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

Cancer Research Network: a Research Resource within Health Care Delivery System (Limited Competition U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-11-502

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility

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

93.393, 93.394, 93.395, 93.399

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support the Cancer Research Network (CRN), a research resource consortium involving as "Members" research organizations within several non-profit Health Maintenance Organizations (HMOs). Originally, CRN was focused on collaborative research made possible through integrated access to clinical datasets from the participating institutions. This FOA uses a different funding mechanism and redefines the role of CRN as a broader resource for cancer researchers at large. The uniqueness of CRN as a cancer resource stems from: (1) the integrated access to clinical data for large, stable, and diverse patient populations that are available through the "parent" HMOs; and (2) the expertise of CRN researchers in conducting clinical cancer research involving large sets of clinical data. Through this FOA, the NCI intends to promote further technical and methodological enhancements of CRN informatics infrastructure as well as efforts to facilitate access of non-CRN-affiliated investigators to CRN data and expertise. The goal is to increase the number and scope of research projects that are based on CRN data and the participation of CRN investigators on such projects. In addition to collaborations on projects funded outside of CRN, CRN will directly support pilot projects that may be initiated either by non-CRN-affiliated investigators or by CRN investigators. It is expected that CRN will implement appropriate organizational and scientific infrastructure and procedures to seek, evaluate, prioritize, co-develop (with the active role of CRN investigators), and conduct such pilot projects. To address the goals of the FOA, CRN is expected to consist of the following components: Administrative Core; Informatics Core; Scientific Program (Working Groups); Outreach and External Collaboration Program; Pilot/Developmental Studies; and Training Program.

Key Dates
Posted Date

September 29, 2011

Letter of Intent Due Date

November 15, 2011

Application Due Date(s)

December 15, 2011

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

March-April, 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

September 2012

Expiration Date

December 16, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support the Cancer Research Network (CRN) as a clinically oriented research resource formed within a network of non-profit Health Maintenance Organizations (HMOs). This FOA is a limited competition solicitation open only to institutions that are “Members” of the current CRN consortium funded by NCI U19 cooperative agreement award.

Original goals for CRN emphasized collaborative research among CRN investigators using integrated access to clinical datasets from the participating institutions with lesser emphasis on providing access to these datasets to outside, non-CRN-affiliated researchers. This FOA seeks to reshape CRN as a broader resource for cancer researchers at large. The uniqueness of CRN as an important resource for cancer research stems from: (1) the integrated access to clinical data for large, stable, and diverse patient populations that are available through the "parent" HMOs; (2) the expertise of CRN researchers in using large sets of clinical data; and (3) access to such large data sets of broad populations (that are suitable for studies of cancer risks) and populations of cancer patients, including patients with rare cancers or complex medical conditions.

Through this FOA, the NCI intends to promote further technical and methodological enhancements of CRN informatics infrastructure as well as efforts to facilitate access of non-CRN-affiliated investigators to CRN data and expertise. The goal is to increase the number, scope, and impact of research projects that are based on CRN data and the participation of CRN investigators on such projects as collaborators, experts, or, if appropriate, scientific leaders. CRN will directly support pilot projects that may be initiated by either non-CRN-affiliated investigators or CRN investigators. In addition, CRN investigators are expected and encouraged to seek relevant collaborations on projects funded outside of CRN.

Background

CRN Environment. Currently, the CRN consists of 14 research “sites” at Member institutions (research divisions) affiliated with non-profit HMOs. All these CRN Member institutions belong also to a consortium of 16 health care delivery organizations with integrated research divisions, known as the HMO Research Network (HMORN, http://www.hmoresearchnetwork.org/about.htm). The HMORN’s goal is to improve health care and transform health care practices through a broad spectrum of population-based research studies. The HMORN research portfolio includes a wide variety of health care topics. In addition to CRN, HMORN has attracted other NIH-funded research programs including HMO Collaboratory (https://commonfund.nih.gov/hmocollaboratory/), the Cardiovascular Research Network (http://www.cvrn.org/), the Mental Health Research Network (http://www.mhrn.info/), as well as several programs funded by Agency for Health care Research and Quality (AHRQ).

The parent HMOs for CRN Members provide care for approximately 11 million individuals. These HMOs offer substantial resources that are potentially useful for the conduct of clinically oriented cancer control research as well as of cancer epidemiology studies. These resources include data for: large, well-defined, and diverse patient populations; long-established administrative and medical records; physician and patient web portals; biospecimen resources; linkages to other data systems such as population-based cancer registries; and capacity for rapid identification and accrual of subjects to longitudinal retrospective and prospective cohorts for observational studies or clinical trials.

