and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
NCI Community Oncology Research Program (NCORP) Community Sites (UM1) |
Activity Code |
UM1 Multi-Component Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-CA-13-013 |
Companion Funding Opportunity |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.393, 93.394, 93.395, 93.399 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) solicits applications from institutions/organizations to participate in NCI's Community Oncology Research Program (NCORP) as NCORP Community Sites. The goal of NCORP is to build upon the scope and activities of NCI's previously supported community networks, the Community Clinical Oncology Program (CCOP) which includes CCOP community sites (CCOPs), Minority-Based CCOP sites (MB-CCOPs), and CCOP Research Bases, and NCI's Community Cancer Centers' Program (NCCCP) by establishing a single community-based research program. NCORP will be an integrated national network to: 1) design and conduct cancer prevention, control, and screening clinical trials; 2) design and conduct cancer care delivery research; 3) enhance patient and provider access to treatment and imaging clinical trials conducted under the reorganized National Clinical Trials Network (NCTN); and 4) integrate disparity research questions into clinical trials and cancer care delivery research. NCORP will consists of three components each with its own FOA: NCORP Research Bases; NCORP Community Sites (covered by this FOA); and NCORP Minority/Underserved Community Sites. The NCORP Community Sites will accrue patients/participants to NCI-approved cancer clinical trials and cancer care delivery research designed by NCORP Research Bases and NCTN Groups. |
Posted Date |
November 8, 2013 |
Letter of Intent Due Date(s) |
December 8, 2013 |
Application Due Date(s) |
January 8, 2014 |
AIDS Application Due Date(s) |
January 8, 2014 |
Scientific Merit Review |
March-April 2014 |
Advisory Council Review |
May 2014 |
Earliest Start Date |
September 2014 |
Expiration Date |
January 9, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and NIH’s Applying Electronically website for more information.
Part 1. Overview Information
Part 2. Full Text of 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 that implement the NCI Community Oncology Research Program (NCORP). The overall goal of NCORP is to bring cancer clinical trials, as well as cancer care delivery research, 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.
Note: The NCTN structures are evolving from the current main clinical trials program, the NCI Clinical Trials Cooperative Groups. Because not all awards for the NCTN components may be in place at the time of NCORP application submission, the further text related to FOA requirements provides dual references, e.g., "Clinical Trials Cooperative Groups or NCTN Operations Centers".
NCORP will support the following components that will be individually awarded through the respective FOAs indicated below:
NCORP Research Base is defined as a research hub for NCORP program. Research Bases must be located at leading institutions with comprehensive expertise in cancer clinical trials, such as institutions that are cancer foundations, healthcare research organizations (including sites of Clinical Trials Cooperative Groups or NCTN Group Operations Centers), NCI-designated Cancer Centers, or integrated healthcare systems. These institutions must have an established organizational structure for the design and conduct of multi-center cancer prevention, control and screening/post-treatment surveillance clinical trials and cancer care delivery research. The Research Base provides scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer prevention, control, and screening/post-treatment surveillance clinical trials, quality-of-life studies embedded within treatment and imaging clinical trials and studies on cancer care delivery. The Research Bases will be responsible for study operations and data management, including timely protocol development, compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements, audits, training, quality assurance, and site support.
NCORP Community Site is defined as a consortium of community hospitals and/or oncology practices or a community-based integrated healthcare system that accrues participants to: 1) cancer prevention, control, and screening/post-treatment surveillance clinical trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well as quality-of-life studies embedded within them; and 3) cancer care delivery research where participants can be defined as patients, practitioners, and/or healthcare organizations.
NCORP Minority/Underserved Community Site is defined as a consortium 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: 1) cancer prevention, control, and screening/post-treatment surveillance clinical trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well as quality-of-life studies embedded within them; and 3) cancer care delivery research where participants can be defined as patients, practitioners, and/or healthcare organizations.
This FOA solicits applications specifically for NCORP Community Site awards. Applicants interested in other NCORP components must use an appropriate companion FOA.
Although cancer clinical research has traditionally been conducted at academic medical centers, the bulk of cancer care takes place in the community setting. Expanding clinical research beyond the academic environment allows access to a larger and more diverse patient population treated in a variety of real-world healthcare delivery settings, which can accelerate accrual to clinical trials, allow for feasibility testing of promising new interventions in variable care environments, and increase the generalizability and relevance of study findings. Engaging community oncologists in collaborative research can also facilitate the uptake of effective, evidence-based practices into routine care.
In recognition of the importance of community-based clinical research, three decades ago, the NCI launched the Community Clinical Oncology Program (CCOPs, MB-CCOPs, and CCOP Research Bases) to form a clinical trials network to expand patient and physician access to cutting-edge cancer treatment clinical trials outside of traditional academic medical settings, as well as develop multi-institutional cancer prevention, control and screening clinical trials. In the years since, the CCOP network has become a key component of the national cancer clinical trials enterprise, contributing a substantial proportion of accrual to phase 2 and 3 treatment and imaging clinical trials with significant representation of minority patients, and implementing a series of pivotal and influential multi-institutional clinical trials in cancer prevention, control, and screening as well as health related quality of life studies. In 2007, the NCI’s Community Cancer Centers Program (NCCCP) was initiated to explore ways in which community hospitals could enhance access to care, improve the quality of care, and expand research across the entire cancer continuum with a focus on diverse racial, ethnic, and underserved populations.
Strong clinical trial programs remain essential to address the many unmet needs in cancer prevention, control, screening, and treatment. Yet findings from health services research and the promising role of quality improvement initiatives underscore the critical, complementary role of care delivery structures, processes, and organizational policies as determinants of patient care experiences and outcomes. Systematic studies and improvement of these factors are important in assuring that all patients, specifically those from minority/underserved populations, benefit from the best available knowledge about cancer prevention, control, screening, and treatment.
The importance and influence of cancer care delivery on patient care have led to the emergence of cancer care delivery research as a multidisciplinary field of scientific investigation that studies how complex, multi-level forces including social factors, financing systems, organizational structures and processes, health technologies, provider and individual behaviors affect cancer outcomes, access to cancer care, the quality and cost of cancer care and ultimately the health and well-being of cancer patients and survivors. Its focus includes individuals, families, organizations, institutions, providers, communities, populations, and their interactions. As the bulk of cancer care occurs in a community setting, community-based care organizations must be a key focus of cancer care delivery research that seeks to understand and improve patient outcomes based on these factors.
NCORP, while maintaining a vigorous program for the design and conduct of cancer prevention, control, and screening clinical trials and participation in NCTN treatment and imaging clinical trials, will expand the scope of activity to include cancer care delivery research. An important component of NCORP will be research on the diverse and multi-level factors that affect access to and quality of care in the community and also increase the focus on minority/underserved populations that are underrepresented in clinical trials and for which cancer care delivery issues are of great importance.
