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
Centers on Telehealth Research for Cancer-Related Care (P50 Clinical Trial Required)
Activity Code
P50
Announcement Type
New
Related Notices

  • April 26, 2021 - Pre-application Webinar for RFA-CA-21-029. See Notice NOT-CA-21-073.

Funding Opportunity Announcement (FOA) Number
RFA-CA-21-029
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.399, 93.395, 93.393
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to fund P50 Centers dedicated to advancing a national telehealth research agenda focused on improving cancer-related care and outcomes across the cancer control continuum in a rapidly changing healthcare, policy, technology, and communication environment. Centers are expected to generate and disseminate a robust evidence base for patient-centered, sustainable telehealth models of cancer care delivery.

Centers will foster innovations to improve cancer care delivery by researching real-time, patient-provider telehealth communication using new tools, research methods, and technologies. Each Center will focus on one overarching cancer-focused telehealth research theme that will frame the Center’s scientific activities. Each Center will leverage a clinical practice network able to support multiple cancer-focused telehealth research studies, including two rapid-cycle pilot projects and one large-scale pragmatic randomized control trial. A centerpiece of each Center, the pragmatic trial will evaluate the integration of telehealth-delivered cancer care into a real-world clinical environment, evaluating improvements in patient access, quality of care, patient-provider communication, and health outcomes. Centers will disseminate evidence-based approaches to telehealth-focused cancer care to the broader clinical care and cancer control communities.

Collectively, the P50 Centers on Telehealth Research for Cancer-Related Care will represent a national initiative at the forefront of cancer-related telehealth research committed to improving access to care, care quality, patient-provider communication, and health outcomes across the cancer control continuum.

Key Dates

Posted Date
April 08, 2021
Open Date (Earliest Submission Date)
June 20, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 20, 2021 Not Applicable Not Applicable November 2021 January 2022 April 2022

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. No late applications will be accepted for this FOA.

Expiration Date
July 21, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall 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,

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. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) invites applications for P50 Centers on Telehealth Research for Cancer-Related Care (hereafter, Centers). The program will fund Centers dedicated to advancing a national telehealth research agenda focused on improving cancer-related care and outcomes across the cancer control continuum in a rapidly changing healthcare, policy, technology, and communication environment. Centers are expected to generate and disseminate a robust evidence base for patient-centered, sustainable telehealth models of cancer care delivery.

Centers will foster innovations to improve cancer care delivery by researching real-time, patient-provider telehealth communication using new tools, research methods, and technologies. Each Center will focus on one overarching cancer-focused telehealth research theme that will frame the Center’s scientific activities.

Each Center will include the following components: An Administrative Core, a Research and Methods Core, and a Clinical Practice Network. Centers must propose two pilot studies enabling rapid-cycle, iterative research and one large pragmatic randomized controlled trial (‘pragmatic trial’). A centerpiece of each Center, the pragmatic trial will evaluate the integration of telehealth-delivered cancer care into a real-world clinical environment, evaluating improvements in patient access, quality of care, patient-provider communication, and health outcomes. Centers will disseminate evidence-based approaches to telehealth-focused cancer care to the broader clinical care and cancer control communities.

Collectively, the P50 Centers on Telehealth Research for Cancer-Related Care will represent a national initiative at the forefront of cancer-related telehealth research committed to improving access to care, care quality, patient-provider communication, and health outcomes across the cancer control continuum.

Key Definitions for this FOA:

Telehealth: Telehealth practices are classified based on the interaction type and communication format used. Interactions include: (1) provider-provider interactions (health information exchanges between healthcare professionals) and (2) patient-provider interactions (health information exchanges of patients, family, and caregivers with healthcare professionals). Telehealth communication formats can be synchronous (real-time) or asynchronous (sequential). Synchronous telehealth examples include phone calls and videoconferencing; asynchronous telehealth examples include the capture and forwarding of medical images, patient-generated health data, and secure messaging through patient portals. For the purposes of this FOA, applicants must evaluate synchronous patient-provider telehealth communication as the primary telehealth component. NCI expects competitive applications to also include asynchronous telehealth elements in support of these efforts.

Cancer Control Continuum: The cancer control continuum describes the various stages of cancer care including cancer etiology, prevention, screening, detection, diagnosis, treatment, survivorship, and end of life.
 

Model of Care Delivery: The process for delivery of care, including what type of care is delivered, when this care is delivered, and by whom.
 

Pragmatic Trial: Pragmatic trials are trials that aim to test interventions in settings to which the results are intended to apply and be used outside the context of a research study (pending supportive trial outcomes). Pragmatic trials are purposively designed to maximize external validity and applicability to real-world settings while maintaining internal validity. Trial design features that should be considered when planning for trial that is pragmatic in nature and overall intent include (but are not limited to) selection of primary outcome, primary analysis, setting, organization, eligibility (patients and/or providers), delivery, flexibility (delivery, adherence), follow-up, and recruitment approaches. For the purposes of this FOA, applicants must propose a pragmatic randomized controlled trial (’pragmatic trial’) with the main goal of producing rigorous, relevant and applicable evidence for the use of telehealth in cancer-related care delivery.

Rapid-Cycle Research: Rapid-cycle research is a process by which practical problems are identified and addressed using study designs and data analytic methods that are incremental and contextually informed.
 

Health Disparities: Health disparities are differences in the incidence, prevalence, mortality, and burden of cancer and related adverse health conditions that exist among specific population groups. These population groups may be characterized by gender, age, race, ethnicity, education, income, social class, disability, geographic location, or sexual orientation.
 

Access to Care: Access to care is reflected across five characteristics and expectations of healthcare providers and patients: affordability, availability, accessibility, accommodation, and acceptability.
 

Digital Divide: The digital divide refers to the economic, educational, health, and social inequalities between those who have access to communication-related technologies (e.g., computers, smartphones, broadband internet) and those who do not.
 

Healthcare Providers: Healthcare professionals who deliver cancer-related care. Examples include, but are not limited to, physicians, physician assistants, nursing practitioners, nurses, psychologists, social workers, and patient navigators.
 

Patient-Centered Communication: Patient-centered communication refers to the following processes and outcomes of the patient-provider interaction: eliciting, understanding and validating the patient’s perspectives; understanding the patient within their own psychological and social context; reaching a shared understanding of the patient’s problem and its treatment; helping a patient share power by offering meaningful involvement in choices related to their own health; and building a stronger patient-provider relationship.
 

Clinical Trials: The NIH definition of a clinical trial stated in NOT-OD-15-015 applies to this FOA. A clinical trial is defined as research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.


Background

Rapid Adoption of Telehealth due to COVID-19
Due to the onset and continuation of the COVID-19 pandemic, there has been a dramatic increase in the use of telehealth, and specifically virtual visits, to deliver care across the cancer control continuum. Several factors have contributed to the recent expansion of telehealth services: the need to lower exposure for those at higher risk for severe COVID-19-related illness; increased patient interest in and acceptability of this technology; and temporary changes in long-standing health services reimbursement and regulatory policies. Given this rapid and widespread integration of virtual visits and payment models, it is likely that telehealth approaches in cancer-related care will persist after the COVID-19 pandemic subsides. Despite this trend, telehealth remains an understudied model of delivering care across the cancer control continuum.