Original CRN Goals and Their Evolution. Initially, the concept of CRN as a research network within the HMOs environment was based on access to health care data through administrative records, chart review, and the participation of HMO health care providers and members through surveys, intervention studies, and trials. In recent years, the HMOs affiliated with the CRN have fully implemented various important innovations such as electronic medical records (EMR) systems and extensive patient web portals. These innovations have changed the landscape for conducting research within these HMOs and increased the value of their data as a research resource, which has greatly enhanced the potential for studies on system/physician/patient communications and patient-reported outcomes.

In addition to these changes, the scope of CRN research has evolved. The CRN was initially conceptualized as a program to conduct research on cancer prevention, early detection, treatment, long-term care, surveillance, cancer communication, and dissemination. These areas reflect the traditional main strengths of the HMO research centers, whose investigators have considerable expertise in epidemiology, health services, and health systems intervention research. With time, the CRN has evolved to support a much broader research agenda that includes: validating and disseminating research findings on molecular and genomic markers in community health care settings; understanding genomic, environmental, life-style, and iatrogenic contributions to cancer risk and prognosis in the context of large epidemiological cohorts; conducting prospective comparative effectiveness research (through observational studies, evaluating natural experiments or innovative trial designs such as cluster randomization); examining clinical outcomes for patients with rare cancers or complex medical conditions that cannot be examined in existing NCI clinical trial groups; implementing innovative decision-support interventions to improve cancer care; and developing and validating novel informatics tools.

Main CRN Accomplishments.The CRN has served a unique function in greatly enhancing NCI’s capacity to support research within the context of health care organizations. The advantages of a research infrastructure like CRN have been recognized across the NIH, as several programs have built research infrastructures that emulate the CRN model. CRN activities included many CRN-initiated research projects, which have led to additional peer reviewed funding, and more than 200 research publications (for details, see http://crn.cancer.gov/).

Key to CRN research accomplishments has been the development and use of the Virtual Data Warehouse (VDW), which is the informatics core of the CRN federated data system. VDW provides information technology systems and tools that make it possible for researchers at diverse CRN research sites to create and share relevant data. VDW enables the identification, standardization, harmonization, and sharing of data elements across multiple CRN health care system-based research sites, while ensuring the privacy of individual patient information (as required by Federal regulations). The VDW has been endorsed and supported by the entire HMORN as well as by the management of the individual HMOs.

The VDW includes: 1) a series of computerized data sets stored behind separate security firewalls at participating HMORN sites that include variables with identical names, formats, and specifications and identical variable definitions, labels, coding, and definitions; 2) a set of informatics tools—hardware and software—that facilitates storage, retrieval, processing, and managing VDW datasets; 3) a set of access policies and procedures governing use of VDW resources; and 4) documentation of all elements of the VDW. Data elements for the VDW derive from HMO administrative data, HMO archival medical records, and HMO EMRs. VDW data will also be linked to other HMO research resources, such as cancer registries, biospecimens, and geographic information. These developments greatly increase the capacity for the CRN to develop rigorous and sharable research information, but also pose challenges for continuing and enhancing the transformation of health care system data elements into usable and serviceable research data sets.

Potential and Need for Further Improvements in CRN Functions as Research Resource. CRN has started to evolve from an internally focused research program to a collaborative research resource. To optimize the scientific value of the CRN, this transition needs to be accelerated and expanded. CRN offers unique capabilities and tools to generate novel research data using extensive datasets for patient populations served by affiliated HMOs. Further enhancements are needed to the VDW to improve these tools and to improve generation of useful and shareable research data for a broader range of research projects. Data abstraction and survey instruments as well as instruments that provide feedback to health care providers and patients participating in intervention studies may be better developed. There is also potential for improvement to informatics tools that could allow: the translation of narrative medical records text into definable research data; the identification and tracking of biospecimens; ability to identify CRN HMO patients populations (or identify population-based records) and HMO providers for retrospective observational studies or prospective interventional studies or pragmatic trials; and institutional arrangements to facilitate rapid Institutional Review Board (IRB) approval for complex, multi-site studies.

