Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

NCI National Clinical Trials Network - Network Lead Academic Participating Sites (UG1)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

Reissue of RFA-CA-12-013

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-17-059

Companion Funding Opportunity

RFA-CA-17-056, U10 Cooperative Clinical Research – Cooperative Agreements;

RFA-CA-17-057, U10 Cooperative Clinical Research – Cooperative Agreements;

RFA-CA-17-058, U10 Cooperative Clinical Research – Cooperative Agreements;

RFA-CA-17-060, U24 Resource-Related Research Projects – Cooperative Agreements;

RFA-CA-17-061, UG1 Clinical Research Cooperative Agreements - Single Project

Number of Applications

Each applicant organization may submit only one application as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.394, 93.395

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications from institutions/organizations that propose to maintain or establish Network Lead Academic Participating Sites (LAPS) for the NCI National Clinical Trials Network (NCTN). The NCTN Network LAPS will provide scientific leadership by helping to develop and conduct clinical trials in association with one or more adult Network Groups and will contribute substantial accrual to clinical trials conducted across the entire NCTN.

Key Dates

 

Posted Date

October 20, 2017

Open Date (Earliest Submission Date)

December 19, 2017

Letter of Intent Due Date(s)

December 19, 2017

Application Due Date(s)

January 19, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this FOA.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

May-June 2018

Advisory Council Review

October 2018

Earliest Start Date

March 2019

Expiration Date

January 20, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) is one of six FOAs that support the comprehensive effort by the National Cancer Institute (NCI) to provide the infrastructure for the conduct of national clinical trials through the National Clinical Trials Network (NCTN). The primary goal of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and advanced imaging trials across a broad range of cancers, modalities, and diverse patient populations as part of the NCI's overall clinical research program for adults, adolescents and young adults, and children with cancer. The NCTN also conducts, as necessary, preliminary studies needed for development of definitive trials, especially umbrella/basket trials and rare tumor trials, when an extensive, national patient catchment area is required. 

The NCTN Program supports the following clinical trials infrastructure components through individual awards made under the respective FOAs indicated below:

NCTN - Network Group Operations Centers under RFA-CA-17-056 (U10)

NCTN - Network Group Statistics and Data Management Centers under RFA-CA-17-057 (U10)

NCTN - Canadian Collaborating Clinical Trials Network under RFA-CA-17-058 (U10)

NCTN - Network Lead Academic Participating Sites under RFA-CA-17-059 (UG1) - this FOA

NCTN - Network Radiotherapy & Imaging Core Services Center under RFA-CA-17-060 (U24

NCTN-Network Group Integrated Translational Science Centers under RFA-CA-17-061 (UG1)

The purpose of this funding opportunity announcement (FOA) is to solicit applications from institutions/organizations that propose to maintain or establish Network Lead Academic Participating Sites (LAPS) for the NCI National Clinical Trials Network (NCTN). The NCTN Network LAPS will provide scientific leadership by helping to develop and conduct clinical trials in association with one or more adult Network Groups and will contribute substantial accrual to clinical trials conducted across the entire NCTN.

 
Background

On March 1, 2014, after several years of extensive consultation and coordination with numerous stakeholders, the NCI transformed its longstanding Cooperative Group Clinical Trials infrastructure program into the new NCI National Clinical Trials Network (NCTN) for the conduct of large-scale, national, oncology treatment and advanced imaging clinical trials in an era of precision medicine. 

Recent advances in deciphering the cancer genome, along with the emergence of successful immunotherapies, have fundamentally changed our approach to cancer treatment and have introduced new challenges to performing clinical trials. Due to the low incidence of certain molecular abnormalities, the development of targeted therapies often requires an infrastructure for the conduct of clinical trials that can screen large numbers of patients with the same or different cancer type to identify those patients whose tumors contain the distinct molecular targets of the therapies being tested. Immunotherapeutic approaches also present a similar challenge in that not all tumor types respond to this approach, and selecting the cancer types most likely to respond is critical for success.

