Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.cancer.gov/)

Title: Coordinating Center for the Barrett’s Esophagus Translational Research Network (U01)

Announcement Type
New

Request For Applications (RFA) Number:  RFA-CA-10-015

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.396

Key Dates
Release Date: August 13, 2010
Letters of Intent Receipt Date: December 5, 2010
Application Receipt Date: January 5, 2011
Peer Review Date: May 2011
Council Review Date: August 2011
Earliest Anticipated Start Date: September 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 6, 2011

Due Dates for E.O. 12372

Not Applicable.

PRE-APPLICATION CONFERENCE CALL

The NCI anticipates holding a pre-application conference call to which all interested prospective applicants are invited. NCI Program and Review staff persons will explain the goals and objectives of the Barrett’s Esophagus Translational Research Network (BETRNet) funding opportunity announcements (FOAs), discuss the application peer review process, and answer questions. Information about this pre-application conference call will be available at (https://dcb.nci.nih.gov/News/Pages/Barrett'sEsophagusRFA.aspx).

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
       1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
       1. Principal Investigator Rights and Responsibilities
       2. NIH Responsibilities
       3. Collaborative Responsibilities
       4. Dispute Resolution Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

This National Cancer Institute (NCI) Funding Opportunity Announcement (FOA) solicits applications for the BETRNet Coordinating Center, a component of the Barrett’s Esophagus Translational Research Network (BETRNet).

The BETRNet overall objective is to achieve a better understanding of esophageal adenocarcinoma (EA) biology, improve EA cancer risk stratification and prediction, provide strategies for EA prevention, and better define individuals at risk. BETRNet will comprise the following components:

The ultimate goal of BETRNet is to decrease the incidence, morbidity and mortality of EA by addressing opportunities associated with understanding it’s only accepted precursor lesion, Barrett’s Esophagus (BE). Research Centers are expected to explore these opportunities through innovative high impact transdiciplinary research focused on development of validated  risk assessment tools as well as improved EA patient management. The program is designed to foster transdisciplinary collaboration within each Research Center and across the Centers. Through these collaborative efforts, BETRNet can accelerate the integration and translation of important research findings generated from individual laboratory-based, clinical and/or population studies into clinical applications.

Role of BETRNet Coordinating Center. The main goal of the BETRNet Coordinating Center is to integrate and aid efforts across the BETRNet with the objective of facilitating transdisciplinary research. In particular, the BETRNet Coordinating Center will support BETRNet communications and operations, data management and bioinformatics, patient registry with virtual biorepository, and Network evaluation.

Background

While the overall incidence and mortality rate of cancers have declined in recent years, the incidence of EA has continued to rise. EA now accounts for at least 2% of US cancer-related deaths in men and has the fastest growing incidence of all cancers in the United States (U.S.). In the past three decades, EA incidence has increased more than 600% in men aged 65 years and older and notwithstanding progress in multimodality therapies, the overall 5-year survival rate is still estimated at 15%. Furthermore, esophagectomy with or without neoadjuvant radiation therapy often incurs early postoperative complications and long term devastating functional abnormalities. Likewise, medical therapies are still highly toxic, and remain unsatisfactory in response duration and overall survival benefit. The completion of any therapy for EA is most often followed by tumor recurrence or distant metastasis that leads to severe morbidities and eventual death. The natural course of the disease is insidious and debilitating, becoming clinically apparent only in advanced stages that are refractory to treatment and are resource-intensive. Effective cancer preventive measures will benefit not only affected individuals but also the public at large.

Significance of Barrett’s Esophagus. Central to the development of cancer preventative and clinical management measures is the better understanding of the etiology of EA. Neoplastic progression in the esophagus is a multi-decade process characterized by genomic instability and accumulation of molecular alterations in cell clones. Histologically, EA is thought to arise from the injury of the esophageal mucosa by frequent reflux of gastric contents that result in a sequence of metaplasia to low-grade dysplasia, high-grade dysplasia, and carcinoma. The metaplasia to dysplasia phase of this sequence is known as Barrett’s esophagus. BE is diagnosed in approximately 10% of patients who are referred to endoscopy for gastroesophageal reflux disease (GERD) symptoms. BE, the only widely accepted precursor lesion to EA, is defined as the replacement of the normal squamous epithelium of the distal esophagus by columnar epithelium with intestinal metaplasia. Patients with BE are at least 30 times more likely to develop EA than patients without BE.

