Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Cancer Institute (NCI)
U01 Research Project Cooperative Agreements
Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) solicits applications for Connecting Underrepresented Populations to Clinical Trials (CUSP2CT), a program that will implement and evaluate multilevel and culturally tailored outreach and education interventions with the primary goal of increasing referral and ultimately, accrual of underrepresented racial/ethnic (R/E) minority populations, to NCI-supported clinical trials (CTs) (National Clinical Trial Network (NCTN), NCI's Community Oncology Research Program (NCORP), and Experimental Therapeutics Clinical Trials Network (ETCTN)). The target population(s) should include individuals from underrepresented racial/ethnic (R/E) minority populations. Applicants should address cancer health disparities (CHD) through a network of local multidisciplinary and integrated partners that include community health educators (CHEs), lay health advisors (LHAs), community members, healthcare providers, and researchers working in coordination to educate and refer R/E minority populations to NCI-supported CTs, and increase awareness in providers about R/E minority participation in NCI clinical trials. This will require multilevel outreach and education interventions at the CT site, provider, and/or patient levels. The proposed interventions should be informed by relevant theories, frameworks, or models. Further, the interventions should be guided by baseline information on participant, health care provider and facilitator -related strategies for increasing CT referral of R/E minority populations. It is expected that U01 grantees will establish partnerships with the community, primary care providers, and other stakeholders to enhance identification of R/E minority referral barriers and interventions to NCI-supported CTs.
A companion funding opportunity (see U24 funding opportunity RFA-CA-21-058) will support a Data, Evaluation & Coordinating Center (DECC) that will provide experienced project management for CUSP2CT Program activities, which include data receipt, management, and analysis from U01 sites, metrics development for program evaluation, and identification and dissemination of successful interventions and best practices.
The research activities will address key issues that affect diversity in clinical trials and will improve the dissemination of information and care into underserved communities, where they are needed most.
October 19, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| November 19, 2021 | Not Applicable | Not Applicable | February 2022 | May 2022 | July 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 application will be accepted for this Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) solicits applications for Connecting Underrepresented Populations to Clinical Trials (CUSP2CT), a program that will implement and evaluate multilevel and culturally tailored outreach and education interventions with the primary goal of increasing referral and ultimately, accrual of underrepresented racial/ethnic (R/E) minority populations, to NCI-supported clinical trials (CTs) (National Clinical Trial Network (NCTN), NCI's Community Oncology Research Program (NCORP), and Experimental Therapeutics Clinical Trials Network (ETCTN)). The target population(s) should include individuals from underrepresented racial/ethnic (R/E) minority populations. Without adequate representation, especially in therapeutic trials, cancer disparities are likely to increase as R/E populations may not be able to fully benefit from cutting-edge treatments and the promises of precision medicine. Applications should address cancer health disparities (CHD), through a network of local multidisciplinary and integrated partners that include community health educators (CHEs), lay health advisors (LHAs), community members, healthcare providers, and researchers, working in coordination to educate and refer R/E minority populations to NCI-supported CTs, and increase awareness in providers about R/E minority participation in NCI clinical trials. It is expected that U01 grantees will establish partnerships with the community, primary care providers, and other stakeholders to enhance the identification of R/E minority referral barriers and interventions to NCI-supported CTs.
CUSP2CT is comprised of two Funding Opportunity Announcements (FOAs) that solicit applications for:
Key Definitions for this FOA
CUSP2CT Program: Refers to the combined effort of the U01 Grantee Sites, U24 Data and Evaluation Coordinating Center, and the NCI to advance the science of implementation of multilevel interventions to increase rates of CT referral and ultimately, participation among R/E minority populations.
CUSP2CT Program Steering Committee: Includes representatives from the CUSP2CT DECC, each U01 Grantee site, and the NCI.
CUSP2CT Data, Evaluation, and Coordinating Center (DECC): Includes the U24 coordinating center funded through the companion RFA-CA-21-058.
