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

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

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

This Funding Opportunity Announcement (FOA) is one of three FOAs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to take advantage of large and diverse patient populations receiving care in a variety of community oncology settings. The purpose of this Program is to engage these cancer patient populations in rigorous studies focused on cancer control, prevention, and care delivery.

NCORP will support the following components that will be individually awarded through the respective FOAs indicated below:

• NCORP Research Bases (see RFA-CA-18-015)
• NCORP Community Sites (this FOA); and
• NCORP Minority/Underserved Community Sites (see RFA-CA-18-017)

NCORP Research Bases will serve as research hubs for the NCORP program. Research Bases are expected to:

• Provide an established organizational structure, with scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical research, as well as quality-of-life studies embedded within treatment and imaging studies.
• Assume responsibility for study operations and data management, including efficient protocol development, compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements, auditing, training, quality assurance, and support to Community Sites and Minority/Underserved Community Sites.
• Conduct their research activities at an institution with comprehensive expertise in cancer clinical research, such as a cancer foundation, healthcare research organization (including NCI's National Clinical Trials Network Group Operations Centers), or NCI-designated Cancer Center.
• Integrate health disparities across all focus areas as appropriate.

NCORP Community Sites are consortia of community hospitals and/or oncology practices, which may or may not be formally affiliated in a healthcare system, that accrues participants to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.

NCORP Minority/Underserved Community Sites are consortia of community hospitals and/or oncology practices, a public hospital, or academic medical center that has a patient population comprising at least 30% racial/ethnic minorities or rural residents and accrues participants to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.

Key Definitions for the context of this FOA:

The terms Clinical Research and Clinical Trials in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch).

NCI Central Institutional Review Board (Central IRB): is a centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards (https://www.ncicirb.org/about-cirb/).

Community Site Primary Affiliate: In the context of NCORP community-based structure, a "primary affiliate" refers to a hospital, cancer center, physician practice, or other institution where patients/participants are enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials and other human subjects research available to the NCORP Community Site or Minority/Underserved Site.

Community Site Sub-Affiliate: In the context of NCORP community-based structure, a "sub-affiliate" refers to a practice or organization that contributes to the overall accrual of a primary affiliate site but is located in a separate geographic location(s), is part of the primary affiliate’s business entity, and is managed by the primary affiliate under the primary affiliate site’s Federal Wide Assurance (FWA).

Research Base Member Sites: Members sites affiliated with a given Research Base may include NCORP Community and Minority Underserved Community Sites, Main members, affiliates, and Lead Academic Participating sites.

Whereas various academic medical centers play a crucial role in cancer clinical research, the majority 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 healthcare delivery settings, which can accelerate accrual to cancer clinical trials and other human subjects research and increase the generalizability and relevance of study findings. In addition, research in community settings reflects the complexity of cancer care delivery and engages community oncologists in research to develop care delivery approaches that can be implemented within usual clinical workflow.

The NCI has supported cancer clinical research within community settings for over three decades. The participation of community oncologists, non-oncology specialists, and primary care physicians in cancer clinical trials has facilitated the introduction of research advances into practices throughout the country. The era of genomics and molecularly-targeted therapy necessitates shifts in the delivery of cancer-related care.

The foundation of NCORP is the conduct of multi-site cancer clinical trials and other human subjects research in primary focus areas of cancer control, prevention and care delivery. In addition, NCORP plays an important role in the National Clinical Trials Network (NCTN), a major NCI-supported infrastructure for cancer clinical trials. Approximately 30 -35% of the patients enrolled on NCTN clinical trials, including precision medicine studies, are from NCORP sites.

The NCORP Community Sites and Minority/Underserved Community Sites have responded to many of the challenges associated with implementation of precision medicine by providing quality specimens for genomic sequencing and establishing a multidisciplinary team to support the newer generations of clinical research. Recent advances in technology are providing new opportunities to characterize premalignancies in ways that will enhance the development of cancer prevention interventions, and biomarkers of response to those interventions, and biomarkers of risk. NCORP’s diversity in patient age, race/ethnicity, and geographic location as well as partnerships with non-oncology practices provides a natural laboratory for the development of strategies for precision prevention to improve efficiency and to balance the risks and benefits of interventions. Similarly, the role of the immune response is increasingly incorporated in cancer prevention research. Cancer screening research to reduce aggressive cancer incidence and to identify over-diagnosis is needed to reduce overall cancer mortality, both in therapy and for prevention. Community organizations have proven to be well positioned to promote the science in symptom management, cancer prevention, surveillance and improve diversity of participation in clinical research.

