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
Innovative Approaches to Studying Cancer Communication in the New Information Ecosystem (R21 Clinical Trial Optional)
Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type
Reissue of PAR-22-165
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • 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)
PA-25-295
Companion Funding Opportunity
PA-25-294 , R01 Research Project
Assistance Listing Number(s)
93.399
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) announces its interest in supporting meritorious research projects in three distinct domains related to cancer communication: 1) the utility and application of new cancer communication surveillance approaches; 2) the development and testing of rapid cancer communication pilot interventions using innovative methods and designs; and 3) the development and testing of multilevel cancer communication models emphasizing bidirectional influence between levels. For such projects, applicants should apply communication science approaches to the investigation of behavioral targets and health outcomes related to cancer prevention and control. Applications should utilize one or more innovative communication research methodologies.

Funding Opportunity Goal(s)

The overall goals of this NOFO is to reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results through dissemination and diffusion strategies.

Key Dates

Posted Date
November 21, 2024
Open Date (Earliest Submission Date)
January 16, 2025
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
February 16, 2025 * March 16, 2025 * Not Applicable July 2025 October 2025 December 2025
June 16, 2025 * July 16, 2025 * Not Applicable November 2025 January 2026 April 2026

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.

Expiration Date
September 08, 2025
Due Dates for E.O. 12372

Not Applicable

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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This notice of funding opportunity (NOFO) is intended to encourage research projects in three distinct domains related to cancer communication: 1) utility and application of new cancer communication surveillance approaches, 2) development and testing of larger-scale interventions using innovative methods and designs, and 3) development and testing of multilevel cancer communication models emphasizing bidirectional influence between levels. Applications should apply one or more innovative methodologies (including, but not limited to, social media data mining, Natural Language Processing (NLP) techniques, online social network analysis, mixed methods approaches, crowdsourcing research tools, online search data, Ecological Momentary Assessment, testing of mobile and digital technologies to facilitate communication and health engagement, neuroscience and biobehavioral approaches to communication, artificial intelligence, visual data analysis, and geographic information systems) across the cancer control continuum, from prevention, early detection, diagnosis, treatment, and survivorship, to end of life. Relevant topics include, but are not limited to, effectively communicating cancer risks; affecting positive behavior change relevant to cancer prevention and control (e.g., tobacco use, diet, physical activity, cancer screening, alcohol consumption, sun protection); enabling patient-centered cancer care and effective navigation of the healthcare system; offering informational, social, and psychological support in cancer care as well as in decision-making about cancer screening and treatment; and maximizing quality of life for survivors and their caregivers, including the utilization of palliative care. Multilevel approaches are encouraged. Intervention studies should consider applicability across multiple contexts (e.g., health systems, family- or community-based settings, or virtual/online communities). Studies should assess outcomes related to cancer prevention and control (e.g., knowledge; attitudes; beliefs; health/science literacy; trust; perceived risk; decision making in vaccination, screening and treatment; information inequalities; social support; shared decision making; persuasion; caregiving; behavioral intentions; preventive behaviors; and policy support, among others).

This NOFO has a companion  with a similar scientific scope which utilizes the Research Project Grant (R01) mechanism.

 

Background and Rationale

The cancer information ecosystem continues to evolve, as characterized by a rapid diffusion of mobile and digital technologies, widespread Internet penetration, and the growth of online communities, social media, and wikis, along with a host of other participative, bidirectional channels. These changes have dramatically altered the way we conceptualize and carry out health communication research, including the ways we approach intervention development, media effects research, dissemination research, and real-time monitoring of individual health behavior, population health, and public discourse related to cancer. Indeed, the new communication ecosystem has altered the ways in which people are exposed to health information in their daily lives. Most intentional health information seeking now happens online, and incidental health information exposure occurs mainly through online sources, including social media. These developments offer many new levers for interventions that must be informed by updated conceptual models, new sources of empirical data, and innovative analytic approaches. Research is especially needed to accommodate an expansion from the traditional communication platforms of the previous decades to the always-on, ubiquitous communication channels prevalent in the new media environment. Likewise, new empirical methods are needed to integrate and synthesize the digital traces made available in the new information ecosystem, from passive sensors in mobile and wearable devices, to online discourse in social media channels, to the integrated measurement of patient outcomes recorded through patient portals. The hypodermic needle communication approach, characterized by delivering, diffusing, and disseminating information from a central source to individuals, patient groups, communities, or the general public, has shifted toward multi-directional, participative discourse, whereby individuals, providers, and communities participate actively in communication about topics relevant to cancer prevention and control.

