National Institutes of Health (NIH)
National Cancer Institute (NCI)
U01 Research Project Cooperative Agreements
- September 2, 2022 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022. See Notice NOT-OD-22-190
- June 07, 2022 - Notice of Preapplication Webinar for RFA-CA-22-016, Pediatric Immunotherapy Network (PIN) (U01 Clinical Trial Optional). See Notice NOT-CA-22-089
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) intends to solicit applications for the Pediatric Immunotherapy Network (PIN). The overall goal of this FOA is to establish a collaborative network consisting of investigators with relevant expertise to develop and advance novel translational immunotherapy approaches for children and adolescents with solid tumors including brain tumors. This FOA solicits U01 applications for discrete research projects that address relevant research opportunities focused on pediatric solid tumors (e.g., mechanisms of immune evasion, development of pre-clinical models, discovery and validation of novel therapeutic targets, development of novel pediatric immunotherapy agents and treatment approaches such as cancer vaccines, cellular therapy, and combinations with immunotherapy agents. Successful applicants will become members of the Pediatric Immunotherapy Network (PIN), which will address current challenges in pediatric cancer immunotherapy and accelerate the pace at which effective immunotherapies are realized for pediatric solid tumors.
August 27, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 27, 2022 | September 27, 2022 | Not Applicable | March 2023 | May 2023 | July 2023 |
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.
No late applications will be accepted for this Funding Opportunity Announcement
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The overall goal of this funding opportunity announcement (FOA) is to establish a network of collaborating investigators to identify and advance research opportunities for investigating immunotherapy concepts for children and adolescents with solid tumors including brain tumors toward clinical applications.
The primary goals of this network, the Pediatric Immunotherapy Network (PIN), will be the discovery and validation of novel pediatric cancer immunotherapeutic targets; development of new immunotherapy pre-clinical testing and treatment approaches; and improved understanding of pediatric specific anti-tumor immunity and pediatric immune evasion mechanisms to advance new, more effective immune-based therapeutic regimens for pediatric solid tumors.
This FOA solicits U01 applications for discrete research projects that address relevant research opportunities focused on pediatric solid tumors (e.g., mechanisms of immune evasion, development of pre-clinical models, discovery and validation of novel targets, development, validation, and pre-clinical testing of novel immunotherapy agents and treatment approaches such as cancer vaccines, cellular therapy, and combinations with immunotherapy agents).
Background
While there have been major advances in applying immunotherapy to some childhood cancers, there are no effective immunotherapy options for most pediatric patients with solid tumors. For example, treating children with refractory leukemia with anti-CD19 chimeric antigen receptor (CAR)-engineered T cells have led to dramatic improvements in survival. The advances in these subsets of pediatric cancer patients provide the scientific and empirical justification to warrant expansion of immunotherapies to the broader pediatric cancer patient population. Conventional treatments such as radiation and chemotherapy lead to devastating late effects and long-term morbidities in the survivors, including secondary malignancies, cardiac, neurologic, and cognitive adverse effects, and developmental disorders. Solid tumors are especially hard to treat in pediatric patients as they are aggressive, often metastasize and can recur. For children and adolescents with high-risk metastatic and/or relapsed disease, survival remains poor. Survival outcomes for high-risk neuroblastoma, the most common extracranial solid tumor, are around 60%. Central Nervous System (CNS) tumors are the most common type of solid tumor in children and often lead to fatal consequences. Children with high-grade glioma such as diffuse intrinsic pontine glioma (DIPG) and glioblastoma multiforme (GBM) have a dismal five-year overall survival of <20% and over the past few decades, little improvement has been observed in treatment of children with brain tumors. Therefore, a major goal of this concept is to stimulate development of novel immunotherapeutic strategies that will lead to safer, more effective therapies for pediatric cancer patients with solid tumors including brain tumors.
