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

Research Centers for Improving Management of Symptoms During and Following Cancer Treatment (UM1)

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-17-042

Companion Funding Opportunity

RFA-CA-17-043, U24, Resource-Related Research Projects--Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.395

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative established to accelerate cancer research. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): the Implementation of Integrated and Evidenced-based Symptom Management Throughout the Cancer Trajectory. The purpose of this specific FOA is to promote research on the implementation and evaluation of integrated symptom monitoring and management systems for use in cancer care delivery through a Research Consortium. This research will provide new insights and valuable evidence that can be used to guide efforts on a nation-wide basis to improve symptom control for cancer patients during treatment and survivorship.

The consortium will consist of three Research Centers (to be supported by this UM1 FOA) and a Coordinating Center (to be funded under a companion U24 FOA, RFA-CA-17-043).

Each Research Center is expected to:

 (1) Deploy an integrated symptom monitoring and management system in a group of clinical practices, and

 (2) Test the impact of that system on patient outcomes, cancer treatment delivery, and healthcare utilization using a randomized design.

The Research Centers will be expected to interact with the Coordinating Center and engage in collaborative activities with the entire consortium. Collaborative activities will be supported scientifically and coordinated administratively and logistically by the Coordinating Center.

Key Dates
Posted Date

October 18, 2017

Open Date (Earliest Submission Date)

December 17, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

January 17, 2018), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this FOA

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2018

Advisory Council Review

August 2018

Earliest Start Date

September 2018

Expiration Date

January 18, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative established to accelerate cancer research. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): the Implementation of Integrated and Evidenced-based Symptom Management Throughout the Cancer Trajectory. The purpose of this specific FOA is to promote research on the implementation and evaluation of integrated symptom monitoring and management systems for use in cancer care delivery through a Research Consortium. This research will provide new insights and valuable evidence that can be used to guide efforts on a nation-wide basis to improve symptom control for cancer patients during treatment and survivorship.

The Consortium will consist of three Research Centers (to be supported by this UM1 FOA) and a Coordinating Center (to be funded under a companion U24 FOA, RFA-CA-17-043).

Each Research Center is expected to:

 (1) Deploy a cohesive integrated symptom monitoring and management system in a group of clinical practices, and

 (2) Test the impact of that system on patient outcomes, cancer treatment delivery, and healthcare utilization using a randomized design.

The Research Centers will be expected to interact with the Coordinating Center and engage in collaborative activities with the entire consortium. Collaborative activities will be supported scientifically and coordinated administratively and logistically by the Coordinating Center.

Key Definitions in the context of this FOA

Patient-Reported Outcomes: measurements of any aspects of a patient’s health status (such as symptoms or functioning) that are provided directly by the patient.

Healthcare System: a collection of primary and specialty care clinicians and support staff, medical facilities, and organizational structures which together provide the environment for the comprehensive delivery of healthcare services related to the cancer care.

Background

NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's ambitious goal of making a decade's worth of progress in cancer research in 5 years, now called the Beau Biden Cancer MoonshotSM Initiative.  The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for symptom management. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer MoonshotSM Initiative, including support for this FOA.

Need for improved symptom management for cancer patients in healthcare delivery settings. The symptom burden experienced by people with cancer is considerable. Cancer and its treatments produce deleterious symptoms that can persist long after treatment is completed and disease is eradicated. Across disease stages and phases of care, approximately 33% of cancer patients report three or more co-occurring symptoms (e.g., pain, fatigue) that they rate moderate to severe. Poorly controlled symptoms negatively affect health-related quality of life and functional status, and can lead to costly visits to emergency departments, often resulting in hospitalization. Adverse symptoms can lead to delays, in or discontinuation of, cancer treatment. Such disruptions may decrease treatment effectiveness and increase risk for recurrence and death. Adherence problems due to poor symptom control are especially salient among minority and medically underserved cancer patients. Finally, negative effects of treatment have been found to increase the likelihood that patients will not return to work, even if they are disease-free, and impair the ability to work among those who do return.

