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Cancer Patient Population: Each SPORE must document access to a substantial patient population for the organ site or group of related cancers that are the focus of the application and provide reasonable assurance that the patients and human specimens needed for translational research are readily available. Describe the access to cancer patients and populations for conducting current and projected therapeutic, prevention, detection, and control research within the SPORE and collaborating institutions.
If the EAB has not yet been established, describe needed areas of expertise but do not contact new EAB members until after peer review. A letter of support from the institution must be attached addressing: the commitment to support the proposed SPORE, a plan describing how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPORE research effort will be given a high priority within the institution.
The letter should describe the integration and synergies between the institutional resources and those of the overall SPORE and its components. Whenever there is dependence on Institute-wide Core Resources, a letter of agreement from the Core Director should be included. In the case of a SPORE that involves two or more institutions, the applicant institution must submit 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.
These funds can be used to support anticipated as well as unanticipated activities during the funding period. SPOREs are expected to establish processes and infrastructure to support the meaningful sharing of data and information generated through the proposed research activities. Project Narrative: State the relevance of the Research Project's activities to public health.
Other Attachments: The following "Other Attachments" may be included with the Project in order to aid in the review of applications.
Each co-leader must commit individually to a minimum of 0. It is not necessary that the co-leaders commit an equal amount to the project. The additional funds must be requested only in the budget s of qualified EPPS project s. 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.
At least one specific aim must address a human endpoint. Start each sub-section 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.
NOTE: Provide clear and specific cross-references to information in other sections of the application such as the Personal Statement in the Biosketches; Cores; etc.
Briefly, a hyperlink must NOT be included in the application including Research Strategy; irrespective of number of videos, total duration must not exceed 5 minutes maximum file size 25MB ; contact responsible Scientific Review Officer for video material submission at least 30 days prior to review. The number of human subjects in a population science or prevention study may exceed the human subjects limit. Collaborative trials using this opportunity may also include correlative studies. Specific programmatic requirements pertaining to qualified EPPS projects are described in the key definitions section.
For each qualified EPPS project, there must be a laboratory element addressing relevant mechanistic aspects of human cancer biology and all aims must be EPPS-focused. The project may involve genetic, epidemiological, behavioral, social, applied, and surveillance studies.
If a 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. Two-Project Option for Renewal Applications optional : In addition to significance, innovation and approach, applicants should discuss data from the previous project period that supports the broader study proposed and how the questions addressed are best fit for a collaborative multi-institutional structure.
Provide the beginning and ending 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. Explain any significant changes to the specific aims and any new directions that will be taken. Letters of Support: Attach appropriate letters specific to the 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 subawardees and from collaborating institutions should also be provided. 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. Institutional Commitment: Discuss how the 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 in order to aid in the review of the application. Budgets are also required for each consortium subcontract if they are part of any Cores.
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. The application must address how related activities e. 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.
Describe the plans for achieving detailed annotation of parameters of collection and preservation that are pertinent to the pre-analytic and analytic considerations of potential SPORE studies as well as essential pathological, clinical, and family history information needed for conducting a wide range of translational research activities.
Describe quality measures used in this Core. Describe the informatics that will be used for tracking specimens, as well as linkage to clinical and follow-up data sets. Address development, acquisition, storage, and usage of standardized reference specimens and materials, and any other services related to the analysis of specimens e.
Describe integration with the cancer center biospecimen core resources and the clinical laboratory. If significant collaborations have emerged from this Core, over and beyond the distribution of specimens, the data should be discussed in this section, but the details of the collaboration itself, including the strategy for moving the project through the translational research pathway to the clinic should be discussed in the SC section of the Overall component.
Additional Shared Resources Cores e. These Cores may also include other analytical or non-hypothesis-driven research activities designed to enhance a service. Address plans for prioritization of services if necessary. If a Clinical Core is proposed, the application also should discuss how duplication in the reporting of clinical trial data to the NCI will be avoided.
For New Applications, summarize the preliminary studies that support the ability of the Core to provide the proposed services. For renewal applications, use of the Core facilities and services by projects and developmental programs during the current funding period should also be clearly documented.
Letters of Support: Attach appropriate letters relevant to each Core detailing the nature and extent of participation. Facilities and Other Resources: Institutional Commitment: Discuss how the institutional commitment to the DRP, if provided, will specifically facilitate the research proposed.
Other Attachments: The following "Other Attachments" may be included in order to aid in the review of applications. Tables, graphs, figures, diagrams and charts relevant to the DRP component. Budgets are also required for each consortium subcontract if they are part of the DRP.
DRP funds should be used for research activities and cannot be used for the purchase of any large equipment. 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 projects as examples. 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 projects.
Letters of Support: Attach appropriate letters relevant to the DRP detailing the nature and extent of participation. Facilities and Other Resources: Institutional Commitment: Discuss how the institutional commitment to the CEP, if provided, will specifically facilitate the research proposed. Tables, graphs, figures, diagrams and charts relevant to the CEP component. Budgets are also required for each consortium subcontract if they are part of the CEP.
These funds are restricted to the CEP. Research Strategy: Clearly describe the plans for this program including the policies, criteria, and processes for selecting candidates e. Special efforts should be made to include women, individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities. 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.
Renewal applicants should provide this information in addition to their past performance on recruiting women, individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, and the track record of awardees supported on the SPORE.
Support of a CEP awardee should not exceed 2 years. Similar to the DRP, outstanding career enhancement projects may be promoted to full projects to replace those that are not meeting their translational research objectives within the SPORE or projects that have been completed.
Successful CEP awardees may be provided continued support as project co-leaders of the promoted projects. See Part 1. Section III. Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants. NIH and Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. This initiative is not subject to intergovernmental review. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. 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. 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.
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. 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. 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. Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Only the review criteria described below will be considered in the review process.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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