CRN research resources also include HMO investigators with a range of expertise in cancer research as well as HMO investigators, programmers, and information technology experts with a specialized knowledge of the complex local data systems. Their available expertise is one of the most important aspects of the CRN resource. This human potential can be better channeled to serve a broader scientific community. In the last few years, the CRN has made substantial gains in engaging researchers at non-CRN-affiliated academic institutions to utilize the CRN data, capabilities, and expertise. It is recognized that CRN has initiated developing explicit and proactive processes and procedures for encouraging and facilitating collaborative research projects with investigators external to the CRN. Nonetheless, further efforts in these directions are warranted and strongly encouraged.

GENERAL REQUIREMENTS

Applicants responding to this FOA must thoroughly and comprehensively address the current main objective of the CRN Program, which is to elevate and enhance the role of CRN as a resource for collaborative clinically-oriented cancer research.

CRN is expected to function as a resource to the broad cancer research community mainly through the following activities:

Scientific Areas Relevant to CRN Goals. Areas that CRN applicants may choose to focus on include, but are not limited to, the examples listed below. It is the responsibility of the applicants to determine and justify an optimal mix of scientific areas for the overarching goals of CRN.

It is anticipated that CRN awardees will create several Scientific Working Groups organized around selected scientific themes and/or methodological areas.

To ensure efficient conduct of the activities outlined above, the proposed CRN structure must include the following organizational and functional components:

For details regarding individual components, see Section IV. Content and Form of Application Submission.

PROGRAM EVALUATION. The CRN program will be subject to external evaluation near the end of the funding period (to be coordinated by the NCI Program Staff). Such evaluation is part of NIH efforts to optimize the efficiency of the funded research. The evaluation process will involve monitoring and assessing the progress of the CRN program toward achieving its goals. This aspect includes evaluating the quality, value, and accessibility of the CRN as a cancer research resource and the quality and scientific impact of the research that utilizes the CRN data and expertise. For the efficient evaluation of the Program, cooperation of the CRN awardee will be important and expected.

CRN GOVERNANCE

The CRN research resource will be governed by the CRN Steering Committee. The Steering Committee will also be responsible for overall scientific oversight of the CRN research resource. Steering Committee will form a subcommittee of experts (Scientific Consulting Panel) as external advisors to CRN. Details on the composition and functions of CRN Steering Committee and the Scientific Consulting Panel are provided in Section VI.2.A. Cooperative Agreement Terms and Conditions of Award.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCI intends to commit an estimated up to $4 million per year (total costs) for 5 years to fund one award.

Award Budget

Applicants may request a project period of up to 5 years, and a budget (in total cost) up to $4 million per year in total costs. Although the financial plans of the NCI provide support for this program, award pursuant to this funding opportunity is contingent upon the availability of funds and the receipt of a sufficiently meritorious application.

Award Project Period

5 years

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only institutions that are current members of CRN consortium supported by the NCI U19 cooperative agreement award are eligible to apply. Note that it is not expected that all current Member institutions will necessarily continue to participate in the CRN consortium. It is up to the discretion of eligible institutions to decide which of them will serve as applicant institution (i.e., it may be the current awardee institution or another eligible Member institution).

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 must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

Applicants are encouraged to designate a lead PD(s)/PI(s) (based in the institution submitting the application) and a second PD(s)/PI(s), who would share the responsibilities but would also be capable of leading the entire CRN (in case the lead PD(s)/PI(s) is unable to continue serving in this role). If only one PD/PI is designated, applicants must identify a PD(s)/PI(s) potential replacement candidate, i.e., a senior investigator who will be qualified to take over the PD(s)/PI(s) responsibility for the entire CRN if such need arises.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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

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

The letter of intent should be sent to:

Paul Doria-Rose, D.V.M., Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, Room 4110, MSC 7344
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8574
FAX: (301) 435-3710
Email: doriarop@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following additional requirements:

Detailed Budget for Initial Budget Period, Budget for Entire Proposed Period of Support

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5).

Use additional Form Pages 4 and 5 to provide detailed separate budget information (first year and cumulative budgets for the entire project period) for the individual application components. This information must include:

Budget pages for Administrative Core;

Budget pages for Informatics Core;

Budget pages for Scientific Program (Scientific Working Groups);

Budget pages for Developmental Pilot Studies Program;

Budget pages for Outreach and External Collaboration Core; and

Budget pages for Training Program.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to include in Section 3 "Research Strategy" the following sub-sections A-G:

A. CRN Overview;

B. Leadership and Administrative Core;

C. Informatics Core;

D. Scientific Program (Scientific Working Groups);

F. Developmental Pilot Studies Program;

E. Outreach and External Collaboration Core; and

G. Training and Professional Development Program.

Standard sub-sections of Section 3. Research Strategy of the PHS 398 Research Plan are replaced by the new sub-sections A-G (corresponding to individual application components, see details below); and

The PHS 398 standard page limit for Research Strategy is replaced by individual limits indicated below for the new sub-sections A-G.