Patient-reported outcomes (PROs). The importance of directly capturing the perspective of patients on their own health status and recognition that patients are an essential source of information about their symptom experience and its impact on their functioning have become a major focus of research. To better assess and manage cancer patient symptoms, there has been growing interest in the use of patient-reported outcomes (PROs) to enable standardized symptom assessment. PROs have been shown to be valid and reliable tools for assessing symptoms and are being used increasingly as outcomes in clinical trials. Given this increased uptake in clinical research settings, their use in applied clinical settings has become easier and more appealing. Research demonstrates that oncology care providers consider PRO data to be clinically useful and that collection of PROs as part of clinical care is generally feasible and acceptable to patients. To support their collection, electronic systems have been developed and are in use at several major cancer centers for patient self-reporting of symptoms using established PRO assessment tools. Advantages of electronic systems over paper-and-pencil approaches include the ease of administration and scoring, reduced patient burden (e.g., via computer adaptive testing), and the capability of integrating findings into electronic health record (EHR) systems and existing workflows. However, many of the systems for symptom data capture are idiosyncratic, rarely interoperable, and generally do not provide evidence-based symptom management recommendations in response to symptom reports. Thus, there is a substantial need for systematic, uniform data capture and presentation across clinical settings. In addition, research is needed on the best approaches to streamline PRO data collection and use these data to aid in doctor-patient communication, decision-making, and care-coordination across practice settings (e.g., between primary and specialty care practices and among specialty care practices).

Clinical use of PROs. Going beyond feasibility and acceptability, results of controlled studies demonstrate the benefits of collection of PRO data and their delivery to cancer care providers. Clinical use of PROs has been shown repeatedly to improve patient-physician communication about symptoms and individual studies have demonstrated improved symptom control, increased use of supportive care measures, and greater patient satisfaction. The cumulative evidence suggests that effects are likely to be enhanced if clinicians and patients are provided with clear guidance on how to respond to symptom reports. Accordingly, there is an emerging consensus that development and adoption of integrated symptom monitoring and management systems represent the most effective way to use PROs to improve symptom control.

Research Objectives and Main Requirements

Overview. The focus of the Research Consortium supported by this FOA is to use implementation science approaches to accelerate adoption of integrated systems that collect patient-reported symptom data and use these data to trigger a clinical response consistent with evidence-based guidelines. Implementation science approaches to be proposed for this FOA must be systematically planned with a goal to accomplish sustaining changes in clinical practice.

Goals and Expected Role of Research Centers. Each Research Center is expected to deploy an integrated symptom monitoring and management system in a group of clinical practices and to test that system using a randomized design. This approach is expected to yield a rigorous evaluation of the extent to which elements of the system are adopted and the impact of the system on patient outcomes, cancer treatment delivery, and healthcare utilization.

The proposed Research Centers should be capable of (and plan for) accomplishing the following goals during the project period:

  • Yield optimal models for implementing integrated systems into routine clinical practice;
  • Verify whether adoption of integrated systems to be assessed can reduce the harmful effects of poorly controlled symptoms; and
  • Create the foundation for effective, scalable and sustainable symptom management approaches in routine cancer care.

General Requirements on Study Design

The proposed studies must use a pragmatic, randomized design that:

  • Provides an integrated symptom monitoring and management system to a group of clinical practices based on implementation science principles;
  • Measures the extent of adoption and identifies processes that contribute to success in adopting the system; and
  • Determines the impact of the integrated system on patient outcomes (e.g., symptom reports, functional status), cancer treatment delivery (e.g., adherence to prescribed medications), and healthcare utilization (e.g., emergency room visits).

Required Research Center Characteristics

The proposed Research Center must adopt all the required characteristics listed below.

Integrated cancer symptom monitoring and management system. The integrated system must include regular assessment of cancer patient symptoms in a set of clinical practices. Symptom assessment must include pain or fatigue, along with other symptoms that are relevant for the patient population selected (e.g., by cancer type and stage of disease). Management strategies must be based on current clinical guidelines for symptom management. The system must provide point of care clinical decision support and care-coordination based on the presence and severity of symptoms. Deployment of the integrated system must be based on implementation science principles that take into account patient, provider, and practice characteristics and beliefs, knowledge, and abilities regarding proposed changes in clinical practice.

Patient Populations and Healthcare Delivery Practices

Patients in the clinical practices should vary by type of cancer and may vary by age group (e.g., they may include pediatric or older adult patients). Each integrated symptom management system must collect information (at the practice level) from patients representing at least two out of three phases of the cancer treatment continuum:

(1) Treatment with curative intent (i.e., as patients receive surgery, standard- or high-dose chemotherapy, biological therapy, and/or radiotherapy with curative intent);

(2) Treatment with non-curative/palliative intent (e.g., for patients with advanced or metastatic disease who receive chemotherapy, biological therapy, and/or radiotherapy to control or slow advance of their disease); and

(3) Cancer survivorship (i.e., patients who have completed active cancer treatment with curative intent, including those who may be receiving maintenance or prophylactic cancer treatment).