The NCTN's integrated and collaborative network infrastructure has allowed the Program to meet the challenges of evaluating emerging therapies within its broad investigator base drawn from NCI-designated Cancer Centers, the NCI Community Oncology Research Program (NCORP), Minority/Underserved NCORPs, and other academic and community hospitals and private practitioners across the U.S. and internationally. The primary focus of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and investigation of new advanced imaging techniques; however, appropriate preliminary studies needed for development of potential definitive trials, especially umbrella/basket trials and rare tumor trials oriented to discovery, are also conducted when an extensive, national patient catchment area is required. With its state-of-the-art clinical trials infrastructure, the NCTN implements and completes trials far more rapidly than in the past. The NCTN has streamlined trial registration, data management, and tumor banking processes. It has a Cancer Trials Support Unit (CTSU) to provide online access to all materials and a Central Institutional Review Board (CIRB) to make ethics review easier and less redundant across the country. The NCTN also has appeal for industry partners as evidenced by the large number of biotechnology and pharmaceutical companies that collaborate on NCTN precision medicine trials harnessing next generation DNA and RNA sequencing methods to inform treatment choices. NCTN's resources are ideal for screening large numbers of patients to identify patients whose tumors exhibit the molecular features that may be responsive to new, targeted treatments and/or immunotherapy approaches. In addition, biospecimens collected from patients on NCTN trials are available to help determine the underlying biological reasons for response and resistance to therapy

The NCTN has also continued to promote the evaluation of multi-modality treatments, including surgery and radiotherapy in combination with novel agents, and has maintained a commitment to the conduct of trials in special populations (e.g., children, adolescents, young adults, and underserved populations) and involving patient with rare tumors. This focus allows the NCTN Program to complement, rather than duplicate, research conducted by the private sector.  Annual accrual to NCTN trials has remained in the 17,500 to 22,000 patient range in mostly large phase 2 and phase 3 trials, but with a larger number of patients now screened on study to determine whether they might benefit from the therapy under evaluation.

Each of the key components of the NCTN Program is described briefly below.

  • Network Group Operations Centers: The Operations Centers provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations with specific scientific strategy and goals. The Operations Centers' scientific goals may include strategic innovation in advanced technology for specific research areas (e.g., advanced imaging methods/agents, radiotherapy) and the testing of innovative concepts and tools in prospective, multi-institutional clinical trials. Operations Centers are responsible for trial operations including timely protocol development and management, compliance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulatory and patient protection requirements, audits, training, quality assurance, and site support. The Operations Centers are expected to be closely integrated with their corresponding Statistics and Data Management Center in all aspects of trial operations through jointly developed policies and procedures for clinical trial development and conduct. The Operations Centers are also responsible for Network Group administration, including financial management, monitoring of member institution/site performance, coordination of biospecimen collection from patients on clinical trials, and adherence to all applicable NIH/NCI policies and regulations. Network Group Operations Centers may also provide trial operations for NCI Division of Cancer Treatment and Diagnosis (NCI/DCTD) approved, multi-center phase 2 and phase 3 trials originating outside the Network Groups.
  • Network Group Statistics and Data Management Centers: These Centers are responsible for providing the statistical expertise required to ensure effective scientific design and conduct of clinical trials as well as leadership in innovation in statistical methodology. These Centers are also responsible for data management, data analysis, and statistical analysis for NCTN trials led by their affiliated Network Group Operations Center as well as for translational and other ancillary studies associated with the trials.
  • Network Group Integrated Translational Science Centers: These awards provide support for leadership and expertise to facilitate incorporating translational science into Network Group clinical trials.
  • Network Lead Academic Participating Sites (LAPS) - this RFA: These academic institutions/sites provide scientific leadership in development and conduct of clinical trials in association with one or more adult Network Groups as well as substantial accrual to clinical trials conducted across the entire NCTN.
  • Network Radiotherapy and Imaging Core Services Centers: This institution/organization provides scientific and technical expertise for incorporation of appropriate, integrated quality assurance and image data management for applicable clinical trials conducted by the NCTN that require specialized quality assurance or imaging data management and/or assessment for radiotherapy and imaging interventions. In addition, the Center also provides similar services for other approved NCI-supported clinical trials network programs (e.g., NCI/DCTD early phase clinical trial network program, NCI Division of Cancer Prevention (NCI/DCP) NCI Community Oncology Research Program).
  • Canadian Collaborating Clinical Trials Network: This Canadian organization is a non-profit clinical trials organization capable of being a full partner with the U.S. Network in the conduct of large-scale, multi-site clinical trials. Incorporation of a Canadian Clinical Trials Network as a collaborating partner brings an additional advantage as U.S. Network Groups are anticipated to have Canadian member sites. A Canadian network is able to help reduce duplicative regulatory staff at each U.S. Network Operations Center.