There are several major barriers to fully realize the potential of immunotherapeutic approaches to successfully treat pediatric cancers, especially solid tumors:
- Low immunogenicity: Pediatric cancers typically have low mutation burdens (nonsynonymous mutation rates of < 1 per Mb), are much less likely to express neoantigens and hence, are less susceptible to immune checkpoint blockade therapies. For many pediatric solid tumors, the key genomic alterations are loss of tumor suppressor genes through large chromosomal deletions or the activation of oncogenes through either amplification or translocation leading to fusion oncoproteins. These fusion proteins often have low immunogenicity and efforts to target them using immunotherapy remain largely unsuccessful.
- Need for pediatric-specific therapeutics: Most immunotherapeutic strategies based on targeting cancer-specific cell surface antigens are developed explicitly for adult malignancies. The expression patterns of the target antigens in pediatric cancers have not been fully considered and need to be studied in the context of expression relative to normal developing tissues in children from birth through adolescence.
- Need for identification of pediatric solid tumor immunotherapeutic targets: Identifying and validating the optimal childhood cancer surfaceome for immunotherapy targeting remains a challenge, particularly for pediatric solid tumors which manifest heterogeneity in target antigen expression. Suitable targets for hematological tumors have been identified and effectively targeted (e.g., CD19-targeting CAR T-cell products for B-ALL, CD22-targeting antibody-drug conjugate (ADC) inotuzumab ozogamicin for B-ALL, and CD30-targeting ADC brentuximab vedotin for Hodgkin lymphoma and anaplastic large cell lymphoma). While a large body of discovery-based genomic profiling work has been completed on solid tumors, the integration of DNA and RNA sequencing approaches with cellular membrane proteomic profiling (surfaceome) to define the proteins that are uniquely and abundantly expressed on pediatric solid cancers and show little or no expression in normal childhood tissues remains at an early stage. In addition, even with effective immunotherapies such as CD19-targeting CAR T cells, antigen loss is emerging as a challenge that limits durability of remission, a primary goal of pediatric cancer treatment.
- The pediatric-specific immunosuppressive solid tumor microenvironment (TME): It is evident that the disabling TME of solid pediatric cancers differs from its adult counterpart, thus requiring age-specific investigation of the TME. Effective immunotherapies for solid tumors will not only require identifying novel tumor antigens and targeting T cells and other immunotherapeutics to recognize these antigens, but in addition, will require strategies to disrupt the immunosuppressive properties of the TME.
A key result of the apparent low immunogenicity of pediatric cancers is that the therapeutic strategies that are being prioritized involve engineering antibodies or immune cells to recognize antigens selectively expressed on pediatric cancers. Hence, approaches such as ADCs, bispecific T-cell engaging antibodies, CAR T cells, and engineered natural killer (NK) cells are a primary focus. These approaches are well-advanced for lymphoid malignancies because of the ability of patients to tolerate temporary loss of selected lymphoid cells expressing the target antigen of the immunotherapy agent. While the remaining challenge for lymphoid malignancies is to optimize existing effective treatments and address mechanisms of resistance, the challenge to researchers studying pediatric solid tumors is to identify comparable specific antigens for these tumors and to then develop effective immunotherapy treatments with acceptable toxicity profiles that target these antigens. The successful application of immunotherapy to pediatric brain tumors has additional challenges such as low permeability of the blood-brain barrier besides limited known target (s) and lack of appropriate model systems. The role(s) of maturing microglia and the developing brain need to be considered while designing immunotherapies for pediatric brain tumor patients.
Specific Objectives, Research Scope, and Main Requirements for this FOA
Research Scope and Objectives
This FOA solicits applications for discrete research projects to establish the Pediatric Immunotherapy Network (PIN), which will consist of teams of investigators with relevant expertise that will work in a collaborative research network with the goal of understanding the unique barriers to developing effective immunotherapy approaches for pediatric solid tumors, and for translating these concepts toward clinical applications (clinical trials optional). Given the unmet clinical need, the scope of PIN will be limited to investigating solid tumors including brain tumors.
