities. 

 7. Research Objectives

The SPOREs are focused on organ-specific cancers, groups of highly related cancers, or cancers driven by common activation pathways or cross-cutting themes (including, but not limited to, targeting of commonly mutated oncogenes or reactivating tumor suppressor genes; cancers centered around a common biological mechanism; pediatric cancers; or cancer research with a unique focus on population groups experiencing differences in cancer outcomes.). 

Pre-application Communications with NCI Staff

Each prospective SPORE applicant is advised to schedule a pre-application consultation with the NCI staff using contact information in Section VII of this NOFO. The consultation should be scheduled at least 4 to 6 months in advance of the application due date and is intended to help the PD/PI (along with one or more of his/her intended co-investigators) understand the Program and its translational objectives and discuss strategies for preparing a competitive application. NCI staff will clarify SPORE requirements, and current NCI budget allocations, and describe the peer-review process. The NCI staff can also answer questions about the NCI-supported clinical trials and other collaborative resources that might be available beyond the funded activities of the SPORE as part of planned vertical collaborations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 not allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. 

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. 

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 How to Apply - Application Guide.

The applicant institutions should have a demonstrated ability to conduct translational research (see key definitions) in the prevention, early detection, diagnosis, and/or treatment of human cancer. Investigators may only serve as a PI/multi-PI on one funded SPORE P50 at a time. However, investigators may have other roles (i.e., Co-Leader, Core Director) on multiple SPORE P50s concurrently, even from more than one institution.

Minimum Research Base: In order for a SPORE application to be considered for award by NCI, the application must include four or more independent investigators who currently serve as PDs/PIs (or Project Leaders) on peer-reviewed research grants (e.g., R01, R21, P01, U01, U10, U19, U54, American Cancer Society [ACS], U.S. Department of Defense [DOD], or equivalent) or are overall chairpersons or site chairpersons on an active NCI-sponsored clinical trial. These activities must be directly related to the cancer(s) being investigated in the SPORE or the specific expertise required for the SPORE. PDs/PIs supported by the NCI's non-mentored "K" career development grants or the R00 portion of the K99/R00 award may also be included in the research base requirement if the career award is directly relevant to the cancer(s) being investigated or the specific expertise required for the SPORE project. Please note that an investigator who is a PD/PI on multiple qualified grants or clinical trials counts only once towards the research base, and to qualify, the investigator must be the PD/PI on the highlighted activity. The qualifying investigators also must serve on the SPORE as a PD/PI, a multi-PD/PI, project Co-Leader or Shared Resources Core Director. Applications that do not meet the Minimum Research Base requirement will be considered not responsive and will not be reviewed or considered for funding.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Note: It is acceptable for investigators to concurrently submit the same or overlapping Research Project as a SPORE Research Project and an independent R01, R21, etc., application to the NIH. However, PD(s)/PI(s) must be prepared to relinquish the R01 (or other single Research Projects) award if both are determined to be eligible for funding. Investigators may not concurrently submit both a P01 and a P50 application requesting support for the same projects/activities. The potential overlap will be evaluated by NCI staff prior to award; submitted applications will not be reviewed if they do not conform to NIH policies or if they fail to meet the minimum requirements of the SPORE Program.

An applicant organization cannot have multiple SPOREs with the same overall scientific focus/theme, even if there is no overlap in scientific content. Moreover, an applicant organization cannot have a SPORE with a Research Project that overlaps with the overall scientific focus/theme of another SPORE at the applicant organization. This is particularly relevant for SPOREs focused on groups of highly related cancers or a cross-cutting theme. 

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required and must include Scientific Collaboration section as well as a Data Management & Sharing (DMS) plan attachment
• Administrative Core: required
• Shared Resources Cores (use for Shared Resources Cores which includes the required Biospecimen/Pathology Core and optional other Cores)
• Research Projects: minimum of three research projects required 
• Developmental Research Program (DRP): required
• Career Enhancement Program (CEP): required

Overall Component

When preparing the application, use Component Type 'Overall'.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Follow standard instructions.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide overall goals/abstract/summary for the entire SPORE application.

Project Narrative: In the "Project Narrative", the relevance of the SPORE's research to public health should be stated.

Facilities and Other Resources: Provide a description of all resources available for the entire SPORE. 

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" may be included with the Overall component to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the Overall component may be attached and cross-referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative. New information is not allowed in Other Attachments. 

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

If an applicant's institution is associated with an NCI-designated Cancer Center, the SPORE PD/PI should hold a senior position in the Cancer Center. Alternatively, if this position is not currently held, an appointment for such a position should begin once NCI SPORE funding is secured. The PD/PI's prominent role in the Cancer Center is expected to facilitate interactions between the SPORE and Cancer Center leadership. The PD(s)/PI(s) of the SPORE may be the Cancer Center Director. 

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.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Each PD/PI must serve a combined effort across all components of at least 2.4 person months (PM) unless there are three or more PD/PIs in multiple PD/PI applications. In such a case, the minimum level of effort can be reduced to 1.8 PM for each multiple PD/PI. 

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.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Succinctly list the specific objectives and goals of the SPORE as a whole. Summarize the expected outcome(s) of the SPORE as a whole, including the impact that the results of the proposed translational research will have on prevention, early detection, diagnosis and/or treatment of the organ-site specific cancer, group of highly related cancers, or cross-cutting cancer theme chosen for study. 

Research Strategy: Organize the overall Research Strategy section in the specified order using the instructions provided below. Start each subsection with the appropriate heading: Overall Significance; Overall Innovation; and Overall Approach. Additional subsections of Preliminary Studies (for new and renewal applications) and Progress Report (for renewal applications) must be included in this section as well. This section should be used to discuss the overall translational strategies that will be employed in the SPORE to reach human endpoints within the project period. In addition, discuss planned activities relating to Scientific Collaboration in a separate subsection. Applications may include discussions of all the projects together for overall significance, innovation, and approach for the SPORE, or discuss each project separately. PDs/PIs of renewal applications should succinctly address the most significant translational research achievements in the current funding period of support, including results that were the basis of further movement across translational and clinical trial programs, and their potential impact on human cancer. Renewal applications should also discuss the use of the SPORE's flexibility to replace projects that are not meeting translational research milestones or that have been completed successfully with new, promising projects, during the current award period.

Overall Significance

• Explain the importance of the proposed translational goals, including the overarching problems or critical barriers to translational progress in the field of study.
• Explain how the SPORE as a whole will improve scientific knowledge, technical capability, and/or clinical practice in prevention, detection, diagnosis or treatment of cancer in the specific organ site(s).
• Describe how the concepts, methods, technologies, treatments, services, or preventive interventions that drive translational research for the organ site(s) will be changed if the overall aims are achieved. 

Overall Innovation

• Explain how the overall SPORE challenges and seeks to shift current translational research or clinical practice paradigms.
• Summarize novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used in the projects and/or Shared Resources Cores.
• Summarize how the SPORE will improve or refine existing theoretical concepts, approaches, methodologies, instrumentation, or interventions, or apply them in new ways, to enhance translational cancer research.  