Over the past decade, automated and machine-learning methods have become integral to public health research, with online content being used as data; Internet and mobile platforms being used for survey research; and electronic health records (EHR) and personal health records (PHR) becoming increasingly important for both objective and self-reported data. Investigators have begun gathering information from novel domains such as mobile apps, social media, and online forums, in order to assess individual- and population-level exposures and trends. These new technologies and platforms enable users to interact and generate content and data, in contrast to traditional communication endeavors (e.g., health promotion campaigns, instructional videos, static Web Sites, and text message systems) where users passively consume content. Altogether, data from these evolving platforms and technologies can provide an in-depth and comprehensive account of an individual’s experience, social context, and the public information environment in which he or she interacts with health-related information. This paradigm shift necessitates the continued development of funding opportunities that align with the new media landscape and evolving information ecosystem. There is a pressing need to support a new set of research questions, sampling strategies, intervention opportunities, measurement techniques, and conceptual frameworks to ensure relevance and adaptation of communication research to address critical behavioral targets across the cancer control continuum.

The growth of new media also offers unique opportunities to address communication inequalities and the digital divide as they relate to cancer-related health disparities. Recent studies have suggested that racial and ethnic minorities and underserved groups are using social media and mobile platforms at the same rate as their Non-Hispanic White counterparts thus reversing traditional notions of the digital divide. On the other hand, there remain socioeconomic, geographic, and other disparities that predict health literacy and access to, trust in, and differential use of online health communication channels, and those disparities warrant further investigation.

The current information ecosystem also allows for new approaches to public health and cancer communication surveillance efforts. The terms infodemiology and infoveillance describe large-scale monitoring and data mining in public health and health communication that are largely predicated on the massive volumes of data that can be retrieved from Internet sources. Although work in this area has increased over the past two decades, the field is still relatively nascent, and would benefit from a more refined set of replicable methods and tools, as well as additional research to assess and improve the utility of these approaches for public health generally and cancer control specifically. To date, most efforts have focused on infectious diseases (mainly influenza), and while relatively little research has been done on topics relevant to cancer control, newer studies have looked at e-cigarettes, HPV vaccine communication, and cancer screening, among other cancer-relevant topics. Despite this progress, the research that has been conducted to date has largely been limited to a narrow set of platforms (e.g., Google Trends and Twitter), leaving a large number of potential sources of data especially those focused on image and video sharing underutilized. While many studies have looked at search volume trends as a proxy for public interest or awareness, and analyzed the sentiment and content of publicly available social media posts in order to glean insights into the public’s attitudes, perceptions, and beliefs about specific health topics, many novel avenues for research such as the use of Internet data to evaluate health campaigns, the generation of neighborhood-level data from geocoded social media posts, and the use of social media data to investigate online product marketing have, so far, remained understudied. Further investment is needed to determine whether these approaches can inform cancer control surveillance, intervention development, and policy efforts. There is an opportunity to leverage the rapidly evolving information ecosystem for cancer communication surveillance and to assess the impact of communication on individuals behaviors, health outcomes, and population health, in addition to exploring opportunities for applying innovative approaches and technologies in intervention research.

While the new communication ecosystem offers many opportunities for novel research, it has also introduced additional risks, as well as challenges to mitigating these risks. From the spread of health-related misinformation, to mistrust in science and health experts, individuals interacting with health and cancer information on social media may encounter false information or remain in information silos . Lack of information gate-keeping and rapid information sharing pose new challenges for public health endeavors, warranting research to assess the extent of misinformation sharing, to examine its health effects at both the individual- and population-levels, and to develop and test interventions to curb the negative consequences of misinformation.

As a primary funder of cancer-related behavioral research, NCI seeks to continue support for the use and integration of non-traditional data collection and analytic techniques in cancer communication science. These methods tend to be more nimble and better able to accommodate the changing communication landscape than traditional research methods, and may include social media data mining, Natural Language Processing (NLP) techniques, online social network analysis, crowdsourcing research tools, online search data, Ecological Momentary Assessment, neuroscience and biobehavioral approaches to communication, artificial intelligence, visual data analysis, and geographic information systems, among others. These methods, adopted from a diverse set of behavioral, cognitive, and social science disciplines, will complement traditional approaches to assessing exposure to cancer information, media effects, and intervention effects.

Specific Research Objectives

This NOFO is intended to encourage research projects in three distinct domains related to cancer communication:

1) Utility and application of new cancer communication surveillance approaches;

2) Development and testing of rapid cancer communication interventions using innovative methods and designs;

3) Development and testing of multilevel cancer communication models emphasizing bidirectional influence between levels.