CUSP2CT U01 Grantee Site: Includes U01 projects funded through this FOA.
Healthcare System: A group 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 cancer prevention, screening, diagnosis, survivorship, and end-of-life care.
Cancer Health Disparities (CHD): Health disparities are differences in the incidence, prevalence, mortality, and burden of cancer and related adverse health conditions that exist among specific population groups. For the purposes of this FOA, the focus is on race and ethnicity.
Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to accessing health coverage and basic health care services. A full description can be found at https://www.nimhd.nih.gov/about/overview/. Racial and ethnic categories and definitions for NIH diversity programs and for other reporting purposes are described in NOT-OD-15-089.
Underrepresented: The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity.
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'.
Clinical Trial Referral: A clinical trial referral is defined as the act of sending a patient/participant to an investigator to learn more about a clinical trial and to be evaluated for suitability for participation.
Multilevel Intervention: An intervention that includes multiple components that target change at two or more levels of individuals, healthcare or public health providers, or healthcare/community settings, and that measures outcomes at two or more levels. Selection of multilevel intervention components across different levels should be guided by relevant theories, models, or frameworks; a review of the extant literature; and local assessment of barriers and facilitators, and should include a priori hypotheses of how components are expected to affect each other, as well as inform the selection and measurement of proposed outcome(s).
Healthcare or public health providers: Examples include but are not limited to physicians, nurse practitioners, community health workers, and patient navigators involved in delivering healthcare practices, programs, interventions, and other health-focused services to individuals.
Healthcare and/or community settings: Organization(s) in which individuals receive health-focused services across the cancer care continuum. Examples include but are not limited to clinics (e.g., primary care, specialty care), hospitals, cancer centers, federally qualified health centers, integrated delivery systems, health departments, and community-based organizations.
Experimental Study Design: Study design that includes manipulation (i.e., exposure to at least one intervention), randomization, and a control group. Examples of experimental study designs include randomized controlled trials, cluster-randomized controlled trials, group randomized controlled trials, pragmatic randomized controlled trials, and stepped-wedge cluster randomized controlled trials.
Quasi-Experimental Study Design: Study design that includes manipulation (i.e., exposure to at least one intervention), no randomization, and a control group. Studies must include prospective exposure to an experimental condition (i.e., multilevel intervention) and include a control condition (e.g., standard-of-care, comparison condition, time-attention control). Examples of quasi-experimental study designs include interrupted time series, regression discontinuity, and nonequivalent control group.
Background
NCI, through the Center to Reduce Cancer Health Disparities (CRCHD) in collaboration with several Offices and Divisions at the NCI, assessed the state-of-the-science in CT participation and accrual. The effort was focused on R/E minority populations and the identification of major research opportunities that could uniquely benefit the support of NCI-supported CTs and could lead to significant advances in our understanding of cancer CTs. Specifically, the initiative was envisioned to focus on multilevel interventions to increase R/E minority individual referral, a first step in CT accrual from underrepresented communities where participation rates are equivalent when people are invited to participate.
Challenges Associated with CT Accrual of R/E Minority Patients. R/E minority populations experience disproportionately higher rates of incidence, morbidity, and mortality for numerous cancer types in comparison to Non-Hispanic Whites (NHW). However, despite higher rates of cancer incidence and mortality, the representation of R/E minority populations in cancer CTs, including therapeutic and non-therapeutic trials, remains low in some disease areas. Without adequate representation, especially in therapeutic trials, cancer disparities are likely to increase as R/E minority populations may not be able to fully benefit from cutting-edge treatments and the promises of precision medicine.
Multilevel Interventions to Increase CT Referral and Accrual. Numerous barriers and challenges to R/E minority participation in CTs have been identified that span multiple levels: site, provider, and patient levels. Studies have demonstrated that targeted outreach and education to R/E minority patients and strategic engagement of providers increases participation in CTs. Research further shows that patient navigation supported by LHAs can increase CT participation among R/E populations, and that input from a trusted provider can facilitate CT participation. While these studies have demonstrated limited success in addressing known barriers and diversifying CTs, systematic, coordinated, and integrated approaches have not been widely implemented and reported on.