Overall Approach

• Summarize the strategies, methodologies, and analyses that will be used to accomplish the overall specific aims and objectives of the SPORE.
• Address potential problems, alternative strategies and benchmarks for success in achieving the aims of the overall SPORE.
• Explain how the SPORE as a whole will establish strategies to enhance feasibility and manage high risk aspects of the work, particularly if any of the proposed projects or aims in the Shared Resources Cores are in the early stages of development.
• Discuss the collaboration of applied researchers (e.g., clinical researchers, pathologists, epidemiologists) with basic investigators in the design and implementation of translational research that is most likely to have an impact on human cancer.
• Explain how the proposed research Projects, Developmental Research and Career Enhancement Programs, and Shared Resources Cores will, together, address the overall goals and aims of the SPORE more effectively than if the projects were done as independent grants.
• Describe a program wide consent process that would inform patients about the risks and rewards of participating in the clinical study of the SPORE program; and the possibility that some anonymized data may be shared with academic and private sector collaborators. Such sharing may enable future research uses of individual patient information that cannot be fully anticipated at the time of consent.
• Explain how each Shared Resources Core is justified and will provide centralized high-quality services to the SPORE as a whole and produce an economy of effort and/or save overall costs compared to each project in the SPORE performing its own tests, assays, animal derivations, clinical studies, etc.
• Describe the resources and processes to be used to apply the appropriate standards to represent the data and information being generated through the proposed SPORE research activities and to submit these data to the appropriate NIH/NCI data repositories.
• The inclusion of the following is encouraged:
  • Patient, research, and/or community advocates with a collective patient perspective.
  • Early Detection, Prevention, or Population Science (EPPS, see key definitions section).
  • Research projects that bring together investigators from multiple institutions to facilitate the development of large-scale team-based projects.

Preliminary Studies

Summarize the preliminary studies that led to developing the SPORE application. More detailed preliminary studies sections should be included in the individual research projects and Shared Resources Core(s).

Scientific Collaboration (SC)

Information related to scientific collaborations must be provided within the Overall component. The definition of Horizontal and Vertical Collaborations in the context of this NOFO may be found in Part 2 Section 1 Key Definitions. Succinctly address the following:

• Describe planned, ongoing, and completed Horizontal Collaborative projects and programs with defined milestones. Explain how these joint efforts advance the translational goals of the SPORE.
• Describe planned, ongoing and completed Vertical Collaborations with defined milestones. Explain how these joint efforts advance the field of science and future clinical practice. 
• Explain how mature SPORE findings are transitioned to other NCI supported clinical trial mechanisms or other governmental or non-governmental programs. 
• Applications should describe potential collaborative arrangements to support therapeutic and biomarker development and to expand population based and cancer preventions studies beyond the scope of the SPORE, contingent on the success of early-stage clinical studies.

Progress Report (for Renewal Applications)

• Summarize the major achievements of the overall SPORE in the current funding period. More detailed progress reports should be included in the individual research projects, DRP, CEP, and Shared Resources Cores. Discuss new research opportunities that have arisen from SPORE research in the current funding period. If an overall major scientific achievement of one or more collaborative studies has emerged during the current funding period, it should be described in detail in the Scientific Collaboration section within the Overall component, including the nature, logistics, and milestones, of moving the SPORE research across translational and clinical trial mechanisms. Project specific collaborations and associated scientific data should be included under individual research projects.
• Explain any significant changes to the program during the current funding period, including the use of the SPORE "flexibility option", and any new directions proposed in the new funding period. For renewal applications, summarize changes from the last review by listing new, continuing, completed, and discontinued projects, identifying the previous number of each component. Explain the decision to discontinue, substantially modify, or propose new projects or Cores. Describe the impact of these changes on the overall SPORE. Discuss how recommendations of the External Advisory Board, Internal Advisory Board (if proposed), and the SPORE leadership have influenced these changes.
• Discuss any opportunity or problems that arose in moving a discovery forward for commercialization during the past funding period. Report any patent or licensing activities related to the translational research supported by the SPORE.

Progress Report Publication List: Include here publications and accepted manuscripts that cite the SPORE grant and have resulted from projects that are not being continued in this application. Emphasize in bold font each listed publication that is the result of formal collaborations with other SPOREs, or with other funded NCI networks, such as the NCI Clinical Trials Network, the Early Detection Research Network (EDRN), or the Experimental Therapeutics Clinical Trials Network (ETCTN). For publicly available citations, PMC submission identification numbers (PMCID), if required, should accompany the full reference. Publications resulting from projects that are continuing in the proposed application should be included within each Research Project component section. Copies of these publications should not be included as appendix material. 

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type 'Admin Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Core: Administrative Core
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Follow standard instructions. 

Research & Related Other Project Information (Administrative Core)

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 Summary/Abstract: Provide overall goals/abstract/summary for the Administrative Core.

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.

Facilities and Other Resources: If this component will benefit from a funded institutional, local, state, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" should be included with the application. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the Administrative Core component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative. New information is not allowed in Other Attachments.
• Attach a figure showing the institutional organization chart for decision-making and administration within the program.
• Attach a table showing the person months effort for SPORE named key personnel dedicated to each Research Project, Core, and the Developmental Research Program (DRP) and Career Enhancement Program (CEP).
• Attach a table that describes for each Shared Resources Core the percentage of effort that is dedicated to each Research Project, CEP and DRP. This table should be referred to in the narrative(s) of each component served by the Shared Resources Core. 

Project /Performance Site Location(s) (Administrative Core)

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.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Admin Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
• A SPORE Administrator who has experience managing multi-project grants involving clinical trials should be included in the Senior/Key person list. An effort of 1.2 PM is recommended.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The SPORE PD/PI (or at least one of the SPORE PD/PIs in multiple PD/PI applications) is expected to serve as Core Lead of the Administrative Core with minimum effort of 0.6 person month (PM). If multiple PDs/PIs serve as co-Core Leads, each must devote a minimum effort of 0.6 PM. The minimum total effort for PD/PIs on a SPORE application is 2.4 PM. However, if a SPORE is submitted as a multiple PD/PI application with three or more PD/PIs, the required total minimum is reduced to 1.8 PM each. The minimum PM time commitment should be an aggregate of efforts in different components.

Budgets are also required for each consortium (subaward) if they are part of the Administrative Core.

Budgets for costs to cover the travel of (up to) 10 investigators per SPORE to NCI-sponsored meetings/workshops and NCI-related activities, and allowable advocate-associated costs should be included. Any costs related to advisory board meetings should be included.

Funds should not be requested for participation in grant review meetings, special emphasis panels, and other evaluation groups where reimbursement derives from other sources.

Budget Justification. In the Personnel Justification section, discuss the time commitment of the Core Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the Biosketch or Research Strategy section.

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.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Succinctly describe the list of specific objectives and goals of the Administrative Core.