Telehealth: Recent Trends and Applications
To date, telehealth research on cancer-related care has focused primarily on asynchronous methods, leveraging a wide range of mobile phone and electronic health record (EHR) technology through apps, secure messages, and patient portals. The limited research on synchronous telehealth communication has focused largely on specialty services delivered via teleconferencing (e.g., genetic counseling, various forms of supportive care, and health behavior change interventions addressing smoking, exercise, and diet). Innovative telehealth services that leverage synchronous communication, while also integrating clinical and asynchronous data, are needed to broadly demonstrate the ability of cancer-related telehealth to improve access to care, care quality, patient-provider communication, and health outcomes.

Access to Care and the Digital Divide
Integrating telehealth into cancer care delivery and clinical workflows has the potential to reduce access to care disparities by addressing known challenges for patients who live far from healthcare facilities or have other difficulties accessing medical care. For example, telehealth accommodations can facilitate access to healthcare providers for those patients with transportation or mobility challenges. Accessing care can be especially challenging for individuals with elder/childcare responsibilities, limited paid-time-off employment benefits, or increased burden from transportation costs, and telehealth may positively affect healthcare-related availability, accessibility, and affordability for some patients.

In contrast, use of telehealth platforms may further entrench the “digital divide”, that is, availability and access issues among patients with limited or no access to and familiarity with communication-related technologies (e.g., broadband internet, smartphones, computers). Populations with limited digital resources and related literacy are often the same populations that experience increased disparities in cancer incidence, morbidity, and mortality. In general, telehealth may meaningfully improve patient outcomes for some, but without addressing the “double-burden” of limited digital access and cancer disparities, telehealth may entrench and potentially worsen known health disparities across the cancer control continuum. Considerations of simultaneously reducing and incurring cancer health disparities remain an understudied area of telehealth research and practice.

Telehealth Models of Care Delivery
There is a dearth of research focused on telehealth models of care delivery across the cancer control continuum, implemented in real world clinical practices. Telehealth approaches have not been systematically evaluated as part of routine clinical practice, including consideration of: clinical workflow impacts, staffing models and telehealth-focused training, entrenchment of cancer disparities, and acceptability of telehealth services among patients, caregivers, and healthcare providers. As a result, there is a gap in identifying the benefits and challenges of implementing telehealth approaches in routine cancer care and developing resultant interventions to generate the needed evidence base for multiple stakeholder groups. Furthermore, innovative evaluation measures focused on both the process and outcomes of telehealth are needed to ensure these models of cancer care delivery can be comprehensively assessed. A strong, coordinated research effort is needed that yields evidence-based approaches to delivery of care across the cancer control continuum via telehealth that can be broadly applied to diverse clinical settings and patient populations.

Research Objectives

This FOA supports research dedicated to advancing a national telehealth research agenda that addresses the cancer control continuum in a rapidly changing healthcare, policy, technology, and communication environment. Each Center must identify an overarching, unifying research theme that will frame the proposed scientific activities. The research theme must reflect the infrastructure and goals of the proposed Center. The research theme may include a range of methodological, conceptual, and/or technological approaches drawn from disciplines such as: health economics, quality improvement research, implementation science, health communication, data science, and human-centered design. Individual Centers are also responsible for connecting with the other NCI-funded telehealth research Centers to build research capacity, collaborate on common data elements, exchange measures and metrics, and disseminate findings, tools, and resources within the Centers initiative and across the broader clinical care and cancer control communities.

Center Organization

The proposed Center must consist of three components. The scope of each component is defined below:

1. The Administrative Core is expected to manage and coordinate all Center research and activities, within a cohesive organizing framework, including fiscal management, evaluation, communication, and dissemination. The Administrative Core is charged with developing methods and processes for monitoring scientific, dissemination, and fiscal progress and milestones of all Center activities, including the Research and Methods Core, research studies, and Clinical Practice Network. The Administrative Core will develop policies and procedures for the leadership, ethical conduct, clinical trials oversight, and organizational structure of the Center’s activities. The Administrative Core will promote opportunities for graduate students, postdoctoral researchers, and investigators in early stages of independent careers to participate in the Center’s activities. The Administrative Core will be responsible for establishing an External Advisory Board (EAB) of key stakeholders who will provide scientific, planning, evaluation, and dissemination expertise to Center leadership. EAB members will assist the Center with developing and refining strategies for optimizing telehealth services, provide insights into cancer-focused research topics and outcomes, help maximize the external validity of research findings, and support the dissemination of data, tools, resources, and evidence-based findings from the project.

2. The Research and Methods Core is charged with advancing the integration of telehealth into models of cancer care delivery through innovative study designs (e.g., pragmatic trials and rapid-cycle pilot research) and methodological approaches that reflect the Center’s research theme. The Core will be expected to identify and incorporate into the research design process, contextual, and outcome measures relevant to telehealth-delivered cancer-related care. The Core is also expected to consider the development and evaluation of the intervention at multiple levels (e.g., patient, provider, and practice). In addition, the Core will: use mixed methods study designs to assess the effectiveness, acceptability, adaptation, and sustainability of cancer-focused telehealth care; deploy technological innovations and novel statistical approaches as appropriate; and promote common data elements across the Center’s projects. The Research and Methods Core will specifically: oversee the development, implementation, and evaluation of the two pilot studies; provide expert study design and research methods support to the design and execution of the pragmatic trial; and interface directly with the Clinical Practice Network. This Core will also be responsible for evaluating the Center’s research productivity and impact over the funding period. The Research and Methods Core will contribute to activities aimed at disseminating research findings and evidence-based telehealth interventions, care delivery models, and/or implementation strategies to multiple stakeholder groups, and design future projects and grant applications that build from the Center’s research activities.

3. The Clinical Practice Network is a group of clinical practices that deliver cancer-related care and will serve as the environment in which the Center’s research will be conducted and evaluated. It will include clinical personnel and patients able to serve as collaborators on the Center’s research projects, thereby increasing real-world translation of the research. In addition, the size and composition of each Clinical Practice Network should be consistent with the design and methodology of the proposed research. Centers must demonstrate that the selected clinical sites have the electronic infrastructure and integration (e.g., EHR systems, telehealth audiovisual platforms), staffing, patient population, and resources needed to engage in both the pragmatic trial and rapid-cycle pilot studies integrating telehealth into cancer care delivery. In addition to provision of real-time, patient-provider synchronous telehealth, networks are strongly encouraged to demonstrate telehealth services that leverage the integration of clinical and asynchronous telehealth data elements (e.g., patient-generated health data, patient portal use, and email communication). Selection of clinical sites should also be guided by considerations for including diverse patient populations that will facilitate addressing issues of health disparities and access to care, and type, number, geographic location, availability, and diversity of patients, providers, and clinical settings as necessary elements for conducting a pragmatic trial. The Clinical Practice Network is expected to have processes and systems in place for: study-related data collection and management; surveillance of the changing healthcare, policy, and technology environment; and working closely with the Center’s Administrative and Research and Methods Cores on IRB activities and data and safety monitoring. The Center must have an identified and engaged Clinical Practice Network activated by the end of year 1 of the project period.

