EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required)
UG1 Clinical Research Cooperative Agreements - Single Project
Reissue of RFA-CA-13-012
RFA-CA-18-015
RFA-CA-18-016 , UG1 Clinical Research Cooperative Agreements - Single Project
RFA-CA-18-017 , UG1 Clinical Research Cooperative Agreements - Single Project
Each applicant organization may submit only one application as defined in Section III. 3. Additional Information on Eligibility.
93.393, 93.394, 93.395, 93.399
This Funding Opportunity Announcement (FOA) solicits applications from institutions/organizations to participate as "Research Bases" for the National Cancer Institute (NCI)-supported Community Oncology Research Program (NCORP). NCORP is a community-based research network that:
NCORP consists of three components each with its own FOA: NCORP Research Bases (covered by this FOA); NCORP Community Sites; and NCORP Minority/Underserved Community Sites.
The NCORP Research Bases will design and conduct cancer clinical trials and care delivery research studies as well as manage and analyze the data and report the research results.
June 13, 2018
July 31, 2018
July 31, 2018
August 31, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
No late applications will be accepted for this FOA.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
February - March 2019
May 2019
August 2019
September 1, 2018
Not Applicable
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) is one of three FOAs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to take advantage of large and diverse patient populations receiving care in a variety of community oncology settings. The purpose of this Program is to engage these cancer patient populations in rigorous studies focused on cancer control, prevention, and care delivery.
NCORP will support the following components that will be individually awarded through the respective FOAs indicated below:
NCORP Research Bases will serve as research hubs for the NCORP network. Research Bases are expected to:
NCORP Community Sites are a consortia of community hospitals and/or oncology practices, which may or may not be formally affiliated in a healthcare system, that accrues participants to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.
NCORP Minority/Underserved Community Sites are a consortia of community hospitals and/or oncology practices, a public hospital, or academic medical center that has a patient population comprising at least 30% racial/ethnic minorities or rural residents and accrues participants to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.
Key Definitions for the context of this FOA:
The terms Clinical Research and Clinical Trials in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch)
NCI Central Institutional Review Board (Central IRB, https://www.ncicirb.org/about-cirb/): is a centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards.
Community Site Primary Affiliate: In the context of the NCORP community-based structure, a "primary affiliate" refers to a hospital, cancer center, physician practice, or other institution where patients/participants are enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials available to the NCORP Community Site or Minority/Underserved Community Site.
Community Site Sub-Affiliate: In the context of NCORP community-based structure, a "sub-affiliate" refers to a practice or organization that contributes to the overall accrual of a primary affiliate site but is located in a separate geographic location(s), is part of the primary affiliate’s business entity, is managed by the primary affiliate, and is under the primary affiliate site’s Federal Wide Assurance (FWA).
Whereas various academic medical centers play a crucial role in cancer clinical research, the bulk of cancer care takes place in community settings. Expanding clinical research into community settings allows access to a larger and more diverse patient population treated in a variety of healthcare delivery settings, which can accelerate accrual to cancer clinical trials and increase the generalizability and relevance of study findings. In addition, research in community settings reflects the complexity of cancer care delivery and engages community oncologists in efforts to develop care delivery approaches that can be implemented within usual clinical workflow.
The NCI has supported cancer clinical research within community settings for over three decades. The participation of community oncologists, non-oncology specialists, and primary care physicians in cancer clinical trials has facilitated the introduction of research advances into practices throughout the country. The era of genomics and molecularly-targeted therapy necessitates shifts in the delivery of cancer-related care.
The foundation of the NCORP network is the conduct of multi-site cancer clinical trials in primary focus areas of cancer control, prevention and care delivery. In addition, NCORP plays an important role in the National Clinical Trials Network (NCTN), a major NCI-supported infrastructure for cancer clinical trials. Approximately 30 -35% of the patients enrolled on NCTN treatment clinical trials, including precision medicine studies, are from NCORP sites.
The NCORP Community Sites and Minority/Underserved Community Sites have responded to many of the challenges associated with implementation of precision medicine by providing quality specimens for genomic sequencing and establishing the multidisciplinary teams to support the new generation of clinical research. Recent advances in technology are providing new opportunities to characterize premalignancies in ways that will enhance the development of cancer prevention interventions, and biomarkers of response to those interventions, and biomarkers of risk. NCORP’s access to diverse populations in terms of age, race/ethnicity, as well as partnerships with non-oncology practices provides a natural laboratory for the efficient development of strategies for precision prevention and a robust assessment of the risks and benefits tested. Similarly, knowledge of the role of the immune response is increasingly incorporated in cancer prevention research. Cancer screening research is being developed and conducted in the community setting to reduce aggressive cancer incidence, identify over-diagnosis, and determine risk-based screening in the general population. Community research organizations have proven to be well positioned to promote the science in symptom management, cancer prevention, and post-treatment surveillance.
NCORP has streamlined its scientific and operational processes and expanded its review structure with three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees, (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) that provide peer-review for scientific concepts. Access to the Clinical Trials Support Unit (CTSU) allows sites access to all current study materials and the Central Investigational Review Board (CIRB) provides human subjects review, all of which increase efficiency and reduce redundancy. In addition, an infrastructure for cancer care delivery research studies has been built in which both interventional and observational care delivery research studies are being conducted.