NCI-supported CTs. NCI has been supporting clinical trials. For more than 50 years, the NCI National Clinical Trials Network (NCTN), and previously the National Clinical Trials Cooperative Group Program, have been supporting large-scale, clinical treatment trials across the nation. While these trials have successfully led to new cancer treatments, participation from R/E minority patients varies across disease areas. The NCI Community Oncology Research Program (NCORP), which includes Minority Underserved Community Sites, significantly contributes to the R/E minority participation in the NCTN. NCORP works across NCI programs and CT types to bring cancer CTs and care delivery studies to people in their own communities. With NCORP’s support, the NCTN Groups convene committees with site and researcher participants and patient advocates who are focused on addressing disparities in trial participation. NCI’s Experimental Therapeutics Clinical Trials Network (ETCTN) recently launched the Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP) program to provide administrative supplements to cancer centers to enroll at least 24 patients annually to the Experimental Therapeutics Clinical Trials Network (ETCTN) trials, with at least 50% of these patients belonging to a minority/underserved population. The NCTN, NCORP and ETCTN are the three largest NCI supported CT networks that enroll the majority of participants in NCI-supported CTs annually. Therefore, CTs from these NCI-supported networks will be a major focus for CT referrals for the CUSP2CT Program to enhance the diversity of participants. NCI’s Cancer Center Support Grants for NCI-designated Cancer Centers also provide support to NCI CTs and successful discoveries from their investigator-initiated CTs may move into larger trials in NCI’s CT networks. A Community Outreach and Engagement (COE) component was recently made a requirement for Cancer Center Support Grants for NCI-designated Cancer Centers (P30). The COE components are tasked with developing knowledge, best practices, and tools for effective outreach and engagement of the Cancer Center’s catchment area. While impactful, these efforts are being addressed uniquely and individually by each Cancer Center. Lastly, NCI’s Center to Reduce Cancer Health Disparities (CRCHD) has supported several programs over the past 15 years that have informed evidence-based interventions and strategies. Specifically, they are focused on R/E minority outreach and provided feasibility for the community-focused strategies that this FOA seeks to focus on. These include: (1) The Patient Navigation Research Program (PNRP; 2005-2011); (2) The Community Networks Program Centers (CNPC; 2010-2016); and (3) The National Outreach Network (NON; 2010-Present).
Specific Objectives, Research Scope, and Main Requirements for this FOA
Applicants responding to this FOA must propose multilevel interventions intended to improve referral and ultimately, accrual of R/E minority patients to NCI-supported CTs. In addition, each U01 grantee site is expected to coordinate with the Data, Evaluation, and Coordinating Center to develop and use shared evaluation metrics, administratively coordinate CUSP2CT Program activities, and share best practices and recommendations.
Specific Objectives of this FOA
This FOA supports research to test, refine, and examine the impact of a multilevel intervention on rates of CT participation of R/E minority patients to NCI-supported CTs. CUSP2CT represents an opportunity to coordinate efforts to systematically increase referral and ultimately, accrual to NCI-supported CTs while addressing different levels of barriers to clinical trial referral. These implementation platforms should include education and outreach to both the community and to referring healthcare providers, strategically monitored, and updated for optimum results. CUSP2CT aims to employ CHEs, and LHAs as effective liaisons between the community and health care providers and care centers, and minority-serving institutions based on preliminary data and literature.
Research Scope of this FOA
This FOA encourages the submission of applications to implement and evaluate multilevel and culturally and linguistically tailored outreach and education interventions with the primary goal of increasing referral of racial/ethnic (R/E) minority populations to NCI-supported CTs.
Each CUSP2CT U01 applicant must identify an active NCI-supported CT that is soliciting referrals and accruing from one or more of NCI-supported CTs. The following expectations and scope of research activities are listed below.