Research Studies

Centers will be expected to conduct three studies over the award period consistent with the proposed Center research theme:

a) one large-scale pragmatic trial; and

b) two smaller pilot studies allowing for rapid-cycle, iterative research.

Pragmatic Trial: Each Center will conduct a pragmatic trial designed to develop and/or implement patient-centered approaches integrating telehealth into routine cancer-related care delivery. The trial should constitute a fully powered pragmatic trial for the purpose of generating telehealth-focused evidence reflecting the Center’s overall research theme. Intervention outcomes must include, but are not limited to, patient-reported outcomes, healthcare utilization, and clinical outcomes. In addition, the trial must outline an approach to monitor, evaluate, and intervene on issues related specifically to the digital divide, including patients’ access to and ability to use the technology and tools necessary to participate in telehealth-related care. The generated evidence-based telehealth approaches should be transferable, scalable, and sustainable.

It is required that each Center conduct a pragmatic randomized controlled trial (’pragmatic RCT’), where the main goal is to produce rigorous, relevant and applicable evidence for the use of telehealth in cancer-related care delivery. Trial design features that should be considered when planning for a trial that is pragmatic in nature and overall intent include, but are not limited to: selection of primary outcome, primary analysis, setting, organization, eligibility (patients and/or providers), delivery, flexibility (delivery, adherence), follow-up, and recruitment approaches. The trial must include design elements that make it pragmatic in nature and overall intent and must use a randomized controlled trial (RCT) design. Various types of randomized controlled trials (e.g., individual-level RCT, cluster RCT, stepped wedge RCT, stepped wedge cluster RCT) are acceptable, but the specific type should be selected and justified to match the overall objective(s) of the study and ability to answer the research question(s). Investigators may wish to consult resources, such as the NIH Collaboratory Living Textbook of Pragmatic Clinical Trials or the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool when designing a trial that is pragmatic in nature. Projects are encouraged to test the integration of innovative telehealth care delivery that leverages synchronous communication, while also integrating clinical and asynchronous data. The trial will be expected to generate findings that are applicable across diverse patient populations and suitable for use with different provider types, multiple healthcare systems, clinical workflows, and care settings.

Pilot Studies: Centers must conduct two rapid-cycle pilot studies focusing on cutting-edge scientific questions within the Center’s broader research theme. Pilot studies should be developed and launched sequentially over the grant period and leverage the infrastructure, staffing, resources, and stakeholder feedback of the overall Center and the Research and Methods Core. The pilot studies are required to be conducted within the Clinical Practice Network. Given the pilot nature of the studies and timelines, Centers are expected to use rapid-cycle research when designing and conducting pilot studies (e.g., rigorous quasi-experimental designs, rapid qualitative analysis, adaptive trial designs). Innovative cross-disciplinary linkages and high-risk/high-pay-off studies designed to advance innovative telehealth research are particularly encouraged. Research teams are strongly encouraged to not only consider rapidity, but also relevancy, rigor, resources, and replicability. Investigators may wish to use resources such as AHRQ’s guideto rapid-cycle research to delineate the study designs and research methods of their pilot studies. Paired with the pragmatic trial, it is expected that these pilot projects will generate preliminary findings on high-impact topics or signal important intervention adaptations that will accelerate the further evaluation of telehealth-focused models of cancer-related care delivery.

Required Capabilities of Each Center

The proposed Center should be capable of addressing all the following aspects:

  • Conduct research in a real-world clinical care network to test telehealth as a synchronous, patient-provider method of cancer care delivery with the goal of establishing evidence-based telehealth practices.
  • Conduct a pragmatic trial that evaluates telehealth areas of cancer care delivery with respect to access to care, quality of care, and patient-provider communication. Intervention outcomes should include, but are not limited to, patient-reported outcomes, healthcare utilization, and clinical outcomes.
  • Conduct two rapid-cycle pilot studies that will generate preliminary findings on high-impact topics or signal important intervention adaptations that will accelerate telehealth-focused models of cancer-related care delivery.
  • Monitor and evaluate evolving technology, clinical care guidelines, and research methods as well as responsiveness to changes in context (e.g., policy, reimbursement/financing, access) in order to adapt and refine the design and conduct of pragmatic and pilot studies as necessary.
  • Monitor and evaluate issues related to the digital divide, including patients’ access to and ability to use the technology and tools necessary to participate in telehealth-related care.
  • Apply valid, reliable, and feasible measures of telehealth and cancer care delivery to assess outcomes at multiple levels (e.g., patient, provider, system) as well as create new measures when needed to address critical process and health outcome-related research questions.
  • Demonstrate capacity to implement technology (e.g., equipment, software), clinical workflows, patient engagement strategies, and research methods that promote patient-provider synchronous communication, while also integrating clinical and asynchronous patient data when available.

General Expectations of Each Center

Each Center will be expected to contribute to advancements in the field of telehealth research and cancer care delivery as part of its activities. Toward this end, Centers should:

  • Engage a diverse team of multidisciplinary investigators and external advisors to guide implementation and evaluation of the proposed research.
  • Emphasize opportunities to identify and address identified disparities in access to and receipt of telehealth services and/or cancer-related care among disparate populations.
  • Provide opportunities for graduate students, postdoctoral researchers, and new investigators to participate in telehealth and cancer control research.
  • Participate in annual meetings of the Centers on Telehealth Research for Cancer-Related Care over the course of the project period.
  • Collaborate with other NCI-funded Centers on Telehealth Research for Cancer to identify common data elements and measures able to evaluate the benefits of telehealth in cancer-related care.
  • Collaborate with other NCI-funded Centers on Telehealth Research for Cancer to disseminate research findings and products to patients, healthcare providers, health systems, payers, and policymakers.

Non-Responsive Applications

The following types of activities remain outside of the scope of this FOA and are considered non-responsive (non-responsive applications will not be reviewed):

  • Applications lacking evidence that the Center has identified and secured engagement from clinical sites with synchronous, patient-provider telehealth capabilities to participate in its’ Clinical Practice Network.
  • Applications that do not propose a pragmatic trial and two rapid-cycle pilot studies.
  • Applications that do not include a detailed plan to monitor, evaluate, and address health disparities and access to care issues in the proposed research studies.
  • Applications that do not detail a comprehensive plan by which they will monitor and evaluate evolving technology, clinical care guidelines, and research methods as well as responsiveness to changes in context (e.g., policy, reimbursement/financing, access to care) in order to adapt and refine the design and conduct of their pragmatic and pilot studies.
  • Applications that do not provide evidence that the electronic infrastructure (e.g., telehealth audiovisual platforms, EHR systems), equipment, and software needed to integrate patient-provider synchronous telehealth as part of usual care delivery is available, adequately functioning, and can be maintained over the course of the funding period.
  • Applications that do not have a cancer-relevant research focus or fail to articulate how the evidence base generated from the proposed research will affect cancer-related outcomes and care delivery.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

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.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit $3.36M in FY 2022 to fund three awards.

Award Budget

Budget is limited to $800,000 in direct costs per year.

Award Project Period

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 allowed. 