NCORP has streamlined its scientific and operational processes and expanded its review structure with three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees, (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) that provide peer-review for scientific concepts. Access to the Clinical Trials Support Unit (CTSU) allows sites access to all current study materials and the Central Investigational Review Board (CIRB) provides human subjects review, all of which increase efficiency and reduce redundancy. In addition, an infrastructure for cancer care delivery research studies has been built in which both interventional and observational care delivery research studies are being conducted.

Overall Goals of NCORP and Scope of this FOA

The overall goal of NCORP is to bring cancer clinical research studies to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities.

The role of NCORP Research Bases is to serve as a main research infrastructure for NCORP Community Sites and Minority/Underserved Community Sites. Through affiliations with one or more NCORP Research Bases the Sites gain access to this infrastructure as well as provide valuable community perspective and input on the relevance and feasibility of the trial menu.

The roles of NCORP Community Sites and Minority/Underserved Community Sites are to provide access to a diverse patient population from varied delivery settings, allowing enhanced accrual of underrepresented populations such as racial/ethnic minorities, adolescent and young adult (AYA) and elderly, sexual and gender minorities, and rural residents to clinical trials and other human subject studies.

To address the NCORP goals, NCORP Community Sites will be expected to contribute to and focus on the following activities:

• Participate as part of an integrated national network of community organizations to increase the involvement of community oncologists and other medical specialists, and their patients, in multi-institutional cancer control, prevention, and care delivery research, as well as quality-of-life studies embedded within treatment and imaging studies conducted under the NCORP and NCTN.
• Interact with the NCORP Research Bases by: 1) providing insight into clinical significance during concept development; 2) identifying care disparities in their local populations that could be studied; and 3) providing input on feasibility during protocol development.
• Meeting or exceeding the required annual 80 new unique patient/participant accruals evenly distributed between cancer control, prevention, and screening/post-treatment surveillance trials, and treatment and imaging trials, respectively.
• Meet or exceed a required annual minimum of enrolling individual participants or organizations to cancer care delivery protocols. These minima are defined as follows:
• Adult and combined adult/pediatric NCORP Sites will be required to have three care delivery protocols open per year.
• Pediatric NCORP Sites will be required to have two care delivery protocols open per year.
• Meeting or exceeding a required minimum of one Primary Affiliate participating in each cancer care delivery research capacity assessment as offered.
• Participating in bio-specimen collection for biobanks that serve as a scientific resource for NCORP Research Bases.
• Participating in NCORP initiatives to document screening efforts for clinical trial enrollment and to address cancer health disparities (including the maintenance of a detailed screening log).
• Enrolling participants from underrepresented populations; including racial/ethnic minorities, sexual and gender minorities, adolescents and young adults and elderly, and rural residents across all study types and settings to reduce cancer disparities.
• Involving patient advocates in the development and conduct of research.

Scope of Activities for NCORP Community Sites

The scope of research activities for the proposed NCORP Community Sites should encompass three major areas delineated below.

Area 1: Cancer Control Research; and

Area 2: Cancer Prevention Research; and

Area 3: Cancer Care Delivery Research.

• Cancer control research that is aimed at reducing the morbidities associated with cancer and its treatment, as well as improving the quality of life of individuals undergoing cancer treatment or with a history of cancer.
• Cancer prevention research that is aimed at reducing cancer risk, incidence and mortality.
• Cancer care delivery research that seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery.

All of the proposed Community Sites must be capable of participation and accrual to all three areas of research as well as accrual to NCTN treatment trials.