Interactions with Other NCI-supported Programs. In addition to the six key components of the NCTN that are described above that are directly funded by the NCTN Program, other NCI grant and contract-supported Programs and their awardees as well as NCI Advisory Committees have important supporting roles in carrying out the research objectives of the NCTN Program. Thus the NCTN awardees are expected to interact as appropriate with such entities/programs as the NCI Clinical Trials Tumor Banks, the NCI Community Oncology Research Program (NCORP) and Minority/Underserved NCORPs, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards, and NCI Advisory and Scientific Committees, including the NCI Scientific Steering Committees.

Main Research Objectives and Requirements of this FOA

The Network Lead Academic Participating Site application must address the following 2 required functional components related to clinical treatment trials and advanced imaging trials for adult cancer patients only:

  • Clinical Trial Program - This functional component encompasses the LAPS scientific leadership in helping to develop and conduct clinical trials in association with one or more Network Groups, including the LAPS support of NCTN initiatives and mentorship of junior investigators.
  • Site Accrual Program – This functional component provides robust accrual to NCTN trials across the Network, including accrual to rare cancers and accrual from special populations (e.g., minority and underserved communities, adolescents and young adults), as well as timely activation of trials and good clinical trial stewardship.

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

Section II. Award Information
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 scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCI intends to commit $25 million in FY 2019 to fund 30 to 36 awards.  Future amounts will depend on annual appropriations.

Award Budget

The requested budget must not exceed $1,500,000 in direct costs per year.

Award Project Period

The total project period requested may not exceed 6 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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

Eligible institution/organization for the purposes of this application is defined as an academic hospital and/or academic clinic program providing direct medical care to patients that is considered one integral organizational entity under a single financial management system and governance structure. Academic centers for this application are distinguished from large medical centers whose primary mission is patient care. In addition to patient care, academic centers have comprehensive medical training programs and have preclinical laboratories that perform basic research.

Hospitals, clinics, military or Veterans Administration (VA) hospitals or treatment facilities, and health care organizations that may provide services in collaboration with the applicant institution in a network, but which are not an integral component of the academic organization under a single financial management system and governance structure that comprises the applicant institution (i.e., Network Lead Academic Participating Site consisting of an academic center and its essential components) may not be considered part of the academic institution. These other organizations may be considered "affiliates" of the Network Lead Academic Participating Site and be included in the application under the "affiliate" designation only if the Network Lead Academic Participating Site will provide complete management services for the affiliate site related to enrollment of patients on NCTN trials.

An academic institution/organization for the purposes of this award cannot be a NCI Community Oncology Research Program (NCORP) Community Site funded by the NCI Division of Cancer Prevention (DCP).

Foreign Institutions

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.

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

The named PDs/PIs for applications for NCTN Network Lead Academic Participating Sites cannot be named as PDs/PIs on applications for:

  • NCTN - Network Group Operations Centers (RFA-CA-17-056)
  • NCTN - Network Group Statistical and Data Management Centers (RFA-CA-17-057)
  • NCTN - Canadian Collaborating Clinical Trials Network (RFA-CA-17-058)
  • NCTN - Network Radiotherapy and Imaging Core Services Center (RFA-CA-17-060)

However, an individual who is designated as a PD/PI on the application for the NCTN Network Lead Academic Participating Site can, if appropriate, be listed as key personnel on applications for any of the RFAs listed above.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Letter of Intent

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

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

  • 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:

Meg Mooney, M.D.
National Cancer Institute
Telephone: 240-276-6086
Email: NCINCTNRFA@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the specific term of this FOA.