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 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.

Investigators can only serve as a PI/multi-PI on one Center. However, investigators may have other roles (i.e., co-leader, Core director, consultant) on other P50 Centers

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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.  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 NOT-OD-11-101).

Note: It is unacceptable for investigators to concurrently submit the same or overlapping research proposal as a P50 Center Project and an independent R01, R21, etc., application to the NIH. Potential overlap will be evaluated by NCI staff prior to award; submitted applications will not be reviewed if they do not conform to NIH policies or if they fail to meet the minimum requirements specified in this FOA.

An applicant organization cannot have multiple Centers with the same overall scientific focus/theme, even if there is no overlap in scientific content.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Roxanne E. Jensen, Ph.D.
Healthcare Delivery Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
Telephone: 240-276-7588
Email: roxanne.jensen@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Administrative Core Admin Core 12 Required 1 1
Research and Methods Core Core 12 Required 1 1
Clinical Practice Network FOA-Specific 12 Required 1 1
Pragmatic Trial Project 12 Required 1 1
Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

  • Overall: required
  • Administrative Core (Admin Core): one required (one allowed)
  • Research and Methods Core (Core): one required (one allowed)
  • Clinical Practice Network (FOA-Specific): one required (one allowed)
  • Pragmatic Trial (Project): one required (one allowed)
Overall Component

When preparing your application, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide overall goals/abstract/summary for the entire Center application.

Project Narrative: In the "Project Narrative", the relevance of the Center's research to public health should be stated.

Facilities and Other Resources: Provide a description of all resources available for the Center. Document the environment, characteristics and/or commitments of participating institutions.

Other Attachments: The following "Other Attachments" should be included with the overall component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

  • Tables, graphs, figures, diagrams and charts relevant to the Overall component.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: The specific aims should outline the overall vision and goals for the proposed Center on Telehealth Research for Cancer-Related Care. These aims should be overarching and at a high level and distinct from the aims of the individual components. The aims should clearly summarize expected outcomes related to establishing a robust evidence base for telehealth models of cancer care delivery in a rapidly changing healthcare, policy, technology, and communication environment; evaluating access to care, care quality, patient-provider communication, and improved health outcomes across the cancer care continuum; and successful dissemination of evidence-based models of cancer-focused telehealth.

Center Overview: Provide an overview describing the overarching cancer-focused research theme of the Center as well as the Center’s purpose and overall goals. The overview should include the Center’s general plan for the proposed project period and how the Center will achieve its major goals. An essential part of the application is to explain how the proposed research activities are organized around a cohesive research theme that will frame the activities of each required Center component and the research agenda that the Center will complete. The application should clearly articulate the rationale and justification for the Center approach. The unique contribution for the Center and each core should be fully described. Applicants must clearly define the value that is added through Center support to this research area and demonstrate how the impact of the Center will be collectively greater than of the sum of each independent study. Applications must also provide a detailed plan for sharing research resources (e.g., methods and measures, evidence-based approaches) with the clinical care and cancer control communities.

Investigative Team: Provide a discussion on the capabilities of the Center Leadership and how this team will work together to achieve the specific goals of the proposed Center. Without repeating information in individual biosketches, explain how the collective expertise and experience of the investigators will support the team science environment needed to complete the proposed work needed to establish an evidence base of telehealth care across the cancer control continuum.

Center Organization and Integration. Include a concise description of the structure of the Center including the organizing framework. Explain how the components of the Center (Administrative Core, Research and Methods Core, and Clinical Practice Network) will interact to form a multidisciplinary effort and why each component is essential for addressing the organizing framework of the Center.

Commitment to Improving Access to Care. Explain the Center’s commitment to patient populations and communities that experience health disparities and/or digital divide challenges, and how this commitment will translate to evaluable evidence in understanding and addressing access to care barriers, ranging from broad issues such as technology access to elements specific to the proposed telehealth intervention. This commitment must be demonstrated throughout the Center’s research activities and dissemination efforts across the funding period.

Centers on Telehealth Research for Cancer-Related Care Collaboration. Briefly describe plans to participate in the funded Centers initiative steering committee, which will identify and promote collaborative projects, common data elements, measures and metrics, and dissemination activities across all telehealth research Centers funded by NCI. The steering committee will establish standard operating procedures for the larger telehealth Centers initiative. Investigators from the funded Centers initiative will be expected to participate in annual grantee meetings as a means to promote trans-initiative interaction to present results, initiate cross-center collaborations, provide opportunities for career development for early career investigators, and to communicate with other funded Centers' investigators. The Center PD(s)/PI(s) are required to attend the annual grantee meeting; participating faculty, postdoctoral associates, graduate students, and other Center members are all encouraged to attend. Explain how the Center will participate in other NIH/NCI or other government or non-government meetings and workshops, organize collaborative activities, and organize and participate in scientific and programmatic working groups such that information, expertise, and resources are shared from the Centers initiative to complete dissemination and sustainability of a telehealth evidence base in cancer care delivery more rapidly and efficiently.

Letters of Support: Letters of support for the entire application should be provided under Overall. Letters of support should be submitted by all institutions participating in a multi-institution collaboration and should specify institutional expertise and commitment, and if appropriate, the population that the institution serves. Letters of support indicating support and engagement from sites within the Clinical Practice Network are required.

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.

 

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The Data Sharing Plan should be provided only under the Overall component, but it should cover all the activities (Cores and Research) of the Center. Applicants must also address plans for sharing research resources (e.g., methods and measures, assessment and intervention protocols, technology, common data elements, data analytic strategies, de-identified data collected in research studies, evidence-based approaches, etc.) with the clinical care and cancer control communities.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the SF424 (R&R) Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

 

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

 

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Each proposed Center Director must commit a minimum effort of 3 person months (PM) per year overall to the Center and be a leader of the pragmatic trial and of the Administrative Core. The 3 PM should be a total of the Center Director's efforts on his/her project and core(s). The 3 PM requirement applies to each individual listed as a Center PD/PI in a multiple PD/PI Center.

The Leadership of the Administrative Core must commit a cumulative minimum effort of 1.2 PM per year to the Administrative Core. Multiple leaders are allowed for the Administrative Core. If there are multiple leaders for this Core, the combined effort of the identified multiple Administrative Core Leaders must total at least 1.2 PM per year.

Applicants may propose and budget for a Center Administrator to manage day-to-day operations.

The Administrative Core budget should include costs to support:

  • Center Website and Dissemination activities
  • Investigator and external advisory board travel, including travel for the Center PI(s)/PD(s)'s and Core Director's participation in an annual NCI-convened Telehealth Research Center meeting.

Budget Justification. In Personnel Justification section, discuss the time commitment of the Core Director(s) for the overall successful conduct of the Center.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the aims of the Administrative Core and how these will advance the Center’s organizational and fiscal functioning, research capacity to implement the proposed research studies, and dissemination goals.

