Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Cancer Institute (NCI)
U24 Resource-Related Research Projects Cooperative Agreements
Reissue of RFA-CA-15-020 - Genomic Data Analysis Network: Specialized Genomic Data Center (U24)
None
93.393, 93.394, 93.395, 93.396
This Funding Opportunity Announcement (FOA) is designed to support genomic programs managed by the Center for Cancer Genomics (CCG). The overall goal of all CCG programs is to help elucidate the mechanisms of cancer initiation and evolution, as well as resistance to therapy by means of genomic characterization of well-annotated, high quality tumor samples. These data could, in the future, be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. It is not the intent of this FOA to fund follow-up translational and functional studies, but rather to enable the cancer research community to develop a new generation of studies that will leverage the genomic findings from NCI programs for the benefit of cancer patients. NCI project data, both ongoing and completed, will provide a unique reference resource on cancer-specific genomic aberrations for the cancer research community at large.
30 days prior to the application due date
November 12, 2020
No late applications will be accepted for this FOA.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
March/April 2021
May 2021
October 2021
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
This funding opportunity announcement (FOA) is designed to support genomic programs managed by the Center for Cancer Genomics (CCG). The overall goal of all CCG programs is to help elucidate the mechanisms of cancer initiation and evolution, as well as resistance to therapy by means of genomic characterization of well-annotated, high quality tumor samples. These data could, in the future, be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. It is not the intent of this FOA to fund follow-up translational and functional studies, but rather to enable the cancer research community to develop a new generation of studies that will leverage the genomic findings from NCI programs for the benefit of cancer patients. NCI project data, both ongoing and completed, will provide a unique reference resource on cancer-specific genomic aberrations for the cancer research community at large.
To serve the overarching goals of NCI, this FOA solicits applications for highly collaborative Genome Data Analysis Centers (GDACs) that will, in aggregate, form the Genomic Data Analysis Network (GDAN).
Background
Cancer is a complex and heterogeneous disease in which mutations and other genomic and epigenomic abnormalities play a role in both its initiation and progression. Accumulated research data implicate numerous somatic mutations and a more limited number of inherited mutations in carcinogenesis. Understanding cancer-specific somatic mutations can provide important clues regarding the molecular processes underlying the development and progression of certain tumors. Given cancer’s complexity, it is generally believed that only a fraction of alterations that may be useful as characteristic markers of specific tumor types and/or potential molecular targets have been identified to date. Therefore, to be successful, comprehensive genomic analyses of cancer must overcome a broad range of challenges stemming from the biological complexity and heterogeneity of human tumors and subtypes. An important role in tumor heterogeneity is played by the genomic instability, which is inherent to the progression of cancer. The dynamic changes in tumor genomes are influenced by the cellular and biological context, genetic characteristics of individual persons, and environmental factors. Certain similarities exist across tumor types, however any effort to characterize the genomes of tumors in a comprehensive, systematic manner must address the heterogeneity across distinct cancer types and subtypes.
Many research groups are working independently to identify cancer-relevant genomic changes (e.g., alterations in expression profiles, chromosome deletions, amplifications, and/or translocations) in a relatively small number of samples. Cancer-relevant changes have been detected at diverse levels of genomic organization; they include point mutations, chromosomal deletions, amplifications, translocations, and/or changes in the number of individual chromosomes, all of which can, in principle, contribute to transcriptional aberrations. To produce a comprehensive catalog of cancer-specific alterations, in 2006, the NCI and the National Human Genome Research Institute initiated a collaboration to pursue a 3-year pilot project (The Cancer Genome Atlas, TCGA) to determine the feasibility of more comprehensively cataloging the genomic alterations associated with a small number of different human cancers. The pilot project focused mainly on three tumor types: glioblastoma multiforme, serous cystadenocarcinoma of the ovary, and squamous carcinoma of the lung. The pilot project expanded to approximately 30 additional tumor types over the next 4 years, and today, it has accumulated approximately 2.5 petabytes (PB) of data on over 11,000 cases of human cancer. Data analysis to date demonstrates that cancer-associated genes and genomic regions can be identified by combining diverse information from genome analyses with tumor biology and clinical data, and that the sequencing of selected regions can be conducted efficiently and cost-effectively.
