Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
U24 Resource-Related Research Projects Cooperative Agreements
The purpose of this Funding Opportunity Announcement is to solicit applications for Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) U24 Data, Evaluation and Coordinating Center (DECC). The DECC is intended to support CUSP2CT, a program designed to increase referral to NCI-supported clinical trials (CTs) among underrepresented racial/ethnic (R/E) minority populations who experience disproportionately higher rates of incidence, morbidity, and mortality for numerous cancer types in comparison to Non-Hispanic Whites (NHW). They are well-documented underserved groups whose cancer screening and CT participation rates are disproportionately low. CUSP2CT is 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 R/E minority populations, to NCI-supported CTs (National Clinical Trial Network (NCTN), NCI's Community Oncology Research Program (NCORP), and Experimental Therapeutics Clinical Trials Network (ETCTN)). The proposed CUSP2CT Program/Network will be comprised of 4-8 local multidisciplinary and integrated U01 grantee sites and a U24 Data, Evaluation & Coordinating Center (DECC).
Applications should address cancer health disparities (CHD), by employing an integrated network of local multidisciplinary and integrated partners that include community health educators (CHEs), lay health advisers (LHAs), community members, healthcare providers, and researchers, working in coordination to educate and refer R/E minority populations about NCI-supported CTs, and increase awareness about CTs among health care providers. This will require outreach and education interventions at the clinical trial site, provider, and/or patient levels. Specifically, the DECC will support the data and evaluation activities and coordinate a learning collaborative related to the U01 CUSP2CT Grantee Site program (companion RFA CA-21-057). CUSP2CT DECC will provide experienced project management for CUSP2CT Network activities, which include data management, i.e. receipt and warehousing, and analysis from U01 sites. The DECC will lead the collaborative efforts to identify and conduct shared metrics and measures required for program evaluation, identify effective interventions and develop recommendations based on the data. Consequently, the DECC will receive, on a quarterly basis from the U01 sites, all common data elements and all program evaluation-related data including qualitative data such as interviews and focus groups. The DECC will coordinate and facilitate meetings, both virtually and in-person, support manuscript development and publications, and disseminate findings to key stakeholders and the broader community.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| 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 applications 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
The purpose of this Funding Opportunity Announcement is to solicit applications for Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) U24 Data, Evaluation and Coordinating Center (DECC). The DECC is intended to support CUSP2CT, a program designed to increase referral to NCI-supported CTs among underrepresented racial and ethnic (R/E) minority populations who experience disproportionately higher rates of incidence, morbidity, and mortality for numerous cancer types in comparison to Non-Hispanic Whites (NHW). These are well-documented underserved groups whose cancer screening and CT participation rates are disproportionately low. CUSP2CT is 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 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 proposed CUSP2CT Program/Network will be comprised of 4-8 local multidisciplinary and integrated U01 grantee sites and a U24 Data, Evaluation & Coordinating Center (DECC).
Applications should address cancer health disparities (CHD), through an integrated network of local multidisciplinary and integrated partners that include community health educators (CHEs), lay health advisers (LHAs), community members, healthcare providers, and researchers, working in coordination to educate and refer R/E minority populations about NCI-supported CTs, and increase awareness about CTs among health care providers. This will require outreach and education interventions at the clinical trial site, provider, and/or patient levels. Specifically, the DECC will support the data and evaluation activities and coordinate a learning collaborative related to the U01 CUSP2CT Grantee Site program (companion RFA CA-21-057). CUSP2CT DECC will provide experienced project management for CUSP2CT Network activities, which include data management, i.e. receipt and warehousing, and analysis from U01 sites. The DECC will lead the collaborative efforts to identify and conduct shared metrics and measures required for program evaluation, identify effective interventions and develop recommendations based on the data. Consequently, the DECC will receive, on a quarterly basis from the U01 sites, all common data elements and all program evaluation-related data including qualitative data such as interviews and focus groups. The DECC will coordinate and facilitate meetings, both virtually and in-person, support manuscript development and publications, and disseminate findings to key stakeholders and the broader community.
Key Definitions for this FOA
CUSP2CT Network: Refers to the combined effort of the U01 Grantee Sites, Data and Evaluation Coordinating Center, and the NCI to advance the science of implementation of multilevel interventions to increase rates of CT referral and accrual among underserved populations
CUSP2CT Steering Committee: Includes representatives from the CUSP2CT DECC, each U01 Grantee site, and the NCI.
CUSP2CT DECC: Includes the coordinating center funded through this RFA-CA-21-058.
CUSP2CT U01 Grantee Site: Includes U01 projects funded through the companion FOA, RFA-CA-21-057.
Experimental Study Design: Study design that includes manipulation (i.e., exposure to at least one intervention), randomization, and a control group. Studies must include prospective randomization to one or more experimental condition(s) (i.e., multilevel intervention) and include a control condition (e.g., standard-of-care, comparison condition, time-attention control). 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 under this project to enhance the diversity of participants. NCI’s Cancer Center Support Grants for NCI-designated Cancer Centers also provides 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 focused on R/E minority outreach and provided feasibility for the community-focused strategies where the new FOA fits. 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).
Research Objectives and Main Requirements
The CUSP2CT DECC (U24) will operate as supporting infrastructure for the CUSP2CT network. In this capacity, the DECC will collaborate with the U01 investigators and interact with involved NCI staff members and with other stakeholders, as needed.
Major responsibilities of the DECC will include:
Specific functions of the DECC for these two areas will include (but will not be limited to) the following activities:
Evaluation:
Network Coordination:
Convene quarterly meetings of the Steering Committee, comprised of the U01 PIs, the DECC PI/PD, and NCI staff. These meetings will be conducted virtually except the first meeting of the fiscal year will be in-person at NCI facility.