During the start-up and initial phase of NCORP, the expected relative balance in the level of effort between clinical trials and cancer care delivery research will be approximately 90% and 10%, respectively for a given Research Base and this is reflected in the FOA funding estimates. However, funding from other sources can be used to augment the cancer care delivery research efforts.
To address these goals, it is anticipated that NCORP awardees will focus on the following activities:
The current CCOP agenda for clinical trials is expected to be continued under NCORP as its predominant activity. Specifically, the NCORP agenda is expected to include the following aspects:
New areas of special emphasis will include studies addressing mechanisms of cancer symptoms and treatment-related toxicities, observational or longitudinal studies to understand the natural history of cancer symptoms and treatment-related toxicities, molecularly targeted agents to understand toxicities, post-treatment surveillance, underdiagnosis and overdiagnosis, and management of precancerous lesions. Post-treatment surveillance studies will evaluate the use of optimal screening modalities or tumor markers designed to detect recurrences of cancers following curative intent. Methods of diagnosis for cancers will be collected within NCORP trials to facilitate the collection of data required to evaluate over and under diagnosis of cancers (e.g., screening interval breast cancers).
NCORP will also build an infrastructure and research agenda for cancer care delivery research that includes the following:
The NCORP cancer disparities research agenda will integrate into clinical trials and cancer care delivery research, as appropriate, the following:
NCORP’s operating approach will share the principles underlying the transformation of the national cancer clinical trials enterprise and the creation of the NCTN. Essential features include:
Interactions with Other NCI-supported Programs. In addition to the three key components of NCORP which will be directly funded by the NCORP, other NCI-supported research programs and their awardees will have important supporting roles in achieving the research objectives of the NCORP. The NCORP awardees will be expected to interact with such entities/programs as the NCTN, the NCI Clinical Trials Tumor Banks, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards (CIRBs), research programs of NCI’s Center to Reduce Cancer Health Disparities, and NCI Advisory and Scientific Committees including the NCI Scientific Steering Committees.
Program Evaluation: NCORP will be subject to external evaluation (to be coordinated by NCI Program Staff) near the end of the project period. Such evaluation is part of NIH efforts to optimize the efficiency of funded research.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the PHS 398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The National Cancer Institute intends to commit an estimated total of $40.8 million ($35.4 million for cancer clinical trials and $5.4 million for cancer care delivery research studies) for up to 40 awards in FY 2014. Future year amounts will depend on annual appropriations. |
Award Budget |
Application budgets are not limited, but need to reflect the actual needs of the proposed project. Because the nature and scope of the proposed research will vary from application to application, the size of each award will also vary . |
Award Project Period |
5 years |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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
Additional eligibility provisions:
Institutions not eligible to apply include:
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 PHS 398 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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 PHS 398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Each applicant organization may submit only one application in response to this FOA.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS 398 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.
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., M.S.
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 5E502, MSC 9785
Bethesda, MD 20892-9785 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (240) 276-7050
Email: [email protected]
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:
Referral Officer
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 7W412, MSC 9750
Bethesda, MD 20892-9750 (for U.S. Postal Service regular or express mail)
Telephone: (240) 276-6390
Fax: (240) 276-7682
Email: [email protected]
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements.
Research Strategy must consist of the following sub-sections with the indicated page limits:
A. Organization and Structure - 12 pages
B. Leadership - 12 pages
C. Clinical Trials Research Program - 12 pages
D. Cancer Care Delivery Research Program - 12 pages
E. Operations/Data Management Core - 12 pages
The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a UM1 application.
Face Page
All instructions in the PHS 398 Application Guide must be followed .
Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells
All instructions in the PHS 398 Application Guide must be followed.
Table of Contents
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Modify the Table of Contents to include the required sub-sections of Research Strategy:
A. Organization and Structure
B. Leadership
C. Clinical Trials Research Program
D. Cancer Care Delivery Research Program
E. Operations/Data Management Core
Detailed Budget for Initial Budget Period
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Applicants should provide an itemization showing for each expense category how the initial period budget is divided between Clinical Trials expenses and expenses for Cancer Care Delivery Research.
NOTE: Applicants may visit the NCORP website at http://prevention.cancer.gov/ncorp for a worksheet that may help them complete the application budget section.
Budget for Entire Proposed Period of Support
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Applicants should provide within the budget justification an itemization showing for each expense category how the entire period budget is divided between Clinical Trials expenses and expenses for Cancer Care Delivery Research.
NOTE: Budget requests may include the following items: partial support for the PDs/PIs salaries but ONLY for time spent on NCORP organizational/administrative tasks; salary support for full or part-time research nurses, pathologists, administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); handling of investigational drugs related to NCI-approved protocols; travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel); and special personnel needed to support the recruitment and retention of eligible minority participants on clinical trials/studies.
The following items are NOT allowed in the budget requests: costs of clinical care provided to patients (e.g., for patient care reimbursement, transportation costs); salary support for clinical support personnel (e.g., physicist, clinical psychologist, and dosimetrist); and physician compensation (other than specified above for PD/PIs for their NCORP Community Site related administrative activities).
Biographical Sketch
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Resources
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
In addition to standard information, provide in this section documentation of important capabilities and available resources as indicated for specific functional components of the NCORP Community Site below. Relevant information may be provided in tabular form as listed below. Applicants are strongly encouraged to use, as appropriate, table templates provided at http://prevention.cancer.gov/ncorp.
Table 1 NCORP Components/Sub-components
Table 2 NCORP Site Accrual Record
Table 3A Currently Active NCI Clinical trials
Table 3B NCI Clinical trials Expected to be Activated
Table 4 Current and/or Planned Research Base Affiliations
Table 5 NCORP Site Capabilities
Table 6 Past Experience in Cancer Care Delivery Research
Table 7 Audit Summary Report
Table 8 - Number of Newly Diagnosed Cancer Patients by Site
Facilities: List and provide specific details on the available facilities, including laboratories, inpatient and outpatient resources, cancer registries, affiliated providers, delivery systems, etc. Clearly describe space available for administrative activities and personnel to serve as primary locus for data management, quality control, and communication. The description of this administrative space may be included in the Resources Section.
Other Commitments: Provide factual details documenting other resources committed to the program by the participating institutions.
Research Plan
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Specific Aims: Outline the Specific Aims of the proposed Community Site, indicating how they fit into the overall goals of the NCORP Program and the key requirements of the FOA.
Research Strategy: This section must consist of the sub-sections A-E described below.
Sub-Section A. Organization and Structure
Organizational Structure for NCORP Research Activities. Describe the current and/or planned organizational structure under which the applicant proposes to conduct clinical trials and cancer care delivery research. Include an organizational chart.
NCORP Community Sites are expected to function as consortia of the Community Site awardee institution and several partners. Depending on the relationship to the proposed Community Site institution, specific partners are referred to as NCORP Community Site "components" or "sub-components".