Sites will select NCI-supported CTs to promote among primary care and referral providers, and at the same time inform providers about CT resources, such as clinicaltrials.gov, for a thorough list of available NCI CTs for their patient population. U01 applicants will be required to have appropriate infrastructure in place, along with established partnerships from relevant organizations (e.g., Cancer Centers and community-based organizations), although increasing capacity and establishing new partnerships is also encouraged.
Main Requirements for this FOA
Priority Areas
The following are examples of interventions delivered by CHEs/LHAs, that would be responsive to this RFA:
Theory based research designs culturally tailored to R/E minority populations might include Individually Randomized Studies, Group Randomized Studies (e.g., matched clinics randomly assigned to either an experimental or control group) or Quasi-experiments (e.g., pre-post and/or matched control designs). When appropriate, building upon attributes developed for the Clinical Trial Assessment of Infrastructure Matrix (CT AIM) may be proposed. Eligible institutions accrual history to NCI-supported CTs and demonstration that sufficient number of CTs available to provide opportunities to increase referrals will be required. Further, an evaluation plan, tracking, and multilevel intervention strategies must be clearly articulated and all necessary approvals (e.g., IRB) must be obtained prior to the award. Common metrics will be selected from metrics proposed by the awarded U01s. Additional metrics may be added as needed, consistent with the program evaluation plan developed by the DECC in coordination with the steering committee.
Applications that address cancers diagnosed in children, adolescents, and/or young adults are encouraged (in line with the goals of the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2018, Public Law No: 115-180).
Partnerships with Local, Regional and National Programs and Organizations
It is recognized that recruiting R/E minority populations into cancer clinical trials will require leveraging and/or establishing partnerships with key stakeholders such as cancer centers and community based groups, the Specialized Programs of Research Excellence (SPOREs), relevant community and hospital-based programs, including NCI’s National Clinical Trials Network (NCTN; https://www.cancer.gov/research/infrastructure/clinical-trials/nctn), the National Community Oncology Research Program (NCORP; https://ncorp.cancer.gov/), the Clinical and Translational Science Awards Program (CTSA; https://ncats.nih.gov/ctsa), etc. This FOA also expects investigators to leverage and/or establish new partnerships with primary care and referring providers, as well as with community-based organizations, faith-based organizations, and non-profit organizations at the local, regional, and national levels.
Types of Cancer
Applications on cancers of major public health concern (e.g. those of the prostate, breast, colon, and lung) or on cancers that are major causes of cancer-related morbidity and mortality among racial/ethnic minority populations (e.g., those of the cervix, kidney, liver, stomach, blood, etc.) are encouraged. More than one cancer type (or R/E population) may be selected, as long as a sufficient number of participants per R/E minority group can be referred to CTs for meaningful interpretation of results.
Research Team and Main Capabilities
The proposed CUSP2CT U01 Grantee Site must have the following expertise and requisite capabilities in place:
Team Composition
The multidisciplinary team will include an appropriate combination of such specialties as:
Additional Requirements for this FOA
U01 sites must have active enrollment to NCI-supported CTs from one or more of NCI’s clinical trial networks (NCTN, NCORP, and ETCTN). Moreover, U01 grantee sites may select priority CTs to promote among primary care and referral providers and at the same time inform providers about CT resources, such as clinicaltrials.gov, for a thorough list of available CTs for their patient population.
Structure and Governance of the CUSP2CT
The CUSP2CT will include multiple U01 awardees and a U24 awardee (Data and Evaluation Coordinating Center) and will be governed by a Program Steering Committee (SC). The SC will be comprised of representatives from the U01 sites, Coordinating Center, and the NCI and will meet quarterly by videoconference and in-person, if possible, at the CUSP2CT annual network meeting to review referral rates, successful implementation of interventions utilizing CHEs and LHAs, data collection efforts, best practices, and overall progress to date, and as needed.