  • Research Strategy Section is limited to 30 pages.
Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: Applicants must provide the following additional material specified below in support of their application. The attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1. Summary of Lead Academic Participating Site Roster (use filename LAPSRoster). In this attachment, provide a list of the clinical sites that will be participating in patient accrual under the application. A table can be used to show this information with column headings for the major site/institution category (i.e., main academic site, integral component site, or affiliate), name of site/institution, Cancer Therapy Evaluation Program (CTEP) Site ID, city for site, and state for site, sorted by major site/institution category.

The following definitions should be used for the major site/institution category: the main academic site is the major hospital/clinical care center for the applicant, an integral component of an academic center is one that is under the single financial management system and governance structure of the main academic center but may be at a different geographic location (e.g., a clinic center in the suburbs of a city distinct from a downtown location for the academic center). These integral components usually have separate CTEP site codes. Other organizations that are associated with an academic center (e.g., VA Hospitals), but that are not under the same financial management and governance structure, may be considered "affiliates" of the Lead Academic Participating Site and may be included in the application under that designation (i.e., "affiliate"), if the Lead Academic Participating Site will be providing complete management services for the affiliate site related to enrollment of patients on NCTN trials (although the complete management services do not have to include IRB services).

Please Note: Affiliate(s) that meet the description provided above are allowed to be included in the application of the academic center for ease of administration for the academic center

(i.e., so that the NCI funding for data management of NCTN enrollments at the affiliate(s) go to the academic center directly from the NCI), but affiliate(s) do not have to be included in the application. The accrual and other activities of the affiliate(s) are not part of the review criteria for the academic center application – affiliate accrual is only included in the budget request of the academic center as the goal of the academic center award is to provide funding for academic centers and their integral components that have the potential to provide significant scientific leadership and accrual to the NCTN (it is not a goal of the award to build affiliate or regional networks). Thus, an academic center can have all its affiliates or some of its affiliates funded outside of the application. In the circumstance that an affiliate of an academic center with a Lead Academic Participating Site (LAPS) grant is not included in its application, the affiliate would receive its "per-case management" funding via the Network Group it credits with the accrual. If an affiliate is included in a Lead Academic Participating Site application, then that affiliate will receive all NCI funding for data management associated with patient enrollment to any NCTN trial via the LAPS grant (i.e., the affiliate cannot be an affiliate of another institution for purposes of its NCTN program participation in treatment and advanced imaging clinical trials).

Attachment 2. Summary of Key Leadership Staffing for NCTN Network Groups, NCI Steering Committees, and NCTN Initiatives (use filename KeyLeadershipStaff). In this attachment, provide information on NCTN-related positions held by investigators that were at the main academic site for the applicant or integral component of the applicant since the inception of the NCTN on March 1, 2014, through August 31, 2017. Only key senior leadership positions (i.e., Chair or Vice-Chair) on Network Group scientific or administrative committees and standing subcommittees under those main committees should be listed, not general membership on those committees. However, general membership on important Network Group Oversight or Executive committees (e.g., Data Monitoring Committee, Executive Committee) can be included, not just the senior positions on those committees. General membership on NCI disease-specific Steering Committees (e.g., NCI Breast Cancer Steering Committee) or standing Task Forces of NCI disease-specific Steering Committees (e.g., Colorectal Task Force of NCI GI Steering Committee) and other NCTN Initiatives (e.g., NCI Central Institutional Review Boards, NCTN Core Correlative Science Committee) should also be included in this attachment. A table can be used to show this information with column headings for the general category of Network Group/NCI Steering Committee/NCI Initiative, specific category or activity, institution's investigator's position on the committee category, investigator's name, investigator's title and discipline, and length of service on the committee/initiative. The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2014 through August 31, 2017). This attachment should not include information on whether an institutional investigator is a PI on a study as that type of information can be provided in Attachment #5 described below (filename CurrentNCTNTrialPIs).