Clinical Informatics and Information Technology Approaches. Symptoms must be collected via electronic data capture, integrated into electronic health record (EHR) systems, and extracted from EHRs. One, uniform electronic platform must be used for all clinical practices in the Research Center. It is expected that the electronic platform will possess functionality for collecting PROs and providing scored information to clinicians. Data must be collected in formats that allow for sharing across funded Research Centers. The electronic platform must be fully operational (e.g., already embedded within the EHR, or able to seamlessly interface with the EHR such as with online tools, apps, or software with application programming interface capabilities). Awardees may use the early stages of the project for final refinement of the platform at the clinical practice sites as well as for refinement of the process of delivering scored information to patients and clinicians.

Research Center Organization

Each Research Center will be composed of the following functional and structural units:

Administrative Unit

This Core will be responsible for the day-to-day management and administrative coordination of all Research Center activities, and should provide infrastructure that will allow the Research Center leadership to oversee all aspects of symptom management, system implementation and data collection across clinic practices. Because complex, multilevel data will be collected and acted upon from multiple clinical practices for analysis and evaluation, close coordination and efficient lines of communication are needed between this core and the practices.

Research Design and Implementation Unit

This Unit will be responsible for deploying the integrated symptom monitoring and management system using implementation science principles and current cancer clinical practice guidelines. It will be responsible for the design and conduct of the randomized study to evaluate the effectiveness of the integrated system and its scalability and sustainability. It will manage all patient recruitment and retention, as well as coordination of data collection with the Data Management, Statistics, and Informatics Unit.

Data Management, Statistics, and Informatics Unit

This Unit will be responsible for the management of data collected using state-of-the-science informatics approaches. It will be responsible for the collection and management of multilevel patient and healthcare data as well as process-level data to evaluate the implementation of the integrated system. This unit will work with the Coordinating Center (U24) to ensure uniform, interoperable data collection and sharing with the other funded Research Centers. Where there is overlap on PROs or other outcomes assessed, common data elements will be used. Statistical analysis will be planned and performed through this core.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCI intends to commit up to $5.4 million in FY 2018 to fund 3 awards.

Award Budget

Application budgets are limited to no more than $1,120,000 million in direct costs for any budget year.

Award Project Period

A project period of 5 years must be proposed.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 designated as PDs/PIs of the Coordinating Center (U24) application in response to RFA-CA-17-043 are not eligible to serve as PDs/PIs on applications submitted in response to this FOA.

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

A letter of intent is required. The information that it contains will allow 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:

Ashley Wilder Smith, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6714
Fax: 240-276-7906
Email: smithas@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following modifications for this FOA.

The Research Strategy must consist of the following sub-sections with the indicated page limits:

Sub-section A. Overview of the Proposed Center - 6 pages

Sub-section B. Administrative Unit - 6 pages

Sub-section C. Research Design and Implementation Unit - 12 pages

Sub-section D. Data Management, Statistics, and Informatics Unit - 12 pages

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  Biosketches should reflect the PD(s)/PI(s) and key personnel's expertise in implementation science, symptom management, bioinformatics, health services research, clinical cancer care, interdisciplinary team composition, and demonstrated collaboration with research, practice, and policy stakeholder groups.

R&R or Modular Budget

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

Any individual designated as PD/PI must commit a minimum of 1.2 person-months effort per year to the UM1 award. The commitment cannot be reduced in later years of the award.

Applicants must budget for travel expenses for key personnel (e.g., PD[s]/PI[s], program manager/coordinator, and 1-2 other study investigators) to attend one in-person 1.5-day meeting of the program steering committee in the first year and one meeting per year for the remaining four years. The meetings will take place in or near Bethesda, Maryland. Other (non-budgeted) steering committee meetings will be held as teleconferences.

In Budget Justification, provide break down of expenses for individual functional units: Administrative Unit, Research Design and Implementation Unit, and Data Management, Statistics, and Informatics Unit.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Applicants should address the scientific questions to be answered, what specifically will be done during the proposed funding periods, and the impact of addressing the research question on cancer symptom management.

Research Strategy: Applications should describe details for the proposed integrated symptom monitoring and management system and randomized study to evaluate the integrated system, including recruitment approaches, sample size estimates, power calculations, and activities to manage adoption.

Research Strategy must consist of Sub-Sections A-D as defined below.

Sub-Section A. Overview of the Proposed Research Center.