Applicants should apply communication science approaches to the investigation of behavioral targets and health outcomes related to cancer prevention and control. These approaches may include, but are not limited to:

  • Effectively communicating evidence-based cancer information;
  • Addressing and curbing the spread of cancer-related misinformation;
  • Fostering trust in credible sources of information;
  • Improving health literacy;
  • Affecting positive behavior change relevant to cancer prevention and control (e.g., tobacco use, diet, physical activity, cancer screening, alcohol consumption, sun protection);
  • Enabling patient-centered cancer care and effective navigation of the health care system;
  • Offering informational, social, and psychological support in cancer care as well as in decision-making about cancer screening and treatment;
  • Maximizing quality of life for survivors and their caregivers (including the utilization of palliative care).

Proposed projects should be designed to leverage data from new media sources and/or utilize emerging platforms and technologies. Multilevel approaches are encouraged, and intervention studies should consider applicability across multiple contexts (e.g., health systems, family- or community-based settings, or virtual/online communities).

Non-responsive Applications

The following applications are not responsive to this NOFO and will not be reviewed:

  • Applications that do not utilize any innovative methodologies or data sources (such as social media data mining, NLP, online social network analysis, mixed methods approaches, crowdsourcing research tools, Ecological Momentary Assessment, testing of mobile and digital technologies to facilitate communication and health engagement, neuroscience and biobehavioral approaches to communication, artificial intelligence, visual data analysis, online search data, and geographic information systems).
  • Applications that do not focus on topics directly relevant to cancer control (e.g., tobacco use, diet, physical activity, cancer screening, alcohol consumption, sun protection; communicating cancer risk; patient-centered cancer care; decision-making about cancer screening and treatment; quality of life for survivors and their caregivers etc.).
  • Applications that do not include assessment of cancer prevention and control outcomes (such as cancer-related knowledge/attitudes/beliefs, perceived risk, decision making, information inequalities, social support, caregiving, behavior, and policy support).

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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
New
Resubmission

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.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

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.

Award Budget

R21 applications are limited to $275,000 in direct costs for up to 2 years. No more than $200,000 may be requested in any single year.

Award Project Period

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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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.

2. Cost Sharing

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

Number of Applications

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.

    Page Limitations

    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.

    SF424(R&R) Cover

    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.

    R&R or Modular Budget

    All instructions in the How to Apply- Application Guide must be followed.

    R&R Subaward Budget

    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.

    PHS 398 Research Plan

    All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

    Research Strategy:

    Significance: Explain how the project will advance cancer prevention and control; discuss generalizability of the proposed study to additional contexts/topics/populations; specify how the proposed project methods (e.g., data collection and analytic techniques) will contribute to/inform cancer communication science more broadly.
    Innovation: Describe the novel data sources or methods being utilized in the proposed study; explain how the proposed project contributes to the development or refinement of novel methods or techniques in cancer communication research.
    Approach: Demonstrate that the proposed activities are supported by existing evidence and preliminary data.

    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.

    Other Plan(s): 

    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.

    Delayed Onset Study

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

    PHS Assignment Request Form

    All instructions in the How to Apply- Application Guide must be followed.

    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.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement 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.

    Important reminders:

    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), NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Mandatory Disclosure

    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

    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

    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.

    Scored Review Criteria

    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. 

     

    Significance

    • 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.

    Innovation

    • 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.
     

    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).

    Rigor:

    • 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.

    Feasibility:

    • 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 an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex or gender categories.
    • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.
     

    Investigator(s)

    Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

    Environment

    Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

    Additional Review Criteria

    As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

     

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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 research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

     

    When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

     

    As applicable, evaluate the full application as now presented.

     

    As applicable, evaluate the progress made in the last funding period.

     

    As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

    Additional Review Considerations

    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.

     

    For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

     

    Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

    Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

    Section VI. Award Administration Information

    1. Award Notices

    A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

    In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

    Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

    Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

    2. Administrative and National Policy Requirements

    The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

    All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

    Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

    Successful recipients under this NOFO agree that:

    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

    Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

    Successful recipients under this NOFO agree that:

    When recipients, subrecipients, or third-party entities have:

    1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
    2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

    Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Data Management and Sharing

    Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

    4. Reporting

    When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

    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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

    5. Evaluation

    Enter text here.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    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: https://www.era.nih.gov/need-help (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: [email protected] (preferred method of contact)
    Telephone: 301-480-7075

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: [email protected]

    Scientific/Research Contact(s)

    Kelly D. Blake, Sc.D.
    National Cancer Institute (NCI)
    Telephone: 240-281-5934
    Email: [email protected]

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Financial/Grants Management Contact(s)

    Crystal Wolfrey
    National Cancer Institute (NCI)
    Telephone: 240-276-6277
    Email: [email protected]

    Section VIII. Other Information

    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.

    Authority and Regulations

    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 2 CFR Part 200.

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