Awardees will identify shared resources that can support needs across the sites and maximize the collaborative nature and impact of the program. The CUSP2CT DECC, in conjunction with NCI staff, will facilitate collaborations within the program. Applicants responding to this CUSP2CT U01 are expected to familiarize themselves with the companion FOA (RFA-CA-21-058) for the CUSP2CT DECC. As the U01 awardees will interact closely with the DECC, the applicants responding to this FOA need to understand the role and responsibilities of the CUSP2CT DECC as well.
Though the SC will make programmatic and administrative recommendations, NCI/CRCHD Staff will have final authority to approve any proposed recommendations, and activities must comply with NIH, DHHS, and Federal Guidelines.
Additional details on the composition and functions of CUSP2CT Steering Committee are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award.
Non-responsive Applications
The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed.
See Section VIII. Other Information for award authorities and regulations.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NCI intends to commit $4.6 million in FY 2022 to fund 4 to 6 awards.
The application budget for the U01 is limited to $450,000 in direct costs per year.
The scope of the proposed project should determine the 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
LeeAnn Bailey, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5337
Email: leeann.bailey@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biosketches should reflect the PD(s)/PI(s) and key personnel's expertise in community-based participatory research, clinical trial education and outreach, referral-to-care, health services or healthcare delivery research, multilevel interventions, experimental or quasi-experimental designs, and implementation science. Research personnel are also expected to have a track record of conducting studies with multiple stakeholder groups involved in healthcare delivery.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Any individual designated as a PD/PI must commit a minimum of 1.8 person-months effort per year to the project. The PD/PI person-months effort cannot be reduced in later years of the award.
The budgeted effort of other personnel must be appropriate to the needs and objectives of the project.
Applications must include a travel budget for several key personnel (e.g., U01 and U24 PD[s]/PI[s], and program manager) to attend an annual 2-day meeting of the CUSP2CT Steering Committee for the duration of the 5-year CUSP2CT Program. Meetings will take place in the Bethesda, Maryland, area if possible, or via video conference.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Outline the hypothesis/hypotheses being tested and the specific aims of the proposed project.
Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.
Sub-section A. Background and Significance
Define, justify, and explain the rationale for the selection of the R/E minority population(s) focus of the project. Include local data demonstrating CT referral and participation rates that do not reflect the R/E composition of specific cancer(s) of interest in the local population, and inventory of NCI-supported CTs available to R/E minority members in the designated area.
Describe how barriers to CT referral and participation can be addressed.
Sub-section B. Preliminary Data
Describe the overall approach to be pursued. Though preliminary data are not required, if limited preliminary data are provided, they will be evaluated. In lieu of preliminary data, applicants may provide the underlying logic or rationale for pursuing the project in the manner proposed. Summarize what is believed to be the major challenges or risks in the project and alternative approaches that may need to be pursued.
Sub-section C. Approach (divided into 3 phases)
Phase I (Year1): Preliminary and Baseline Assessment
Phase II (Years 2-4)I: Data Collection, Assessment, and Intervention phase
Phase III (Year 5): Final Site Evaluation
Sub-section D. Milestones and Timelines
A timeline (including milestones) is required for the U01 grantee Phases I, II and III. The timeline and milestones should reflect overall objectives of each phase. Milestones should be well-defined and include objective criteria for success. Annual milestones should function as indicators of a project's progress and will be used to evaluate the application in peer review and in consideration of funding for the project in non-competing award years. Timelines must include metrics for assessing progress for each phase, including specific milestones for progressing from the preliminary and baseline phase, the data collection, assessment and intervention phase and the final site evaluation phase. Milestones and timelines should be provided under separate headings at the end of the 'Approach' section for the U01 Grantee Site project. The following are particularly important:
a) Provide appropriately detailed criteria by which milestone achievement will be assessed;
b) Provide a detailed timeline for the anticipated achievement of each milestone and overall goal; and
c) Identify any impediments that could require a revision to the research plan, milestones, and/or timeline along with a discussion of alternative approaches.
