PAR-25-243: Basic Research in Cancer Health Disparities (R01 Clinical Trial Not Allowed)

PAR-25-243: Basic Research in Cancer Health Disparities (R01 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). Supports research addressing cancer health disparities.

PAR-25-243: Basic Research in Cancer Health Disparities (R01 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title Basic Research in Cancer Health Disparities (R01 Clinical Trial Not Allowed) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Exploratory/Developmental Grants See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) encourages grant applications from investigators interested in conducting basic, mechanistic research into the biological/genetic causes of cancer health disparities.

These research project grants (R01) will support innovative studies designed to investigate biological/genetic contributors of cancer health disparities, such as (1) mechanistic studies of biological factors associated with cancer health disparities, including those related to basic research in cancer biology or cancer prevention strategies, (2) the development and testing of new methodologies and models, and (3) secondary data analyses.

This NOFO is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can expand available resources and tools, such as biospecimens, patient derived models, and methods that are necessary to conduct basic research in cancer health disparities.

Funding Opportunity Goal(s) The overall goals of this NOFO is to identify cancer risks and risk reduction strategies, to identify factors that cause cancer in humans, and to discover and develop mechanisms for cancer prevention and preventive interventions in humans. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description This notice of funding opportunity (NOFO) encourages grant applications from investigators interested in conducting basic, mechanistic research into the biological/genetic causes of cancer health disparities.

These research project grants (R01) will support innovative studies designed to investigate biological/genetic contributors of cancer disparities, such as (1) mechanistic studies of biological factors associated with cancer disparities, including those related to basic research in cancer biology or cancer prevention strategies, (2) the development and testing of new methodologies and models, and (3) secondary data analyses.

This NOFO is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can expand available resources and tools, such as biospecimens, patient-derived models, and methods that are necessary to conduct basic research in cancer health disparities.

In the United States, several racial/ethnic populations demonstrate increased incidence and/or more aggressive disease for specific cancer types. For example, African American males have higher rates of prostate and lung cancer, compared to their Caucasian-American counterparts, and both males and females exhibit a higher incidence of colorectal cancer and multiple myeloma.

Hispanic/Latino individuals have the highest rates of cervical cancer and pediatric acute lymphoblastic leukemia (ALL) and one of the poorest survival rates for ALL. Similarly, Asians and Pacific Islanders have the highest incidence rates for liver and stomach cancer while American Indians and Alaska Natives have both the highest incidence and the highest mortality rates in kidney and renal pelvis cancer.

The causes of these cancer health disparities are multifactorial, including barriers in access to healthcare, cultural barriers, environmental disadvantage, differences in diet and lifestyle, ancestry-related risk factors, persistent co-morbidities, and chronic stress exposure due to discrimination and social isolation.

An increasing number of studies demonstrate that even when socioeconomic and access to care factors are accounted for, incidence and mortality gaps persist between racial/ethnic populations for some cancer types, which suggests a role for biological contributors. Such studies have included identification of ancestry-related differences in DNA, RNA, and/or protein expression that are associated with cancer risk and/or progression.

Other studies have shown the presence of differential tumor microenvironment components among diverse racial/ethnic populations indicating a potential role for immunity and inflammation in contributing to cancer health disparities. These complex biological factors may enhance understanding of the differences observed in cancer incidence, prevalence, morbidity, and mortality rates among underrepresented populations.

The NCI encourages investigations of such biological factors to increase our understanding of the mechanisms that play a role in cancer health disparities.

Specific Research Objectives The DCB supports research on the discovery and characterization of basic pathways and mechanisms that regulate the development of a pre-malignant state, initiation of cellular transformation and cancer cell progression, formation of the tumor microenvironment, metastasis, and host responses to cancer, including immunologic or metabolic responses.

The CCHE supports cancer health disparity research focused on basic, hypothesis-driven studies that explicitly address the unequal burden of cancer amongst racial/ethnic or other underserved populations across the cancer continuum (prevention, early detection, diagnosis, treatment, and survivorship).

The DCP supports research that will generate new information about molecular processes that are susceptible to intervention throughout the cancer continuum until invasive cancer and underlying mechanisms of cancer and its sequelae (i.e., mechanistic studies on the prevention or treatment of acute and chronic symptoms and morbidities related to cancer and its treatment), developing effective cancer screening and prevention strategies, discovering early detection biomarkers, and pinpointing mechanistically targeted nutrients in cancer prevention.

This NOFO encourages basic research projects that will develop and test new methodologies and new research technologies focused on specific topics in cancer health disparities.

The availability of annotated clinical samples as well as enabling technologies (genomics/epigenomics, proteomics, metabolomics, single-cell analysis, imaging) make it feasible to study biological factors that contribute to cancer health disparities among different racial/ethnic populations.

Research projects must propose to investigate the interplay of race/ethnicity and/or other social determinants with cancer biology to mechanistically explain an unequal burden of cancer among populations. As such, proposed studies are encouraged to use biospecimens, patient-derived models, and/or data sets derived from different racial/ethnic and/or underserved groups.