The strength of TCGA was to produce unprecedented multi-dimensional data sets using an extended number of samples to provide statistically robust results that sets the stage for a new era in the discovery of new cancer interventions. The integrative analyses leading to the formulation of an unanticipated hypothesis on a potential mechanism of resistance highlights precisely the value and power of such project design, demonstrating how unbiased and systematic cancer genome analyses of large sample cohorts can lead to important discoveries.
Three key lessons learned from the TCGA project were that to be able to interpret the results generated by the various characterization platforms the Centers had to utilize high quality molecular analytes; perform experiments utilizing strict standardized protocols; and deposit the results in structured formats in publicly accessible databases. The last lesson strongly impacted on the ability of the various analytical groups to extract meaningful results from the genomic data generated. The unique aspect of TCGA Project was the development and function of an integrated research network. Due to the TCGA success, it is envisioned that all future NCI-sponsored genomics projects will utilize a similar model. The intent of NCI is to conduct a coordinated and comprehensive, genome-wide analysis of cancer-relevant alterations by simultaneously applying several technologies to interrogate the genome, epigenome or transcriptome in large collections of quality-controlled cancer biospecimens derived from specific cancer types. To accomplish this goal, NCI projects include multidisciplinary teams of investigators and associated institutions that collectively provide biological data, as well as inform strategies for sequencing. The progress in understanding some cancer-associated molecular alterations and the accompanying advances in technology suggest that it is now possible to obtain comprehensive genomic information from multiple tumor types to catalog most, if not all, of the genomic changes associated with cancer and correlate the molecular data with clinical parameters and outcomes to solve hereto unanswered clinical questions. Ultimately, in collaboration with and in support of the NCI’s extensive program of individual projects in cancer research, such efforts are expected to accelerate the identification of markers for prevention and diagnosis and novel targets for the development of therapeutic drugs, as well as provide the basis for a refined clinical understanding of patient stratification in therapy.
Current Structure of the NCI Genomic Characterization Network (NCI-GCN)
The NCI Genomic Characterization Network (NCI-GCN) includes the following major organizational and functional components. All awardees must be able to interact with every component in a cooperative fashion to reach the goals of the network (see below):
Clinical Data Center (CDC):
The CDC serves as the intake center for all clinical data gathered on the tumors to be characterized. As such, they receive the raw clinical data from the Tissue Source Sites (TSS), process it to remove all personally identifiable information (PII) or protected health information (PHI) and deposit the de-identified data into the GDC for public release.
Biospecimen Processing Core (BPC):
The BPC serves as the tissue processing center and provides the molecular biomolecules for NCI-approved projects. Standard operating procedures are used for sample collection, pathological examination, biomolecule (e.g., DNA and RNA) extractions, quality control, laboratory data collection, and biomolecule distribution to the Cancer Genome Characterization Centers. The samples are required to have patient informed consent for the public release of data or an IRB waiver.
Genome Characterization Centers (GCCs):
GCCs conduct high-throughput comprehensive genome-wide analyses using validated technologies (e.g., gene expression profiling, detection of chromosomal segment copy numbers alteration) to reveal the spectrum of genomic changes that exist in human tumors and to identify genomic regions for further characterization. The data generated by the characterization centers is the main (but not only) starting point for the analysis performed by the GDACs.
Genomic Data Analysis Network (GDAN):
The aggregated capabilities of the awardees from the present FOA will produce the bulk of the analysis required to interpret the data generated by the GCCs described above. This group will work closely and collaboratively with all other components of the pipeline and be responsive to the necessities of the analysis requests posed by the Analysis Working Groups (AWGs) that will be formed for each NCI-approved project.
Data Management, Storage and Public Access:
The whole of the data generated by NCI-approved projects is presented to the scientific community though publicly-available databases that contain not only the raw data and associated metadata, but all of the analysis files generated in the course of each project. At the time of this FOA, that task is performed by the GDC. Awardees are expected to adapt their submission pipelines as necessary to accommodate the need to submit to the GDC.
Proposed Structure, Specific Research Areas, Overall Goals and Research Objectives for GDACs for this FOA
1. Structure
This FOA is intended to fund an integrated group of GDACs, each of them tasked to cooperatively perform the molecular analyses as requested by CCG project stakeholders. A GDAC is a core dedicated to the analysis of the data generated by the GCCs and other collaborators for any and all CCG-approved projects.