Research Strategy: The Research Strategy must address all required and expected characteristics and attributes of the Administrative Core identified in Section I. The Research Strategy must consist of the sub-sections defined below:

  • Administrative Core Overview: The Center must have a clearly articulated Administrative Core that should serve to lead and integrate the organizational and fiscal, research capacity, and dissemination-focused aims. Describe the Administrative Core’s plans for facilitating collaboration and synergy between all Center components, providing administrative oversight of the proposed research studies, and monitoring and evaluating overall Center progress across the Center cores and related activities, and coordinating the Center’s dissemination efforts.
  • Operational Structure:  

Describe the plans for management and integration of Center activities, communication, and evaluation of progress across the Center. Describe the leadership and communication strategies to manage and track progress of the multiple studies conducted within the Center. The application should describe an administrative structure that maximizes efficiency through program planning and monitoring, a capacity development and maintenance plan, opportunities for investigators to conduct integrative work, and plans for review and evaluation throughout the study period. The administrative structure must include an External Advisory Board (EAB). Composition of the EAB may include, but not be limited to, representatives reflective of diverse perspectives: healthcare providers, technology experts, patients/caregivers, support staff, researchers, policymakers, and health system representatives. A description of when and how the Center will engage with the EAB throughout the project period should be included. Applicants must NOT list or contact potential members of the External Advisory Board but should describe what expertise is needed and the process by which members will be selected.

  • Investigative Team: Include a description of the Administrative Core leadership structure and concisely describe oversight mechanisms that will be used by the Center PD(s)/PI(s). Provide a discussion on the capabilities of the Core Leadership and how this team will work together to achieve the specific goals of the proposed Administrative Core. Without repeating information in individual biosketches, explain how the collective expertise and experience of the investigators will support the team science environment needed to successfully manage the Center’s infrastructure, finances, and research activities focused on establishing and disseminating an evidence base of telehealth care in cancer.
  • Research Experiences for Early Stage Investigators: Describe how the Administrative Center will promote opportunities for graduate students, postdoctoral researchers, and investigators in early stages of independent careers to participate in interdisciplinary research. Describe opportunities to work with and learn from participating investigators (e.g., in-house lecture series, webinars, visiting scholars series, meetings with potential practice partners from new community settings), opportunities for investigator-initiated pilot projects by postdoctoral researchers and junior faculty, and opportunities that capitalize on other unique institutional resources and contribute to substantive research experiences.
  • Center Evaluation: Describe a plan with dedicated personnel that articulates how Center activities will be evaluated, including metrics for each of the Center’s specific aims, upon which Center progress will be judged. Evaluation plans should reflect evaluation targets for the various activities within the Center, and iterative data collection and analysis methods across the project period. Explain how the Administrative Core will also coordinate the evaluation of the Center's research activities and public health impact in collaboration with the Research and Methods Core and Clinical Practice Network. Describe how the evaluation plan will be used to iteratively refine the Center's ongoing activities and inform plans for future collaborative research. This plan should also detail a comprehensive process by which the proposed Center will monitor and evaluate evolving technology, clinical care guidelines, and research methods as well as responsiveness to changes in context (i.e., policy, reimbursement/financing, access) in order to adapt and refine the design and conduct of their pragmatic and pilot studies as necessary. Explain how the Center will monitor and evaluate simultaneous reductions in and possible exacerbation of cancer health disparities and implement remediation plans as needed.

Timeline and Milestones. The Administrative Core is responsible for developing – and subsequently monitoring – a graphic Timeline and a descriptive Milestones section that encompasses all Center components and research activities. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include alternative strategies should any component efforts fail to perform as expected. During the project period, the Center PI(s)/PD(s) will be expected to refer to these milestones in annual progress reports.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Resource Sharing Plans should only be provided in the Overall component of the application.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

 

Research and Methods Core

When preparing your application, use Component Type ‘Core'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research and Methods Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research and Methods Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research and Methods Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Application guide states that Project Narrative is required. However it is only required for the Overall component. If you would like the applicant to provide a project narrative for this component, update the above instructions accordingly. Specific names provided for Other Attachments must be no more than 50 characters including spaces.

Project /Performance Site Location(s) (Research and Methods Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research and Methods Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • It is expected that Methods Core Lead(s) demonstrate competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere.

Budget (Research and Methods Core)

Budget forms appropriate for the specific component will be included in the application package.

The Leadership of the Research and Methods Core must commit a cumulative minimum effort of 1.8 person months (PM) per year to the Core. Multiple leaders are allowed for the Research and Methods Core. If there are multiple leaders for this core, the efforts of the identified leaders must total at least 1.8 PM per year.

Outline requested budget for pilots planned over the course of the award. This budget request may include funding for equipment, software, and computing resources. Funds for research supplies and equipment should not be duplicated in other parts of the budget.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research and Methods Core)

Specific Aims:

Describe the aims of the Research and Methods Core, and how it will advance the Center’s research theme, overall goals, research activities, and dissemination of evidence-based telehealth models of cancer care delivery.

Research Strategy:

The Research Strategy must address all required and expected characteristics and attributes of the Research and Methods Core identified in Section I. The Research Strategy must include the following subsections defined below:

Research and Methods Core Overview: Describe how the Research and Methods Core will advance the integration of telehealth into models of cancer care delivery through innovative study designs (e.g., pragmatic trials and rapid-cycle pilot research) and methodological approaches that represent emergent areas (e.g., implementation science, health communication, data science and bioinformatics, health economics, and human-centered design). Describe the Core’s leadership, operational support of the Center’s research studies, and primary responsibilities (e.g., IRB, data management, measurement, evaluation). Discuss how the Research and Methods Core will facilitate integration with the Clinical Practice Network.

Investigative Team: Include a description of the Research and Methods Core leadership structure and concisely describe oversight mechanisms that will be used by the Center PD(s)/PI(s). Provide a discussion on the capabilities of the Core Leadership and how this team will work together to achieve the specific goals of the proposed Research and Methods Core. Without repeating information in individual biosketches, explain how the collective expertise and experience of the investigators will support the team science environment needed to successfully manage the Core’s focus on advancing the integration of telehealth into routine cancer care delivery through innovative study designs and methodologies.

Development and Operational Support of Research Projects: Detail how the Research and Methods Core will facilitate the development, implementation, and evaluation of the Center's research activities, including the pragmatic and pilot projects. Describe how the Core will identify and apply scientific, technological, statistical, data management, and methodological innovations and tools. This may include, but not be limited to, pragmatic trials, rapid-cycle research, measures development, integration of clinical and asynchronous data, participant selection/patient engagement, and monitoring of study progress. Describe how the Core’s efforts will accelerate and diversify the generation of a high-quality telehealth focused evidence base focused on cancer-related care. Describe how the Research and Methods Core will provide expert conceptual, methodological, technical, and analytic statistical support to the Center's investigators and Clinical Practice Network.

Describe the facilities and resources that will be available for conducting the Center’s research activities, including a Central IRB and centralized data collection and management services. Present the plan for data collection, data quality assurance, and data management for the Center’s research studies.

Generate Innovative Research Methods and Evaluation Measures: Detail how the Research and Methods Core will focus on developing and evaluating innovative process, contextual, and outcome measures relevant to telehealth-delivered cancer-related care, including new measures to broaden assessment of the effectiveness, acceptability, adaptation, and sustainability of cancer-focused telehealth care at multiple levels (e.g., patient, provider, clinic, health system, payers). Describe how the Core will promote common data elements across the Center’s projects, and when applicable across the telehealth research Centers initiative. Describe how methods will be adapted to evaluate telehealth integration in cancer care delivery (e.g., novel assessment and mixed methods data collection strategies; incorporating complex healthcare data; emerging technologies).