Research Strategy: Succinctly address the following items:

Leadership: Describe the plans for the organizational, administrative, and scientific management (both basic and clinical research) of the SPORE program. Describe and/or diagram the chain of authority for decision-making and administration within the program.

Administrative Management: Describe the plans for fiscal management, grant administration, and meeting coordination. Quality control and communication aspects of the grant for all institutions is involved should be discussed. Include a succession plan that describes the process for changing leadership if the SPORE PD(s)/PI(s) is no longer willing or able to lead the SPORE. A statement of commitment to attend NCI-sponsored meetings/workshops and other NCI-related activities should also be included.

Cancer Patient Population: Each SPORE must describe and document access to a substantial patient population for the cancer organ site, subtype, or group of related cancers that are the focus of the application.Provide reasonable assurance that the patients and human specimens needed for translational research are readily available. A consortium agreement may be established between institutions to provide adequate access to clinical specimens and/or patient populations. For renewal applications, document the accomplished translational goals, including evidence of human subject enrollment on clinical/population research studies during the past funding period.

Planning and Evaluation Activities: Discuss the planning and evaluation of SPORE activities, e.g., the evaluation of productivity of existing Research Projects and Shared Resources Core; the process for discontinuing Research Projects and replacement and the responses to important translational research opportunities.

Describe the establishment of a required External Advisory Board (EAB) and the recommended Internal Advisory Board (IAB), if proposed. If the EAB/IAB has already been established, list active members. If the EAB has not yet been established, describe needed areas of expertise but do not contact new EAB members until after peer review. In addition to the list, describe the role of the EAB/IAB in planning and evaluation processes.

The PD(s)/PI(s) of the SPORE are expected to make decisions about the continuation or discontinuation of Research Projects in consultation with the EAB, as well as with other lead investigators on the SPORE. 

Interaction between the SPORE and NCI-designated Cancer Center: If a SPORE application originates from an institution that is supported by an NCI Cancer Center Support Grant (CCSG; P30), the following are also expected:

The SPORE must be an integral part of the Cancer Center, and the lines of authority should be clearly indicated.

• Cancer Center Director(s), or their designee, are encouraged to directly interact with the proposed SPORE (e.g., serve as an Internal Advisory Board member).
• The applicant should discuss how the SPORE will interact synergistically with existing P30 programs and their resources to maximize both SPORE and Cancer Center research objectives. While the SPORE is expected to become an integral element within the NCI-designated Cancer Center, a distinct institutional commitment to the SPORE must still be maintained throughout the term of the SPORE grant.
• The proposed Cores within the SPORE should not duplicate any available facility already in place and supported by another granting mechanism (e.g., P30, P01, U01, U10, DOD, etc.). Applicants may, however, augment pre-existing Cancer Center or institutional resources to direct these activities toward more effective fulfillment of the requirements of the SPORE. For example, the SPORE should use the Cancer Center-specific IRB(s) and DSMB(s) as well as other clinical trial resources, whenever possible.

Integration between SPORE, Institution, and NIH/NCI initiatives: In addition to the Cancer Center describe how the SPORE integrates with other NCI-supported institutional resources (e.g., use of clinical data and safety management systems, biostatistics, etc.).

Letters of Support: Attach letters of support addressed to either the SPORE PD(s)/PI(s) or the NCI and must be signed by the appropriate institution's leaders (e.g., Dean of the School of Medicine, President, Vice President for Research).

A letter of support from the institution's leadership must be attached describing: 

• The institutional commitment to support the proposed SPORE.
• A plan for how the institutional commitment will be established and sustained.
• How the institution will maintain accountability for promoting scientific excellence. 
• How the SPORE research effort will be given a high priority within the institution.
• The integration and synergies between the institutional resources and those of the overall SPORE and its components.

The institutional commitment may come in the form of support for the recruitment of scientific talent, providing protected time for physicians, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution.

A separate letter of support from the Cancer Center is required for host institutions associated with an NCI-designated Cancer Center. The NCI-designated Cancer Center letter of support should describe:

• The integration and synergies between the Cancer Center resources and those of the overall SPORE and its components.
• Delineation of organizational relationships and responsibilities between the SPORE and the NCI-designated Cancer Center.
• If the SPORE PD/PI does not hold a prominent position within the Cancer Center, describe the future authority of the SPORE PD/PI within the Cancer Center once the NCI SPORE funding is obtained.
• If there is dependence on Institute-wide Core Resources, a letter of agreement from the Core Director should be included.

SPORE involving two or more institutions must include a formal written agreement(s) from the other participant organization(s) that states how the participating institution will commit to the SPORE. The primary institution (as well as any participating institutions) is strongly encouraged to demonstrate commitment by providing financial support to the Developmental Research and Career Enhancement Programs on an awarded SPORE, as well as to other programmatic needs identified as high priority in the application.

The institution(s) is encouraged to provide the SPORE PD/PI with discretionary funds. These funds can be used to support anticipated as well as unanticipated activities during the funding period.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within 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.   

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Shared Resources Cores

When preparing your application, use Component Type "Core'.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Shared Resources Cores)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Core(s) starting with "Core A: Title", "Core B: Title", etc.
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Shared Resources Cores)

Follow standard instructions. 

Research & Related Other Project Information (Shared Resources Cores)

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 Summary/Abstract: Provide overall goals/abstract/summary for the Shared Resources Core

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.

Facilities and Other Resources:

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Institutional Commitment: Discuss how institutional commitment to the Core will facilitate the research proposed. Examples include providing support for recruitment of scientific talent, providing discretionary resources to the Core Director, assigning specialized research space, cost sharing of resources, and other assurances proposed by the applicant institution.

Other Attachments: The following "Other Attachments" should be included with each Core component to aid in the review of the application. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the Shared Resources Core component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.
• Distribution of Shared Core's Effort to Research Projects.
• Provide an attachment entitled "Data Systems for the (insert unique name) Core". The attachment should describe the development and use of the Shared Core's bioinformatics and data management capabilities for data administration, as applicable to the cancer center, the institution, or activities associated with other NIH/NCI initiatives.
• If a Biostatistics Core is not proposed, and biostatistics/bioinformatics activities are instead described in the Research Project components, then describe these activities in the corresponding "Data Systems" attachment for each Research Project.

Project /Performance Site Location(s) (Shared Resources Cores)

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.

Research & Related Senior/Key Person Profile (Shared Resources Cores)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Shared Resources Cores)

Budget forms appropriate for the specific component will be included in the application package.

Budgets are also required for each consortium (subaward) if they are part of any Cores.

Core Director(s) must commit to a minimum of 0.6 PM of effort.

Budget Justification. In the Personnel Justification section, discuss the time commitment of the Core Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

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.

PHS 398 Research Plan (Shared Resources Cores)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Succinctly list the specific objectives and goals of the Core.

Research Strategy: If a proposed Core appears to duplicate other facilities at the applicant institution(s), justification should be provided along with an explanation for why these institutional resources cannot be used for the SPORE activities.