Studies investigating age and/or sex disparities, in the absence of race/ethnicity variables, are not solicited. Research projects using a comparative research design between at least two populations are encouraged, in which one or more is underserved. Projects that are strictly hypothesis-generating, exploratory, and correlative studies are discouraged.

As this NOFO is focused upon basic research, immediate clinically translational potential of the proposed project is NOT a requirement for the proposed projects. Research topics of interest include but are not limited to : Early detection and cancer prevention Understanding how risk factors, including environmental exposures and social determinants of health impact risk and development of precancerous lesions.

Examination of how stress impacts the progression of symptoms across different population groups. Understanding how persistent co-morbidities across specific populations impact cancer development, progression, and response to treatment. Understanding the role of human virome/viral infection history and its relation to cancer risk in racial or ethnic populations.

Revealing and testing mechanistic hypotheses derived from the use of AI or other computational analysis of large existing datasets. Elucidation of molecular mechanisms that differentiate incidence and prevalence of precancers using spatial omics technologies. Cancer initiation and progression Causal drivers of cancers with disparate incidence, burden, and/or outcome in underserved populations or racial and ethnic populations.

Genetic and/or epigenetic mechanisms of cancer onset, progression, and outcome among racial or ethnic populations, such as epigenetic drivers and or suppressors. Understanding how self-reported race and/or ethnicity or ancestry impacts disease penetrance in individuals who inherit a cancer susceptibility gene. Understanding if self-reported race and/or ethnicity or genetic ancestry have a role in the recurrence of precancerous lesions.

Similarities and differences in cancer metabolism (e.g. alterations in metabolic fuel sources, fatty acid synthesis, lipid metabolism, glycolysis, nutrient uptake) that lead to cancer disparities. Role of the microbiota in cancer disparities during tumorigenesis, progression, and response to therapy.

Role of the oncogenic pathogens in the development of cancer health disparities during tumorigenesis and progression in underserved populations groups.

Investigating cancer immunology and the basic biological mechanisms underpinning anti-tumor immune responses, immune regulation of the development and spread of tumors, and approaches to improve immune targeting and destruction of cancer cells, Understanding if there are unique biological considerations to how cancer is initiated and progresses in health disparities populations.

Symptom Management during cancer and its treatment Identify underlying mechanisms of symptoms that are responsible for altering treatment regimens that increase the risk of mortality for racial/ethnic minority patients with cancer. Biological bases of differences among racial/ethnic populations in responses to cancer immunotherapies and/or development of immune-related adverse events induced by cancer immunotherapies.

Understanding the process through which precision therapies improve symptom management to reduce health disparities. New 3D cellular models, organoids, xenografts, patient-derived models, and micro physiological systems designed to recapitulate and investigate cancer health disparities. New computational approaches to discover, predict, and test biological mechanism that underlie cancer health disparities.

Non-responsive Applications The following types of studies are not responsive to this NOFO- applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding: Studies that do not propose cancer health disparity research. Studies investigating age and/or sex disparities, in the absence of race/ethnicity variables.

Behavioral, social, environmental, or community/population-based studies that are not incorporating biological mechanisms in the specific aims. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited 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 NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) 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 their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: The Research Strategy must clearly describe the following within the appropriate section (i.e., Significance, Investigator(s), and Approach), in accordance with the simplified review framework: Factor 1. Importance of the Research (Significance and Innovation) Significance .

Describe how the proposed research may advance the understanding of biological mechanisms contributing to cancer health disparities in underrepresented and/or underserved populations.. Factor 2. Rigor and feasibility (Approach) Approach : Describe how the approach is appropriate to evaluate how biology may influence risk, incidence, and/or progression of cancer in underrepresented and underserved populations.

Factor 3. Expertise and Resources (Investigator(s) and Environment) Investigator(s) : Describe how the investigative team is well suited to investigate biological mechanisms contributing to cancer health disparities For multidisciplinary teams, explain how the team’s collective expertise will complement and contribute to successfully achieving the projects specific aims.

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

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E. O.

12372) 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 Section 7.

9. 1 Selected Items of Cost. 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted. 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. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide. See more tips for avoiding common errors.

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

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V. Application Review Information 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: Immediate clinically translational potential of the proposed project is NOT a requirement for this FOA.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. Factor 1.

Importance of the Research (Significance and Innovation) Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.

Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study. Evaluate the extent to which innovation influences the importance of undertaking the proposed research.

Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Evaluate the extent to which the proposed research project has the potential to advance the understanding of biological mechanisms contributing to cancer health disparities in underrepresented and underserved populations. Factor 2. Rigor and Feasibility (Approach) Evaluate the scientific quality of the proposed work.

Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility). Evaluate the potential to produce unbiased, reproducible, robust data. Evaluate the rigor of experimental design and whether appropriate controls are in place.

Evaluate whether the sample size is sufficient and well-justified. Assess the quality of the plans for analysis, interpretation, and reporting of results. Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.

For applications involving human subjects or vertebrate animals, also evaluate: the rigor of the intervention or study manipulation (if applicable to the study design). whether outcome variables are justified. whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.

whether the sample is appropriate and sufficiently diverse to address the proposed question(s). For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research.

Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science. Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work.

For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances. For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population.