Inadequate Clinical Management of At Risk Patients. Currently, chronic GERD patients are screened for BE and, if diagnosed to have BE, they are subjected to endoscopic surveillance. Studies demonstrate that patients with malignancy detected at surveillance endoscopy have cancers at an earlier stage and better survival than those with no surveillance. The value of surveillance, however, is questioned by other studies demonstrating that only about 60% of patients diagnosed with EA have a prior diagnosis of GERD and less than 5% have a prior diagnosis of BE. Furthermore, although the increased risk of EA in BE patients has been observed consistently, only 0.5% of endoscopically monitored BE patients progress to EA per year (with the high-grade dysplasia patients progressing at an annual rate of 5% to 20%). These findings suggest that despite decades of research, current management of EA neoplasia is still inadequate because at risk patients are rarely identified. Moreover, criteria for screening and endoscopic surveillance still need to be established in a proper randomized trial. Given the threat of a highly lethal cancer, both patients and physicians typically opt for the most aggressive strategies for treatment and surveillance even with procedure-related risks. This situation has perpetuated the extremely low yield in defining at risk patients by current strategies despite their very high costs. Clearly, better understanding of the biology of EA carcinogenesis, including host and environmental factors is urgently needed for effective, individualized cancer risk evaluation and for improved patient care.

BE as a Model to Study the Biology of EA. As a model to study the malignant transformation process, BE offers the potential for rapid scientific and clinical advances that could be applied to other cancers besides EA. Unlike most premalignant lesions (e.g., colon adenomas) that are excised after detection, BE lesions are left in place. Their changes over time can be monitored endoscopically with relative ease and safety. BE’s long asymptomatic premalignant phase allows sequential collection of tissues and other specimens that can be used to study the genetics and molecular biology of cancer formation as well as the changes caused by environmental exposures, response to interventions, and the impact of risk and protective factors. From a biological perspective, molecular alterations associated with Barrett’s metaplasia such as COX-2 over-expression, inactivation of p53, aneuploidy, and DNA methylation are common to many solid tumors and can be used as biomarkers of cancer risk and neoplastic progression. Moreover, these aberrations may be exploited as potential targets for preventative and therapeutic strategies.

Understanding the mechanisms that promote the progression of BE to EA and the changes associated with this precursor lesion, especially at the genomic and proteomic levels, could eventually lead to novel interventions to prevent malignancy and/or control the progression of intervention-resistant clones.

Need for Collaborative Approaches to BE-EA Research. Whereas research on BE-EA biology has revealed various molecular and cellular alterations associated with the malignant transformation of BE to EA, systematic studies are needed to assess the significance of these aberrations for the EA transition. Such investigations require access to sufficient number of relevant biospecimens and associated clinical data. This factor limits the capabilities of individual BE investigators, especially those involved mainly in basic research. Conversely, interdisciplinary collaborations among basic, translational, and clinical investigators and sharing resources (including biospecimens) across institutions offer the potential to advance BE-EA research rapidly. The recognition of these needs gave rise to the BETRNet initiative, specifically designed to facilitate translational “team science” approach to BE-EA research by establishing a dedicated network of investigators with strong NCI support and effort coordination.

Patient Registry with Virtual Biorepository. Central to this collaborative network is the development of a multi-institutional patient registry that will include clinical, longitudinal, and epidemiological data and data sets associated with the biospecimens that are collected and available at each participating site. The cohort of patients will include individuals at all levels of risk for BE and EA, providing opportunities for understanding the natural history of the disease and determining risk stratification criteria (molecular, environmental, and epidemiological). Such a registry/virtual biorepository is envisioned to function as a centrally coordinated shared resource. The establishment of this resource should significantly increase opportunities to develop and assess novel minimally invasive and noninvasive technologies for patient stratification and, thereby, improve patient management. Moreover, the resource is expected to greatly facilitate novel interventions to target premalignant processes leading to EA. Both aspects should contribute to improving EA clinical outcomes.