NCORP Trans-network Interactions

All NCORP participants will be expected to work jointly towards the overall NCORP goals by using the following general strategies:

• Development and maintenance of a governance and organizational structure to coordinate NCORP activities at the Community Site. The organizational structure of the Community Site should be established with clear and appropriate staff roles and reporting responsibilities.
• Development of a plan and process for prioritizing the NCORP and NCTN trials to be activated at their institutions.
• Development of procedures for timely protocol data submission that are clearly communicated to all investigators at the Community Site.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Additional eligibility provisions:

• Applicant institutions must be healthcare providing entities (such as consortia of community hospitals and/or oncology practices, integrated care systems, etc.) with the exceptions listed below.

Institutions not eligible to apply include:

• An NCI-Designated Cancer Center.
• An institution that is an awardee of a NCTN Lead Academic Participating Site funded through RFA-CA-17-059 funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI.
• Department of Veterans Affairs hospitals or military treatment facilities are not eligible to apply. Such institutions may be included in an application as a member(s) of a consortium led by an eligible applicant institution, provided that they are not be meant to be the major contributor to patient accrual.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Worta McCaskill-Stevens, M.D.
Telephone: 240-276-7050
Fax: 240-276-7847
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exception:

• Research Strategy Section is limited to 30 pages

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

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

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

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

Facilities & Other Resources:

Provide documentation on the characteristic of the scientific environment in which the cancer clinical trials and other human subjects research will be conducted. Include such aspects as:

• The salient features of the facilities and other resources available (committed) for use by the proposed Community Site. Appropriate space must be available for administrative activities and personnel to serve as primary locus for data management, quality control, patient recruitment and evaluation, and communication.
• Organizational chart and a list of the primary affiliate(s) and sub-affiliate(s) (as applicable) that will be accruing participants to NCORP and NCTN clinical trials and other human subjects' studies. Definitions of primary affiliate and sub-affiliate can be found under the key definitions section of this FOA. A table can be used to list the entity category (primary affiliate or sub-affiliate), name of entity, site identifier (e.g. Cancer Therapy Evaluation Program (CTEP) ID), City and state where the entity is located.
• A diagram (and/or map) showing the distances between the above entities (including administrative office and shared resources) and location of proposed personnel.
• A table documenting the radiation oncology treatment facilities within the applicant’s practice detailing by individual Community primary- and sub-affiliate Sites those with radiation therapy treatment machines on site.
• Characteristics of the catchment area from which approximately 80% of the primary affiliate(s) and sub-affiliate(s) patients are drawn, including geographic boundaries, referral patterns, and cancer care delivery resources that are not included in the application (i.e., cancer centers, hospitals, clinics, and physicians). Also include estimates of the population demographics in the area, including percentages by age category (1 to 14, 15 to 39, 40 to 64, and 65+); sex; race/ethnicity; and at least one measure of socioeconomic deprivation (e.g., poverty or insurance coverage levels).
• A table documenting an estimate of the incident cancer cases receiving care at the primary affiliate(s) and sub-affiliate(s) in the past 12-month period for which data are available, including percentages by age category (1 to 14, 15 to 39, 40 to 64, and 65+); sex; race/ethnicity; and at least one measure of socioeconomic deprivation (e.g., poverty or insurance coverage levels).
• A list of the applicant’s current collaboration(s) and engagement(s) with professional organizations and/or research organizations, such as academic medical centers, to further define relevant cancer care delivery research in community settings.
• List collaborations, directly related to cancer disparities research, in which the applicant team participants including cancer disparities research conducted by NCTN Groups, academic medical centers, and other research organizations.
• Provide a table documenting the most prevalent underserved populations in the catchment area, the applicant’s experience in caring for these populations, and efforts to engage with these populations in the community.

Other Attachments:

Applicants must provide the following additional material specified below. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks). Suggested table templates to capture information for Attachments 1,2, and 3 are available at: https://ncorp.cancer.gov/resources/applicants.html.

Attachment 1: Accrual Cancer Control, Prevention, Treatment or Imaging Trials (use filename: Accrual CPTI).

Provide a summary table on accrual accomplished by the applicant team to NCI-sponsored cancer control, prevention and treatment trials as well as studies sponsored by other non-profit organizations during the past 5 years (end date of July 31, 2018). The summary table should include enrollment onto NCI-tissue acquisition studies, if applicable.