  • Overall Research Direction. Outline the overall goals for the Center and an overarching research strategy for the implementation of the integrated symptom assessment and a rigorous assessment of anticipated benefits. Summarize the main characteristics of the clinical practices that will participate. Describe proposed benefits in terms of patient health outcomes, cancer treatment delivery, and healthcare utilization. Explain the anticipated potential of the proposed research activities in terms of providing new insights and valuable evidence that can be used to guide efforts on a nation-wide basis to improve symptom control in people with cancer.
  • ·    Leadership Structure and Key Roles: Define the general organizational and governing structure, lines of authority and decision-making processes proposed to ensure efficiency and effectiveness of communication and roles.
  • ·    Relevant Past Performance. Summarize the collective performance of the applicant team as a whole in the past 5 years in leading and managing studies using implementation science principles, symptom science research, and other relevant research. Demonstrate the team's capabilities and cumulative accomplishments but do not repeat the information from individual researchers' biosketches.
  • ·    Health Disparities. Address how populations with health disparities and their data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates. Each Research Center is required to address disparities in access to and utilization of symptom assessment and management services (e.g., conduct research with community-based practices that serve diverse patient populations and have limited on-site professional resources for symptom management). Thus, clinical practice selection must include practices that provide care to underserved patients based on geographic location, race-ethnicity, income, and/or socioeconomic status. Symptom monitoring and management systems may be tailored for underserved populations including those with low digital literacy, low educational attainment, and non-English speakers.
  • ·    Perspective Beyond the Project Period. Explain how the proposed Research Center may create the foundation for effective, scalable and sustainable symptom management approaches in routine cancer care.

Sub-Section B. Administrative Unit.  Address the following aspects.

  • ·    Describe plans for the day-to-day oversight, management and coordination of activities across the clinical sites within the Research Center.
  • ·    Explain how the proposed unit will provide logistic support for the Research Center leadership.
  • ·    Outline existing or proposed processes for shared governance or collaborative arrangements across clinical practices allowing for consistency, coordination, and shared resources.
  • ·    Describe process for coordination with U24 Coordinating Center.

Sub-Section C. Research Design and Implementation Unit. Explain how the Unit will approach design and conduct of a randomized study to evaluate the effectiveness of the integrated symptom monitoring and management system. Explain how the study is expected to successfully address the need for evidence-based models of symptom assessment and management applicable across a wide range of clinical settings, symptoms, and patient populations. The description must address all the required and expected characteristics and attributes identified in Section I. Specific aspects to address include (but are not limited to) the following:

  • ·    Designing the integrated system for scalability and sustainability, and planning for deployment in clinical sites;
  • ·    Regularly assessing symptoms using measures validated for use in cancer populations and available for electronic administration
  • ·    Providing clinical decision-support based on evidence-based clinical practice guidelines applicable to people with cancer with appropriate follow-up (e.g., outcome interpretation guidance, referral to supportive care services, provision of patient self-management resources);
  • ·    Planning for system integration in clinic workflow (may include adaptations as needed, use of audit and feedback, alerts for severe symptoms, reminders);
  • ·    Assessing potential benefits of the integrated system such as patient symptom control, functional status and well-being, treatment modification (e.g., dose changes, delays in or discontinuation of treatment), treatment adherence, and healthcare utilization (e.g., referrals, services provided, emergency room visits), and other factors as relevant;
  • ·    Planning for the evaluation of the integrated system (in conjunction with the Data Management, Statistics, and Informatics Unit) through a pragmatic trial with appropriate design (e.g., stepped wedge);
  • ·    Developing an approach to examining barriers and facilitators to implementation at the provider, team and organizational levels;
  • ·    Describing implementation processes and strategies (e.g. training, technical assistance, audit and feedback strategies, practice facilitation, infrastructure, incentives, barrier reduction);
  • ·    Collecting qualitative and quantitative data on multi-level contextual factors that affect implementation outcomes (e.g., acceptability, adoption, costs, fidelity, potential for scalability/spread, and sustainability). Multi-level contextual factors may include provider, team, and organizational attributes such as provider attitudes and competencies, team cohesiveness and culture, and healthcare organization readiness, resources, and community engagement;
  • ·    Coordinating data collection with the Data Management, Statistics, and Informatics Unit; and
  • ·    Planning for the creation of materials to describe best practices for future integration of the system by other healthcare delivery practices.