The GDACs will:
(1) develop and implement new bioinformatic and computational tools to capture key biological parameters such as pathway analysis, data integration with visualization, and integrated cancer biology;
(2) develop pipeline and network-wide quality control methods for the system; and
(3) process/integrate analytical data from other components of NCI-GCN to generate disease level findings and interpretations as well as cross-disease analyses.
These goals will necessitate continuous communication and interactions among the members of NCI-GCN. Each member of the GDAC group will have distinct functions and capabilities and be responsible for individual analytical components. It is expected that there will be up to fourteen GDACs. The applications could include suggestions on how the future GDAC awardees would interact as the GDAN.
It is expected that up to 10 multi-disciplinary, interactive GDACs will be established under this FOA. GDACs could develop analytical cores as follows:
The GDACs will take advantage of highly skilled researchers in a single facet of the genomic landscape to produce results from analysis of a limited set of platforms. These GDACs will work closely to serve the needs of the Analysis Working Groups (AWGs) that will be convened to interpret the data of each project and sub-project. The analysts assigned to these GDACs must be dedicated full time, as they will be expected to work with a number of AWGs simultaneously while being responsive to all of them in a timely fashion. It is expected that up to fourteen awards of this class will be made.
2. Specific Research Areas
Applications to this FOA must address at least one of the following areas, but the applications are encouraged to address a combination of them, depending on the competencies of the applicant(s):
3. Overall Goals
All GDACs will work together to:
1) develop a strategy for data flows from the GDACs to the GDC;
2) determine the various types of analyses to be performed that are relevant to the needs of the analysis working groups; and
3) optimize the mechanism(s) for communicating back to the stakeholders in the project as well as the scientific community. GDACs will also be responsible for submitting their results on the identified cancer-associated molecular alterations to the GDC in the format accepted by the CCG program director.
This FOA is open to all qualified individuals and institutions and does not require prior participation in any previous NCI genomics project (TCGA, TARGET, CGCI, etc.)
Note on Key Terms Used in the FOA:
4. Overall Research Objectives for GDACs
This FOA is intended to fund an integrated group of GDACs with each of them tasked to cooperatively perform the molecular analyses as requested by CCG project stakeholders. As a whole the GDACs will:
(1) develop and implement new bioinformatic and computational tools (or adapt existing ones to capture key biological parameters such as pathway analysis, data integration with visualization, and integrated cancer biology;
(2) develop pipeline and network-wide quality control methods for the system; and
(3) process/integrate analytical data from other components of NCI-GCN to generate disease level findings and interpretations as well as cross-disease analyses.
These goals will necessitate continuous communication and interactions among the members of NCI-GCN. Each member of the GDAC group will have distinct functions and capabilities and be responsible for individual analytical components. It is expected that there will be up to ten GDACs. The applications could include suggestions on how the future GDAC awardees would interact as the GDAN.
5. Required Team Expertise
Each GDAC applicant team must have current expertise in computational data analysis and genomics-specific bioinformatics as well as clinical oncology and/or cancer biology. GDACs would benefit greatly by being jointly led by two investigators, such as:
(1) an expert in bioinformatics/computation; and
(2) either a clinical oncologist or a cancer biologist who can help to guide the analyses and contribute to the interpretation of the results at the disease-level.
All GDACs can differ by the proportion of the effort devoted to the development of novel analyses, but each GDAC will be required to develop novel approaches to data analysis and data integration as needed, if the tools to perform the required tasks do not already exist. The analytical pipelines will be available as a resource to the scientific community for data integration and for advanced translational evaluation of genomic data. The analytical pipelines may result in valid conclusions which are not 100% concordant due to the different analytical methods used. The GDACs will need to develop annotation which will be made available along with the pipeline to explain any differences in data interpretation to the research community.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
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The NCI intends to support up to 10 GDAC awards for a total of $10 million (total costs). Future year amounts will depend on annual appropriations.
Application budgets are limited to $300,000/year in direct costs, but need to 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Other
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Jean C. ZenKlusen, PhD
Center for Cancer Genomics Program Office
National Cancer Institute (NCI)
Telephone: 301-451-2144
Email: jz44m@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Each GDAC applicant team must have current expertise in computational data analysis and genomics-specific bioinformatics as well as clinical oncology and/or cancer biology. Accordingly,
GDAC applicants are strongly encouraged to take advantage of the multiple PDs/PIs option. For example, the proposed GDACs may include one PD/PI with primary expertise in bioinformatics and another PD/PI with primary experience in cancer biology or clinical oncology.