Attachment 2: Accrual to Cancer Care Delivery Research Studies (use filename: Accrual CCDR).

Provide a table summarizing accrual accomplished by the applicant team to NCI-sponsored cancer care delivery research studies, if applicable, and to cancer care delivery studies sponsored by other organizations, if applicable, during the past 5 years (end date of July 31, 2018).

Attachment 3: Collective Bodies/Committees Essential for Community Site Functions (use filename: Committee Memberships).

• Renewal Applications: Provide a table summarizing the participation of members of the applicant team (over the past 5 years) on collective bodies relevant to the activities and goals of NCORP Community Sites (oversight boards, steering committees, etc.). A table can be used to show the Category (e.g. type of committee, Steering Committee), member status (e.g. chair, vice chair),and length of service in the role.
• New Applications: Without repeating information in biosketches, list local, state or national roles held by senior/key personnel staff that demonstrate leadership or activities that highlight the cancer care needs of the proposed community research.

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

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions apply.

A minimal effort level of 1.2 person-months is required for each PD/PI regardless of whether that individual is designated as contact PD/PI or not. (This commitment cannot be reduced below that level during the projects period).

In the Budget Justification attachment, in addition to standard items for this attachment, provide a breakdown of the direct costs showing separate dollar amounts for both Control/Prevention and Cancer Care Delivery research activities. Provide such information for each budget period requested as well as for each budget category for which funds are requested.

NOTE: The following costs are not supported under this FOA;

• Costs associated with routine patient care.
• Costs for alterations and renovations.

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

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

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

Specific Aim: Outline the overall goals for the proposed Community Site in terms of accruing patients, clinicians, organizations to cancer control, prevention and care delivery clinical trials and to other human subjects' studies developed and conducted by NCORP Research Bases.

Research Strategy: Organize the Research Strategy section with sub-sections in the specified order and follow the instructions provided below. Start each sub-section with the appropriate sub-section heading.

Sub-section A. Overview, Accomplishments, and Organization

Overview. The application should provide an overview that addresses the following:

• Outline the overall organization of the proposed Community Site and the major collective strengths of the team.
• List main capabilities relevant to the goals of Community Sites.
• Define the overall priorities for the proposed Community Site in terms of such aspects as:
• implementation of clinical trials in cancer control, prevention, and care delivery.
• other human subjects research relevant to those clinical trials; and
• ability to participate in cancer treatment and imaging trials (beyond NCORP studies).

Progress Report (for Renewal Applications)

• Provide a summary of the group’s accomplishments relative to participation in cancer control, prevention and care delivery clinical trials and other human subjects research as well as cancer treatment and imaging trials during the current project period.

Relevant Accomplishments (for New Applications)

• Provide the highlights of the group's accomplishments relative to implementing cancer control, prevention, care delivery and treatment clinical trials and other human subjects research in the group’s practice setting(s) during the past 5 years. (Note that additional documentation for these aspects is requested under Other Attachments section of the application: Attachment 1 and 2).

Multi-institutional Organization and Structure. Define the organizational structure in terms of "Primary Affiliate(s)" or "Sub-Affiliate(s)," depending on their relationship to the proposed Community Site institution. If the NCORP Community Site applicants propose more than one Primary Affiliate or Sub-Affiliate, each must be listed in the application. Description should include (but is not limited to) the following aspects:

• The association of primary affiliate(s)/sub-affiliate(s) to each other and to the NCORP awardee Community Site, if applicable.
• Any unique features and expertise that the participating clinical practices contribute to the NCORP Community Site, with particular attention to accrual that reflects the diversity of the local community.
• Structures and relationships that support accrual to cancer screening studies.
• Collaboration between adult and pediatric affiliates, if applicable.
• Interactions with primary care, radiology, radiation oncology and other providers (e.g., urologists, genetics counselors, etc.) that may be research collaborators with the applicant.
• The role of pathologists and the team responsible for tissue acquisition for research.
• Include the extent to which the above disciplines have participated in past research and plans to engage them in future research within the applicant site.

Note that additional documentation for Sub-section A is requested under "Other Attachments" (Attachment 1 and 2) and under "Facilities & Other Resources".