Definition of Community Site Component: In the context of NCORP Community Site structure, a "component" 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. In addition, one or more of the NCORP Site components are expected to participate in cancer care delivery research. Community Site awardee will be regarded as a "primary component".
Definition of Community Site Sub-Component: In the context of NCORP Community Site structure, a "sub-component" refers to a practice or organization that contributes to the overall accrual of a component site but is located in a separate geographic location(s), is part of the component s business entity, and is managed by the component.
If the NCORP Community Site applicants propose more than one component or sub-component, each must be listed to be considered part of NCORP. Describe the relationship of component(s)/sub-component(s) to each other and to the NCORP awardee Community Site, if applicable. Include a diagram showing the distance between these entities (including administrative office and shared resources) and location of proposed personnel.
NOTE: Information on the applicant’s component(s)/subcomponent(s) may be summarized in a table as described in the Resources Section above.
The applicant should identify at least one component that will participate in cancer care delivery research. Provide rationale to justify why specific component(s) are selected for this role. The component(s) should be able to implement on-site cancer care delivery research, provide organizational data (e.g., financial, service utilization, processes of care) in support of cancer care delivery research, and mentor other component(s) in their NCORP awardee network in cancer care delivery research. These capabilities can all be provided by a single component or by more than one component. Alternatively, the various capabilities may be distributed over two or more different components. If the applicant has more than one component designated to participate in cancer care delivery research, describe the relationship of component(s) to each other.
Catchment Area. The applicants must delineate their catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. Provide an estimate of the percentage of oncologists in the service area that will participate in the NCORP Community Site and a description of patient referral patterns within the catchment area. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. A description of the study population in the applicant’s catchment area should be provided with percentages by gender, race and ethnicity, as well as measures of social deprivation, such as socioeconomic status, poverty status and insurance status. Applications should provide information regarding the percentage of patients in the catchment area for the following age categories: 1-15, 15-39, 40-64, 65+; and percentage of patients in their cancer registries over the age of 65.
Clinical Practice Structure and Partnerships. Describe the types and sizes of the participating components/subcomponent(s) that will be included in the NCORP Community Site (e.g., outpatient/inpatient practices, hospitals/clinics/cancer centers), as well as the number of participating oncologists, primary care and other providers. Describe relationships with primary care and other providers that will be research collaborators with the applicant. Relationships with key community partners (e.g., faith-based organizations, advocacy groups, and community coalitions) and planned strategies to engage the community partners in increasing clinical trials education and outreach and facilitating wider community participation by patients and providers in clinical trials and cancer care delivery research should be described.
Institutional Commitment. All the consortium components' must be fully committed to participation in clinical trials, and, as applicable, cancer care delivery research. This section of Reasearch Strategy should include strategic statements and overview narrative relevant to the commitments to the program.
Facilities. Briefly describe the salient features of the facilities and other resources available (committed) for use by the proposed Community Site. Indicate the main efforts needed (or already conducted) to integrate these facilities/resources into one functional system, in particular if they are in geographically different locations and/or in different institutions. If appropriate, include a map or a scheme showing all the locations and their connectivity (by roads, by information technology, etc.). Indicate any systemic cross-institutional/cross-location enhancments that might be needed and are planned by the participating institutions. Specify any actions that are needed to ensure that appropriate space is available for administrative activities and personnel to serve as primary locus for data management, quality control, and communication.
Sub-Section B. Leadership
Outline the leadership structure and the roles of PD/PI and other senior investigators. [Note that for applications designating multiple PD(s)/PI(s), a separate section Leadership Plan must also be completed as per standard PHS 398 instructions). If the multiple PDs/PIs option is not chosen, applicants must identify a substitute PD/PI candidate to assure continuity and a smooth transition of leadership when necessary.
In addition, either the PD/PI (or one of the multiple PDs/PIs) or another senior researcher must be designated to have leadership responsibility for the cancer care delivery research program. The qualifications and experience of these individuals must be described, documenting their respective abilities to organize and manage a community oncology program that includes cancer prevention, control, screening/post-treatment surveillance, treatment and imaging clinical trials and cancer care delivery research as well as experience in accruing patients/participants to clinical trials and/or conducting cancer care delivery research. The application should also describe the strategy used by the PD(s)/PI(s) and the Institutional official to delegate leadership responsibility with respect to the clinical trials and cancer care delivery research selected for activation by the NCORP Community Site and how the responsibility is delegated among Key/Senior individuals.
A mentoring plan or program for leadership development within the NCORP Community Site is recommended. If such a plan exists or is under development, it should be described in the application.
It is expected that the PD(s)/PI(s) of the NCORP Community Site will already be established as leader(s) in some capacity in the community served by the Site. Characterize briefly these leadership roles played by PD(s)/PI(s) and other senior investigators (if applicable). Describe, for example, their relationships with community leaders in government and other organizations with goals related to cancer care including the quality of and disparities in cancer care (e.g., advocacy groups, county/state agencies). The impact of these activities on the success of the NCORP Community Site as well as on the overall community should be described including the potential to translate research findings into community oncology practices. In addition, the application should describe the leadership positions held by the PD(s)/PI(s) with affiliated Research Bases and contributions made in that position along with their impact. Parallel descriptions should be given for other Key/Senior personnel, if applicable. Finally, leadership roles of the PD(s)/PI(s) and other Key/Senior Personnel in national research organizations and professional societies should be described.
Other Professional Personnel. The application should propose a committed multi-disciplinary oncology research team of professionals appropriate for its expected clinical trial participation. With regard to cancer care delivery research, the component(s) proposed for participation should have a committed team involving oncologists, primary care and other providers, other professionals (e.g., administrators, care coordinators, genetic counselors), staff responsible for managing databases (e.g., cancer registries, electronic medical records, claims databases) and a senior administrator to facilitate implementation of studies that address organization and processes of care. A description of both teams, how they plan to operate and interact, and how they plan to lend their expertise to achieve the goals of the application should be provided.
Sub-Section C. Clinical Trial Research Program
Experience. Describe the applicant’s experience relative to implementing cancer clinical trials in the applicant’s practice setting(s) and provide a detailed summary of the applicant’s accrual to NCI-approved cancer prevention, control, screening/post-treatment surveillance, treatment, and imaging clinical trials as well as to any cancer clinical trials sponsored by other non-profit organizations during the past 5 years. In addition, describe the applicant’s contributions (if any) during the past 5 years to the research agenda of the Cooperative Groups and CCOP Research Bases with which the applicant has been affiliated.
NOTE: Supplementary information on the applicant’s accrual record may be summarized in a table as described in the Resources Section above.
Research Priorities. Describe the plans and approaches for implementing and conducting NCI-approved cancer clinical trials in the practice setting(s) of the community served by the applicant team, including approaches for engaging patients from minority and underserved populations, and hospitals, clinics and other cancer care settings that serve these populations.