Other sections of the PHS398 Research Plan remain unmodified and should be completed following standard instructions.

Sub-Section A. CRN Research Resource Overview (up to 12 pages)

In this section, outline the following aspects:

Sub-section B. Leadership and Administrative Core (up to 12 pages)

In this section, describe/define the following aspects:

Note: Commitment of each participating institution/organization must be properly documented by respective letters of intent to establish consortium (to be included in Section 14 of Research Plan “Letters of Support”).

Sub-section C. Informatics Core

In this section, address the following aspects:

Describe also concrete plans for developments of informatics infrastructure/tools/solutions in the following areas:

Sub-section D. Scientific Program (Scientific Working Groups) (up to 12 pages total)

In this section, address the following aspects:

Note: It is neither expected nor required that all Scientific Working Groups will directly involve investigators from all CRN research sites. Rather, applicants should justify the composition of each Scientific Working Group in terms of investigator strengths and technical resources that individual participating sites can contribute. Still, applicants are encouraged to plan that specific research projects that might be conceived and implemented by a Scientific Working Group include integrated data acquisition and other types of participation across the resource as appropriate.

Sub-section E. Developmental Pilot Studies Program (6 pages)

In this section, address the following aspects:

Sub-section F. Outreach and External Collaboration Core (6 pages)

In this section, address the following aspects:

Note: It is expected that this Core will be directed by a PhD level individual with assistance from another individual with at least Masters level training and with experience in outreach and collaboration activities. As justified, appropriate administrative and technical support staff may also be proposed.

Sub-section G. Training Program (6 pages)

The Training Program must be designed to serve the overall goal of developing investigators’ understanding of the potential advantages and limitations of CRN resources, the procedures/ processes involved, and analytic tools and methods that are appropriate for conducting multi-site research projects using complex data sets. In this section, address the following aspects:

Note: For the purpose of this Training Program, a “junior” investigator is defined as a doctoral-level researcher who has never received as a PD/PI an independent funding such as NIH R01 grant or equivalent. This definition includes postdoctoral fellows. In rare situations, mentees may include also more senior investigators seeking career transition and experience in CRN multi-site studies. Candidates for Mentors are expected to be knowledgeable about CRN as a research resource and should have experience in directing as the PD/PI of at least one CRN-based multi-site research project.

OTHER REQUIREMENTS

Plans for the Administrative Core should include logistical support for several activities listed below. (Respective funds for these activities should be identified on the budget for the Administrative Core).

Annual CRN Scientific Meeting: Applicants must plan for one meeting of CRN investigators per year. These meetings will be co-organized by the CRN Steering Committee and the NCI with logistic support provided by the CRN Administrative Core. During these meetings, CRN leadership, investigators, NCI program staff members, and invited experts will discuss scientific progress and other issues relevant to CRN as a research resource. CRN applicants must budget appropriate travel funds to cover participation in these annual CRN Scientific Meetings of the following persons:

Support for the Activities of the CRN Steering Committee: The Administrative Core must support logistically the meetings of the CRN Steering Committee (two per year face-to-face and additional monthly meetings by teleconferences).

Scientific Consulting Panel. Applicants should budget appropriate moderate consultation and travel costs for the expected number of members of the Scientific Consulting Panel. When describing the plans for that Panel, outline the types of expertise desired. However, do NOT identify or contact any potential candidates, as that would adversely influence the selection of potential reviewers.

Leadership Visits to CRN member sites. Applicants should also plan for leadership visits to all the CRN member sites at least once every other year and budget appropriate modest travel costs.

NCI Site Visits. Because of the complexity of the CRN, NIH/NCI program staff members will conduct at least one administrative site visit at the Research Resources Coordinating Center. CRN applicants must agree to participate in this process and should plan for one visit (budget costs associated with such visits to the CRN side, e.g., travel funds for collaborating investigators to be invited).

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398 Application Guide, with the following modification:

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

It is expected that in addition to adhering to the general NIH policy on data sharing, CRN data sharing plan will address the following specific aspects:

1) Data sharing within CRN for multi-site developmental pilot projects and/or between single-site developmental pilot projects and the Informatics Core ; and

2) Data sharing with investigators who are not funded through CRN, including CRN-affiliated investigators and external (i.e., non-CRN-affiliated) investigators.