Specific Research Objectives and Requirements for the BETRNet Coordinating Center

General Requirements for the BETRNet Coordinating Center:

BETRNet Coordinating Center (to be funded as a result of this FOA) will have an important role in integrating the efforts of individual BETRNet Research Centers to be funded under a companion FOA (RFA-CA-10-014). BETRNet Coordinating Center will be expected to provide administrative and logistic support infrastructure for the BETRNet Research Centers. The Coordinating Center must be able to connect available resources and serve as research data management center.

The Coordinating Center will be expected to integrate activities of all of the awarded BETRNet Research Centers to minimize resources/effort duplication and utilize existing resources. In addition, the Coordinating Center will have substantial responsibility for ensuring the continued self-evaluation of BETRNet awardees and the evaluation of the entire BETRNet Program.

To fulfill these roles, the Coordinating Center applicant team must have prior experience in coordinating large multi-site programs, providing infrastructure to support the required administrative activities of such a program, including, but not limited to, monitoring and coordinating the joint activities of all the participating sites, preparing required reports, addressing logistics and preparing for group meetings, site visits, outcome dissemination, and Steering Committee meetings.

The Coordinating Center applicants must have appropriate professional expertise and experience in the areas defined above. The applicant institution must have the necessary facilities to meet the specific requirements defined in the FOA.

Strategic Goals for the BETRNet Coordinating Center:

BETRNet Coordinating Center applicant team must address the following strategic objectives:

  1. Facilitate multi-institutional, transdisciplinary translational research through scientific, administrative, and organizational support with emphasis on efficient communication, coordination of efforts, and scientific collaboration across multiple research institutions;
  2. Facilitate and mediate contacts between BETRNet awardees and NCI program staff members to allow for efficient interactions, consultations, and oversight functions;
  3. Create and manage a patient registry with virtual biorepository that will encompass clinical and demographic information of all patients participating in the BETRNet program as well as available biospecimens at participating sites;
  4. Create and manage relevant logistic infrastructure including bioinformatics for research data management, clinical data monitoring, and other requirements to support the BETRNet Research Centers; and
  5. Create opportunities to disseminate results across multiple venues.

Required Structure and Main Components of the BETRNet Coordinating Center

All BETRNet applicants must address the main aspects for the proposed Coordinating Center (for details see Section IV. Content and Form of Application Submission) presented below.

1. Leadership and Administrative Core. The Coordinating Center must be able to provide close coordination of transdisciplinary research efforts of the BETRNet Research Centers. This role will require strong leadership, scientific insight, and managerial capacity to bring diverse teams together.

Because of the central requirement for interactions across BETRNet Research Centers, the Coordinating Center will be responsible for the following activities:

a)     Providing administrative leadership in coordinating BETRNet activities and serving as a hub for the BETRNet Research Centers and the entire BETRNet Program;

b)    Assisting the BETRNet Steering Committee in assembling appropriate  panels such as a subcommittee of experts to advise the Steering Committee;

c)     Facilitate the establishment of topical “Working Groups” across BETRNet awardees as recommended by the Steering Committee (e.g., clinical interventions group, a specimen collection and biomarkers group) relevant to the funded BETRNet research and scientific needs across the Network;

d)    Providing logistical infrastructure for the entire BETRNet and facilitating trans-network functions and activities;

e)     Facilitating and mediating contacts between BETRNet Research Centers awardees and NCI staff members to allow for efficient interactions, consultations, and oversight functions;

f)     Providing logistical and administrative support for all of the activities of the Steering Committee and its subcommittee(s)/Working Groups; and

g)    Organizing the midterm workshop of BETRNet investigators (in cooperation with the NCI representatives), monthly committee calls for all BETRNet Research Centers, and meetings of Working Groups to be recommended by the Steering Committee.

2. Data and Bioinformatics Core. BETRNet Coordinating Center must establish and operate a centralized data collection, management, analysis, and dissemination core for the entire network (i.e., a Data and Bioinformatics Core).

The main goals of this core are to facilitate standardization of metrics, data sharing, and results dissemination across BETRNet and between BETRNet and the NCI.