Potential areas of focus may include (but are not limited to):
- Identify, characterize, and determine antigenic epitopes that are uniquely and abundantly expressed on childhood and adolescent cancers (at diagnosis, recurrence and in metastatic sites) and that show little or no expression in normal childhood tissues using integrated DNA and RNA sequencing approaches in combination with proteomic profiling.
- Discover and generate a catalog of novel pediatric tumor-associated antigens on pediatric cancers at the post-translational level, e.g., surfaceome and peptidome across pediatric tumors.
- Investigate pediatric specific anti-tumor immunity and pediatric immune evasion mechanisms of solid tumors.
- Characterize unique molecular, cellular, and immune profiles specific to the pediatric tumor immune microenvironment.
- Investigate the unique immune infiltrates and receptor expression in the pediatric tumor immune microenvironment.
- Characterize the pediatric metabolic landscape across the pediatric tumor immune microenvironment.
- Develop enhanced non-invasive analytical technologies (e.g., liquid biopsies, image guided technologies, sample sparing assays, etc.) suitable for pediatric studies.
- Basic immune mechanisms and novel hypothesis generating studies utilizing existing pediatric clinical trial data.
- Develop and validate optimized, highly specific binders (e.g., antibody-based, or T-cell receptor-based binders, aptamers, affinity ligands) for novel pediatric cancer immunotherapy targets that can be subsequently incorporated into appropriate therapeutic delivery constructs (e.g., antibody-drug conjugates, bispecific antibodies, engineered NK and T-cells).
- Propose preclinical studies that focus on the development, optimization, and testing of immunotherapy agents with priority given to agents that can be effective against immunologically cold pediatric tumors.
- Develop candidate novel immunotherapy agents that can be subjected to preclinical testing as single agents and in combination with other immuno- and non-immuno-therapies in anticipation of potential clinical development.
- Develop immune profiling and immune-monitoring approaches including identification of biomarkers to predict the efficacy and toxicity and characterize the response to novel immune-modulating therapies in pediatric cancer patients.
- Develop novel synthetic immuno-engineering approaches that address challenges for pediatric solid tumors.
- Define unique immunosuppressive pathways or attributes of the pediatric immune system and tumor microenvironment that can be targeted to improve immunotherapy outcomes.
- Develop pre-clinical models for pediatric solid tumors such as immune-competent animal models, humanized mouse models, or innovative immune-inclusive tumor organoid models to evaluate novel immunotherapy agents and combinations.
- Correlative studies or reverse translation studies using clinical specimens to interrogate mechanism of response or resistance to immunotherapy.
- Pilot clinical trials such as those seeking to evaluate safety signals in the pediatric population or demonstrate an agent’s engagement of its proposed mechanism or target occupancy.
- Develop strategies to modulate the pediatric tumor microenvironment to make immunotherapy agents such as CAR T cells, engineered NK cells, and T cell engaging agents more effective.
- Target pediatric solid tumor cell intrinsic and extrinsic mechanisms of immunotherapy response and resistance, including modification of epigenetic pathways and the microbiome.
Collaborative Requirements
Once funded, the U01 awardees will be expected to work collaboratively with all members of the PIN to share data and resources, discuss shared challenges, and work together to move the field forward. Investigators may be expected to coordinate with and leverage technology from related NCI-sponsored informatics initiatives, in collaboration with NCI program staff. These initiatives include: 1) the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research; and 2) the NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact.
Multiple Project Director/Principal Investigator (PD/PI) and multi-institutional collaborations are encouraged in order to achieve the breadth of expertise required for a comprehensive approach to pediatric immunotherapy research and to accelerate the pace at which effective immunotherapies are realized for pediatric solid tumors. Collaborative teams should have diverse and multi-disciplinary strengths across basic and/or translational science to achieve their scientific research objectives.