For both types of data sharing, address policies, procedures, and documentation needed to ensure the protection of individual identities of providers and patients in shared data.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project; and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of an award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)  

6. Other Submission Requirements and Information

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR) and responsiveness by the NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, note the following:

The emphasis and priority of this FOA are on the continued development and enhancement of the CRN as a research resource and on increasing the utilization of the CRN data, HMO-enrolled patient populations, and expertise as a cancer research resource for multi-site, collaborative research projects, both within the CRN and with external investigators.  All the required components will be assessed in terms of how well they can contribute to these overall goals.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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 resource that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific for this FOA: How well do the proposed areas of research focus and Scientific Working Groups take advantage of the unique strengths of the CRN and its environment? What is the likelihood that the proposed plans will lead to a better optimized, coherent, and scientifically productive stewardship of the CRN as a unique research resource?

Investigator(s)

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

Specific for this FOA: Are the key investigators sufficiently knowledgeable about the CRN and its role as research resource? How extensive has been their participation in collaborative, multi-site CRN-based research projects?

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?

Specific for this FOA: What novel approaches have been/will be used by the CRN investigators to capture relevant information from EMR and other clinical data for research purposes?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CRN resource? 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? 

Are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA: How well does the existing CRN capacity and proposed directions of changes fit with the goal of CRN serving primarily as a unique research resource? How sufficient are the proposed actions and plans to maintain, leverage, and augment research resource capacities of CRN? What is the likelihood of success of the proposed Research Program and other CRN functional components to expand the scope of CRN research by engaging investigators from academic centers outside of the CRN to successfully work in collaboration with CRN investigators? Will the resource effectively facilitate collaborative research projects involving non-CRN researchers as consultants, co-investigators, or project directors?

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?

Specific for this FOA: What are the capabilities of the lead institution to provide effective administrative support for the proposed network? How well does the proposed governance and organizational structure address the need to ensure coherence, integration, and synergy across the five components of the project? How well does the proposed governance/organizational structure address the need to ensure coherence, integration, and synergy across the CRN resource and other HMORN-related research projects?

Additional Review Criteria - Overall

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

1. Criteria for Overall Resource Integration: Are the functions/roles of individual CRN components adequately defined and their responsibilities optimally divided? How adequate is the proposed governance/organizational structure in terms of the need to ensure coherence, integration, and synergy across the CRN and other HMORN-related research programs? How well do the plans match the over-arching goals of increasing the scope and functionality of the CRN as a research resource and increasing the quality, scientific breadth, and number of multi-site and collaborative research projects?

2. Criteria for Administrative Core: How well does the proposed administrative core serve the goal of ensuring the efficient and effective day-to-day administrative and scientific operation of the CRN research resource? Will the core as proposed be sufficient for performing all the anticipated functions? Are the proposed personnel, resources, and organization adequate for these tasks?

3. Criteria for Informatics Core: How well does the proposed Informatics Core serve the goal of increasing the overall scope and research functionality of the VDW, including development of additional specific data elements and data domains within the VDW? How adequate are the proposed personnel, resources, and organization for the goal of developing innovative methodologies and informatics tools and approaches that would enhance the potential value and utility of CRN data for research purposes? What is the likelihood that the Informatics Core, as proposed, will substantially contribute to enhancing the scope, quality, and research functionality of the CRN resource?

3. Criteria for Scientific Program:  How well do the proposed Scientific Program and Scientific Working Groups serve the goal of conceptualizing and implementing CRN research strategies? How optimal are the selected areas of scientific focus in matching the profiles of the participating investigators and member institutions? What is the potential of the proposed Scientific Program to inspire high quality collaborative studies and generate scientifically significant results that would have an important impact on policy and practice related to reducing the burden of cancer morbidity and mortality? How sufficient are the plans for the Scientific Working Groups in terms of shaping the strategic directions for optimizing the VDW and the entire CRN data systems for research in their selected scientific areas of focus? Are there adequate plans to engage non-CRN researchers as members of scientific working groups?

4. Criteria for Developmental/Pilot Studies Program: How well will the proposed Developmental/Pilot Studies Program serve the goals of increasing the scope of research based on CRN data? Will this Program support sufficiently pilot projects to enhance VDW data system and other CRN research tools and methodologies? How adequate is this Program in terms of plans and procedures for soliciting, evaluating, and selecting pilot projects? How optimal are the proposed processes and efforts for ensuring that the conducted developmental/preliminary projects indeed generate preliminary results that could form the basis of competitive grant applications to separately fund full research projects based on CRN data?  What is the likelihood that the proposed program of Pilot Studies will eventually result in a substantial increase in collaborative research projects that utilize the CRN resource and are successful in competing for peer-reviewed funding from other sources?