The Bioinformatics Core must provide infrastructure for data collection and archiving to meet standards for common data systems and future data repositories. Specifically, informatics and data sharing approaches proposed for the BETRNet Coordinating Center must aim at achieving compatibility (minimum silver level) with the NCI's caBIG. Applicants are expected to plan using established caBIG applications, as feasible. In addition, the Core must have capabilities to provide statistical support for study design across the BETRNet.

3. Patient Registry with Virtual Biorepository Core. BETRNet Coordinating Center applicants must plan for creating and maintaining a patient registry with virtual biorepository Core. This Core must set up a registry database with clinical and demographic information of all patients participating in the clinical studies under the BETRNet program. In addition, the Core must collect and include in the registry database information on the availability of biological specimens at all the BETRNet participating sites. The biospecimen data must include information about the regulatory approvals of specimen collections and the level of informed consent.

The Core must allow for efficient sharing of information across the BETRNet as well as facilitate and track the distribution of available biospecimens to BETRNet investigators, consistent with achieving the goals of the program.

4. Integration and Self-Evaluation Core. The proposed BETRNet Coordinating Center must have a well developed capacity to enable timely self-evaluation mechanisms promoting effective self-correcting actions. In this area, the Coordinating Center will have to closely collaborate with the BETRNet Steering Committee (see below), individual BETRNet Research Centers, and NCI Program staff members.

This self-evaluation Core should track the relevant performance benchmarks of each BETRNet Research Center and compare its performance to the other Centers. Outcomes to be assessed will include peer-reviewed publications, translational advances, and other factors related to the effectiveness of a collaborative research model. The outcomes will help the Steering Committee and individual BETRNet Research Centers to take corrective steps and optimize their performance.

In addition, to the self-evaluation, the entire BETRNet program will be subject to external evaluation to be coordinated by the NCI Program Staff (see below). The self-evaluation of the BETRNet awardees (and the activities of this Core) will be essential for facilitating and enhancing the external program evaluation. BETRNet Coordinating Center (and specifically this Integration and Self-Evaluation Core) will be expected to cooperate with NCI in the evaluation process.

Governance of the BETRNet

The BETRNet (i.e., the Research Centers and Coordinating Center) will be governed by the BETRNet Steering Committee.

Details on the composition and functions of BETRNet Steering Committee are provided in Section VI.2.A.3, Terms and Conditions of Cooperative Agreement “Collaborative Responsibilities.”

External Evaluation of the Program

As the efficiency of the funded research is an increasing priority for NCI, BETRNet awardees will be expected to participate in an external evaluation process coordinated by involved NCI program staff members. The purpose of the evaluation process is to monitor and assess the performance of the BETRNet program toward achieving its goals. This component includes evaluating the quality and innovation of the research conducted at the BETRNet Research Centers and Coordinating Center, as well as assessing critical intermediate determinants of the overall success, such as infrastructure development and capacity building, linkages, resource and data sharing arrangements within and among BETRNet components, and the translational nature of the research.

In terms of the overall impact of the BETRNet Program, particular focus areas will be improved understanding of EA carcinogenesis, and the development of EA risk stratification criteria and patient management modalities that are based on the biological mechanisms of the disease.

The relevant outcomes to use as measures of program success will be identified from the conceptual framework presented earlier and from other theoretical models and empirical evidence in the literature.

Other Related Funding Opportunities

This FOA is parallel to a separate U01 FOA (RFA-CA-10-015), which solicits applications for the BETRNet Coordinating Center.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH U01 Cooperative Agreement award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". 

2. Funds Available

The estimated amount of funds available for support of one center awarded as a result of this announcement is $500,000 for fiscal year 2011. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

NOTE: Investigators designated as PDs/PIs on any BETRNet Research Center (U54) application cannot serve as PDs/PIs on a Coordinating Center U01 application.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. An applicant institution may submit only one application in response to this FOA.

Resubmissions. Applicants may not submit a resubmission application.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo -- Telephone: (301) 435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NOA).