If a SPORE application is submitted from an institution with an NCI-designated Cancer Center the application must address how related activities (e.g., specimen banking) are coordinated with the Cancer Center. Prior to an award, NCI will carefully review proposed SPORE Core activities and budgets for overlap with ongoing CCSG Cores. It should be the objective of all involved Core directors to make sure that biospecimen-related, biostatistical, bioinformatics, and clinical activities are performed in a cost-effective and coordinated manner.

Biospecimen/Pathology Core (Required)

Describe the plans for collecting and distributing human cancer site-specific and/or related specimens as appropriate for the cancer site. Describe the plans for annotation of parameters of collection and preservation as well as essential information needed for conducting all proposedtranslational research activities. These plans should include detailed biospecimen quality assurance and control measures and standardization of procedures across performance sites to ensure sample quality.  Describe the informatics for tracking specimens, as well as linkage to clinical and follow-up data sets. Networking with informatics systems at other SPORE sites is encouraged but is not required. Address development, acquisition, storage, and usage of standardized reference materials, and any other services related to the analysis of specimens . Describe and justify research activities to improve Core services and how they benefit the SPORE. Describe integration with the Cancer Center biospecimen Core resources and the clinical laboratory.

Provide a plan for prioritizing distribution of biospecimens to SPORE scientists and others based on the merit of the proposed translational cancer research projects. Renewal applications should include a list of the studies and/or collaborations that benefited from this Core, as well as a summary listing the numbers and types of specimens accrued and distributed during the previous funding period. If significant collaborations have emerged from this Core, beyond the distribution of specimens, the data should be discussed in this section, but the details of the collaboration itself should be discussed in the SC section of the Overall component.

Other Cores (Optional)

Additional Shared Resources Cores (e.g., biostatistical, clinical, animal, etc.) may be proposed to supportone or more Research Projects. A Biostatistical Core is strongly encouraged. Recommendations for the Biostatistical Core are below:

• Describe the statistical analysis plans for each experiment including justification of power calculations and sample sizes, the appropriate statistical tests that will be used for analysis and the assessment of data quality and reproducibility.
• Describe any innovative statistical methodologies that are used.
• Describe the effort level, expertise, education, duties/responsibilities for key personnel and staff.
• Describe the crosstalk between this core and the Research Projects/Programs. 

For all Cores, describe the facilities and/or services that will be provided, and state the rationale for centralizing them in the Core, rather than including them in individual Research Projects. Indicate why the Shared Resources Core is an essential part of the SPORE. Address plans for prioritization of services (if necessary).

For renewal applications, use of the Core facilities and services by Research Projects and Developmental Programs during the current funding period should also be clearly documented.

Progress Report Publication List (for Renewal Applications): List all publications and accepted manuscripts resulting from previously funded Core(s) that are being continued in the proposed SPORE application and that cite the SPORE. Emphasize in bold font each listed publication that is the result of formal collaborations with other SPOREs, or with other funded NCI networks, such as the NCI's National Clinical Trials Network (NCTN) or the Early Detection Research Network (EDRN). Copies of these publications should not be included as appendix material.

Letters of Support: Attach appropriate letters relevant to each Core detailing the nature and extent of participation.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within 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.

PHS Human Subjects and Clinical Trials Information (Shared Resources Cores)

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Research Project

When preparing your application, use Component Type 'Project.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project starting with "Project 1: Title", "Project 2: Title", etc.
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Follow standard instructions. 

Research & Related Other Project Information (Research Project)

Project Summary/Abstract: Provide overall goals/abstract/summary for the project.

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: State the relevance of the Research Project's activities to public health. Note: ASSIST screens will show an asterisk for this attachment indicating it is required.

Facilities and Other Resources: If this component will benefit from a funded institutional, local, state, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The filename provided for each attachment will be the name used for the bookmark in the application image.

• Provide an attachment having a title that contains the phrase "Data Systems for Project" and also contains the Research Project number.  The attachment should describe the development and use of the Research Project's bioinformatics and data management capabilities for data administration, as applicable to the cancer center, the institution, or activities associated with other NIH/NCI initiatives.
• If a Biostatistics Core is not proposed, and biostatistics/bioinformatics activities that support the Research Project are instead proposed within the Project component itself, then include the relevant data management information in this attachment. For Research Projects with clinical trials, include the following information in the "Data Systems" attachment if there is no Biostatistics Core:
  • The procedures for data management and quality control of data at clinical site(s) or at center laboratories, as applicable.
  • The methods for standardization of procedures for data management to assess the effect of the intervention and quality control.
  • The plan to complete data analysis within the proposed period of the award.
• To aid in review of the application, Tables, graphs, figures, and images relevant to the Research Project may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific Project.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with category of 'basic co-leader, clinical co-leader, or applied co-leader' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
• Each Research Project is required to have a minimum of one basic and one clinical-or-applied scientific leader working together on each project, making a minimum of two Research Project co-leaders. 

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Each Research Project must include both basic and applied/clinical Co-leaders who will use their combined expertise to design and implement the project. Each Co-leader must commit individually to a minimum of 0.6 person months (PM) of effort. It is not necessary that the Co-leaders commit an equal amount to the project.

Applications that include one or more qualified Early Detection, Prevention, or Population Science (EPPS) Research Project(s) may request (with appropriate justification) additionally up to $120,000 direct costs/year per grant for each of the 5 years to support the project(s). The additional funds must be requested only in the budget(s) of qualified EPPS project(s). If an application has more than one EPPS Research Project, the applicant may divide up to $120,000 among the EPPS Research Projects. The additional funds should not be used to support non-EPPS Research Projects but can be used toward Cores that support the proposed EPPS Research Project(s). The amount of EPPS funding allocated for each project and supporting Core(s) must be specified in a paragraph entitled, EPPS Project Funding, on the Project and Core budget justification pages. For definitions of qualified EPPS projects, see Key Definitions.

For SPORE-designated clinical trials the SPORE-funded budget for the clinical trial should be included and described.

Budget Justification. In the Personnel Justification section, discuss the time commitment of the Project Leaders and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

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.

PHS 398 Research Plan (Research Project)

A minimum of three Research Projects, each with a human endpoint, must be proposed. At least one Research Project must have a clinical trial as a specific aim. The clinical trial must be SPORE initiated and the trial protocol must be developed by the SPORE investigators and be funded in part or in full by the SPORE.

Each Research Project must meet the definition of translational research as described in the key definitions section.

In each SPORE Research Project, at least one of the following types of human endpoints should be proposed:

• Early phase clinical trials of new investigational drugs, biologics, experimental procedures, medical devices, or combinations;
• Early phase clinical trials of new combinations or new uses of Food and Drug administration (FDA)-approved agents and devices;
• Discovery and development of biomarkers, only when measurements are made in human specimens, or directly in human subjects;
• Laboratory studies that begin with an observation in the clinic, for example development of therapeutic resistance, and use human specimens to generate new clinical hypotheses;
• Population, behavioral, or psychosocial studies, when these studies address and measure mechanistic aspects of the biology of the disease, and
• Investigational New Drug (IND)-directed toxicology studies conducted following a pre-IND meeting with the FDA in which the plan proposed by the investigators is acceptable to the FDA.