5. Criteria for Outreach and External Collaboration Core: How well does the proposed Core serve the goals of increasing the knowledge and understanding of the CRN resource in the general cancer research community and in increasing the efficiency and effectiveness of the negotiating and navigation processes involved in implementing CRN collaborations with external investigators? What is the likelihood that this Core will substantially facilitate the access of external investigators to CRN as a data and expertise resource? Will these efforts be sufficient to expand the scope of research based on CRN data and markedly increase collaborations between CRN-non-affiliated investigators on joint projects with CRN investigators?

6. Criteria for Training Program: How well does this Training Program serve the goals of engaging and training researchers to become competent and confident at initiating and leading CRN-based multi-site, collaborative research studies? What is the likelihood that the Training Program will substantially contribute to the increase in the usage of CRN as a resource and, ultimately, the number of successful competitively funded research projects that are led by researchers trained under this program?  

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

The committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the CRN resource 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/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

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 the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

The PD(s)/PI(s) assumes responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the CRN research in accordance with terms and conditions of the award. 

The CRN will be subject to periodic self-evaluation and external evaluation (coordinated by the NCI). The CRN awardee and member institutions will be expected to participate in such evaluations.

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:

A designated NCI Program Director, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. As needed, additional NCI scientific staff members with relevant expertise may also become substantially involved in CRN activities as Projects Scientists or Coordinators.

NCI staff members who are substantially involved in the activities of CRN will not attend peer review meetings of renewal and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

In addition, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice. If this individual becomes substantially involved in the CRN activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NCI waiver if such participation is essential.

The NCI Project Scientists and other substantially involved Program staff members will assist CRN by:

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to the CRN awardee and/or member institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of Joint Responsibility include the following:

CRN Steering Committee. The CRN Steering Committee will serve as the main governing board for the CRN Initiative. The Steering Committee will consist of the following voting members:

NOTE: Each voting member representing CRN will have one vote (including those individuals who may have multiple responsibilities, e.g., being a representative of a Member Institution and a Leader of one of CRN Programs). Regardless of the number of NCI representatives, the NCI will collectively have only one vote.

The CRN Steering Committee may form subcommittees as needed. One such subcommittee to be established in the first year of the award is a Scientific Consulting Panel, a body of experts representing non-CRN-affiliated scientists.

If needed, additional individuals may be added to the CRN Steering Committee as non-voting members by a decision of the existing voting members. These additional non-voting members may include, for example, other NCI and NIH Program Staff members, and/or Program Staff members from other Federal Agencies (e.g., Centers for Disease Control and Prevention). PD(s)/PI(s) of grants using the CRN research resource may also be invited when their presence is needed.

The CRN Steering Committee will meet twice per year in person and monthly via phone conference. One of the two face-to-face meetings is expected to be scheduled during the annual CRN Scientific Meeting.

The CRN Steering Committee will have primary responsibility for:

Scientific Consulting Panel. The Scientific Consulting Panel will operate as a subcommittee to the Steering Committee, advising the Steering Committee and providing technical expertise to the entire CRN. This panel will comprise scientific experts not affiliated with the CRN institutions and may include scientists from academic and other research institutions as well as from NIH. Members of the Scientific Consulting Panel will be selected by the Steering Committee in consultation with the NCI Project Scientist. The Scientific Consulting Panel will be charged with the following activities:

Members of the CRN network will be required to accept and implement policies approved by the CRN Steering Committee to the extent consistent with the applicable grant regulations.

Annual CRN Scientific Meetings. The CRN Steering Committee (with logistic assistance of the Administrative Core) will co-organize with the NCI the annual CRN Scientific Meetings. These meetings should coincide with one of two per year face-to-face meetings of the Steering Committee.

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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Annual progress report is expected to specifically include information on progress of Scientific Working Groups and the status of their selected areas of scientific excellence. This information should include progress in developing data elements and other research resources related to the scientific area of focus, the status of collaborative research projects in this area, scientific publications, and other relevant accomplishments. A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Paul Doria-Rose, D.V.M., Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, MSC 7344
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8574
FAX: (301) 435-3710
Email: doriarop@mail.nih.gov

Peer Review Contact(s)

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Sy L. Shackleford
National Cancer Institute
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-2037
FAX: 301-496-8601
Email: shacklefords@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 Parts 74 and 92.


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