Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
R21 Exploratory/Developmental Research Grant
Reissue of PA-17-243 - Secondary Analysis and Integration of Existing Data to Elucidate the Genetic Architecture of Cancer Risk and Related Outcomes (R21)
PAR-20-276, R01 Research Project Grant
93.393; 93.396; 93.172; 93.121
Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) along with the National Human Genome Research Institute (NHGRI) and National Institute of Dental and Craniofacial Research (NIDCR) encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate the genetic architecture of cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer genomic and epidemiology by supporting the analysis of existing genetic or genomic datasets, in combination with other omics and environmental, clinical, behavioral, lifestyle, and molecular profiles data. Applicants are encouraged to leverage existing genetic data and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in genomic and epidemiology cancer research.
Not Applicable
Standard dates apply.
The first standard due date for this FOA is October 16, 2020
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
Standard dates apply
Standard dates apply
Standard dates apply
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
Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) along with the National Human Genome Research Institute (NHGRI) and National Institute of Dental and Craniofacial Research (NIDCR) encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate the genetic architecture of cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer genomics and epidemiology by supporting the analysis of existing genetic or genomic datasets, in combination with other omics and environmental, clinical, behavioral, lifestyle, and molecular profiles data. Applicants are encouraged to leverage existing genetic data and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in genomics and epidemiology cancer research.
This FOA runs in parallel with another FOA of identical scientific scope, PAR-20-276 , which utilizes the Research Grant (R01) mechanism.
Background and Rationale
National Institutes of Health (NIH) and other research funding organizations support numerous genomic and functional genomics studies that generate a large amount of genotype, phenotype, gene expression, and epigenetic data, which continue to be made available to the scientific community. Many of these datasets have not been analyzed to their full potential and further investigation will provide opportunities to answer important research questions at relatively low cost.
Several NCI programs support genomic and epidemiologic research to understand and clarify cancer risk, progression, and outcomes. These studies generate a wealth of individual- and population-level data, including molecular, lifestyle, clinical, and environmental data. Leveraging these various types of data through innovative data modeling and analysis allows new questions to be addressed and helps to advance the field of cancer research. NIH has made it a priority to make data more Findable, Accessible, Interoperable, and Reusable (FAIR) to researchers to further biomedical research, through several sharing policies, including the 2003 Data Sharing Policy, the 2015 Genomic Data Sharing (GDS) Policy, and the NCI Cancer Moonshot Public Access and Data Sharing Policy. NIH requirements for data sharing in grant applications, combined with public and private sector initiatives by donors, journals, and foundations, have led to unprecedented amounts of available data for secondary research. Publicly available molecular measurements have been successfully utilized to discover novel biomarkers of disease and to find novel uses for existing therapeutics.
The goal of this initiative is to address key scientific questions relevant to cancer genomics and epidemiology by supporting the analysis of existing genetic or genomic datasets, in combination with other omics, environmental, clinical, behavioral, lifestyle, and molecular profiles data, from various data sources whose number is expected to continue increasing as more data become available through data sharing.
Specific Research Objectives and Scope of the FOA
The integrative analysis of molecular data, especially the vast amount of genomic data obtained in recent years, has great potential to illuminate the complex interactions among genes, gene products, and the environment and thereby redefine cancer at the molecular level and lead to novel hypotheses regarding prevention and treatment of cancer.
Applicants are encouraged to leverage existing genetic or genomic data and perform innovative analyses of the existing data. Applications may include new aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer genomics and epidemiology. In addition, priority will be given to applications that incorporate at least one of the following features: the investigation of phenotypes not studied before using the proposed existing dataset, incorporation of additional studies or alternative data sets, exploration of multiple genetic and environmental factors, integration with multiple omics and other epidemiologic variables, and/or development or application of novel analytical approaches.
Specifically, through this FOA, the NCI along with NHGRI and NIDCR, encourages submission of applications that propose to leverage existing genetic or genomic data and could include one or more of (but not limited to) the following aspects:
This FOA capitalizes on NIH's and NCI's past investments in several programs that have supported genomic and epidemiologic research of cancer risk, progression, and other health-related outcomes by leveraging the generated molecular, lifestyle, clinical, and environmental data. All data analyses must concern genomic and epidemiologic research designed to elucidate the etiology, incidence, prevalence, natural history, pathophysiology, or cancer-related outcomes.