Experiments using cell lines, xenografts, patient-derived xenografts (PDX), organoids, paired germline samples, or engineered tissues may be important to the translational studies proposed and are encouraged but are not sufficient to meet the human endpoint requirement.

An IND-directed toxicology study can serve as a human endpoint, but it is not sufficient to satisfy the clinical trial requirement.

Clinical and/or epidemiological research that does not include a wet laboratory or imaging component is not considered translational for the SPORE.

Each proposed Research Project should be designed to test the relevance and/or potential importance of the research to human cancer within the project period of the grant. Research Projects containing basic research (e.g. employing animal models or cell lines) qualify as translational only if a human endpoint is included in the specific aims. To enhance translational relevance and prioritize human based research technologies, applicants are encouraged to incorporate New Approach Methodologies (NAMs) including but not limited to human derived tissues/organoids mathematical/computational modeling, non-invasive human imaging, and real-world human data sources (population science). (When Are Alternatives to Animals Used in Research? Grants & Funding).

Where scientifically valid and justified, NCI will prioritize human-based technologies and models, and funding opportunities may highlight a special emphasis on these approaches. Importantly, NCI will continue to fund research using laboratory animals when it is scientifically appropriate, well-justified, and conducted with proper animal welfare oversight. When animal models are proposed, applicants must clearly justify their necessity and use the minimum number of animals needed for rigorous and reproducible research.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the translational goals of the proposed Research Project and summarize the expected translational outcomes(s), including the impact that the results of the Research Project will exert on the human disease site(s) involved. List succinctly the specific objectives of the Research Project, e.g., to test a stated hypothesis, to generate new hypotheses relevant to translational research, to solve a specific problem that has yet been unsolved in the field, to challenge an existing paradigm or clinical practice, to address any critical barrier(s) to progress in the field of translational cancer research, or to develop new technologies, detection methods, or biomarkers appropriate for testing in human cancer patients or populations at risk for cancer. At least one specific aim must address reaching a human endpoint.    

Research Strategy: Organize the Research Strategy, using the instructions given below, including the Preliminary Studies (for New Projects) and Progress Report (for Renewal Applications). Start each subsection with the appropriate heading. Experimental details should be cited using the Bibliography and References Cited section and need not be detailed in the Research Strategy.

Only Phase I and early Phase II clinical trials (generally up to 100 human subjects) may be supported by funds from the SPORE program. The number of human subjects in a population science or prevention study may exceed the 100 human subjects limit, if appropriate. SPOREs are strongly encouraged to establish collaborative clinical trial activities across NCI-funded mechanisms early in the development of projects that have clinical trials/studies as their goals.

For multicenter, randomized Phase II therapeutic trials (>100 patients), SPOREs wishing to collaborate as an inter-SPORE endeavor or with investigators funded by other grant mechanisms, should use the appropriate NCI Disease Specific Steering Committees and their Task Forces (CCCT - NCTN Steering Committees - NCI). This collaboration should work to develop clinical concepts from early SPORE trials that could move forward, beyond SPORE grant support, to the NCI's National Clinical Trials Network (NCTN). Collaborative trials using this opportunity may also include correlative studies. Correlative studies associated with an NCTN trial may be supported within a SPORE Research Project.

It should be noted that a clinical trial may not be the goal of many SPORE Research Projects. Some Research Projects will reach a human endpoint by using human specimens in the laboratory to expand upon observations made in the clinic, a process known as "reverse translation." However, when biomarker studies are ready for clinical trials, SPOREs are encouraged to collaborate with trans-NCI clinical trial mechanisms to validate the biomarkers clinically.

SPORE applications may include qualified Early Detection, Prevention, or Population Science (EPPS) Research Project(s). If a particular component is proposed as a qualified EPPS Research Project, the applicant must provide a statement in the Specific Aims section of that component confirming its designation as EPPS. Specific programmatic requirements pertaining to qualified EPPS Research Projects are described in the key definitions section. For each qualified EPPS Research Project, there must be a laboratory component addressing relevant mechanistic aspects of human cancer biology and all aims must be EPPS-focused. The Research Project may involve genetic, epidemiological, behavioral, social, applied, and surveillance studies. If an existing qualified EPPS Research Project is discontinued before expiration of the SPORE project period and a substitute project is not qualified as an EPPS project, the grantee will lose the additional EPPS funds for the remaining term of the SPORE award.

Significance

• Explain the importance of the problem or the critical barrier to progress in translational cancer research that the proposed Research Project addresses.
• Describe the scientific premise for the proposed Research Project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.
• Explain how the proposed translational science Research Project will improve scientific knowledge, technical capability, and/or clinical practice in the organ site(s) studied.
• Describe how the concepts, methods, technologies, treatments, services, or preventive interventions that drive organ site cancer research will impact the field if the proposed aims are achieved.

Innovation

• Explain how the Research Project challenges and seeks to shift current translational research or clinical practice paradigms.
• Describe any novel theoretical concepts, approaches or methodologies, instrumentation, or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation, or intervention(s).
• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the Research Project. Include how the data will be collected, analyzed, and interpreted.  Emphasize how the experimental design and methods proposed will achieve robust and unbiased results.
• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the specific stated aims and the overall aim of reaching a human endpoint within the 5-year funding period.
• If the Research Project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.
• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.

If a Research Project contains a clinical trial, describe the study keeping the relevant review criteria in mind, but do not duplicate information in the required clinical trial documents (e.g., PHS Human Subjects and Clinical Trials Information Form or IRB-approved clinical trial protocol):

• Describe the scientific rationale/premise of the study that is based on previously well-designed preclinical and/or clinical research.
• Describe the planned analyses and statistical approach for the proposed study design.
• Demonstrate that the eligible population is available.
• Address potential ethical issues.
• Describe how the recruitment timelines are feasible and adequate to monitor accrual.
• If appropriate, address the need for randomization (or not), masking, controls, and inclusion/exclusion criteria.
• Address the differences, if applicable, in the intervention effect due to sex and race/ethnicity.
• Describe the plans to standardize, assure quality of, and monitor adherence to, the clinical protocol and data collection or distribution guidelines.
• Describe the plan to obtain required study agent(s).
• Describe how existing available resources, as applicable, will be used.
• Address compliance to Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), if applicable.

Preliminary Studies for New Research Projects: For new Research Projects, include information on Preliminary Studies as part of the Approach section. Discuss the preliminary studies, data, and/or experience of the Co-leaders of the Research Project that are pertinent to the project. Discuss any preliminary plans for vertical and/or horizontal collaborations in the SC section of the Overall component.

Progress Report for Renewal Applications: For renewal applications, provide a Progress Report as part of the Approach section. Provide the beginning and end dates for the period covered since the last competitive review.

Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. For completed aims, state whether the work will be continued outside the SPORE through another trans-NCI funded mechanism or other non-NCI funded mechanisms and refer to the Overall component (SC section) where this will be more fully described. Explain any significant changes to the specific aims and any new directions that will be taken.  

If applicable, provide a brief description of how the SPORE has complied with all NIH data sharing policies.

Progress Report Publication List (for Renewal Applications): List all publications and accepted manuscripts resulting from previously funded projects that are being continued in the proposed SPORE application and which cite the SPORE. Emphasize in bold font each listed publication that is the result of formal collaborations of this Research Project with other SPOREs or with other funded NCI networks, such as the NCI's National Clinical Trials Network (NCTN) or the Early Detection Research Network (EDRN). For publicly available citations, PMC submission identification numbers (PMCID), if required, should accompany the full reference. Copies of these publications should not be included as appendix material.

Letters of Support: Attach appropriate letters specific to the Research Project detailing the nature and extent of participation. The letter of commitment from the host institution should describe the integration and synergies between the institutional resources and those of the SPORE project.  If applicable, letters of commitment from proposed subawardees and from collaborating institutions should also be provided.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within 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.

A copy of a draft or Institutional Review Board (IRB)-approved clinical trial protocol, along with informed consent forms, are required and must be included in the Appendix if the trial is already underway or is anticipated to begin within the first year of the award. If the trial will be performed during the latter part of the grant term (i.e., delayed onset), submission of these items to NCI program staff is required prior to the initiation of the trial.

PHS Human Subjects and Clinical Trials Information (Research Project)

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Developmental Research Program (DRP)

When preparing your application, use Component Type 'Dev Res Prog.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (DRP)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project: "Developmental Research Program"
• Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (DRP)

Follow standard instructions. 

Research & Related Other Project Information (DRP)

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 Summary/Abstract: Provide overall goals/abstract/summary for the DRP.

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.

Facilities and Other Resources: Institutional Commitment: Discuss how the institutional commitment to the DRP, if provided, will specifically facilitate the research proposed.

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" may be included to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the DRP component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.
• Inclusion of the RFA, timeline, review and award information is encouraged.

Project /Performance Site Location(s) (DRP)

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.

Research & Related Senior/Key Person Profile (DRP)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'DRP Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (DRP)

Budget forms appropriate for the specific component will be included in the application package.

Budgets are also required for each consortium (subaward) if they are part of the DRP.

DRP Director(s) must commit to a minimum of 0.3 PM of effort.

The DRP, as a required component of a SPORE, must be maintained throughout the entire term of the grant. A minimum commitment of $50,000 direct costs per year from SPORE funds must be proposed and maintained for DRP Projects. The NCI will monitor the activities of the DRP during non-competitive years to ensure that the NCI commitment is being maintained. DRP funds should be used for research activities and cannot be used for the purchase of any large equipment.

Budget Justification. In the Personnel Justification section, discuss the time commitment of the DRP Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

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.

PHS 398 Research Plan (DRP)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific objectives and goals of the DRP.

Research Strategy: Clearly describe the process for solicitation of DRP Projects and the institutional review process for evaluating and funding pilot and/or collaborative DRP  Projects that generate feasibility data. These funds are intended to remain flexible and to support studies of 2 years or less. The expectation is that successful feasibility studies that have translational potential will replace full projects that are not progressing satisfactorily toward their translational research objectives within the SPORE or projects that have been completed or will be the subject of a new grant application.

New applications should describe the processes to be used to set up the DRP within the SPORE and the process to be established for the continuous reviewing and funding of the pilot and collaborative projects based on quality and importance to the overall SPORE goal. New applicants may also supply a short description of eligible DRP Projects as examples and describe plans for monitoring funded projects. Renewal applicants should include their track records of funding pilot projects, methods of monitoring and assessing ongoing pilot projects, and short descriptions of other potentially eligible DRP Projects.

Progress Report Publication List (for Renewal Applications): List all publications and accepted manuscripts resulting from the previously funded DRP component and which cite the SPORE grant. Emphasize in bold font each listed publication that is the result of formal collaborations between the DRP and other projects within the SPORE, with other SPOREs, or with other funded NCI networks, such as the NCI Clinical Trials Network (NCTN) or the Early Detection Research Network (EDRN). For publicly available citations, PMC submission identification numbers (PMCID), if required, should accompany the full reference. Copies of these publications should not be included as appendix material.

Letters of Support: Attach appropriate letters relevant to the DRP detailing the nature and extent of participation.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within 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.

PHS Human Subjects and Clinical Trials Information (DRP)

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Career Enhancement Program (CEP)

When preparing your application, use Component Type 'Career Enh Prog.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (CEP)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project: "Career Enhancement Program"
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (CEP)

Follow standard instructions. 

Research & Related Other Project Information (CEP)

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 Summary/Abstract: Provide overall goals/abstract/summary for the CEP.

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.

Facilities and Other Resources: Institutional Commitment: Discuss how the institutional commitment to the CEP, if provided, will specifically facilitate the research proposed.

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" may be included in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the CEP component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.
• Inclusion of the RFA, timeline, review and award information is encouraged.

Project /Performance Site Location(s) (CEP)

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.

Research & Related Senior/Key Person Profile (CEP)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'CEP Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (CEP)

Budget forms appropriate for the specific component will be included in the application package.

Budgets are also required for each consortium (subaward) if they are part of the CEP.

CEP Director(s) must commit to a minimum of 0.3 PM of effort.

The CEP, as a required component of a SPORE, must be maintained throughout the entire term of the grant. A minimum commitment of $50,000 direct costs per year from NCI SPORE funds must be proposed and maintained for CEP projects. These funds are restricted to the CEP. The NCI will monitor the activities of the CEP during non-competitive years to ensure that the NCI commitment is maintained. CEP funds should be used to support research activities, including partial salary support for the candidate, research personnel, supplies, travel, and/or other expenses, and cannot be used for the purchase of any large equipment.

Budget Justification. In the Personnel Justification section, discuss the time commitment of the CEP Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

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.

PHS 398 Research Plan (CEP)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific objectives and goals of the CEP.

Research Strategy: Clearly describe the plans for this program including the process for soliciting and awarding applications and the policies, criteria, and processes for selecting candidates (e.g., advanced post-doctoral fellows who are ready to transition to a faculty position within the next year, junior faculty, and established investigators). The plan should include the number and types of positions that will be made available, the criteria for eligibility and selection of candidates, a description of the selection process, and the process for mentoring or advising junior level candidates or monitoring the progress of all candidates. New applicants should provide short descriptions of potential candidates, as well as the names and research activities of mentors/advisors. Renewal applicants should provide this information in addition to the scientific track record of awardees supported on the SPORE. Support of a CEP awardee should not exceed 2 years.

Similar to the DRP, outstanding CEP Projects may be promoted to full Research Projects to replace those that are not meeting their translational research objectives within the SPORE or Research Projects that have been completed. Successful CEP awardees may be provided with continued support as Project Co-leaders of the promoted CEP projects.