All instructions in the SF424 (R&R) Application Guide must be followed.
Leadership Effort Commitment: The contact PD/PI must commit and maintain through the life of the award a minimum of 2.4 person-month of effort. For other PDs/PIs (if designated), a minimum effort of 1.2 person-month per PD/PI is required.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Define Specific Aims of the proposed visualization in GDAC. The proposed aims must be consistent with achieving the required objectives.
Research Strategy: Use standard sections (Significance, Innovation, and Approach), address all the objectives and specific requirements defined below.
Overall GDAC Profile: Explain how the research team will approach the creation of a user interface that allows for the exploration of large quantities of genomic data, generate integrated results, and/or inspire and facilitate higher-level interpretations of the genomic patterns. The goal must be to ensure that all anticipated research outcomes are of quality, rigor, and novelty enabling the cancer research community to develop a new generation of studies that would leverage cancer genomics for the benefit of cancer patients. (Note, however, that the actual conduct of translational and/or functional studies that follow-up on genomics findings are out of scope for this FOA.)
GDAC Objective 1: Development of innovative bioinformatics and computational tools and methodologies (requires drawing clinical and biological correlations). In addressing this objective, provide sufficient details to document that your plans are consistent with the following Requirements for Objective 1:
GDAC Objective 2: Conduct Integrative analysis of data sets generated by GCCs using the bioinformatics tools developed by each GDAC. In addressing this objective, provide sufficient details to document that your plans are consistent with the following Requirements for Objective 2:
Interactions across GDACs (Optional): Applicants may outline their perspective/suggestions on how the future GDAC awardees would interact to maximize the benefits for the stated programmatic goals.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Note that the NCI Program Staff may negotiate modifications to these plans prior to funding
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: Will the proposed activities significantly advance the overall goals of the NCI genomic projects? Does the proposed plan ensure the integration with other GCCs, GDACs and other components of the NCI genomic pipeline?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: How strong is the applicant team in terms of expertise in computational systems biology and pathway mapping capabilities? Does the applicant provide a reasonable plan for bringing collaborators and resources together to accomplish the goals of the FOA?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the applicant propose innovative ways to process and integrate genome-wide data in the context of disease-relevant associations?
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?
Specific to this FOA: Will the analytical approaches, data analysis methods and tools and quality control measures yield reliable and meaningful results for the goals set in this FOA? How well does the applicant’s plan for the construction and sharing of analytical pipelines address the NCI genomic goals?
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?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
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.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the 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).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer AdvisoryBoard. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
These Terms and Conditions of Award apply to all individual GDAC U24 awardees. All the awardee institution(s), principal investigators (PI/PDs) and other key personnel must agree to collaborate on the goals of the Center for Cancer Genomics.
Awardees and Principal Investigator Rights and Responsibilities
The PD/PIs will have primary responsibility for defining the specifics of the projects within the guidelines of this FOA and for performing all scientific activities. The PD/PIs must accept the close coordination of various aspects of scientific and technical management of the project by the NCI Project Scientists (outlined in the sections below).
The Principal Investigators will have the primary responsibility for:
The lead PD/PIs will be responsible for the overall coordination of project activities scientifically and administratively at the awardee institution as well as any and collaborating institutions.
Specific responsibilities of the GDACs awardees will include:
NIH Responsibilities
An NCI Program Director(s) (acting as a Project Scientist(s)) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. These NCI Staff Members will provide substantial input in terms of overall program coordination and directions,
The NCI staff (NCI Project Scientists, Project Coordinators) will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.
Additionally, an NCI Program Director(s) acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as a Project Scientist). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver.
The NCI Project Scientist will:
The NIH reserves the right, with the advice of the CCG Programs Office, to suspend or reduce the award of those project participants who fail to share and disseminate data on a schedule established by the CCG Programs Office or who are judged by the CCG Programs Office to make insufficient progress in technology improvements.
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 and composed of: 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.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Jean C. ZenKlusen, PhD
National Cancer Institute (NCI)
Telephone: 301-451-2144
Email: jz44m@nih.gov
NCI Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email:crystal.wolfrey@nih.gov
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.
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