Addressing health disparities and improving inclusion is an area of interest across NIH, and research is needed to better understand the underlying factors contributing to disparities in several cancer types. While it is expected and understood that the research application will be constrained by the limited availability of existing genomic and epidemiologic data in minorities, the research plan should nevertheless adequately describe the investigators efforts, successes and challenges in finding and including in the analysis any relevant available datasets representing minority populations, as well as address the translational impact of findings on these populations.
NCI focus. Applicants should consider the relevance of their proposed analyses to those NCI programs and priorities that can be tackled through the study of existing genomic and epidemiologic data, possibly together with other omics or clinical data. Potential applicants are encouraged to speak with the listed NCI program officials to discuss the relevance of the proposed research topic(s).
NHGRI focus. NHGRI welcomes applications that develop new approaches for elucidating the genetic architecture of human health and disease and that are broadly applicable to multiple diseases and outcomes, in addition to cancer. NHGRI is particularly interested in applications to develop novel methods for integrating multiple types of genomic data and possibly other data types. Projects that focus only on tumor genomics will not be appropriate for NHGRI funding.
NIDCR focus. NIDCR supports secondary data analysis and data integration research in the assessment of cancer risk, progression, and outcome that are relevant to oral, oropharyngeal, and salivary gland cancers. NIDCR will also consider applications that incorporate new statistical or computational methods to help improve the accessibility and/or speed of dissemination of data resources. Potential applicants are encouraged to speak with the listed NIDCR program officials to discuss the relevance of the proposed research topic(s).
This initiative optimizes the use of resources for epidemiologic studies by leveraging existing resources rather than creating new ones. The initiative will highlight examples of how data sharing and integration can strengthen cancer genomic and epidemiology research findings, thereby helping to overcome the real and perceived barriers to data sharing. In addition, it aims to encourage the collaboration of investigators outside of usual research groups.
Data Sources
Applicants are encouraged to collaborate with investigators holding publicly as well as non-publicly available data sets, using innovative statistical strategies to link methodologically comparable datasets.
A large volume of genotype and phenotype data are available to the scientific community. Some examples currently include (but are not limited to) the following:
This mechanism can also be used to merge secondary data sets with other data sets to better address important research hypotheses. For example, if allowed by informed consent, genetic datasets could be matched with hospital datasets or vital statistics.
Applicants who plan to utilize data not currently in their possession (originated from another party) should confirm availability of the data and the willingness and permissibility of the original investigators to share the data for the purposes of the secondary analyses, in accordance with all applicable rules for the protection of human subjects.
Collaborations and Authorship
Projects developed in response to this FOA must include expertise such as cancer epidemiology, omics, biostatistics, bioinformatics, and/or computational biology.
Any publications resulting from awards funded under this FOA must include acknowledgment of the source of shared data and any funding sources which supported the initial data collection.
Applicants should discuss co-authorship plans with original and/or contributing investigator(s) prior to submitting an application.
Data Sharing
Awardees are expected to broadly share the cleaned and harmonized datasets, analysis tools, and any other software developed for the secondary analysis and integration of the data, when appropriate and consistent with the participant informed consent. Sharing of adequate documentation and explanation is also encouraged so that data and tools can be used by researchers not associated with the original study.
Other Requirements
Applications can be related to but must be distinct from the specific aims and methods of the original data collection.
The primary analyzed data can be derived/redefined from existing data but should not be newly collected from study participants nor newly generated from existing biological specimens.
The FOA will allow up to 10% of the budget towards experimental approaches for validation of key findings.
Non-Responsive Applications
The following types of studies are outside the scope of this FOA and applications describing them will be considered non-responsive:
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Direct costs are limited to $275,000 over a two-year project period, with no more than $200,000 in direct costs allowed in any single year.
The maximum project period is 2 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
Federal 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.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
The FOA will allow up to 10% of the budget towards experimental approaches for validation of key findings.