Letters of Support: Applicants must include letters of support from collaborating entities (e.g., hospitals, clinics, health departments, community-based organizations, 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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The emphasis for this FOA is to support projects with the primary goal of increasing referral of racial/ethnic (R/E) minority populations to NCI-supported clinical trials (CTs) by the implementation and evaluation of multilevel and culturally tailored outreach and education interventions.
In determining the merit of applications, reviewers will emphasize key issues that affect diversity in clinical trials, and the interventions that will be employed through the CHEs and LHAs to improve the dissemination of information and care into underserved communities, where they are needed most. The reviewers will also focus on the feasibility of the proposed activities to create opportunities that establish meaningful, integrated linkages within the community to increase health equity and diversity in NCI-supported CTs.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific for this FOA
What is the potential of the proposed multilevel intervention to significantly increase rates of R/E referral, and participation to NCI-Supported CTs?
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 for this FOA
How appropriate and diverse is the research team's expertise to manage pilot testing, refinement, and assessment of the impact of the multilevel intervention on R/E referral? For example, how appropriate is the team's expertise in culturally and linguistically tailored education and outreach? How appropriate is the expertise to manage healthcare services or healthcare delivery research; implementation science; multilevel interventions; experimental or quasi-experimental study designs; health disparities; and partnership research? What is the likelihood that all stakeholders will be able to collaborate and work together to complete the proposed multilevel intervention?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific for this FOA
To what extent does the proposed multilevel intervention include completely novel approaches or innovative adaptation of existing approaches? How appropriate is the selection of components of the multilevel intervention based on local data regarding barriers and facilitators to the adoption and implementation of evidence-based interventions? How sound are the proposed referral pathways to NCI-supported CTs that would require minimal resource investment on the part of health care organizations, including linkage to community-based resources that could ease the referral burden on providers and their staff?
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?
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?
Specific for this FOA
How appropriate are the plans for addressing data collection? How rigorous and feasible is the plan to pilot test, refine, and assess the impact of the multilevel intervention on the rates of R/E minority individual referral and participation? How acceptable are the plans for facilitating the NCI Public Access and Data Sharing Policy?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Milestones
How clearly are the steps and milestones defined? How feasible and quantifiable are the milestones with respect to proposed objectives?
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
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).
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.
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 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:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, 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.
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, 2 CFR 200 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 recipients 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 for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the following primary responsibilities:
Additional responsibilities include:
NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion various activities of the recipients. Specific responsibilities of the NCI Project Scientist(s) will include the following aspects:
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.
Areas of Joint Responsibility include:
CUSP2CT Network Steering Committee. CUSP2CT U01 recipients funded under RFA-CA-21-057 and the U24 awardees funded under RFA-CA-21-058 will form, together with the NCI, the Steering Committee, which will be the main governing body for the CUSP2CT Network. The CUSP2CT Network Steering Committee will be composed of a representative from each U01 grantee site and the CUSP2CT Coordinating Center who will have one vote each.
If needed, other NIH staff members may also participate in CUSP2CT Network Steering Committee meetings as non-voting members. A PI, representing a CUSP2CT U01 Research Center, will be selected to serve as chairperson of the CUSP2CT Network Steering Committee starting at the first meeting of the CUSP2CT Network Steering Committee following award issuance. All CUSP2CT Network Steering Committee decisions and recommendations that require voting will be based on a majority vote.
The CUSP2CT Network Steering Committee will meet quarterly by videoconference and in-person, if possible, at the CUSP2CT annual network meeting.
The CUSP2CT Network Steering Committee will:
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 recipient. This special dispute resolution procedure does not alter the recipient'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.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
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 recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: 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
LeeAnn Bailey, M.D., Ph.D.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276-5337
Email: LeeAnn.Bailey@nih.gov
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.
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