Attachment 3. Summary of Important Primary Scientific Achievements on NCTN Clinical Trials by major cancer category, trial phase, and trial number (use filename PrimaryScienceAchievements). In this attachment, provide information on important primary scientific achievements that were reported out since the inception of the NCTN on March 1, 2014, through August 31, 2017 with contributions by the academic site member/investigator while he/she was at the main academic site for the applicant or integral component of the applicant. The primary scientific achievement refers to the Primary Endpoint(s) for the NCTN clinical trial (or legacy NCTN trial from the prior NCI-sponsored Cooperative Group Clinical Trials Program) specified in the protocol document. Applicants should briefly explain the importance of the achievement regardless of whether results were positive or negative as it is the importance of the achievement itself that is the focus for review, not the number of publications. A table can be used to show this information with column headings for the general cancer site category (e.g., breast, hematology - leukemia, gastrointestinal - colorectal cancer), trial phase, year of publication of study primary outcome or FDA indication or other significant impact, Network Group Trial # and brief title, manuscript or abstract reference, brief description of the importance of the primary scientific achievement, and brief description of the contribution made by the institution member/investigator). The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2014 through August 31, 2017).   

Attachment 4. Summary of Other Important Achievements for NCTN Clinical Trials by major cancer category, trial phase, and trial number (use filename OtherScienceAchievements). In this attachment, provide information on other important achievements associated with trials that were reported out since the inception of the NCTN on March 1, 2014, through August 31, 2017 with contributions by the academic site member/investigator while he/she at the main academic site for the applicant or integral component of the applicant. Other important achievements refer to important information from secondary endpoints or sub-studies of NCTN clinical trials (or legacy NCTN trial from the prior NCI-sponsored Cooperative Group Clinical Trials Program) specified in the protocol such as validation of an integrated biomarker or other important analyses (e.g., meta-analyses; special population analyses). Applicants should briefly explain the importance of the achievement as it is the importance of the achievement itself that is the focus for review, not number of publications.). A table can be used to show this information with column headings for the general cancer site category (e.g., breast, hematology - leukemia, gastrointestinal - colorectal cancer), trial phase, year of publication of study primary outcome or FDA indication or other significant impact, Network Group Trial # and brief title, manuscript or abstract reference, brief description of the importance of the important other achievement, and brief description of the contribution made by the institution member/investigator). The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2014 through August 31, 2017). Please Note: Quality of Life (QOL) sub-studies in NCTN trials funded by DCP NCORP Research Base grants should not be included in this table as those activities are funded and reviewed under the DCP NCORP Research Base grants.

Attachment 5. Summary of Leadership on NCTN Clinical Trials by Major Cancer Category, Trial Phase, and Trial Number (use filename CurrentNCTNTrialPIs). In this attachment, provide information on NCTN clinical trials leadership (i.e., PI and/or co-PI status for the main NCTN trial and/or                   co-PI or Champion (i.e., study liaison for accrual and trial monitoring and conduct for a NCTN Group not leading the main trial) for any NCTN trial or legacy NCTN trial that was open to accrual in the Network for at least 6 months after inception of the NCTN on March 1, 2014, through August 31, 2017. Please note that this information refers only to those individuals at the main academic site for the applicant or integral component of the applicant involved in the main trial (primary scientific endpoint), not in sub-studies embedded in the trials (e.g., ancillary studies) or oversight of other components of the trial (e.g., pathology, laboratory/correlative studies). A table can be used to show this information with column headings for the general cancer site category (e.g., breast cancer, gastrointestinal cancers, genitourinary cancers, leukemia, lymphoma, myeloma), trial phase, date of trial activation, date of trial closure to accrual (or list trial accrual as still on-going), institution's investigator's position on the trial (i.e., main trial PI/co-PI or co-PI/Champion status for other Network Groups participating in the main NCTN trial, investigator's name, and investigator's title and discipline. The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2014 through August 31, 2017).