Sub-Section D. Data Management, Statistics, and Informatics Unit. The description must address all the required and expected characteristics and attributes identified in Section I. Specific aspects to address include (but are not limited to) the following:

  • ·    The proposed scheme for all data collection and management, including the collection and management of the multilevel patient and healthcare data as well as process-level data to evaluate the effectiveness of the integrated symptom monitoring and management system;
  • ·    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)
  • ·    Utilize state-of-the-science informatics and data collection to allow for static PRO assessment (i.e., using forms with the same standard set of questions) or dynamic assessment (e.g., computer adaptive testing);
  • ·    Demonstrate ease of use via user-friendly, intuitive, and easily navigable patient and clinician interface to facilitate point of care discussions.
  • ·    Describe the plan for analysis of multi-level, mixed methods data to explain implementation effectiveness
  • ·    Analyze qualitative and quantitative data on multi-level contextual factors and implementation outcomes
  • ·    Linking disease and treatment information to outcomes (e.g., PROs, healthcare utilization data)
  • ·    Anticipated interactions with the Coordinating Center (U24) and propose approaches to ensure uniform, interoperable data collection and sharing with the other funded Research Centers (address the use of Common Data Elements, CDEs);
  • ·    Plans for the statistical support for the Research Design and Implementation Unit, including the statistical approaches to study design and results analysis; and
  • ·    Plans to synthesize data and emerging findings and share those with stakeholders in the practice settings on an ongoing basis to foster learning from process and outcome data.

Letters of Support: Applicants must include letters of support from collaborating healthcare organizations or systems (e.g., hospitals, clinics, health departments, agencies, etc.).

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.
  • Addressing the Cancer Moonshot Public Access Pilot Program: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that (1) describes their proposed process for making resulting Publications and to the extent possible, the Underlying Primary Data immediately and broadly available to the public; (2) if applicable, provides a justification to NCI if such sharing is not possible.  NCI will give competitive preference and funding priority to applications with a data sharing plan that complies with the strategy described here. The data sharing plan will become a term and condition of award.
  • Guiding Principles for Cancer Moonshot Biobanking Activities: The goal in developing these guiding principles is to accelerate research by a) increasing the availability of biospecimens for Cancer Moonshot-related and other biomedical research through facilitation of investigator to investigator sharing of biospecimens, and b) increasing the reproducibility of Cancer Moonshot research through improved biospecimen practices and corresponding annotation. These guiding principles also seek to facilitate, where possible, increased engagement of research participants through researchers’ communication of aggregate research results and, in some cases, individual genomic findings that may be medically actionable for research participants.  NCI will give competitive preference and funding priority to applications that conform to the "Guiding Principles for Cancer Moonshot Biobanking Activities" (http://biospecimens.cancer.gov/programs/cancermoonshot/principles) and are consistent with the "2016 NCI Best Practices for Biospecimen Resources" (https://biospecimens.cancer.gov/bestpractices/).

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

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). 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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

 Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies [e.g. genome-wide association studies (GWAS)]), types of outcomes (e.g., PROs), and patient registries. NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.  For NCI-relevant CDEs, please visit  CDE (Common Data Element) Browser

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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 there a strong scientific premise for the project? 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 strong is the potential of the Research Center, as proposed, to implement a rigorous integrated symptom monitoring and management system? What is the likelihood that such a system will help improve symptom control, healthcare utilization, and cancer treatment delivery?

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 range of experience of the investigative team correspond with the ability to facilitate research on the implementation of integrated symptom monitoring and management in community-based oncology practices?

Are key disciplines (e.g., clinical, implementation science, supportive care, informatics) appropriately represented in the team? 

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 approaches in addressing the potential challenges of providing integrated symptom management for cancer care? How novel are the methods for planning for the generation and dissemination of materials to other practices to encourage integrated symptom monitoring and management once the project is completed? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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: What is the likelihood that the Research Center will be able to comprehensively plan for and document the process of initial implementation of the integrated symptom monitoring and management system? What is the likelihood that the Research Center can complete a randomized study that yields data on relevant outcomes across the participating practices? Does the application contain acceptable plans for addressing the NCI Cancer Moonshot℠ Public Access and Data Sharing Policy?

Administrative Unit: How efficient and effective will this unit be in supporting administrative and coordinating functions?

Research Design and Implementation Unit: How capable is this unit to work with the participating practices to prepare for the implementation of an integrated symptom monitoring and management system?  How strong is the ability of this unit to develop, deploy, and maintain an integrated system in the participating practices?

Data Management, Statistics, and Informatics Unit: How strong is the ability of this unit to collect the various types of data required for the proposed research?  How capable is this unit in carrying out the planned analyses and in preparing data for cross-cutting analyses?