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: December 5, 2010
Application Receipt Date: January 5, 2011
Peer Review Date: May 2011
Council Review Date: August 2011
Earliest Anticipated Start Date: September 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Ellen Richmond
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2146, MSC 7322
Bethesda, MD 20892-7322
Telephone: (301) 435-2466
Email: richmone@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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 non-USPS delivery)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material 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

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at 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 a competing or non-competing 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 the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm).

6. Other Submission Requirements

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

BETRNet Coordinating Center (U01) applicants must demonstrate in the application their ability to meet:

For the BETRNet Coordinating Center application submitted in response to this FOA, the standard PHS 398 Research instructions for application preparation are altered as follows:

Table of Contents (PHS 398 Form Page 3):  Modify Form Page 3 of the PHS 398 to include the following sub-sections A-E under Section 3 “Research Strategy” of the PHS 398 Research Plan:

A. Overview of the Proposed Coordinating Center;

B. Leadership and Administrative Core;

C. Data and Bioinformatics Core;

D. Patient Registry with Virtual Biorepository Core; and

E. Integration and Self-Evaluation Core.

Budget

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). Include appropriate budget pages for any sub-contractual arrangements proposed.

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 following individual application components:

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Section 3. Research Strategy of the PHS 398 Research Plan must consist of the following sub-sections A-E (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 subsections A-E.

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

A. Overview of the Proposed Coordinating Center (up to 12 pages)

In this section, describe the following aspects:

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

In this section, describe the following aspects:

C. Data and Bioinformatics Core (up to 6 pages)

In this section, describe the following aspects:

D. Patient Registry with Virtual Biorepository Core (up to 6 pages)

In this section, describe the following:

E. Integration and Self-Evaluation Core (up to 6 pages)

In this section, describe the following:

OTHER REQUIREMENTS

Overall Responsibilities. Applicants must agree to adhere to all the responsibilities and obligations defined in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award.”

Site Visits. Because of the complexity of the BETRNet, NCI program staff members will conduct at least one administrative site visit. BETRNet applicants must agree to participate in this process and should plan for one visit (with appropriate budget, including travel for collaborators and other necessary costs).

Travel Funds. Applicants must plan appropriate travel funds for the PD(s)/PI(s) and team leaders to participate in the scientific workshop that will be conducted in the midterm of the award.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD only, and include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information, see the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088 and http://grants.nih.gov/grants/gwas/.

In addition to the general NIH requirements, the following provisions specific to this FOA apply:

(d) Specimens Sharing: All BETRNet awardees will be expected to provide information about the availability of biospecimens at their institutions as well as associated clinical/demographic information to the Patient Registry with Virtual Biorepository created and maintained by the Coordinating Center. All BETRNet investigators are expected to be willing to share biospecimens and related information with other BETRNet investigators pursuant to the terms of the informed consent and consistent with achieving the goals of this program. In line with these requirements, BETRNet awardees are expected to structure the informed consent document and other human subjects procedures with considerations for the wider sharing of data and specimens collected under the BETRNet award.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support 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/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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? 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 New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for: 1) protection of human subjects from research risks; and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

A. Overall Vision of the Coordinating Center:

How well will the proposed Coordinating Center serve the goals of BETRNet? How nearly adequate are research infrastructure, programs, and collaborations to support the BETRNet research centers?

B. Research Team, Leadership, and Administrative Core:

Is there adequate evidence for the managerial and collaborative capabilities of the proposed Coordinating Center leadership? How appropriate is the leadership structure of the proposed Coordinating Center in terms of (a) the overall goals of BETRNet initiative; (b); the coordination of multiple institutions participating in a given BETRNet Research Center; and (c) the participation in and coordination of cross-BETRNet activities? Are the backgrounds, expertise, and commitments of the PD(s)/PI(s) and other key personnel sufficient for the proposed scope of activities and in line with the overall goals of the BETRNet initiative?

C. Data and Bioinformatics Core:

How well does the proposed core meet the overall BETRNet goals? Does the core have the appropriate capabilities to support proposed projects and data sharing among all BETRNet participating sites? How adequate are the plans to achieve compatibility with the NCI's caBIG as well as the use of caBIG applications to facilitate data and resource sharing across BETRNet? Does the core have sufficient capabilities to provide statistical and other support in study design across the BETRNet?