Attachment 6. Summary of Accrual for All NCTN Clinical Trials - All Diseases and All Trial Phases (use filename SummaryAllAccrual). In this attachment, provide documentation of patient accrual on NCTN clinical trials since the inception of the NCTN on March 1, 2014, through August 31, 2017 from the main academic site for the applicant and any integral components of the applicant (not affiliate sites). Accrual figures should include the unique number of patients enrolled on each NCTN trial regardless of whether the accrual was a screening or an intervention accrual (biospecimen submissions should not be counted as accrual). However, because of the large number of screening accruals on the three NCTN Precision Medicine Trials of LUNG-MAP (trial # S1400), Adult MATCH (trial # EAY131), and ALCHEMIST (trial # A151216), patient accrual to these trials should be presented separately from all other accrual. Therefore, the accrual information can be provided in two tables - one table for the number of unique patients enrolled on the three NCTN Precision Medicine Trials with large screening components (i.e., S1400, EAY131, A151216) and one table for accrual to all other NCTN trials. The column headings for each table should include all trial phases (pilot/other, phase 1, phase 2 (including phase 1/2 trials), phase 3 (including phase 2/3 trials) and total column summing accrual across all trial phases. The timeframe for the period of accrual should be provided as a sub-heading for each table (e.g., March 1, 2014 through August 31, 2017).

Attachment 7. Summary of Accrual for Major Disease Categories - All Trial Phases (use filename SummaryAccrualMajorCancerSite).  In this attachment, provide documentation of patient accrual by major disease category on NCTN clinical trials since the inception of the NCTN on March 1, 2014, through August 31, 2017 from the main academic site for the applicant and any integral components of the applicant (not affiliate sites). Accrual figures should include the unique number of patients enrolled on each NCTN trial regardless of whether the accrual was a screening or an intervention accrual (biospecimen submissions should not be counted as accrual). However, because of the large number of screening accruals on the three NCTN Precision Medicine Trials of LUNG-MAP (trial # S1400), Adult MATCH (trial # EAY131), and ALCHEMIST (trial # A151216), patient accrual to these trials should be presented separately from all other accrual. Therefore, the accrual information can be provided in two tables - one table for the number of unique patients enrolled on the three NCTN Precision Medicine Trials with large screening components (i.e., S1400, EAY131, A151216) and one table for accrual to all other NCTN trials. The column headings for each table should include major disease category (e.g., breast cancer, gastrointestinal cancers, genitourinary cancers, leukemia, lymphoma, myeloma), all trial phases (pilot/other, phase 1, phase 2 (including phase 1/2 trials), phase 3 (including phase 2/3 trials), and total column summing accrual across all trial phases by major disease category. The timeframe for the period of accrual should be provided as a sub-heading for each table (e.g., March 1, 2014 through August 31, 2017).

Attachment 8. Summary of Timelines for Local Activation of NCTN Clinical Trials at Main Academic Site and Integral Component Sites (use filename SummaryActivationTimelines).  In this attachment, provide information on the timeline for the initial activation/opening of NCTN trials at the main academic site and integral component sites if those sites open studies via a different process and different timeline from the main academic site (do not provide this information for affiliates). This information should be provided only for NCTN trials that activated on or after the inception of the NCTN on March 1, 2014, through August 31, 2017. This information may be provided in a table with column headings for the site name, site category (main academic site or integral component), major disease category, trial phase, trial number and brief title, date the study was activated/opened for patient accrual by the Lead Group, date the trial was submitted for evaluation by at the site, date the trial opened at the site for patient enrollment, # days from evaluation to opening at the site, and an optional comments field. The data in the table should be sorted by major disease/cancer category, Lead Group trial activation date, and trial #. Please note that the date the site began the process for evaluation of opening the trial is the date the site starts with formal resource or other review of the trial by a review committee at the site. This is not the date that the study is submitted for IRB review (if NCI CIRB review was not used) unless submission for IRB review was done simultaneously with review of the trial by the site prior to the site deciding to open the study.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

a) General determination of level of overall funding. The NCTN provides general total cost support for different types of accrual for LAPS depending on the accrual type category and site category where patient enrollment occurred. For intervention accrual at the main academic site and all integral component sites, total cost funding for "per case management" is expected to be provided in the range of $4,800 to $6,000 for each patient enrolled on treatment trials. For affiliate sites, this total cost funding for "per case management" range is expected to be $2700 to $3900 for each patient enrolled on treatment trials. For all sites (regardless of category type), this total cost funding range is expected to be $600 for "screening only" accrual on treatment or primary imaging trials (i.e., patient does not go onto the intervention phase of the trial), $1,500 for base interventional accrual on primary imaging studies, and $600 for 1 patient biospecimen collection per enrollment on a treatment or primary imaging trial. 