Describe in narrative form the types of cancer prevention, control, screening/post-treatment surveillance, treatment, and imaging clinical trials the applicant expects to activate during the award period and include a description of the processes by which the applicant will select an adequate number of clinical trials to meet or exceed accrual requirements and/or planned accrual goals. The application should also describe why the proposed clinical trial categories are appropriate for the patients/participants in the NCORP Community Site's catchment area.
Include a list of the NCI cancer prevention, control, screening/post-treatment surveillance, treatment, and imaging clinical trials that are currently active as well as a list of the clinical trials that the applicant plans on activating during the next year. Applicants who are not current CCOP/MBCCOP award holders should provide a list of the currently active clinical trials that they would expect to activate as an NCORP Community Site if such clinical trials were still open to accrual once NCORP awards are made as well as proposed implementation plans for activating such clinical trials including specifics on patient/participant recruitment, compliance and follow-up, etc.
Describe the readiness and capacity of the consortium components to participate in clinical trials addressing the mechanisms of cancer symptoms and treatment-related toxicities, molecularly-targeted agents to understand toxicities, post-treatment surveillance, underdiagnosis and overdiagnosis, and management of precancerous lesions. The application should also describe readiness and capacity to collect biospecimens and an approach to facilitating understanding and adoption by community-based physicians of genomic medicine and targeted cancer therapies as well as educating cancer patients and at-risk individuals about these modalities.
The applicant’s recruitment and retention plans should be described, including outreach efforts and methods for engaging the community it serves, which may involve patient advocates. The plans for recruiting women, racial/ethnic minorities, and underrepresented populations (e.g., elderly, adolescents and young adults, patients who are under-and uninsured, and patients who reside in rural or low resourced urban areas) must be described. The information on women and minorities must be included under Inclusion of Women and Minorities.
NOTE: Information on the applicant’s currently active NCI clinical trials and/or NCI clinical trials expected to be activated may be summarized in tables as described in the Resources Section above.
Research Base Affiliations. The Research Base affiliations of the NCORP Community Site should be described in the application. Applicants without current CCOP or MB-CCOP awards should indicate their plan(s) for affiliations based upon their review of existing Research Base portfolios. The rationale for choosing these Research Base affiliations should be discussed. In addition, the application should outline plans for contributing to the scientific agenda of its affiliated Research Bases over the next project period. Examples of contributions might include: participation/membership in Research Base scientific committees or community liaison committees; serving as Chair(s) on cancer clinical trials; authorship of joint publications, etc. The process for eliciting and incorporating community input that informs the Research Base scientific agenda should also be described.
NOTE: Information on the applicant’s current and/or planned Research Base affiliations may be summarized in a table as described in the Resources Section above.
Accrual Plans. Each application must include plans for achieving accrual goals to cancer prevention, control, screening/post-treatment surveillance, treatment and imaging clinical trials over the next project period (5 years). Applications must include evidence that the NCORP Community Site can meet or exceed the required annual 80 new patient/participant accruals evenly distributed over the available cancer prevention, control and screening/post-treatment surveillance clinical trials versus treatment and imaging clinical trials, respectively.
Sub-Section D. Cancer Care Delivery Research Program
Background and Experience. Describe the capabilities to support the implementation of the cancer care delivery research in the following areas: genetic counseling, multidisciplinary care, care coordination/navigation processes, supportive/palliative care and outreach programs for minority/underserved populations. Describe the strategies (if any) used by practitioners and senior management at the institution(s) to support the implementation of cancer care delivery research. Outline the applicant's potential contribution of the requested data to multi-site studies. Mention other strategies considered including allowing staff to participate as subjects of research. Describe the level of proficiency of medical staff in the reporting of high quality medical data. List the participation in institutional, national and/or regional initiatives focused on improving the quality of care such as: American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI ), Commission of Cancer Rapid Quality Reporting System (RQRS), and Medicare's Physician Quality Reporting System (PQRS).
NOTE: Information on the capabilities of the component(s) designated for participation in cancer care delivery research in genetic counseling, multidisciplinary care, care coordination/navigation processes, supportive/palliative care and outreach programs for minority/underserved populations may be summarized in a table as described in the Resources section above.
If applicable, describe the history and experience of the designated component(s) in conducting cancer care delivery research during the past 5 years (e.g., comparative effectiveness research, survey studies). The description should include experience of relevant clinical professionals and other staff working together as a team in implementing cancer care delivery research as well as experience working with and merging multiple datasets (e.g., registry, medical record, financial data) and providing data to outside researchers and entities. Data provided in such studies could include existing secondary data or prospective data collected from patients, practitioners and/or other organizational personnel through surveys, focus groups or other methods.
NOTE: Information on the past experience of the component(s) designated for participation in cancer care delivery research may be summarized in a table as described in the Resources Section above.
Research Priorities. The application should identify specific study categories in which the component(s) proposed for participation in cancer care delivery research will participate as well as the processes used by the component(s) for selecting, implementing, and conducting NCI-approved studies. This cancer care delivery research may be observational or interventional in design. Observational studies may address patterns of care or service utilization, alternative organizational structures (e.g., integrated healthcare systems versus free-standing hospitals), programs to improve health behaviors, etc. Interventional studies may address implementation of new technologies (e.g., decision-making tools to support genomically-informed therapies), new approaches for multi-modality therapy planning and delivery, patient navigation and other care processes, incorporation of new types of information (e.g., patient reported information) into clinical decision-making, etc. These studies may also incorporate disparities research questions.
If the designated component(s) have experience in cancer care delivery research, describe the types of studies for which they offer particular capabilities and strengths to the NCORP network. If the designated component(s) are new to cancer care delivery research, describe approaches the institution(s) will use for enhancing their understanding of and preparedness for conducting cancer care delivery research. All applicants should also describe the strategies that their designated component(s) will take in the shaping of NCORP’s emerging cancer care delivery research agenda.
The application should include a description of the approaches to be used by the designated component(s) for involving oncologists, primary care physicians, other professionals (e.g., administrators, care coordinators, genetic counselors), and staff responsible for managing databases (e.g., cancer registries, electronic medical records, claims databases) in cancer care delivery research. Applicants should also describe plans for the designated component(s) to engage patients from minority/underserved populations, and hospitals, clinics and other cancer care settings that serve these populations.
Provide plans explaining how the designated component(s) will collect and manage data on program characteristics, patterns of care and organizational policies and make these data available to the affiliated Research Bases. These data would be expected to include but not be limited to: descriptions of organizational structures, in-depth information on specialists and specialized programs (e.g., palliative care), service utilization data, billing/financial data, quality monitoring data, and organizational policies such as personnel practices, clinical protocols and reimbursement arrangements. Describe any perceived barriers in the types of data that the designated component(s) would be able to report to investigators for approved studies.