D. Patient Registry with Virtual Biorepository Core:

How appropriate and balanced are the proposed plan to create a virtual registry with biorepository? Are the plans well justified and include appropriate safeguards for privacy and confidentiality protections of identifiable data? Does the plan describe a program that will efficiently support the sharing of specimens and information across the BETRNet?

E. Integration and Evaluation Core:

How well does the evaluation plan demonstrate the capacity of the BETRNet Coordinating Center to collaborate with the BETRNet Research Centers and NCI program staff on critical evaluation of scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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.

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.

Resubmission Applications.  Resubmissions are not allowed for this FOA.

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. Revisions are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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. Foreign are not allowed for this FOA.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official

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. See also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. 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 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.

2. A.1. Principal Investigator Rights and Responsibilities

The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of BETRNet Coordinating Center research in accordance with terms and conditions of the award.

The Principal Investigator(s) will have the primary responsibility for:

The BETRNet Coordinating Center will be subject to periodic self-evaluation and external evaluation of the entire BETRNet Program (coordinated by the NIH). The BETRNet Coordinating Center Awardee will be expected to participate in such evaluations.

All BETRNet institutions/organizations will be expected to share with other BETRNet awardees knowledge, data, research materials, and any other resources necessary and relevant to the BETRNet Program.

All BETRNet awardees (Coordinating Center and BETRNet Research Centers) will be responsible for ensuring that Informatics and data sharing approaches used are compatible with caBIG.

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 HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

Designated NCI Program staff members, acting as Project Scientists, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Main NCI responsibilities to BETRNet awardees (both Research Centers and Coordinating Center) include:

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those BETRNet awardee 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.

The NCI Staff members will coordinate an external evaluation of the BETRNet Program.

The substantially involved NCI Project Scientists will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Some Program Officials may also have substantial programmatic involvement (as Project Scientists). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

2.A.3. Collaborative Responsibilities

The BETRNet Steering Committee will serve as the main governing board for the BETRNet initiative.

The committee will consist of the following voting members:

Additional NIH staff members may participate in Steering Committee meetings as non-voting members.

The BETRNet Steering Committee will meet one time per year in a face-to-face meeting. Two co-chairs of the BETRNet Steering Committee will be selected for every 12 months by the committee to coordinate its operation. The BETRNet Steering Committee co-chairs will meet with NCI Project Scientists – members of BETRNet onetime per month by telephone conference.

Additional non-voting members to serve in an advisory capacity may be added to the BETRNet Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies (e.g., Food and Drug Administration).

The BETRNet Steering Committee will have primary responsibility for:

The BETRNet Steering Committee will establish the Scientific Advisory Panel (a subcommittee of experts) to serve the BETRNet Steering Committee and the awardees.

The Scientific Advisory Panel will be comprised of scientific experts from outside the BETRNet initiative and be charged with the following activities:

BETRNet Steering Committee is also expected to form topic-specific Working Groups, which will be a resource of cross-BETRNet expertise. Representatives from the NCI organizational units as well as other NIH institutes or other Federal agencies (e.g., FDA) will participate in Working Groups as appropriate (but will not serve as chairs of these Working Groups).

Members of the BETRNet network (i.e., BETRCs awardees and Coordinating Center awardee) will be required to accept and implement policies approved by the BETRNet Steering Committee.

2.A.4. Dispute Resolution Process

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 16.

3. Reporting

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.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research; peer review; and financial or grants management issues:

1. Scientific/Research Contacts:

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Ellen Richmond, M.S., R.N.
GI and Other Cancers Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2146, MSC 7317
Bethesda, MD 20892-7317
Telephone: (301) 435-2466
FAX: (301) 480-4137
E-mail: richmone@mail.nih.gov

Rihab Yassin, Ph.D.
Cancer Cell Biology Branch
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, EPN Suite 5000, MSC 7393
Bethesda, MD 20892-7393
Telephone: (301) 496-7028
FAX: (301) 402-1037
E-mail: ry38k@nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Emily Tran
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Boulevard, EPS Suite 243
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7249
FAX: (301) 496-8601
Email: trane@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.