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 children, 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: Do the healthcare practices encompassed by the proposed Research Center provide sufficient access to relevant racial/ethnic minority and/or other medically underserved populations such that the Research Center’s research can be used to address and improve disparities in symptom monitoring and management? How extensive are existing on-site professional resources for symptom management at the Research Center? How ready is the proposed Research Center to implement the proposed integrated symptom monitoring and management system?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children 

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 children 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

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 (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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:

  • 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.
  • Will receive a written critique.

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 National Cancer Advisory 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.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Defining objectives and approaches, overseeing planning and conducting studies, analyzing and interpreting results, and publishing reports of studies conducted under this award;
  • Assuming responsibility and accountability to the applicant organization (which, in turn, will be responsible to the NCI for the performance and proper conduct of the research in accordance with the terms and conditions of the award;
  • Collaborating with Investigators in the other Research Centers and the Coordinating Center on pooled or collaborative Consortium activities;
  • Serving as voting members of the Consortium Steering Committee and attending regular and ad hoc Steering Committee meetings (e.g., teleconferences) and in-person Steering Committee meetings once a year;
  • Accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee to the extent consistent with applicable grant regulations;
  • Coordinating efforts and cooperating with the other awardees of the Consortium and with NCI Program staff;
  • Implementing the approved research resource sharing plan;
  • In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.
  • Leveraging, where feasible, technology from related NCI-sponsored informatics initiatives, for example The NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research.
  • Coordinating with and leveraging, where feasible, the technology of The NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact (cbiit.cancer.gov/cancerdatacommons).

Each Consortium awardee and the entire Consortium programmatic initiative will be subject to external evaluation (coordinated by the NIH); Consortium Awardees will be expected to participate in such evaluations.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NCI Program Directors serving as a Project Scientist(s) will be involved in assisting and coordinating interactions and collaborations among the various investigators.

Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Program Officials may also have substantial programmatic involvement (as Project Scientists).

Specific activities of substantially involved NCI staff members will include:

  • Monitoring the operations of Consortium components and activities;
  • Reviewing the progress the Consortium;
  • Making recommendations to the Steering Committee on strategic directions and improvements to components and activities;
  • If appropriate, collaborating scientifically on research projects involving Consortium investigators;
  • Advising the awardees on specific scientific issues as well as programmatic priorities;
  • Facilitating access to NCI resources and expertise;
  • Serving as liaison between the Consortium investigators and NCI staff members;
  • Monitoring the scientific progress of the entire Initiative;
  • Participating on the Consortium Steering Committee;
  • Assisting the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.
  • Promoting collaborative research efforts that involve interactions with other NCI-sponsored programs, projects, and centers;
  • In cooperation with the NCI Center for Bioinformatics, assisting the awardees with relevant aspects of bioinformatics and/or information technology;
  • Coordinating external evaluation of the Consortium.

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act.  In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.

Areas of Joint Responsibility include:

Steering Committee: The Steering Committee will be the main governing body for the Consortium. The Steering Committee will be composed of the following voting members:

  • Two representatives from each Consortium UM1 Research Center and U24 Coordinating Center award (the PD(s)/PI(s) or a PD/PI and a designated senior investigator) who will have one vote each; and
  • NCI Project Scientist(s) (who will have collectively one vote).

Additional NIH staff members, and at least one cancer survivor (advocate) serving in an advisory capacity, may participate in these meetings as non-voting members. This decision will be made by the existing voting members of the Steering Committee. These members may include representatives from NCI extramural divisions and a representative from the NCI CBIIT.

The Chair of the Steering Committee will be selected from the representatives of all awardees.

The Steering Committee will meet monthly via phone conference and in person once every year, at locations selected by the Steering Committee in consultation with the NCI. Applicants should budget for in-person meetings to occur in the Washington, D.C., metropolitan area.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientists will serve on such sub-committees, as they deem appropriate.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

  • Setting the overall research priorities for the Consortium and identifying emerging research opportunities which can be best explored through a joint collaborative effort via the Consortium;
  • Establishing general Consortium policies and procedures;
  • Establishing policies and procedures for collaborative projects, protocols, and Consortium-defined projects, including defining how such collaborative activities/ studies (to be supported by the restricted set-aside funds on each award) will be initiated, formulated, and presented to the Steering Committee for recommendation regarding collaborative execution.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

Ashley Wilder Smith, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6714
Email: smithas@mail.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)

Crystal Wolfrey 
National Cancer Institute (NCI)
Telephone: 301-496-8634 
Email: wolfreyc@mail.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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