From the estimated "ballpark" total cost level funding for all anticipated, the applicant should create a standard grant "level-of-effort" budget using the cost categories for the standard R&R budget application. The applicant can allocate the total cost amount across all allowable cost categories in any amount or distribution pattern that the applicant believes is appropriate. The applicant can request more (or less) than the estimated amounts with appropriate budget justification; however, budgets that are based on estimated ranges for the infrastructure costs associated with per case management.

To justify the budget, the applicant needs to describe using an "Accrual Input # Table or Narrative" in the budget narrative detailing the number of patients expected to be accrued in the "screen only" category for treatment and/or imaging trials, intervention category for treatment trials, intervention category for primary imaging trials, and 1 patient biospecimen collection for each enrollment on a  treatment or primary imaging trial by category site type (main academic site and integral components versus affiliates).

Please Note: Scientific leadership positions in the Network Groups will be funded by the Network Groups Operations Centers or associated Network Group Statistical and Data Management Centers (i.e., support for the activities of academic center investigators on Network Group oversight committees such as the Data Safety Monitoring Committees or Executive Committee and support for study chairs as well as Chair and Vice or Co-Chairs of scientific committees and administrative committees). Applicants can include these scientific leadership positions as accomplishments for the review to demonstrate how the LAPS application has the potential to provide leadership for the NCTN Program, but budget support for these positions if provided is included in the Network Group Operations Centers and SDMCs application budget, not in the LAPS application budget.

b) Travel Expenses. Applicants must budget travel funds for two persons (two PDs/PIs or one PD/PI and an additional senior investigator) to attend up to 4 NCTN Network Lead Academic Participating Site in-person meetings over the grant's entire project period in addition to other travel expenses.

c) NCI does not support costs associated with routine patient care as a budget expense under this FOA.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Outline succinctly the overall goal and research strategy for applicant to provide scientific leadership in development and conduct of clinical trials in association with 1 or more adult NCTN Network Group(s) as well as substantial accrual to clinical trials conducted across the entire NCTN.

Research Strategy: Organize the overall Research Strategy section with sub-sections in the specified order and using the instructions provided below. Start each sub-section with the appropriate sub-section heading: Sub-section A. Lead Academic Participating Site Overview; Sub-section B. Lead Academic Participating Site Clinical Trial Program; and Sub-section C. Lead Academic Participating Site Accrual Program.

Sub-Section A. Lead Academic Participating Site Overview - Address the following:

  • Describe the governance and organizational capabilities and commitment relevant to the award as well as the general expertise of the senior leadership team as a whole for the Lead Academic Participating Site (LAPS) application.

Sub-Section B. Lead Academic Participating Site Clinical Trial Program - Address the following areas:

  • Describe the LAPS' scientific leadership in development of NCTN clinical trials and in the scientific activities of the NCTN, including activities with all the Network Groups to which the LAPS belongs as well as activities related to NCI initiatives for the NCTN Program such as participating in the NCI Central Institutional Review Board (NCI CIRB), NCI Scientific Steering Committees and Task Forces, and NCI NCTN Core Correlative Science Committee.
  • Describe how institutional activities related to the NCTN across various disciplines and departments at the LAPS are coordinated and how activities and responsibilities will be carried out among the PD(s)/PI(s). Describe how the LAPS selects NCTN clinical trials to activate and how funding associated with patient enrollment and clinical data collection and management is distributed to the various disciplines and clinical departments involved in the conduct of NCTN trials.
  • Describe the most important achievements since the inception of the NCTN that show potential for achievement in the NCTN Program as well as the potential for mentorship of junior investigators clinical trial research within the NCTN.