Progress Report Publication List (for Renewal Applications): List all publications and accepted manuscripts resulting from the previously funded CEP component which cite the SPORE grant. Emphasize in bold font each listed publication that is the result of formal collaborations between the CEP and other projects within the SPORE, with other SPOREs, or with other funded NCI networks, such as the NCI's National Clinical Trials Network or the Early Detection Research Network (EDRN). For publicly available citations, PMC submission identification numbers (PMCID), if required, should accompany the full reference. Copies of these publications should not be included as appendix material.

Letters of Support: Attach appropriate letters specific to the CEP detailing the nature and extent of support and/or participation.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within 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.

PHS Human Subjects and Clinical Trials Information (CEP)

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide. 

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists for inclusion in the SPORE application will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program in accordance with the Terms and Conditions provided in this NOFO.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this NOFO, note the following: 

Scoring: Reviewers will provide an overall Impact Score for the entire SPORE based on their assessment of each of the review criteria below, considering the merit of Research Projects, clinical trials, population science studies, Cores, Developmental Research, and Career Enhancement Programs, and scientific collaborations in the determination of scientific merit of the entire application.

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 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 project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the 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 Center rigorous? If the aims of the 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?

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 or community behaviors? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the 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 Center 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 Center?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the Center, 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?

Innovation

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?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? 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 Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, 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, sex, 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 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?

Environment

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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?

Scientific Collaboration (in the Overall component)

The Scientific Collaboration section is part of the Overall component. Reviewers will assign a numerical score to only this section of the Overall component based on the following criteria.

• Horizontal Collaborations: Do any/many of the proposed Research Projects (and the Developmental Research Program, if appropriate) detail scientific collaboration with investigators outside of the SPORE, including other SPOREs, other NIH/NCI programs, or other government or non-government organizations such that information, expertise, and resources are shared to complete translational goals within the SPORE more rapidly and efficiently? Are the plans to promote collaborative Research Projects by the SPORE leadership adequately addressed? For new SPORE applications, are plans described for collaborative Research Projects, and are these plans sufficient? For renewal applications, have proposed milestones and timelines in collaborative activities been reached? Does the participation in and outcome of collaborative projects and programs contribute to the overall translational goals of the SPORE?
• Vertical Collaborations: For renewal applications, has the SPORE participated in trans-NCI mechanisms, or has it partnered with ongoing trials for SPORE-initiated biomarker studies, or has it used other grant or contract mechanisms to expand clinical studies that were begun in the SPORE, collaboratively outside the P50 mechanism, or has it partnered with industry to continue the development of a SPORE concept? Have proposed milestones and timelines in collaborations been met? Has the SPORE leadership played an important role in moving SPORE concepts through translational/clinical development so that patients can most rapidly benefit from SPORE research? For new applications, is there a plan for potential collaborative agreements in developing cancer therapeutics and biomarkers, and for expanding population and cancer prevention studies beyond the limits of the SPORE, should early clinical studies prove to be successful? 

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions (as applicable), 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 project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For Center involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria - Administrative Core, Shared Resources Core(s), Projects, and NOFO-Specific Components

• Review Criteria for Administrative Core

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

Leadership

How sufficient are the scientific qualifications, involvement, leadership, and time commitment of the Co-leaders for the requirements of the proposed SPORE? (Leadership for collaborations will be reviewed in the Scientific Collaboration section, part of the Overall component.)

Administrative Management

How well does the plan for the Administrative Core adequately address how the SPORE will be managed administratively, including the fiscal and data operations? How adequately are the communication aspects of the SPORE facilitated by this Core addressed, particularly if there is more than one institution involved in the proposed research? How adequate is the evidence that appropriate clerical and administrative personnel and quality controls are in place for the smooth running and total integration of the SPORE? How adequate and appropriate are the qualifications, experience, and commitment of the Shared Resources Core Director(s) and other key personnel for providing the proposed facility or services? Will this Core provide adequate meeting/travel support, and support for the advisory boards? How adequate are the qualifications, experience, and commitment of the Core Director(s) and other key personnel? How well does the proposed plan include a succession plan for SPORE leadership that could be enacted in the event that the SPORE PD(s)/PI(s) is no longer willing or able to lead the SPORE? If patient advocates are included, how appropriate are their activities to the goals of the SPORE?

Institutional Commitment

How sufficiently documented are the institutional commitment for facilitating the research objectives of the SPORE (e.g., through special facilities, recruitments, discretionary funding, supplemental resources for CEP and DRP)?

Integration of the SPORE within the Institution

How well are the activities of SPORE projects and proposed Cores integrated into the institution? How well does the entire SPORE integrate with the existing cancer center/institute (e.g., use of clinical data and safety management systems, biostatistical and other Cores, etc.)? How evident are coordination and communication or the plans for coordination and communication across all components of the SPORE and among all participating institutions at the overall SPORE level?

Cancer Patient Population

How sufficient is the access to patients and populations for conducting current and projected therapeutic, prevention, detection, and control research adequate to ensure likely success of the SPORE?

Planning and Evaluation of Activities

How adequate are the plans for and/or track record of evaluating the translational research productivity of existing Projects and Cores for the requirements of the proposed SPORE? How sufficient are the plans for and/or track record of use of advice from internal and external advisors? For renewal applications, what evidence is given that the flexibility available to the SPORE has been used effectively?

• Review Criteria for Shared Resources Core(s)

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

How does the Shared Resources Core(s) provide essential functions or services for at least one project? How appropriate is the plan describing how the bioinformatics and data management capabilities of the Shared Resources Core, as relating to the cancer center, institution, or activities of other NIH/NCI initiatives, and how it will be developed and used for data administration?

• Biospecimen/Pathology Core

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

Investigator

How sufficient is the evidence of proficient personnel dedicated to the activities of specimen collection, annotation, quality control, storage, distribution, and analysis? How sufficient is the oversight of the collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks? For renewal applications, how effective are the performance and relative time commitments of these individuals based on the past accomplishments of the Core.

Approach

How adequately does the plan for this Core address the development, annotation, and maintenance of a human cancer site-specific specimen resource, including linkage of specimens with pre-analytical parameters and pathological, clinical, and family history data that maximize their potential use in translational research?

How adequately does the plan address and prioritize the distribution of specimens within and outside the SPORE? For renewal applications, how clear is the documentation of the use of specimens by SPORE investigators within full and developmental projects, as well as the details, if applicable, describing the distribution and use of SPORE collected specimens outside the SPORE and/or institution?

If applicable, how adequately does the plan address the performance of specimen analysis (e.g., tissue microdissection, immunochemistry) and/or the development of new technologies and methodologies that enhance or benefit activities of the SPORE? For renewal applications, how clear is the documentation demonstrating that these analyses were critical to the success of certain projects and are worthy of continued support, if requested?

How adequately does the plan give sufficient evidence that the activities of the Core are well integrated with those of the Projects and that the investigators within the Projects are working closely with those of the Core to meet Project objectives?