Sub-Section E. Operations/Data Management Core
Institutional Review Board (IRB). Outline the processes the consortium has in place for ensuring compliance with regulations for IRB approval and informed consent (compliance with 45 CFR 46) related to research involving human subjects. A detailed description should be included under Protection of Human Subjects of the application and cross-referenced to this sub-section of the Research Strategy. Describe current (or planned) use of the NCI's Central IRB for cancer treatment clinical trials from NCTN Network Groups and their local IRBs for cancer prevention, control, and screening clinical trials and cancer care delivery research. Describe the approach for ensuring that IRB(s) with adequate expertise in cancer care delivery research is available.
Operations. Outline the standard operating procedures of the applicant’s team for activating clinical trials as well as for recruiting, enrolling and monitoring patients/participants. Describe the infrastructure the applicant has in place to oversee day-to-day operations for conducting clinical trials. Also describe the procedures to be implemented at the component(s) proposed for participation in cancer care delivery research for activating studies and recruiting, enrolling and monitoring participants. In addition, describe the plans for communication among physicians and components and incentives for their participation in studies.
Data Management & Quality Assurance. Procedures for data management and investigational drug monitoring must be described in the application. For both clinical trials and cancer care delivery research, address the following items:
In addition, for cancer care delivery research, address the following:
Describe how data management responsibilities are distributed within and between components/sub-component(s) and the central applicant office, if applicable. Describe how NCI and FDA requirements for investigational drug management are handled. The internal quality assurance plan of the applicant must be described in detail for both clinical trials and cancer care delivery research. Assurance of quality is the joint responsibility of the NCORP Community Site and its affiliated Research Bases. The applicant should describe its policies and procedures for complying with federal regulations related to confidentiality of patient data, including the Health Insurance Portability and Accountability Act (HIPAA) regulations.
Audit Performance. For applicants whose components currently participate or have previously participated in CCOP Research Base clinical trials, a brief description of the overall summary audit(s) results should be provided.
NOTE: The summary audit report information may be summarized in a table as described in the Resources Section above.
Protection of Human Subjects: In addition to standard items, provide essential details of the processes the consortium has in place for ensuring compliance with regulations for IRB approval and informed consent (compliance with 45 CFR 46) related to research involving human subjects. Cross-reference this description to Sub-section E of the Research Strategy).
Targeted/Planned Enrollment Table: Information on the targeted/planned enrollment for minorities and members of both genders and children, if applicable, should be based on accrual summarized across all diseases for the planned project period, not on a study- or disease-specific basis.
Letters of Support: In addition to standard items, include copies of affiliation agreements with Research Bases or Research Base letters of intent to support applicants.
Also include letters documenting institutional commitments of the participating institutions. If applicable include letters of intent to establish a consortium.
Letters of support for component sites participating in Cancer Care Delivery Research should indicate the degree to which sites and senior management are willing to provide service utilization, claims or service encounters, cancer registry, practice (e.g., national quality reporting), and financial data.
Resource Sharing Plan:Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS 398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
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 received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in
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.
The emphasis of this FOA is on the ability of the proposed Community Site to recruit, enroll, and retain participants in multi-institutional cancer prevention, control, and screening/post-treatment surveillance clinical trials, quality-of-life studies embedded within treatment and imaging clinical trials and studies on cancer care delivery. Proper affiliation and meaningful contributions to the studies led by NCORP Research Base are also essential.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NCORP Community Site 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 NCORP Community Site 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 research infrastructure such as NCORP Community Site that by its nature is not innovative may be essential to advance a field.
Significance
Does the NCORP Community Site address an important problem or a critical barrier to progress in the field? If the aims of the NCORP Community Site 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?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the NCORP Community Site? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: Are the qualifications, training, and experience of the PD(s)/PI(s) appropriate for organizing and managing a community oncology research program that includes accrual to NCI-approved cancer prevention, control, screening/post-treatment surveillance, treatment and imaging clinical trials and cancer care delivery research? How experienced are the PDs/PIs and other senior investigators in terms of leadership roles in the community or nationally in the areas that may enhance the NCORP Community Site and/or the research agenda of the affiliated Research Bases? How effectively has the applicant assembled a multidisciplinary oncology team for implementing a clinical trials agenda? Has (have) the component(s) proposed for participation in cancer care delivery research assembled a committed team for implementation of cancer care delivery research?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the NCORP Community
Site? 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?
If the NCORP Community Site involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Organization and Structure
(Note: This entire criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately).
Organizational Structure. How appropriate is the planned organizational structure to accomplish the proposed research activities?
Catchment Area. How complete is the information provided on the catchment area (e.g., geography, population, number of components)? Is the patient and provider pool large enough to ensure that the program will be able to meet or exceed the accrual requirements?
Clinical Practice Structure and Partnerships. Is the clinical practice structure appropriate in terms of the types and sizes of components (e.g., outpatient/inpatient practices, hospitals/clinics/cancer centers) and the number of participating oncologists, primary care and other providers? In particular, is this structure adequate to support accrual goals and the conduct of cancer care delivery research ?
Institutional Commitment and Facilities. How convincing are the supporting documents for institutional commitment from the components? Are the available facilities and resources, including laboratories, in-patient and outpatient resources, cancer registries, and space for administrative activities adequate to support the proposed research activities?
Clinical Trials Research Program
(Note: This entire criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately).
Experience. How successful has the applicant team been over the past 5 years in meeting or exceeding the minimum annual accrual goals for their clinical trials? How successful has the applicant been over the past 5 years in contributing to the research agenda of affiliated Research Bases and Cooperative Groups, if applicable?
Research Priorities. Are the applicant s priorities for implementing NCI-approved cancer clinical trials well thought out and appropriate for the applicant’s organizational structure and capacity?
Does the applicant have a well-reasoned approach to facilitating understanding and adoption by community-based physicians and patients of genomic medicine and targeted cancer agents?
Are the recruitment, retention, and outreach plans for clinical trials described likely to be effective?
Research Base Affiliations. Are the current or proposed affiliations consistent with the rationale provided in the application? How likely is the applicant to contribute to the scientific agenda of its affiliated Research Bases over the next project period, including participation in scientific or community liaison committees; serving as Chair(s) on cancer clinical trials; authorship of joint publications, etc.?
Accrual. Are the proposed participant accrual plans matching the history of accrual by the applicant team, the overall size of the applicant and its components and the catchment area served? What is the likelihood that the applicants will be able to achieve the required minimal or exceed the number of 80 accruals per year over the proposed project period?
Cancer Care Delivery Research Program
(Note: This entire criterion will receive one individual score).
Experience and Research Priorities. How strong are the applicants' capabilities in the proposed areas of focus for cancer care delivery research? Are the study categories proposed by the applicant appropriate for the experience and capabilities of the Site component(s) designated for participation in cancer care delivery research?
Operations/Data Management Core
(Note: This entire criterion will receive one individual score).