Sub-Section C. Lead Academic Participating Site Accrual Program - Address the following areas:

  • Describe the LAPS plan for robust accrual to NCTN trials across the Network, including accrual to rare cancers and accrual from special populations (e.g., minority and underserved communities, adolescents and young adults) as well as community outreach programs to achieve robust accrual. LAPS applicants should provide information on past minority and underserved community accrual to NCTN trials.
  • Describe the operational efficiency of trial activation and conduct by the LAPS (including the timeliness of data submission and auditing results as well as how quickly the LAPS activates NCTN trials). 
  • Describe the ability of the LAPS to conduct trials with good clinical trial stewardship as demonstrated by audit results from accrual to NCTN trials and data submission timelines/quality on NCTN trials. 

Letters of Support: If the application includes affiliates for which the lead academic center provides complete management services, the application section on Letters of Support should include Letters of Support from the affiliate organizations acknowledging that the affiliate site supports its inclusion in the application and  agrees to receive NCI funding for  patient data management on all NCTN trials they participate in via the LAPS grant should it be funded (i.e., an affiliate cannot be an affiliate of another institution for purposes of its NCTN Program participation; it would only participate and receive funding for patient data management in NCTN trials through the applicant's LAPS grant.

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. Since it is expected that the applicants will follow the Resource Sharing Plans of

the associated Network Group(s)' Operations Center(s) leading trials on which it participates, the

applicant should indicate in its application that it is bound by these plans (i.e., the resource sharing plans that may have been submitted by the associated Network Group(s) including but not limited to general NIH/NCI data sharing as well NIH/NCI genomic data sharing).

The Data Sharing Plan and other resource plans (or rationale for not providing sharing certain resources) should be provided in the research application; however, prior to funding of an award, all resource sharing plans will also need to be reviewed and approved by NCI/DCTD program staff prior to any award in order to ensure that the plans are in compliance with the NIH/NCI regulations and Terms of Award for this key component of the NCTN Program.

Appendix:

  • Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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.

 
Overall Impact

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).

Scored Review Criteria

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.

Significance

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?

Investigator(s)

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? 

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 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?  

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? 

Additional Review Criteria

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.

  • Does the LAPS applicant demonstrate capacity to provide scientific leadership in the NCTN Network Groups as well as for other NCTN initiatives and programs such as participation in the NCI Central Institutional Review Board (NCI CIRB)?
  • Does the LAPS applicant demonstrate the potential to overcome critical barriers for robust accrual for NCTN trials, across disease areas, including trials in rare cancers, and for special populations, including minority and/or underserved populations as well as adolescence and young adults? Does the LAPS applicant have active programs to recruit minorities and underserved patient populations to NCTN trials?
  • Does the LAPS applicant demonstrate the potential for robust accrual (e.g., 55 to 70 patients per year or more) to multi-institutional NCTN trials?
  • Does the LAPS applicant have processes in place for timely activation of NCTN trials?
  • Do NCTN clinical trials conducted at the LAPS applicant's sites appear to be conducted in accordance with good clinical practice as evidenced by audit results and data quality/submission timelines? 
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 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

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)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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 on the basis of established PHS referral guidelines 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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

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 Lead Academic Participating 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 Lead Academic Participating 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 LAPS scientific involvement in oncology treatment research, including advanced imaging research and radiation oncology research, associated with NCTN trials.
  • Involvement in auditing of Network LAPS 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.
  • Review of accrual and overall performance of NCTN trials by the LAPS institutions.
  • Advising awardees concerning mechanisms established for quality control of therapeutic and diagnostic modalities used in NCTN clinical trials.
  • Monitoring the progress and performance of this key component of the NCTN Program.
  • 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 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 NCTN Program, as appropriate.
  • Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCTN Program related to LAPS support of and participation in NCTN clinical trials that might impact the awards.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened.  It will have three members: a designee of the Steering Committee chosen without NIH staff voting; one NIH designee; and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Meg Mooney, M.D.
National Cancer Institute
Telephone: 240-276-6086
Email: NCINCTNRFA@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.

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