Sub-Section B. Leadership and Administrative Unit - Address the following areas:

• Outline the governance structure under which the applicant proposes to conduct cancer clinical trials and other human subjects' research within the NCORP network.
• In this context, characterize the collective leadership expertise in conducting and overseeing (CCP&CD) research as well as NCTN treatment and imaging trials, involvement in clinical trials-related collective bodies/committees, etc. (Note that additional documentation for this aspect is requested under Other Attachments: Attachment 3.)
• Outline the roles and lines of responsibilities of PD(s)/PI(s) and other senior investigators:
• If the multiple PDs/PIs are not designated, identify a substitute PD/PI candidate to assure continuity and a smooth transition of leadership when necessary.
• Designate either the PD/PI (or one of the multiple PD(s)/PI(s)) or another senior researcher to have leadership responsibility for each of the following areas:
  • cancer care delivery research program,
  • symptom science research program,
  • cancer control and cancer prevention research program as well as
  • cancer disparities integration.
• Address how the leadership plans to encourage community engagement to facilitate ethnic/racial diversity in clinical trials and other human subjects research.
• Explain any other leadership-related and/or administrative/coordination aspects, as applicable. Include, for example, the orientation and mentoring of new individuals to serve in leadership positions within the NCORP Community Site.

Sub-Section C. Clinical Research Program - Address the following areas:

In this subsection, explain how the proposed NCORP cancer clinical research program will include the required research activities (cancer control, prevention and care delivery clinical trials and other human subjects research as well as cancer treatment and imaging trials and integration of cancer disparities across all focus areas as appropriate).

Provide a description of the following:

• The types of CCP&CD protocols the applicant would expect to activate during the award period. Include a description of the criteria to be used and process by which applicants will select studies that will be appropriate for their community and practice setting and meet accrual minimums.
• The plans for implementing and conducting the selected studies, including approaches for engaging patients from populations typically underrepresented in research as well as practices and organizations from hospitals, clinics, and other healthcare settings.
• The applicant’s anticipated strategies for recruitment and retention of patient/participants, including, as applicable, the role of patient advocates.
• If applicable, note any innovations related to accrual and recruitment strategies.
• Challenges surrounding recruitment and retention of patients as well as clinicians and other staff and any approaches to address these challenges.
• The plans for achieving accrual goals to CCP&CD clinical trials and other human subject studies over the next project period (6 years) to meet the requirements defined in Section 1:
• Adult and combined adult/pediatric NCORP Sites will be required to have three care delivery protocols open per year.
• Pediatric NCORP Sites will be required to have two care delivery protocols open per year.
• As applicable, explain how the proposed Community Site can contribute to other NCI programs focused on precision medicine, e.g., by tissue acquisition.

NOTE: See Accrual Goals referenced under Section I:

• Meeting or exceeding the required annual 80 new unique patient/participant accruals evenly distributed between cancer control, prevention, and screening/post-treatment surveillance trials, and treatment and imaging trials, respectively; and
• Meet or exceed a required annual minimum of enrolling individual participants or organizations to cancer care delivery protocols, etc.
• The current capacity for cancer care delivery research, particularly the recruitment of clinicians and collection of organization-level data, and plans to expand this research to additional Primary Affiliates and Sub-affiliates.
• The planned Research Base affiliations during the next project period:
• Provide rationale for choosing these Research Base affiliations.
• Explain how the proposed Community Site may contribute to the scientific agenda of its affiliated Research Bases. Examples of contributions might include: participation/membership in Research Base scientific committees or community liaison committees or serving as study Chair(s)/Co-investigator.

Sub-Section D. Operations/Data Management Unit - Address the following areas:

General Operations

• The processes the applicant and Primary Affiliate(s) and Sub-Affiliate(s) have in place for ensuring compliance with regulations for research involving human subjects, including processes for IRB approval, informed consent, and other aspects relevant to protection of human subjects.
• Current (or planned) use of and participation in the NCI's Central IRB which is required of all applicants.
• Outlines of the standard operating procedures for activating clinical trials and other human subjects research; recruiting, enrolling, and monitoring participants; data collection and management; adverse event reporting; and investigational drug monitoring.
• Processes for communicating with Primary Affiliates and Sub-Affiliates.
• Steps to ensure that investigators and other staff maintain sufficient proficiency level with regard to the conduct of clinical cancer research, e.g., involving mandatory periodic training (such as Good Clinical Practice training).