Are the processes for ensuring compliance with regulations for IRB approval and informed consent (compliance with 45 CFR 46) related to research involving human subjects adequate? Do the applicants use (or plan to use) optimally the available relevant central and local resources? Are the procedures for investigational drug management in compliance with NCI and FDA requirements?
Are the procedures and workflow processes for activating clinical trials and studies on cancer care delivery as well as for recruiting, enrolling, and monitoring patients/participants clearly defined and adequate? Are the plans for communication among physicians and components and the incentives for participation in clinical trial and cancer care delivery research well-reasoned?
Do the data management procedures appear to be adequately robust for all the proposed activities? Is the internal quality assurance plan/program clearly outlined and robust enough?
Do the clinical trial summary audit results confirm adequate performance?
As applicable for the NCORP Community Site proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed NCORP Community Site involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 NCORP Community Site proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS) These plans are not applicable to the NCORP Community Site FOA..
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 the National Cancer Institute, 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 response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center and 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.
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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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.
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 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
The
PD(s)/PI(s) will have the primary responsibility for:
General responsibilities for the conduct of clinical trials. The awardees programmatic responsibilities for the conduct of the clinical and cancer care delivery research supported under the Cooperative Agreements are described in the sections and documents listed below (including subsequent modifications of these documents) which are incorporated by reference as program-specific Terms and Conditions of Award:
Throughout these Terms and Conditions of Award, NCORP Community Site refers to the organizational structure which is composed of the key personnel (including the scientific and administrative leaders at the Site) responsible for implementing NCORP studies and collaborating on research goals of NCORP with NCORP Research Bases. In addition, throughout these Terms and Conditions of Award, NCORP Community Site, refers to the main community site as well as any component and sub-component site(s) included in the award.
Awardees are allowed to accept funds from non-governmental sources to support NCORP research that is not supported in part or in full by the NCI. These funds are considered Program Income (e.g., additional per case data management funding supplementing the NCI/DCP per case data management funding, support for correlative science studies that use biospecimen or image collections funded by the NCI/DCP for clinical trials under the NCORP Program) and must be reported under the Terms and Conditions of Award for the NCORP Program unless they are associated with an exempted category under the NIH grant policy for program income, available at http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch8.htm#_Program_Income.
All key components of the NCORP Program must report these funds to the NCI on an annual basis (in the non-competitive Type 5 application the annual progress report) and must indicate the clinical trial that the funds are being used to support (or other functional component if the funds are not provided to support specific clinical trials). The Terms and Conditions of Award for all the Cooperative Agreements under the NCORP Program define the operational principles under which the awardees must function to ensure the independence of the research conducted regardless of whether program income is or is not available for any of the awards.
Definition of an NCORP Community Site
An NCORP Community Site is defined as a consortium of community hospitals and/or oncology practices or a community-based integrated healthcare system that accrue participants to: 1) cancer prevention, control and screening/post-treatment surveillance clinical trials designed and conducted by NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging trials, as well as quality of life studies embedded within them; and 3) cancer care delivery research studies (where participants can be defined as patients, clinicians, and/or healthcare organizations). NCORP Community Sites will also develop and enhance their data collection and study implementation capabilities related to cancer care delivery research, provide organizational data (e.g., financial, service utilization, processes of care, policies) in support of cancer care delivery research studies, and provide site mentoring (as appropriate) in cancer care delivery research.
Definition of Component: 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 as well as cancer care delivery research studies if one or more of the NCORP components has been designated to participate in cancer care delivery research. A letter of agreement between the NCORP Community Site and each component(s) must be included in the grant application. OHRP assurance requirements must be met.
Definition of Sub-Component: A sub-component is a practice or organization that contributes to the overall accrual of a component site but is located in a separate geographic location(s), is part of the component’s business entity and is managed by the component.
Annual Accrual Threshold
The sites will need to demonstrate the ability to meet or exceed the required annual 80 new patient/participant accruals evenly distributed over cancer prevention, control and screening/post-treatment surveillance trials and treatment and imaging trials, respectively. The sites will also need to have at least one component site which will provide data collection and study implementation capabilities related to cancer care delivery research, organizational data (e.g., financial, service utilization, processes of care) in support of cancer care delivery research studies, and mentoring for other participating institutions in cancer care delivery research.
The sites need to have at least one component institution which will provide data collection and study implementation capabilities related to cancer care delivery research, organizational data (e.g., financial, service utilization, processes of care) in support of cancer care delivery research studies, and mentoring for other participating institutions in cancer care delivery research. These capabilities can be provided by a single participating institution or different participating institutions can provide these various capabilities.
Overall Responsibilities for Community Sites
Scientific Leadership & Contribution to NCORP Activities
Investigators at NCORP Community Sites can demonstrate scientific leadership for NCORP studies as well as support of and participation in other NCORP activities in a variety of ways through their membership in the Research Bases, including but not limited to the following:
Young Investigator and Leadership Mentoring/Training
Each NCORP Community Site should provide a mentorship program or activities to involve young investigators at their institution in cancer prevention, control and screening/post-treatment surveillance clinical trials and cancer care delivery research studies and to help train them eventually to take on senior leadership responsibilities for components of research at the institution.
Operational Management (Governance/Organization, Institutional Support, Components)
Governance & Organizational Structure: Each NCORP Community Site is under the leadership of the Site PD(s)/PI(s), who coordinate(s) all the scientific and administrative policies at the institution related to NCORP activities as well as coordination with the Research Bases of which the Community Site is a member. The Multiple Principal Investigator (PD/PI) option is encouraged for these awards given the team science approach of the research effort. Information on the Multiple PDs/PIs Option is available at http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, the Community Site should designate a Contact PD/PI among the multiple PD/PIs. The Principal Investigator (or Contact Principal Investigator under the Multiple PDs/PIs option) or designee is also responsible for all grant-related activities related to this award and for communication about these activities with the appropriate NCI/DCP staff.
The Community Site is responsible for development and maintenance of a governance and organizational structure to coordinate NCORP activities at the institution. The organizational structure of the Community Site should be established with clear and appropriate staff roles and reporting responsibilities, especially with respect to the role and reporting responsibilities of any multiple PD/PIs.
It is anticipated that the Principal Investigator(s) will be integrated into the scientific, clinical and cancer care delivery research activities of each of the Research Bases to which the institution belongs, thereby fostering collaboration between NCORP Network and other investigators at the institution.
NCORP Community Sites will be expected to participate in network-wide cancer care delivery research site data assessment initiatives and integrate these findings to improve their ability to participate in cancer care delivery research studies. Community sites will actively seek participation in cancer care delivery research study concepts that are appropriate to their organization and data collection capabilities.