Dissemination of Methodological Advances and other Center-generated Resources: Describe how the Core will function as a partner with and resource to the other telehealth research Centers, including shared work on common data elements and data sharing (when applicable). Detail the Research and Methods Core’s role in facilitating the dissemination of evidence-based practices focused on telehealth and cancer care to key stakeholders. Describe how collaborative activities among Core investigators and stakeholders will culminate in future projects and grant applications that build from the Center’s research activities. Explain how the Research and Methods Core will improve methods that increase the relevance of research findings for a range of stakeholders, including healthcare providers, administrators, payers, patients/caregivers, policymakers (e.g., economic analyses, policy evaluation, policy implementation, impact analyses).

Evaluation of the Center's Research Productivity and Impact: Describe how methodological and analytic expertise within the Core will contribute to a comprehensive e valuation of the Center's progress, including evaluation of the Center's research progress and impact (e.g., progress on the pragmatic trial, two pilots projects; success at: disseminating research results; developing and disseminating technological, methodological, and analytic innovations; engaging new end-users and forming clinical partnerships to conduct research in clinical practice settings; generating new collaborations and new R01 research projects and grant applications).  

Pilot Studies: Centers must conduct two rapid-cycle pilot studies focusing on cutting-edge scientific questions within the Center’s broader proposed research theme. This section must address all required and expected characteristics and attributes of the pilot studies identified in Section I. In this section, describe one pilot intended to be conducted within the first two years of the study period that advances the research theme of the Center.

  • The initial pilot study should be described in the following sections: Significance, Innovation, Approach, Investigator, and Environment:
     
    • Significance: Describe overall goals and explain how the science proposed in the rapid-cycle pilot research study may advance telehealth research for cancer-related care. This section should also explain the contribution of the pilot study to the overall goals of the Center, how the study will interact with and benefit from other components of the Center and the appropriateness of the Center approach and environment.
    • Innovation: Describe the unique and innovative contributions that will be made by the rapid-cycle pilot research study. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research study. Describe the feasibility of the proposed pilot research study, the advantages of any new methodologies, potential pitfalls, and alternative approaches for the studies and how these might impact on progress in the overall Center.
    • Approach: Describe the specific rapid-cycle research methodology, related measures, and resultant outcomes. To the extent possible, describe how the results of these pilots will inform issues of feasibility, acceptability, preliminary evidence, needed adaptations, and other related outcomes and inform decisions for current and future research.
    • Investigator: Include a description of the pilot project leadership team and how this team will work together to achieve the specific goals of the proposed pilot study. Without repeating information in individual biosketches, explain how the collective expertise and experience of the investigators will support the team science environment needed to successfully implement rapid-cycle pilot research designed to advance telehealth research for cancer-related care.
    • Environment: Describe how the pilot study will leverage the infrastructure, staffing, and resources of the overall Center, the Research and Methods Core, and the Clinical Practice Network.

Process for Developing, Reviewing, Choosing, and Managing Additional Studies. The Center application should describe a detailed, systematic process by which the Research and Methods Core will develop, review, select, and launch one additional pilot related to the overall Center research theme later in the project period (but no later than year 4).

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Resource Sharing Plans should only be provided in the Overall component of the application.

Appendix:

  • Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research and Methods Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

 

Clinical Practice Network

When preparing your application, use Component Type ‘FOA-Specific’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Practice Network)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Practice Network)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Practice Network)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Application guide states that Project Narrative is required. However it is only required for the Overall component. If you would like the applicant to provide a project narrative for this component, update the above instructions accordingly. Specific names provided for Other Attachments must be no more than 50 characters including spaces.

Project /Performance Site Location(s) (Clinical Practice Network)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Clinical Practice Network)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Clinical Practice Network)

Budget forms appropriate for the specific component will be included in the application package.

The Leadership of the Clinical Practice Network must commit a cumulative minimum effort of 1.8 person months (PM) per year to the Network. Multiple leaders are allowed for Clinical Practice Network. If there are multiple leaders for this Network, the efforts of the identified leaders must total at least 1.8 PM per year.

The budget for the Clinical Practice Network may include resources for data management including development or amendment of existing technical and data infrastructure across the sites. With the exception of data analytic support and equipment, the budget should not duplicate other Center expenses.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Clinical Practice Network)

Specific Aims: Describe the aims of the Clinical Practice Network and how it will advance the Center’s research goals and broader dissemination of evidence-based telehealth models of cancer care delivery.

Research Strategy: The Research Strategy must address all required and expected characteristics and attributes of the Clinical Practice Network identified in Section I. The Research Strategy must include the following subsections defined below.

  • Clinical Practice Network Overview: Describe how this Center component will administer and coordinate a Clinical Practice Network committed to integrating telehealth within cancer-related care, while ensuring access to care among patients that experience health disparities and/or the digital divide. Describe how this network will enable and serve as the Center's Clinical Practice Network and research structure, address the Center’s overall research theme, show strong integration with the Center’s Administrative and Research and Methods Cores, and implement the Center’s research studies, including the pragmatic trial and two pilot studies. Justify the size and composition of the Clinical Practice Network to sufficiently support the proposed research projects.
  • Clinical Practice Network Sites: Describe clinical sites that comprise the network, the type of cancer-related care delivery they provide (e.g., primary care, treatment, palliative care). Describe the network’s prior experience in conducting health-related research and/or prioritizing cancer prevention and control. Describe the buy-in from administrative, clinical, and information technology leadership to participate in the Centers initiative. Outline considerations for including a diverse patient population able to identify potential access to care and health disparities associated with telehealth.
  • Investigative Team: Describe the leadership plan and composition of the network including clinic personnel (e.g., administrators, healthcare providers, IT staff, and other support staff) able to serve as collaborators on the Center’s research projects.
  • Network Infrastructure and Telehealth Capacity: Explain how the network will have the electronic infrastructure and equipment, IT support, clinic workflows, personnel, patient population, and resources to support the implementation of the pragmatic trial and two pilot projects focused on telehealth and cancer care delivery over the course of the study period. Describe the full range of current patient-provider, real-time telehealth services relevant to this initiative. Include a discussion of the supplemental clinical and asynchronous data capture and integration (e.g., patient-generated health data, patient portal use, and email communication) that can be used to support the Center’s primary focus on synchronous telehealth interactions. Detail the network’s clinical informatics infrastructure, history of telehealth use, and degree of integration of telehealth with the EHR infrastructure across the network.

Demonstrate the resources and capacity to be a sustainable network that is a part of the Center research during the duration of the grant and, at minimum, one year after the grant’s completion. If not already active, clearly demonstrate plans to activate the clinical practice network by the end of the year 1 project period.

 

Articulate a plan for how to address any network changes due to healthcare policy, communication, technology, and/or other unforeseen circumstances throughout the award period. Explain how the Clinical Practice Network will maintain the capacity to continue the Center’s proposed research.