Structure and Governance of the PIN
The PIN will include multiple U01 awardees and will be governed by a Steering Committee(SC). The SC will comprise of representatives from the funded U01 teams and the NCI and all U01 awardees must be willing to serve on the Steering Committee. The Steering Committee will provide input towards and oversight of PIN collaborative activities, as well as overall integration of efforts among all PIN awardees. The Chair and the co-Chair of the Steering Committee will be PDs/PIs of PIN cooperative agreement awards and will be elected by the Steering Committee. Any member of the Steering Committee can offer nominations for the Chair and co-Chair, including self-nomination. Though the Steering Committee will make recommendations, NCI Staff will have final authority to approve any proposed recommendations, and activities must comply with NIH, DHHS, and Federal Guidelines.
Additional details on the composition and functions of PIN Steering Committee are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award.
Non-responsive Applications
The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed:
- Applications that focus on hematologic malignancies
- Applications that focus on adult tumor indications
Applicants are encouraged to contact NCI Staff to discuss the alignment of their proposed work with the goals of this FOA.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Renewal
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
NCI intends to commit $6,000,000 in FY 2023 to fund 6-8 awards.
Application budgets may not exceed $450,000 in direct costs (excluding sub-award F&A costs) per year and must reflect the actual needs of the proposed project.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
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
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- 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.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Anju Singh, B.V.Sc, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7603
Email: [email protected]
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Budget requests must include costs for the PD(s)/PI(s) to attend the initial in-person PIN kick-off meeting, and for the PD(s)/PI(s) and other members of the project team (up to four people in total) to attend the annual PIN Investigators' meetings. PDs/PIs are encouraged to include early career scientists in Network activities and should include budget to travel at least one graduate student or postdoctoral fellow to the Annual Investigators Meeting.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Include the specific aims of the Research Project and provide a rationale and description of how it fits into organizing framework of the PIN. Describe how the current concepts, methods, and/or technologies in pediatric immunotherapy will be changed if the Specific Aims are achieved.
Research Strategy:
Describe the research strategy using the standard sub-sections of Research Strategy (Significance, Innovation, and Approach) defined in the SF424 Application Guide with additional guidance as defined below. Identify clearly any innovative biological concepts that are proposed to be explored as a potential basis for novel immunotherapeutic strategies for childhood cancers. In addition to standard items, address all of the aspects listed below in the sub-sections as indicated.
Under "Significance", address the following:
Explain the importance of the problem or critical barrier to progress in pediatric cancer immunotherapy that the application is trying to address, and why the proposed approach or technology is needed to realize a solution. Critically evaluate existing knowledge and approaches that have been or are being applied in this area of research and specifically describe how the proposed approach will advance the field.
Under "Innovation", address the following:
Highlight any innovative and/or unique concepts, experimental approaches, methodologies, novel cancer models, etc., that you have available and plan to use.
Under "Approach", address the following:
Project Timeline: A timeline of the initiation and completion of the specific aims/subaims is required. The timeline must be provided in a separate heading at the end of the Approach section.
In applications that include multiple institutions (particularly in separate geographical areas), descriptions of the logistics involved in carrying out the proposed aims to completion within the project period (how tasks that require various and sequential expertise, and how information sharing will be coordinated) must be included.
Health Disparities: If applicable to the type of research projects being proposed, the Research Strategy must address how minority health, health disparity populations or data will be integrated into the proposed studies.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, must include and address a Resource Sharing Plan as defined below.
- A Resource Sharing Plan for data (including genomic data), unique materials (including biological materials such as patient-derived cells, organoids, and tissues), tools, model organisms, reagents, and therapeutics, along with IP and knowhow management must be provided by each U01 Research Project application and must cover all the activities proposed for the U01 Research Project and within the context of the PIN, where applicable.
- Resource Sharing Plan should briefly describe the types of data and computational resources and unique biological resources that are expected to be generated and shared, consistent with achieving the goals of the PIN;
- Resource Sharing Plans are expected to describe plans for anonymization, annotation, multimodal data integration; harmonization; transfer learning; development of robust statistical-, Artificial Intelligence-, and/or Machine Learning-ready datasets to facilitate formats that are accessible to increase the value of these data and unique resources for sharing with the scientific community;
- Formats, analytical algorithms, computational modeling and visualizations, and other bioinformatics tools resulting from this FOA are expected to be compatible with the NIH-approved bioinformatics platforms, such as those designed and implemented by the NCI Center for Bioinformatics platforms (https://cbiit.cancer.gov/data-sharing).