Component & Sub-Component Network: If the Community Site has component(s) and sub-component(s), the component network must be clearly described (including reference to the distinct CTEP institution code(s) for the component(s) and sub-component(s) that are used for patient enrollment). The Community Site is responsible for complete monitoring and management of the enrollment of patients at the component(s) and sub-component site(s) to NCORP and NCTN clinical trials and cancer care delivery research studies if they are included in the award. The component site(s) participating in cancer care delivery research must be clearly identified. Any post-award changes to components or sub-component sites will need to be approved by NCI per the Organizational Change Guidelines (http://prevention.cancer.gov/ncorp).
Institution(s)/site(s) with the following NCTN Network Group membership status may not be included as a component/sub-component site of a NCORP Community Site unless the membership status is relinquished for NCORP Community Site component status:
NCI Adult and Pediatric Central Institutional Review Board Membership (not applicable to cancer care delivery research)
All U.S. institutions/sites participating in NCORP studies are required to use the NCI Central Institutional Review Board (CIRB) for any NCORP study under the NCI CIRB’s purview. The NCI CIRB provides a centralized approach to human subject protection through a process that streamlines local IRB review of adult and pediatric national multi-center cancer treatment trials. The Initiative consists of two central IRBs, one for adult trials and one for pediatric trials. Adult NCORP trials do not currently utilize the CIRB process. See http://www.ncicirb.org for information on the requirements for a signatory institution under the NCI CIRBs.
Study Operations Conduct of Studies and Data Management
The Community Sites should have a clearly articulated process for prioritizing which NCORP trials to activate at their institutions. Investigators at Community Sites form the cornerstone of the research programs for NCORP and must perform at a high level through submission of accurate and timely clinical data as well as ancillary materials necessary to support NCORP (e.g., tumor specimens, imaging studies, pathology slides). The Principal Investigator(s) at each Community Site is responsible for the performance of their component sites for which it provides complete management services and for assuring adherence to NCORP, NCI, OHRP, and FDA policies and procedures.
It is the responsibility of the Principal Investigator(s) at the site to ensure that the procedures for data submission for each NCORP protocol are understood by all investigators at the Community Site and its components as well as at any sub-components, and that protocol-specified data are submitted accurately and in a timely manner to the appropriate NCORP Research Base.
The Community Site should have a process for describing the capabilities of the component(s) designated for participation in cancer care delivery research in the following areas: genetic counseling, multidisciplinary care, care coordination/navigation processes, supportive/palliative care and outreach programs for minority/underserved populations. The Community Sites will identify strategies to be used by practitioners and senior management at the institution(s) to support the implementation of cancer care delivery research including providing requested data in support of multi-site studies and participating and allowing staff to participate as subjects of research.
Quality Assurance and Onsite Auditing
Responsibilities for quality assurance of the data (and biospecimens) submitted for NCORP studies as well as auditing include, but are not limited to, the following:
Site Clinical Trial Accrual
Community Sites are responsible for accrual to all clinical trial studies conducted across NCORP and its components and subcomponents, and for achieving threshold accruals. Investigators at the Community Sites should be involved in the acquisition of protocol-specified tumor specimens and other biospecimens in addition to all relevant protocol required clinical data. Community Site investigators should ensure that biospecimens and/or other data required for ancillary studies are submitted to the appropriate laboratories/tumor banks and Research Base SDMCs.
Community Sites are responsible for assuring that institutional investigators enrolling patients on NCORP studies are NCI registered investigators (i.e., have Form FDA 1572 on file with the NCI). Community Sites also must ensure that the main institution, as well as any components and sub-components, are in compliance with NCI/DCTD/CTEP requirements for storage and accounting for investigational agents, including complying with NCI/DHHS Drug Accountability Records (DAR) procedures as described in the DCTD Investigators' Handbook at: http://ctep.cancer.gov/handbook/index.html and are in compliance with FDA requirements for investigational agents.
Compliance with Federal Regulations for Research
Community Site awardee(s) including the components and sub-components should have policies and procedures for ensuring compliance with federal regulations for the protection of human subjects. These include the following:
IRB Review of the Community Site
Institutional Review Board (IRB) review of the Community Site grant is required. The IRB should determine and document that the Community Site has sufficient mechanisms in place to ensure appropriate data collection and data management of participants enrolled at the site (and components and sub-components, if applicable) and secondary data collected from the site as well as mechanisms to ensure protection of the confidentiality of participant data, given the nature of the research involved. The IRB will provide appropriate expertise for review of cancer care delivery research studies. Information on this requirement for IRB review can be obtained on the OHRP website at: http://www.hhs.gov/ohrp/.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NCI Program staff members acting as a Project Scientists/Coordinators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (e.g., in the role of Project Coordinators). The NCI Project Scientists/Coordinators will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.
Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Program Official is expected to act as the director of the NCORP program. Another NCI Program staff member will be named as Associate NCOPR Director, responsible for cancer care delivery research components of NCORP. These individuals may also have substantial programmatic involvement (as Project Scientists/Coordinators). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.
The main NCI responsibilities are related to research efforts of the NCORP Program and include but are not limited to the following activities:
Details on the NCI roles in the key NCORP activities are provided below.
Research Priorities
NCI/DCP staff members will be responsible for maintaining a clear set of national priorities for cancer prevention, control and screening/post-treatment surveillance research, based upon substantial consultation with experts in the field. Additionally, NCI/DCCPS staff members will maintain a clear set of national priorities for cancer care delivery research, based upon substantial consultation with experts in the field. In selected topic areas, particularly when spontaneous planning does not occur within the Research Bases, DCP and DCCPS staff members (with support from the Coordinating Center for Clinical Trials [CCCT]) will help in coordinating the organization of Study Planning Meetings under the auspices of the NCI Scientific Steering Committees. In addition, DCP and DCCPS staff may support ad hoc scientific meetings to help achieve consensus on critical research problems. These Study Planning meetings and ad hoc meetings will be composed of investigators with established expertise in the particular field of interest and will consist primarily of extramural scientists and members of the SSCs. Priorities will be based upon the state of the science, NCORP Research Base resources, and availability of funds. NCI staff will be responsible for prompt dissemination of the recommendations from these meetings, particularly regarding statements of research priorities from Study Planning meetings, and the Research Bases will be encouraged to address these priorities.
Roles of NCI Staff Members as Scientific Resource for NCORP Research
The NCI staff members will assist NCORP Research Bases as appropriate, in developing information concerning the scientific basis for specific trials or alternative study designs, operational and regulatory issues, and will also be responsible for advising the Research Bases of the nature and results of relevant trials and other studies being carried out nationally or internationally. Where applicable, NCI staff members will also provide updated information to the Research Bases on the efficacy, toxicity, and availability of all Investigational New Drugs (IND) supplied by NCI to the Research Bases. In addition, NCI will advise the Research Bases of potential agents/interventions that will be relevant to new avenues of cancer prevention, control and screening/post-treatment surveillance. NCI will also share with NCORP updated information to compliment research initiatives and projects as part of other NCI research cancer care delivery projects that may be relevant to NCORP research priorities and concept development.