  • Data Collection and Management: Describe processes for coordination of the Clinical Practice Network with the Center’s Administrative and Research and Methods Cores to support integration of common data elements across the Center’s projects (and when applicable the broader Telehealth Research Centers initiative), data collection and management, supporting IRB activities, and data safety and monitoring. Areas to be addressed within this subsection include:
    • Systems for data sharing across the Clinical Practice Network, which could include, but are not limited to, common EHR systems (or interoperable systems), telehealth audiovisual platforms and required equipment/software, history of secure data exchange across network sites and stakeholders
    • Describe the plan for data collection via electronic data capture using robust electronic platform (e.g., integrated systems within EHR or stand-alone systems with interface capabilities with EHR)
    • Demonstrate Information Technology approaches to system operations (deployment of the integrated system) and Clinical Informatics capabilities (e.g., retrieving data out of EHR or electronic platform)
    • Describe data harmonization, techniques, and procedures employed when different EHR systems/platforms are used and related interoperability
    • The proposed scheme for all data collection and management, including the collection and management of the multilevel patient, process, and healthcare data.
    • Describe data extraction relative to telehealth services, clinical and asynchronous data capture
  • Clinical Practice Network Surveillance: Describe plans for how ongoing network activities will be monitored to inform the pragmatic trial and two pilot studies. This plan requires the use of available data to identify baseline telehealth intervention implementation and progress made over time. Describe existing data resources within Clinical Practice Network sites, as well as plans for how improved capacity for data collection will occur over time and how data will inform continuous evaluation and monitoring of the changing healthcare, policy, and technology environment related to telehealth and cancer.

Resource Sharing Plan: 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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Resource Sharing Plans should only be provided in the Overall component of the application.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Clinical Practice Network)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

Pragmatic Trial

When preparing your application, use Component Type ‘Project’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Pragmatic Trial)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pragmatic Trial)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pragmatic Trial)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Pragmatic Trial)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pragmatic Trial)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

It is expected that each Research Project leader be at the forefront in the area of science proposed and have a successful record of bringing novel and significant projects to fruition as the principal investigator.

The Center Director must be the Project Lead for the Pragmatic trial.

Budget (Pragmatic Trial)

Budget forms appropriate for the specific component will be included in the application package.

The Project Lead(s) must commit a total minimum effort of 1.8 person months (PM) per year to each project. Multiple project leads are allowed for Projects. If there are multiple leads on a Project, the combined efforts of the identified project leads must total 1.8 PM per year. Do not include costs for staffing that are already included in the Administrative or Research and Methods Cores.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

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. All information on the sharing of resources should be consolidated in the Overall.

PHS 398 Research Plan (Pragmatic Trial)

Specific Aims: The specific aims should provide a concise description of the goals of the pragmatic trial to be conducted within the Clinical Practice Network.

Research Strategy: Each Center will conduct a pragmatic trial to test patient-centered approaches for integrating telehealth into routine cancer-related care delivery. The pragmatic trial description should be organized with the following sub-headers: Significance, Innovation, Approach, Investigator, and Environment.

Significance: Describe overall goals and the impact of the science proposed in the project. This section should also explain the contribution of the project to the overall goals and research theme of the Center, how the project will interact with and benefit from each of the other Center components (i.e., Administrative Core, Research and Methods Core, Clinical Practice Network), and the benefits of the Center approach and environment to the conduct of the pragmatic trial.

Innovation: Describe the unique and innovative contributions that will be made by the research project. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project. Describe the novel approaches used to integrate telehealth services into cancer care delivery in a real-world clinical environment.

Approach: Describe how the pragmatic trial will develop and test an intervention with the main goal of producing rigorous, relevant and applicable evidence for the use of telehealth in cancer-related care delivery. Explain how design features of the trial, such as primary outcome, primary analysis, setting, organization, eligibility (patients and/or providers), delivery, flexibility (delivery, adherence), follow-up, and recruitment approaches make it more pragmatic in nature. Justify the selection of type of randomized controlled trial (e.g., individual-level RCT, cluster RCT, stepped wedge RCT, stepped wedge cluster RCT) such that it matches the overall objective(s) of the study and ability to answer the research question(s). Describe how the pragmatic trial will test the integration of innovative telehealth care delivery that leverages synchronous communication, while also integrating clinical and asynchronous data. Describe how the trial will generate findings that are applicable across diverse patient populations and suitable for use with different provider types, multiple healthcare systems, clinical workflows, and care settings.

The application should cite pilot data, from the investigative team's prior studies or from the extant literature, to support well-justified hypotheses and the overall approach. The trial must clearly identify primary, secondary, and exploratory study outcomes at multiple levels. These outcomes must include, but are not limited to, telehealth process-related outcomes, healthcare utilization, patient-provider communication, patient-reported outcomes, and clinical outcomes. Consistent with design features of pragmatic trials, describe how the primary outcomes were identified and selected by the investigative team, clinical partners, and relevant stakeholder groups. In addition, describe how the trial will monitor, evaluate, and intervene on issues related specifically to the digital divide, including patients’ access to and ability to use the technology and tools necessary to participate in telehealth-related care.

The approach should justify the scale and scope of the pragmatic trial with respect to:

  • Justification and explanation of trial elements that make it pragmatic in nature
  • Selection of type of randomized controlled trial (e.g., individual-level RCT, cluster RCT, stepped wedge RCT, stepped wedge cluster RCT) and justification for unit of randomization, selection of outcome variable(s), and data analysis
  • Selection, explanation, description, and justification for using either a no-treatment control group (i.e., usual care) or comparison condition. If using no-treatment control group (i.e., usual care), describe methods for measuring and characterizing usual care at baseline and over time
  • Detailed description of effect size, sample size, power estimates, significance level, statistical analysis, sampling approach, attrition (and potential need for oversampling), intraclass correlation (where applicable), and primary, secondary, and exploratory outcomes
  • Description, explanation, and analytic approach for testing primary, secondary, and/or tertiary a priori hypotheses
  • Plans to identify and test predictors, moderators, and mediators of the effect of the telehealth intervention on primary, secondary, and/or exploratory analyses
  • Where applicable, justification and explanation for the selection and use of mixed methods and/or qualitative data collection and analysis), including type of design, sampling approach, sample size, analytic approach, and/or integration with other types of data, to complement the pragmatic trial design.

The application should describe the feasibility of the proposed study, the advantages of any new methodologies, potential pitfalls, and alternative approaches for the project and how these might impact on progress in the overall Center.

Investigative Team: Include a description of the pragmatic trial leadership team and how this team will work together to achieve the specific goals of the proposed trial. Without repeating information in individual biosketches, explain how the collective expertise and experience of the investigators will support the team science environment needed to successfully conduct a pragmatic trial designed to advance telehealth research for cancer-related care.

Environment: Describe how the pragmatic trial will leverage the infrastructure, staffing, and resources of the overall Center, the Research and Methods Core, and the Clinical Practice Network.

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. All information on the sharing of resources should be consolidated in the Overall

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects. See https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/PHSHumanSubjectsandClinicalTrialsInformationForm-Internal_Use_Only.pptx for more information.