Data Management & Quality Assurance. Procedures for data management and investigational drug monitoring must be described in the application. For cancer control, prevention and care delivery research, address the following items:

• Data collection and management processes including: collection from specific sources (e.g., hospital, office, clinic, registry), completion of study forms, collection of patient materials (e.g., pathology slides, port films, etc.) and providing to Research Base.
• The procedures for collecting patient demographic and lifestyle data during screening for research participation
• The process for monitoring data quality such as completeness of surveys and accuracy of records
• Transmission of data to the Research Bases (e.g., batch mode or in real time) and whether mechanisms are in place for electronic data transfer?
• Distribution of data management responsibilities within and between primary and sub-affiliates and the central applicant office, if applicable.
• 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.

• Describe the ability of the NCORP Community Site to conduct cancer clinical trials and other human subjects research with good clinical practice stewardship as demonstrated by audit results from NCI-sponsored studies as well as studies sponsored by other organizations.

Letters of Support

Include letters of institutional commitment and letters of Intent to Establish a Consortium, if applicable from all institutions that will be participating in the proposed Community Site. The letters should indicate specific commitments and capabilities (e.g., in terms of potential for recruiting study participants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Whereas applicants must be prepared for clinical trials in general, definite plans for such involvement will be subject of post-award interactions with NCORP Research Base and NCI. As detailed planning of specific clinical trials is not possible at the time of application, Study Record should NOT be completed.

Delayed Onset Study

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

Both Renewal and New Applications must add and complete the Delayed Onset Study record and must check the box "Anticipated Clinical Trial?"

Study Title--use: "Multiple Delayed Onset Studies"

Justification Attachment: Indicate that the clinical trials will be designed and conducted by the NCORP Research Bases. Once the trial(s) is developed, Community Site awardees will open the study and enroll participants. Indicate that the Community Sites will be required to follow the Data and Safety Monitoring Plans of the NCORP Research Base with which the Community Site is affiliated.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

All Applicants are strongly encouraged to submit an update to patient accrual information:: In a table format include additional patient accrual information not included in the grant application) for the period from August 1, 2018 to December 31,2018 for each site. Note: Use the same format as included in Attachment 1 and 2 under Other Attachments for the original application submission.

Post-submission materials must be received by the NIH no later than 30 calendar days prior to the peer review meeting. Post-submission materials will not be accepted if fewer than 30 calendar days remain before the peer review meeting.

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

For this particular announcement, note the following:

Essential for the quality and merit of the proposed NCORP Community Sites will be their sufficient capability to enroll patients and participants into clinical trials and other human subject studies developed by the NCORP Research Bases. Also essential will be the likelihood that the proposed Community Site will be able to adhere to and meet all regulatory, safety, and data requirements that will be enforced by the affiliated Research Base. Accordingly, the applicant's potential to provide clinical research studies in their communities that contribute to improved patient outcomes and reduced cancer disparities will be a major factor in reviewers' assessment of the application merit.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

In addition, specific for this FOA:

How likely is the proposed Community Site to contribute meaningfully to the NCORP goals in terms of engaging patients/participants and conducting the anticipated range of clinical trials and human subject studies? How much can such studies benefit from the specific community oncology settings, the proposed catchment area, and the opportunities to address cancer health disparities? To what degree can the proposed Community Site contribute to other NCI programs focused on precision medicine, e.g., by tissue acquisition for such efforts?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

In addition, specific for this FOA:

How strong is the background of the team in interactions with other partners involved in the design and implementation of Community Site studies? How well will the team be able to contribute unique expertise and perspectives to such joint endeavors?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

In addition, specific for this FOA:

How innovative are the proposed approaches to accrual and retention, e.g., in the unique local context of each affiliate and sub-affiliate? How well do the proposed data collection, management, and transmission plans take advantage of the growing availability of electronic records and interoperability?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

In addition, specific for this FOA:

How adequately do the recruitment and retention plans consider and propose ways to overcome likely challenges, including accrual of clinicians, and other staff?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, how adequately does the application address the complexity of executing the clinical trial?