Overall Goals of NCORP and Scope of this FOA
The overall goal of NCORP is to bring cancer clinical research studies to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities.
The roles of NCORP Community Sites and Minority/Underserved Community Sites are to provide access to a diverse patient population from varied delivery settings, allowing enhanced accrual of underrepresented populations such as racial/ethnic minorities, adolescent and young adult (AYA) and elderly, sexual and gender minorities, and rural residents to clinical trials and other human subject studies.
The role of NCORP Research Bases is to serve as a main research infrastructure for NCORP Community Sites and Minority/Underserved Community Sites. Therefore, Research Base awardees will be expected to contribute to and focus on the following activities:
Scope of Activities for Research Bases
The scope of research activities for the proposed NCORP Research Bases encompasses three major areas delineated below:
Area 1: Cancer Control Research; and/or
Area 2: Cancer Prevention Research; and
Area 3: Cancer Care Delivery Research.
Research Bases must cover either Area 1, or Area 2, or both. All Research Bases must cover Area 3.
If the proposed Research Base chooses to conduct research in both Cancer Prevention (Area 1) and Cancer Control (Area 2), concept development should be reasonably balanced between the two areas.
Additional details and examples of research appropriate for Areas 1-3 are provided below.
Area 1: Cancer Control Research. Efforts in this area should be aimed to reduce the morbidities associated with cancer and its treatment, as well as improving the quality of life of individuals undergoing cancer treatment or with a history of cancer. Studies can include, but are not limited to:
Area 2: Cancer Prevention Research. Efforts in this area should be aimed at reducing cancer risk, incidence and mortality. Studies can include but are not limited to:
Area 3: Cancer Care Delivery Research. Efforts in this area should seek to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery with an emphasis on diagnosis, treatment, survivorship, and end-of-life care. The most desirable studies will be those that undertake one or more of the following:
Integrating Health Disparities Research. Research seeking to understand and address health disparities should be incorporated into each of the areas referenced above, including both studies focused exclusively on disparities and the inclusion of disparities-related aims in studies with a broad focus. Populations of specific interest include AYA and the elderly; racial and ethnic minorities; sexual and gender minorities; and rural residents.
NCORP Trans-network Interactions
All NCORP participants will be expected to work jointly towards the NCORP network goals by using the following general strategies:
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.
New
Renewal (but only for the awards supported under RFA-CA-13-012)
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Required - Only accepting applications that propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
The National Cancer Institute intends to commit $74.5 million in FY 2019 for up to seven awards.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
All applicants should request a 6-year project period.
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
Governments
Other
The following additional provisos apply:
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.
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.
Only one application per institution is allowed in response to this FOA .The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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:
Worta McCaskill-Stevens, M.D.
Telephone: 240-276-7050
Fax: 240-276-7847
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exception:
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.
Facilities & Other Resources: In addition to standard items for this attachment, the applicants should provide the following information/documentation.
Summary of Collective Bodies/Committees for Research Base Core Functions (use filename: Core Functions).
Provide information on committee memberships held by key investigators that will contribute to the core functions of the proposed Research Base. Memberships may include committees such as Executive and Oversight Committees (all members should be listed); Data Safety and Monitoring Board (all members should be listed); Scientific Committees (list only Chair and Vice-Chair positions - do not include subcommittee heads); Community investigators for each Scientific Committee should be listed; and Administrative Committees (list only Chair and Vice-Chair positions - do not include subcommittee heads). Please Note: A table can be used to show this information with column headings for the Staffing Category for the Research Base (i.e., type of committee), Member status (i.e., Chair, Vice-Chair, Member) general category of Research Base or Network Group/NCI Steering Committee/NCI Initiative, specific category or activity; Member Name, Member Title, Member Institution, and Length of Service in the Position. The date the table was prepared should be provided as a sub-heading (e.g., Information Current as of MM, DD, YY).
Constitution and By-Laws for Site & Investigator Membership in the proposed Research Base (use filename: Membership Constitution By-Laws).
Provide a summary of the Constitution & By-Laws for the proposed Research Base related to both site and investigator membership to illustrate how both sites and investigators are recruited and evaluated.
Other Attachments: Applicants must provide the following additional material specified below. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).
Attachment 1. Summary of Important Primary Scientific Achievements (use filename: Primary Achievements)
Attachment 2: Summary of Other Important Achievements (use filename: Other Achievements).
Attachment 3: Summary Accrual for All Clinical Trials and Related Studies by CCP&CD Category by Members of the Research Base (use filename: Member Accruals).
Attachment 4: Conflict of Interest Policy (use filename: COI).
Provide documentation of the Conflict of Interest Policy used by the proposed Research Base to ensure that staff and investigators working on the design, monitoring, and analysis of specific studies do not have any conflicts of interest with respect to the studies. Include policies to maintain study blinding.
Attachment 5: Model Statistical Analysis Template (use filename: Statistical Template).