PHS Human Subjects and Clinical Trials Information (Pragmatic Trial)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf. 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) and component Project Leads 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. 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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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 - Overall

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).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

How compelling is the justification for the Center’s research theme and the overall significance of the program of research in terms of:

  • Generating an evidence base that will support the integration of telehealth into cancer care delivery models and related clinical workflows;
  • Prioritizing cancer-focused outcomes in care delivery (access, healthcare utilization, patient/provider communication, patient-reported outcomes, and clinical outcomes);
  • Articulating anticipated dissemination, adoption and sustained use of new methods and measurement in telehealth research for cancer-related care and their impact on the broader field;
  • Identifying, evaluating, and addressing telehealth-related issues of access to care in the target population;
  • Justifying a center-based, interdisciplinary approach that will facilitate research in a manner that cannot be accomplished by a collection of individual research project grants (i.e., how the whole is significantly better than the sum of its parts)?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

  • How well does the proposed PD/PI(s) record of leadership in the area of science and their record of scientific achievements support their ability to lead the Center?
  • To what extent does the PD/PI(s) have a proven record that demonstrates his/her ability to organize, direct, and administer complex studies, as well as past participation in collaborative scientific activities?
  • Is (are) the proposed Center Investigator(s) at the forefront in the proposed scientific area? Are the leadership teams for each Core and the Pragmatic Trial adequately described and justified?
  • How well does the range of experience and disciplines of the investigative team correspond with the ability to facilitate research on the integration of telehealth into models of cancer care delivery?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

  • How novel are the proposed research methods in addressing the potential challenges and opportunities of integrating telehealth into models of cancer care delivery?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

  • To what extent will synergy between Center components contribute to accomplishing the overall Center objectives and specific aims?
  • How will the proposed research designs maximize the reliability and replicability of the findings?
  • How feasible is the Center’s plan to address healthcare, policy, communication, and technology changes that may occur during the award period?
  • To what extent does the overall approach take into account the perspective of key stakeholders/end-users and key characteristics of the settings that will implement telehealth-focused cancer care interventions in order to ensure that the research results are feasible in different care delivery settings and systems, and can be broadly disseminated across the cancer control continuum?
  • How adequate are the plans for sharing research resources (e.g., methods and measures, assessment and intervention protocols, technology, common data elements, data analytic strategies, de-identified data collected in research studies, evidence-based approaches, etc.) with the clinical care and cancer control communities?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

  • To what extent has the Center identified and secured engagement from clinical sites with synchronous, patient-provider telehealth capabilities and an adequate EHR infrastructure to participate in its Clinical Practice Network?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Review Criteria - Administrative Core, Research and Methods Core, Clinical Practice Network, and Pragmatic Trial

 

Reviewers will assign only one overall adjectival rating each for the Administrative Core, Research and Methods Core, Clinical Practice Network, and Pragmatic Trial based on the following criteria (these criteria do not receive separate scores).

Review Criteria for Administrative Core

  • How clearly defined is the operational structure, including management plans activities, External Advisory Board establishment, communication, and evaluation of progress across the Center’s Cores and research studies?
  • To what extent will the evaluation plan be useful for iteratively refining the Center’s ongoing activities, informing plans for future collaborative research, and assessing the Center’s public health impact?
  • How well do the proposed plans promote dissemination of research results to both scientific audiences and relevant stakeholders (e.g., patients/caregivers, providers, policymakers)?

Review Criteria for Research and Methods Core

  • Does the Core include expertise and describe strategies that will facilitate development and design of the Center’s pragmatic trial?
  • To what extent does the application identify and apply scientific, technological, and methodological approaches and tools to develop innovative process, contextual, and outcome measures relevant to the evaluation of telehealth integration in cancer care delivery models?
  • To what extent will the Core facilitate research via centralized functions (e.g., IRB review, clinical assessment, data collection/management, quality assurance, data analysis, good clinical practice/human subject protections)?
  • To what extent will the Core function as a national consultation resource beyond the Center collaborations to disseminate methodological advances and other Center-generated resources to the broader field?
  • To what extent is the Core's methodological and analytic expertise to be used to facilitate the Administrative Core’s efforts to evaluate the Center’s research progress and public health impact?

For the proposed pilot projects:

  • How likely is it that the rapid-cycle pilot project detailed in this core will yield preliminary data of sufficient scope and quality to guide the design of future studies consistent with the Center’s research focus?
  • Does the applicant have the necessary expertise and propose a detailed process for identifying, evaluating, and selecting at least one additional, high value pilot project?

Review Criteria for Clinical Practice Network

  • How well has the Network selected clinical practice sites that have the size, composition, infrastructure, technology, staffing, patient population, and resources needed to complete the pragmatic and pilot research studies?
  • How well has the applicant provided evidence and related milestones indicating that the Clinical Practice Network will be activated and fully functional by the end of year 1?
  • How well has the Clinical Practice Network identified and addressed possible issues due to unforeseen changes in healthcare policy, communication, and/or technology throughout the award period?
  • How well has the Clinical Practice Network described its capacity to engage in data collection and management activities, including EHR data extraction and interoperability of systems?
  • How well has the Network identified plans for improving data collection over time and continuously evaluating and monitoring the clinical practice environment?

Review Criteria for Pragmatic Trial

  • To what extent does the pragmatic trial address an important cancer care delivery problem or a critical barrier to progress in the field of telehealth research?
  • How well are the Leads, collaborators, and other researchers suited to conduct the pragmatic trial?
  • To what extent does the pragmatic trial challenge and seek to shift current telehealth and cancer research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions in the context of translational research?
  • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the pragmatic trial?
  • How well has the application described the pragmatic design elements of the trial?
  • To what extent is the selection of the type of randomized controlled trial (e.g., individual-level RCT, cluster RCT, stepped wedge RCT, stepped-wedge cluster RCT) appropriate and well-justified relative to the overall objective and aim of the proposed trial? To what extent is the methodologically sound and able to answer the proposed study hypotheses?
  • To what extent does the study provide explanation and justification for the selection of a no-treatment control group (i.e., usual care) or comparison condition?
  • How well has the application provided a detailed description of the methods of the pragmatic trial, such as the estimated effect size, sample size, power estimates, significance level, statistical analysis, sampling approach, attrition (and potential need for oversampling), intraclass correlation (where applicable), and primary, secondary, and exploratory outcomes?
  • To what extent will the pragmatic trial benefit from unique features of the scientific environment, subject populations, and collaborative arrangement with the Clinical Practice Network?

  • How likely is it that the results will have potential to guide practice decisions (e.g., inform decisions about whether to adopt and implement telehealth models of care or otherwise change current practices) and inform future research directions consistent with the Center's goals?

Additional Review Criteria - Overall

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.

Study Timeline and Milestones

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 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.

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 VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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.

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: Grantee 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 awardee 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).

 

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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 agreementsare 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.

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Roxanne E. Jensen, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7588
Email: roxanne.jensen@nih.gov

Robin C. Vanderpool, DrPH
National Cancer Institute (NCI)
Telephone: 240-276-6558
Email: robin.vanderpool@nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dm437a@nih.gov

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 45 CFR Part 75.


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