How adequately does the plan address if and how the investigators will obtain written informed consent for all prospectively collected tissues/specimens in a manner that will protect patient confidentiality and enable studies?

Environment

How well does the plan augment and/or complement any existing specimen resource supported by a Cancer Center Support Grant (CCSG; P30 grant mechanism) or other funding mechanism(s)? How well do investigators applying from institutions with a CCSG and multiple SPORE grants address their Core will benefit from already established infrastructure, databases, etc., that will enable this specimen Core to be more cost effective and efficient?

• Other Cores

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

Investigator

How adequate and appropriate are the qualifications, experience, and commitment of the Shared Resources Core Director(s) and other key personnel for providing the proposed facilities or services?

Approach

How well-matched is the proposed Shared Resources Core to the needs of the overall SPORE? How well does it provide essential facilities or services for one or more scored research projects? For renewal applications, how well does the application demonstrate the use of each Core by SPORE Projects during the previous funding period?

How well does the plan demonstrate that the activities of the Core are well-integrated with those of the Projects and that the investigators within the Projects are working closely with those of the Core to meet Project objectives?

How well described is the overall quality of the proposed Core services? How adequate are the quality control processes proposed for the facilities or services provided by the Shared Resources Core (including procedures, techniques, and quality control)? How adequate are the criteria for prioritization and usage of Shared Resources Core products and/or services?

How cost-effective will the proposed Shared Resources Core(s) services to the SPORE be? How adequate are the plans to augment and/or complement an existing shared resource supported by an NCI Cancer Center Support grant (P30), if applicable?

Environment

How successfully will the environment for the Shared Resources Core support the program as proposed?

Review Criteria for Research Projects 
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each project. A project does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. An assigned reviewer will give a criterion score for each of the following five criteria for the individual research projects.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

How do preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms support the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention? 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 or community behaviors?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigators

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

Regarding the proposed leadership for the project, how do the PD/PI(s) and key personnel demonstrate their expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? How do they demonstrate that they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, how is the organizational structure appropriate and how does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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?

In addition, for applications involving clinical trials

How well 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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, 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 NOFO: How well does the application address the following, as applicable:

How likely is it that the research will achieve the proposed human endpoint within the 5-year project period? How likely is it that all the aims will be completed within the project period? If the project is ongoing and has changed research direction, how appropriate is the rationale for the new approach? How justified are the plans for (1) protection of human subjects from research risks and (2) inclusion of a range of populations and ages, including groups that have been understudied in previous research, for the scientific goals and research strategy proposed?

Note: Aspects of collaboration unrelated to scientific data will be reviewed in the Scientific Collaboration section (Overall component) and not in the SPORE Research Projects section. How appropriate is the plan describing how bioinformatics and data management capabilities of the project, as relating to the cancer center, institution, or activities of other NIH/NCI initiatives, will be developed and used for data administration?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

What is the justification for the study design and how is it appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? How is the scientific rationale/premise of the study based on previously well-designed pre-clinical 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, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

What are potential ethical issues and how are they 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? How are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

What are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? What is the plan to obtain required study agent(s)? How does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

How are planned analyses and statistical approaches appropriate for the proposed study design and methods used to assign participants and deliver interventions? What are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable and how are they appropriate? How have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? What is there a plan to complete data analysis within the proposed period of the award?

Environment

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 NOFO: How well does the application address the following, if applicable:

• In the case of multiple institutions involved in a single SPORE, how adequate is the plan for communication among investigators to achieve the goals of the grant?
• How evident is the institutional support?
• How evident is the effective use of SPORE Cores?

In addition, for applications involving clinical trials

If proposed, how are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed?

How adequately are the plans to address the capability and ability to conduct the trial at the proposed site(s) or centers? How appropriate are the plans to add or drop enrollment centers, as needed?

If multi-sites/centers, what is the 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?

• Review Criteria for the Developmental Research Program (DRP)

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

How well will the plan for the DRP attract new ideas and pilot studies within and/or outside the SPORE institution(s)? How adequate is the plan for periodic solicitation, review and funding of a spectrum of pilot projects, as well as for promoting pilot projects with translational research potential to full projects within the SPORE?

For renewal applications, how strong is the DRP publication record? How well described are any high-risk/high-impact projects funded through the DRP? How well does data produced by the DRP lead to success in the competition for outside funds or become a full SPORE project(s)? How sufficient was funding from the DRP used for collaborative projects with other institutions/programs?

• Review Criteria for the Career Enhancement Program (CEP)

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

How adequate is the plan to select promising candidates for independent careers (academic, industrial, governmental) in translational cancer research? How adequately does the plan for recruitment, retention and communication address awardee developmental needs? For renewal applications, how are the research activities, independent grant awards, publication(s), and promotion/current status of individuals who have been supported by the CEP addressed?

How well does the plan address the recruitment of prospective candidates?

How well does the plan address periodic review of the CEP awardees and the role of mentors/advisors? For renewal applications, did any CEP projects become full SPORE projects? 

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. 

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities. 

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations 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 recipient 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).

When an award is made, it is the policy of NCI that meritorious projects reviewed as part of the SPORE be funded as part of the SPORE even though other funding may be available. Duplicate funding will not be awarded.

NCI program staff may administratively delete funding or reduce the duration of support for components of SPOREs that are judged by peer review as only having moderate merit and/or is nonessential to the conduct of the SPORE. Also, note that if a required SPORE component, including Scientific Collaborations, is judged by peer review as only having moderate merit, NCI program may decide to not fund the entire application regardless of whether the application is in the fundable range for that fiscal year. Additional funding requested by the applicants for qualified EPPS projects may be removed if, in the judgment of review and/or the NCI Program Official, the proposed research strategy does not meet qualifications established for EPPS projects in Part 2 Section IV, PHS 398 Research Plan (Research Project), under Specific Aims description. 

The NCI program staff may reduce SPORE funding to support only two scientific research projects in cases where the overall outcome of the review is sufficiently favorable for funding but one of the projects is judged by peer review as only having moderate merit compared with the overall impact score. The exercise of this option by the NCI staff is expected to be a rare event. Under no circumstances may a new applicant submit an application with less than three research projects. 

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.  

Prior Approval to Substitute Research Projects

Substitution of the research projects that have been proposed as part of a reviewed and funded SPORE application requires prior approval of the External Advisory Board and the NCI Program Official. Such substitution may be allowed if the original project is not performing as expected (i.e., unlikely to reach its proposed translational goals) or if the translational goals have been accomplished earlier than anticipated. The awardee is required to provide justification of the proposed changes. Project substitutions cannot be approved during the first or last year of the current SPORE project period.

Prior Approval of Pilot Projects

Recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.

The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies. 

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.

Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones.  Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience. 

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. When contacting the email addresses below please add the NOFO number to the subject line to assist routing.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Translational Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI)
Email: NCI_SPORE_Program@nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Email: NIDCR-Program@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Email: deeranotifications@nidcr.nih.gov

Section VIII. Other Information

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 2 CFR Part 200.