If multi-sites/centers, evaluate the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

In addition, specific for this FOA:

How adequate/sufficient is the proposed catchment area in terms of the anticipated needs for NCORP clinical trials and other human subject studies?

How well does the catchment area include a population and care delivery characteristics that reflect the complexity of community oncology practice?

Is the catchment area sufficient to allow the applicant to meet the required annual 80 new unique patient/participant accruals evenly distributed between cancer prevention, control and screening/post-treatment surveillance trials and treatment and imaging trials, respectively?

For adult and combined adult/pediatric NCORP Sites: Is the catchment area sufficient to allow the applicant to meet or exceed the benchmarks for participation in cancer care delivery protocols?

For pediatric NCORP Sites: Is the catchment area sufficient to allow the applicant to meet or exceed the benchmarks for participation in cancer care delivery protocols?

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

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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 primary affiliate(s) sites and sub-affiliate site(s) included in the award.

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

• Development of an overall strategy for supporting the adult and pediatric NCORP and NCTN Group(s) in the development of clinical trials and related studies for the NCORP/NCTN Program and providing senior leadership on NCORP/NCTN Group Committees and for NCORP/NCTN Program Initiatives.
• General responsibilities for the conduct of clinical trials by the NCORP Community Site.
• Oversight and accrual at the NCORP sites on NCORP/NCTN clinical trials.
• Compliance with Part 1 of the NCI Community Oncology Research Program Guidelines dated May 2018, Year (https://ncorp.cancer.gov/resources/applicants/guidelines.pdf) and any subsequent updates to the Guidelines.
• Awardees will comply with the Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI at (https://ctep.cancer.gov/investigatorResources/investigators_handbook.htm), the NCI Guidelines for Auditing Clinical Trials for the National Clinical Trials Network (NCTN) Program, Community Clinical Oncology Program (CCOP)/NCI Community Oncology Research Program (NCORP) and Research Bases at (https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm), and the NCI/DCTD CRADA agreements, and the Intellectual Property Option to Collaborators at (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials and other clinical trials conducted under a NCI/DCTD Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE).
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Designated NCI Program Director(s) will have substantial involvement as a Project Scientist(s).

Additionally, an NCI Program Director, acting as Program Official will be responsible for the normal, scientific and programmatic stewardship of the award and will be named in the award notice. A

Program Official may also have substantial programmatic involvement (as a Project Scientist).

• Working with NCORP Sites to collaboratively manage major issues associated with their participating in the conduct of trials across the Network.
• Informing the PD(s)/PI(s) of the NCORP Sites of scientific opportunities resulting from NCI-supported clinical research programs and facilitating collaborations between the Network Groups and other NCI-sponsored programs.
• Facilitating the NCORP Community Sites scientific involvement in cancer prevention, control, screening and care delivery research as well as oncology treatment research associated with NCORP and NCTN Network Groups.
• Involvement in auditing of NCORP institutions via their membership in the Network Groups with oversight of compliance with applicable DHHS, FDA, OHRP, NIH, and NCI regulations for clinical research involving human research subjects.
• Ensuring compliance with FDA for investigational agents and ensuring compliance with OHRP and other federal regulations for research involving human research subjects including compliance with Good Clinical Practice (GCP) guidelines: http://www.fda.gov/oc/gcp/default.htm and https://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/good_clinical_practices.pdf for applicable NCORP trials.
• Review and monitoring of accrual and overall performance of NCORP/NCTN trials and cancer care delivery research studies by the NCORP institutions.
• Sponsor strategy sessions, when indicated, to discuss specific research initiatives that will involve the NCORP Community Sites participation.
• 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 bio-specimens collected in association with NCORP/NCTN pilot studies.

Areas of Joint Responsibility include:

• General aspects of collaboration on study development and conduct especially with respect to compliance with federal regulations for clinical trial research and participating in activities related to the collective management of the NCORP Program, as appropriate.
• Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCORP Program related to NCORP support of and participation in NCORP/NCTN clinical trials that might impact the awards.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Worta McCaskill-Stevens, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7050
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.