Concept Review
NCI program staff reviews each submitted concept to determine that the proposed research is relevant to cancer prevention, control, and/or care delivery and that the concept includes all required components. NCI program staff will return to Research Bases concepts that do not fulfill these criteria together with a letter that explains the reasons for not accepting the concept for review.
The DCP CRC or DCCPS CRC evaluates all NCORP concepts for the scientific rationale, programmatic relevance; potential impact on cancer prevention, control and care delivery; priority; design; statistical requirements; plans for conducting the proposed study; the feasibility and appropriateness of the research for use by NCORP Community Sites or in a community setting; the existence and nature of concurrent clinical trials/studies in the area of research, including research in other NCI-funded programs that may compete with or complement the proposed study; and, where applicable, the availability of investigational agents.
Protocol Review
DCP/COPTRG will assist the Research Bases in clinical trial design to develop a mutually acceptable protocol compatible with the research interests, capabilities, and needs of the Research Base, its affiliates, and NCI. The protocol review will focus on the inclusion in the protocol of all information and procedures necessary for conducting a successful study. Specific attention is paid to responses to concerns of the SSC and/or DCP/DCCPS conveyed to the Research Base at the time of concept approval. Since the rationale for the study and the broad study design have already received, these are not generally the focus of a protocol review. However, if the protocol differs from the concept in significant ways (e.g. change in endpoint, change in participant eligibility criteria), the Protocol Review Committee will review all aspects of the protocol to determine that the study has scientific validity and is feasible to conduct in NCORP network.
Review of Clinical Trials and Other Studies in NCORP Network for Crediting
All clinical trials and other study designs originating at NCORP Research Bases must be reviewed and approved by the Protocol Review Committee of the Division of Cancer Prevention (DCP) or Division of Cancer Treatment and Diagnosis (DCTD), as appropriate, in order for an NCORP Community Site to receive credit for participant accruals to such studies.
Program Review and Federally Mandated Requirements
NCI/DCP may adjust funding annually based on the planned scope and availability of funding. The NCI may also adjust funding, withhold support, suspend or terminate the award, if NCORP Community Site awardee fails to meet the performance requirements set forth in the Terms and Conditions of Award in the FOA, and/or the level of performance changes dramatically.
Budget Levels for Per Case Management Funding & Budget Adjustments for NCORP
The final decision regarding funding for the all NCORP awards, administrative supplements, and amounts selected for all per case management funding, including special per case management funding and biospecimen per case management funding for specific trials, rests with the NCI/DCP and/or DCCPS. NCI/DCP also sets the threshold levels for accrual for high-performance sites for NCORP (i.e., Community and Minority/Underserved Community Sites, depending on the availability of funding).
The NCORP Director will designate Program Directors to serve as cancer prevention and control liaisons on Data and Safety Monitoring Boards (DSMBs), also known as Data Monitoring Committees (DMCs), for NCORP phase 3 trials as well as phase 2/3 and any other phase 2 trials monitored by the DSMB/DMC. One or more DCP/COPTRG staff will serve as non-voting members at each Research Base DSMB/DMC meeting. NCI/DCP Program Directors will review Research Base mechanisms for interim monitoring of results, will monitor clinical trial progress, and will assess Research Base compliance with NCI-established policies on Data and Safety Monitoring Plans for Phase I and II trials and Data and Safety Monitoring Committees for Phase III trials.
Because NCI/DCP staff serve as non-voting members of the Research Base DSMBs/DMCs, to ensure compliance with NIH/NCI policies and protocol requirements, NCI/DCP staff members recuse themselves from NCI/DCP review of substantive protocol amendments (e.g., amendments for increases in sample size or significant changes in trial design) for any study that is also under review by a DSMB/DMC of which they are members, if confidential outcome data on that study have been previously presented to the DSMB/DMC. When this situation arises, the amendment is reviewed by NCI/DCP staff members who are not members of that DSMB/DMC.
Additional NCI Scientific Support to NCORP Awardees
Each NCORP Research Base, Community Site, and Minority/Underserved Community Site will also have a program staff member(s) from DCP/COPTRG assigned to them who will act as liaisons for scientific matters related to clinical trials and clinical research studies.
The NCI will also assign to each NCORP awardee a program staff member(s) from DCCPS who will have clinical, health services and behavioral research expertise to act as liaisons for scientific matters related to cancer care delivery research studies.
The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. The NCI may also review all records related to awardees performance under the award for appropriate collection, review, and distribution of biospecimens collected in association with NCORP clinical trials.
The NCI reserves the right to reduce award budget, withhold support, suspend, or terminate the award in cases of insufficient patient accrual per the protocol specified timelines and/or NCI/DCP slowly accruing guidelines for clinical trials, inability to meet the scientific aims of the Cooperative Agreement, or noncompliance with the Terms and Conditions of Award.
Areas of Joint Responsibility include:
NCI Program staff members and the NCORP awardees will collaborate on general aspects of study development and conduct. Areas for such collaborations are particularly expected to include various administrative and regulatory aspects such as:
Collective Management of NCORP
In order to provide for collaboration and coordination of policies and procedures for NCORP, collective management is needed. To achieve this goal, a core collective management team (i.e., NCORP Leadership Management Committee) composed of 1 senior leadership representative from each of NCORP Research Bases and key NCI program leadership from relevant Divisions and Centers to discuss major policy issues and address concerns about NCORP. The Committee will make recommendations to senior NCI leadership on the Program. It is anticipated that the Committee will meet on at least a quarterly basis by teleconference and/or in-person. Additional representatives from NCORP may be invited to participate in meetings depending on the issues to be discussed. It is also anticipated that there may be meetings held specific to NCORP Directors of Operations/Group Administrators on a periodic basis to discuss significant issues, as appropriate.
Specific areas that will require recommendations from NCORP Leadership Management Committee include but are not limited to the following:
NCORP Cancer Care Delivery Research Coordination Committee. NCORP will have a designated Committee to coordinate efforts in cancer care delivery research. The Committee will be convened jointly by the NCI and NCORP Research Base awardees. Initially, the committee will consist of the following members:
These initial members of the Committee will decide on its final composition, structure, procedures, etc. Community Sites and Minority/Underserved Community Sites will represented on an ad hoc basis. Additional representatives of Research Bases and NCI as well as external experts may also be involved in the activities of the Committee, e.g. as ad hoc members.
The Committee will have access to NCORP-wide repository information from NCORP Community Sites and Minority/Underserved Community Sites (e.g., cancer registry data, processes of care data and data on organizational characteristics and policies).
The specific functions of the Committee are expected to include:
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 Network Group representatives on the NCORP Leadership Management Committee chosen by them without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. The appeals process and this special dispute resolution procedure do not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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TTY: 301-451-5936
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Worta McCaskill-Stevens, M.D., M.S.
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 Parts 74 and 92.
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