- Data, software, and models from this FOA are expected to be shared in accordance with the policies determined by the NCI Center for Bioinformatics and Information Technology (CBIIT), https://datascience.cancer.gov/data-sharing. For more information see the Cooperative Agreement Terms and Conditions of Award in of this FOA.
- The Sharing plan must address the NIH Policy for Data Management and Sharing, reference https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html for additional guidance
Note that NCI Program staff may negotiate modifications to these plans prior to funding. Specifically, applicants will be expected to abide by the policies and procedures for unique resources and data, software, and computational model sharing within the context of the NCI Cancer Data Ecosystem including infrastructure and resources for access of multi-modal data, elastic computation, and analysis through the Cancer Research Data Commons developed upon availability (see Section VI: Terms and Conditions of Cooperative Agreement).
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post Submission Materials
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.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the 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
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
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?
Specific for this FOA
How well does the proposed project represent an innovative concept, technology, and/or novel approach for developing immunotherapy for pediatric patients with solid tumors?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific for this FOA
To what extent are the project timeline and milestones appropriate and realistic for the proposed research objectives? If applicable, how well does the application address health disparity populations?
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?
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?
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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the 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)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
- 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.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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 institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, 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.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, 2 CFR Part 200 and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
Primary Responsibilities of PD(s)/PI(s)
The PD(s)/PI(s) will have the primary responsibility for:
- Planning and conducting the operations defined by the terms and conditions of the cooperative agreement award. This includes determining research approaches, designing protocols, setting project milestones in consultation with NCI staff, and ensuring scientific rigor.
- Conducting the scientific research in the project, reporting progress and milestones or objectives to NCI staff, reporting results to the scientific community, and disseminating approaches, methods, models, and tools broadly.
- Assuming responsibility and accountability to the applicant organization officials for the performance and proper conduct of the research and administrative functions supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations, and policies.
- Participating in a cooperative, interactive, and collaborative manner with NCI staff, other PIN investigators, and one another to maximize the impact of the PIN and meet Program goals and objectives.
- Serving as voting members of the PIN Steering Committee (PIN SC or SC) that is responsible for the governance of PIN activities (as described below).
- Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the PIN SC.
- Maintaining the confidentiality of the information developed or handled by the PIN, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members of the PIN, as well as any confidential information received by third-party collaborators.
- Facilitating the public release and dissemination of results, data, reagents, models, technologies, and other products generated through this award in a timely manner. All PDs/PIs are expected to share data and resources generated through this award in accordance with the approved plan for making quality-assured data and materials available to the scientific community and the NIH as written in the final version of the grant application, and consistent with sharing policies and recommendations developed and approved by the SC, NIH sharing policies, and the goals of the FOA.
- Ensuring that any industry collaborations should be governed by a research collaboration agreement with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies, and procedures, and any policies and procedures developed by the SC.
- Complying with OHRP and FDA regulations concerning the protection of human subjects if the project involves human subjects and/or NIH-defined clinical research.
- All PDs/PIs must operate in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
- Operating in accordance with processes, goals, and policies established by the SC to the extent of applicable grant regulations.
- Attending an initial face-to-face Kickoff Meeting of the PIN PDs/PIs, followed by at least one PIN investigator meeting annually.
- Adhering to a Network Communication Plan: A consensus Communication Plan will be drafted by the PIN SC during the kickoff meeting of the PIN. This plan will clearly spell out interactive requirements that all PIN investigators are expected to follow, including:
- Participation in regular conference calls with fellow PIN colleagues through contribution to various sub-committees and working groups.
- Participation and presentation of findings at the PIN Annual Investigators' Meeting;
- Coordination of efforts with other members of the PIN.
- Jointly publishing on PIN collaborations in a timely manner.
- Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
Programmatic Involvement of NCI Staff
NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate the various activities of the recipients. Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to, the following aspects:
- Advising the awardees on scientific topics as well as programmatic priorities.