Milestones
In order to ensure success of the CUSP2CT program and network, certain key activities must begin and/or be completed at designated times in the 5 year program.
Year 1:
Years 2 through 4:
Year 5:
CUSP2CT DECC Team Expertise and Composition
The composition of the research team for the proposed DECC must ensure the requisite expertise in program evaluation, data management and analysis, Cancer Health Disparities (CHD), community outreach and engagement including community based participatory research (CBPR). In addition, the team should be capable of effective communications and productive collaborations with various stakeholder groups and have a familiarity with oncology-related referral processes including referral to clinical trials. Therefore, the team is expected to include senior members who have considerable leadership skills and experience in productive collaborations with research teams and multi-stakeholder groups (e.g., clinics, health departments, hospitals, community-based organizations).
It is expected that in order to adequately fulfill evaluation and administrative coordination responsibilities, the CUSP2CT DECC team will need multidisciplinary expertise such as:
Structure and Coordination of the CUSP2CT Network
The CUSP2CT network will consist of multiple CUSP2CT research sites and the DECC. The CUSP2CT network will function as a collaborative network allowing CUSP2CT research sites to address common issues, share best practices and lessons learned, and utilize common metrics and measures where appropriate.
The DECC will be required to interact closely with the CUSP2CT research sites (to be supported under companion RFA CA-21-057). Therefore, the prospective DECC applicants are expected to read RFA CA-21-058 and familiarize themselves with the scope and responsibilities of the CUSP2CT research sites.
CUSP2CT Network Steering Committee: The Network will be governed by the CUSP2CT Steering Committee. The Steering Committee will be comprised of the U01 Principal Investigators and the DECC PI/PD, and appropriate NCI staff.
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 $595,000 in FY 2022 to fund one award.
Application budgets are limited to $350,000 in direct costs. The budget needs to reflect the actual needs of the proposed project.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this 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: [email protected]
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 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.
Budgeted effort of other personnel must be appropriate to the needs and objectives of the project.
Travel Budget: Applications must include a travel budget for several key personnel (e.g., U01 and U24 PD[s]/PI[s], and program manager), and 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.
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 general objectives of the proposed CUSP2CT Data, Evaluation and Coordinating Center (DECC) and the overall approach to achieving these goals.
Research Strategy: The Research Strategy section should document the applicant’s experience in coordinating multi-site research and should outline plans for carrying out the main functions of the DECC. The Research Strategy section must consist of subsections A-D as designated below.
Subsection A. Administrative processes for the DECC
Subsection B. Data Management, Analysis and Evaluation
Subsection C. Trans-CUSP2CT Research
Propose a process for the development and conduct of trans-CUSP2CT research studies (e.g., validation of newly developed measures, identification of best practices). Include a discussion of:
Subsection D. Data Sharing Process Development
Outline a process by which the DECC will work with the CUSP2CT research sites and with NCI to develop policies and procedures for qualified investigators outside of the CUSP2CT network to gain access to data for research purposes.
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 modifications:
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 the 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.
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 likelihood that the CUSP2CT U24 Coordinating Center, as proposed, will meet all the network coordination, evaluation and data standardization needs and help develop shared best practices for the CUSP2CT Network? How well will the proposed CUSP2CT Coordinating Center be able to contribute to the CUSP2CT Network, e.g., by resolving major challenges in network coordination, evaluation, data analysis and best practices? How well will the coordination and facilitation activities of the CUSP2CT U24 Coordinating Center, as proposed, contribute to the success of the CUSP2CT Network in generating best practices and identifying pathways to clinical trial participation for underrepresented racial/ethnic populations?
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 well do the PD(s)/PI(s) demonstrate evidence of experience working productively in collaborative environments? How robust is the participation of PD(s)/PI(s) in any collaborative, multi-center networks? How substantially have the PD(s)/PI(s) contributed to efforts involving referral and recruitment to clinical trials? How sound is the described management plan commensurate with the level of complexity required for this FOA?
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: How appropriate are the proposed evaluation strategies for potentially varied research designs? How sound is the proposed plan to make changes in response to changing needs of the network that the Coordinating Center is supporting?
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 likely are the plans for assisting with CUSP2CT Network activities, providing logistical support, and fulfilling Coordinating Center functions to increase the synergy and productivity of the Network? How strong are the research plans for each of the two major areas of responsibilities: (1) Evaluation; (2) Network Coordination? 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?
Specific for this FOA: How adequate is the infrastructure to meet the needs of the project? How well does the environment promote the collaborations and flexibility required to address the data and evaluation-related issues identified by the proposed CUSP2CT U24 Coordinating Center?
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? Are the milestones feasible and quantifiable 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 Parts 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 resides with the recipients for the project as a whole, 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 primary responsibility for:
In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information to the NCI.
Additional responsibilities include:
NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
One or more designated NCI Program staff members will have substantial involvement as Project Scientists in the awards under this FOA. The specific roles of the substantially involved NCI staff members include the following activities:
Specific responsibilities of the NCI Project Scientist(s) will include the following aspects:
Additionally, an agency program official or IC program director will be responsible for the standard scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
CUSP2CT Program Steering Committee. CUSP2CT U01 recipients funded under RFA-CA-21-057 and the U24 recipients funded under this RFA-CA-21-058 will form, together with the NCI, the Steering Committee, which will serve as the main governing board of the CUSP2CT Program. 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 regulations 42 CFR Part 50, Subpart D and HHS regulations 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: [email protected] (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: [email protected]
Leeann Bailey, PhD, MD
National Cancer Institute (NCI)
Telephone: 240-276-5337
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Crystal Wolfrey
National Cancer Institute
Telephone: 240-276-6277
Email: [email protected]
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.