Provide documentation/example of the proposed Research Base’s standard template used for generating statistical analysis plans for clinical studies as well as the proposed Research Base’s standard "Report of Studies" template for providing information related to ongoing and recently closed studies to its members.
Attachment 6: Audit Policy and On-Site Auditing Summary (use filename: Audit Policy and Auditing Summary).
Attachment 7: Operational Timelines for Development of Clinical Trials and Related Studies (use filename: Study Timelines).
For New applications: Provide information on the timeline for the development and activation/opening of clinical studies designed and conducted by the applicant group. This information should be provided only for clinical studies activated in the past 5 years. This information should be provided in a series of tables so that the data can be provided separately by scientific area (cancer control, prevention, and care delivery) and study design (clinical trial, longitudinal/cohort, observational, descriptive).
Attachment 8: Data Management and Monitoring Policies & Procedures for Clinical Studies (use filename: Data Management and Monitoring).
Attachment 9: Key Procedures to Ensure Security and Confidentiality of Patient Data (use filename: Securing Patient Confidentiality).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions apply.
A minimal effort level of 1.2 person-months is required for each PD/PI regardless of whether that individual is designated as contact PD/PI or not. (This commitment cannot be reduced below that level during the projects period).
In the Budget Justification attachment, in addition to standard items for this attachment, provide a breakdown of the direct costs to show separate dollar amounts for both Control/Prevention and Cancer Care Delivery research activities. Do this for each budget period requested. Provide such information for each budget category where funds are requested.
The following costs are not supported under 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, with the following additional instructions:
Specific Aims: Describe the overall Specific Aims for the proposed Research Base addressing the development and conduct of cancer prevention, control, and care delivery (CPC&CCD) research. The study design, methods, and/or interventions for these areas of research may not by themselves be innovative but address important questions or unmet needs. Explain how the completion of these Aims is expected to advance oncology care and reduce disparities in cancer care and outcomes.
Research Strategy: Organize the Research Strategy section with sub-sections in the specified order and follow the instructions provided below. Start each subsection with the appropriate subsection heading.
Subsection A. Developing and Implementing the Scientific Agenda - Address the following areas:
Overview
Outline the overall strategy and approaches that the applicant team will use to develop and implement its research agenda.
Progress Report
For Renewal applicants:
For New applicants:
Research Priorities
Statistics and Data Management
Accruals
Investigator Participation throughout the NCORP Network
Subsection B. Organizational Leadership, Structure and Operational Management - Address the following areas:
Administrative Leadership
Operational Capacity/Oversight
Scientific Leadership
Subsection C. Challenges to Concept Development of Clinical Studies for NCORP Community Investigators -Address the following areas:
For Renewal applicants:
For New applicants provide:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or 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.
Given that applicants should not propose any specific clinical trials at the time of application, Study Record should NOT be completed.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Both Renewal and New Applications must add and complete the Delayed Onset Study record and must check box "Anticipated Clinical Trial?".
Study Title-- use: "Multiple Delayed Onset Studies"
Justification Attachment: Indicate that the clinical trials will be designed and conducted by the NCORP Research Base during the Project Period. Each clinical trial protocol developed will be subject to approval through the standard NCI procedure that involves an initial concept submission and subsequent review. If the concept receives approval, the next stage will be development of the protocol, which also must undergo review and approval by one of the three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) prior to activation through the NCORP network. Indicate areas of oversight, regulatory compliance monitoring, etc. that will be the responsibility of the proposed Research Base. Indicate aspects of study development and implementation in which Research Base will work jointly with affiliated Community Sites.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCI, NIH. 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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
As this FOA is to support the essential NCORP clinical trials infrastructure, reviewers will assess to what degree the proposed Research Base will be able to fulfill all the required functions, including rigorous study design, focus on interventions that address clinically important questions or unmet needs, as well as optimal interactions with NCI and the member sites enrolling patients to clinical trials.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
In addition, specific for this FOA: Is there a strong scientific premise for the Research Base proposed priorities and menu of clinical trials and other human subject studies in cancer control, prevention, and care delivery for the NCORP network?
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?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
In addition, specific for this FOA: How well does the proposed leadership for the Research Base have the expertise and the ability to organize, manage, and implement the comprehensive clinical trials and other human subject studies menu proposed for the NCORP network?
How well does the organizational structure support the administrative leadership for the proposed Research Base?
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?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Does the application adequately address the following, if applicable?
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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.
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.
Not Applicable.
For Renewals, the committee will consider the progress made in the last funding period.
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.
Not Applicable.
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).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
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:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant
administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement - an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to
support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.
The PD(s)/PI(s) will have the primary responsibilities for:
In addition:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Designated NCI Program Director(s) will have substantial involvement as a Project Scientist(s).
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.
A Program Official may also have substantial programmatic involvement (as a Project Scientist).
Activities of substantially involved NIH staff members will include:
Areas of Joint Responsibility include:
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]
GrantsInfo
(Questions regarding application instructions and process, finding NIH grant
resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Worta McCaskill-Stevens, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7050
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
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 42 CFR Part 52 and 45 CFR Part 75.