- Assisting the network awardees as a liaison in stimulating their broader interactions with other NCI and NIH programs to disseminate results and outcomes and effectively leverage existing NIH/NCI resources and infrastructures (e.g., databases).
- Inform the network about pre-clinical resources available through the NCI such as the NExT program (resources for GMP manufacturing, viral vectors, and toxicology).
- Participating in the development and evaluation of trans-network activities.
- Assisting in avoiding unwarranted duplications of effort across the network.
- Monitoring the operations of the U01 awardees and making recommendations on overall project directions.
- Reviewing the progress of individual U01 awardees and specific activities shared among them.
- Helping coordinate collaborative research efforts including approving restricted supplemental funding for collaborative activities.
- Attending PIN SC meetings.
Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The NCI reserves the right to recommend withholding support, suspension, renegotiation of future support, or termination of any PIN award in the event of (1) a substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application; (2) a failure to meet the PIN policies and procedures; (3) substantive changes in the management of the PIN award that is not in keeping with the objectives of the FOA; and/or (4) failure to make substantial progress towards milestones keeping in mind the agreed-upon go/no-go decisions.
Areas of Joint Responsibility include:
The PIN Steering Committee (PIN SC or SC) will serve as the main governing body for the PIN that will be responsible for the governance of PIN activities as described below.
The PIN SC will consist of the following voting members:
- The PDs/PI(s) of each awarded PIN Research Project (or senior investigator as a proxy when applicable) will collectively have one vote.
- The NCI Project Scientists, whom will collectively have one vote.
Additional non-voting members such as patient advocates and NIH staff members (for example to provide additional expertise ) may participate in SC meetings. Additional non-voting members to serve in an advisory capacity may be added to the SC as needed by a decision of the existing voting committee members.
The SC may decide to establish subcommittees for specific purposes. The NCI Project Scientists and Program Officers may serve on such sub-committees, as they deem appropriate.
The SC will formulate strategic decisions and policies for network-wide activities. The PIN awardees will be required to accept and implement these decisions and policies to the extent consistent with applicable grant regulations. All SC scientific and policy decisions and recommendations that require voting will be based on a majority vote. The PIN SC will be constituted at the initial PIN meeting and will meet regularly (monthly or quarterly), including at least once in-person during the annual PIN Investigators' Meeting. The chairperson(s) of the PIN SC will be selected from the representatives of all awardees and is responsible for coordinating the PIN activities, preparing meeting agendas, and chairing SC meetings. The SC may also choose to replace the PIN SC chairperson(s) at any time based on poor job performance or failure to follow the relevant procedures and guidelines.
Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:
- Establishing network policies and procedures.
- Establishing policies and procedures for collaborative projects, and protocols.
- Formulating policies and procedures for data collection and harmonization.
- Identifying impediments to success and strategies to overcome them.
- Developing shared tools for disseminating information about PIN.
- Discussing important issues relevant to immunotherapeutic approaches in childhood cancer.
- Helping with the planning of major events (such as the annual meeting).
- Identifying opportunities for sharing techniques, materials, information, and tools.
- Facilitating communication and fostering collaboration across the PIN.
- Reviewing the progress of the PIN towards meeting the overall Network goals.
- Developing publication policies to facilitate collaborations and co-publications by PIN members.
- Ensuring the PIN leverages existing NIH resources and programs.
- Evaluating collaborative activities, and providing feedback to the NCI Program Staff; and
- Discussing the implementation of recommendations or suggestions from the NCI and any external consultants and plan a timely implementation strategy.
- Serving as a hub for a broader outreach to the entire extramural research community investigating pediatric cancer immunotherapy.
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
For Preclinical, Clinical and Translational aspects, contact:
Anju Singh, B.V.Sc, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7603
Email: [email protected]
Nita Seibel, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6560
Email: [email protected]
For Basic and Mechanistic aspects, contact:
Lillian Kuo, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7687
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
and Human Services (HHS)