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:
Research Strategy: All applications should include an overall strategy that leverages existing genetic or genomic data, possibly in combination with other omics, molecular, lifestyle, clinical, and environmental data. All data analyses must concern genomic and epidemiologic research designed to elucidate the etiology, incidence, prevalence, natural history, pathophysiology, or cancer related outcomes. The study design should incorporate at least one of the following features: development or application of novel analytical approaches; exploration and integration of genetic data with multiple omics, environmental factors, and other epidemiologic variables; incorporation of additional studies or alternative data sets; and/or investigation of phenotypes not studied before using the proposed existing dataset.
Applications should clearly describe the proposed analytical methods, their feasibility and innovation in comparison to other existing methods and include possible evaluation and validation plans. Applicants should demonstrate knowledge of the proposed data set(s) and include details on data source, number of individuals, number and type of samples, type of genomic and other omics and/or molecular data, epidemiological and clinical information available and included in the analysis. Applicants should address how the proposed data set(s) are suitable and sufficient to fulfill the research aims and describe approaches to overcome challenges associated with small sample sizes, be this cancer types, cell types, or unique human populations. The proposed analyses should be feasible within the timeline proposed.
Addressing health disparities and improving inclusion is an area of interest across NCI and NIH, and research is needed to better understand the underlying factors contributing to disparities in several cancer types. While some progress has been made towards improving the inclusion of diverse populations in genomic studies, racial and ethnic minorities remain underrepresented in these studies. Such underrepresentation may have additional implications for genomic and cancer epidemiologic research, where understanding variation across populations is critical for accurate interpretation of findings. While it is expected and understood that the research application will be constrained by the limited availability of existing genomic and epidemiologic data in minorities, the research plan should nevertheless adequately describe the investigators efforts, successes and challenges in finding and including in the analysis any relevant available datasets representing minority populations, as well as address the translational impact of findings on these populations.
This FOA is tailored to cost effective studies that reutilize existing resources for secondary data analysis, which may lead to findings that warrant experimental validation. Any proposed new experimental data generation within these applications should be limited (<10% of the budget) to the validation of key findings. If appropriate to the proposed science, applicants should describe how their findings could be experimentally tested in a follow up independent study.
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:
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 NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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?
Specific for this FOA
What is the likelihood that the focus of the proposed secondary analyses to investigate novel scientific ideas or new models, systems, tools, methods, or technologies has the potential for contributing significantly to biomedical research in cancer? Have the investigators adequately addressed the translational relevance of the potential findings across populations?
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?
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 for this FOA
How novel are the developed or applied analytical approaches? How well are multiple genetic and omics data, environmental factors, and other epidemiologic variables explored and integrated into the analyses? Which additional studies or alternative data sets are incorporated into the analyses? Are the investigators proposing to analyze phenotypes that have not been studied before using the same existing datasets?
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 for the FOA
How strong is the likelihood that the proposed data set(s) are suitable and sufficient to fulfill the research aims? How adequately have the investigators described their efforts, successes and challenges in finding and including in the analysis any relevant available datasets representing minority populations? How effective are the proposed methods to overcome challenges associated with small sample sizes, be this cancer types, cell types, or unique human populations? If the investigators are proposing new experimental data generation, is it limited to the validation of key findings? How likely is the proposed project to be completed within the timeline proposed?
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?
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.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), 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 Advisory Council. 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.
Not Applicable
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Melissa Rotunno, Ph.D.
National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS)
Telephone: 240-276-7245
Email: [email protected]
Jiayin (Jerry) Li, M.D., Ph.D.
National Cancer Institute (NCI), Division of Cancer Biology (DCB)
Telephone: 240-276-6210
Email:[email protected]
Miguel R. Ossandon, Ph.D.
National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD)
Telephone: 240-276-5714
E-mail:[email protected]
Wendy Wang, Ph.D.
National Cancer Institute (NCI), Division of Cancer Prevention (DCP)
Telephone: 240-276-7117
E-mail:[email protected]
Chiayeng Wang, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 240-276-6624
[email protected]
Erin Ramos, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3288
Email:[email protected]
Lu Wang, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4846
Email:[email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email:[email protected]
Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
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.