Part I Overview Information

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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: Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium (Limited Competition) [U01]

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-01-013.

Request For Applications (RFA) Number: RFA-CA-09-503

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399

Key Dates
Release Date: October 17, 2008
Letters of Intent Receipt Date: Not applicable
Application Receipt Date: December 16, 2008
Peer Review Date: February 26, 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 17, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• The purpose of this limited competition Funding Opportunity Announcement (FOA) is to continue support of the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium by the National Cancer Institute (NCI). The original CanCORS program was established to collect information on approximately 10,000 newly diagnosed lung and colorectal cancer patients. The current reissuance of the program will continue to support follow up studies on the CanCORS-associated lung and colorectal cancer patient cohorts. The currently funded CanCORS Consortium has collected extensive information about medical care received by these cancer patients over the initial acute treatment phase along with information on the clinical and patient-reported outcomes experienced by the patients during this phase. This FOA provides the next phase of funding for a detailed assessment of the quality of follow-up care and the health outcomes among longer-term survivors of lung and colorectal cancer. Dissemination of CanCORS data is also a distinct objective. The currently funded CanCORS Consortium consists of separate awards for a Statistical Coordinating Center (SCC) and seven Primary Data Collection and Research Sites (PDCRs). To allow for a tighter integration in the continuation of the program, all individual components will be supported by one award. Therefore, this FOA solicits a single, joint application from the current SCC and the PDCR awardee institutions that will consolidate these components under a single organizational entity for the next round of follow-up studies on the two CanCORS patient cohorts.
• Mechanism of Support. This FOA will utilize the NIH cooperative agreement (U01) funding mechanism.
• Funds Available and Anticipated Number of Awards. The anticipated number of awards is one.
• Budget and Project Period. The NCI has set aside approximately $11 million (total costs) over a 3-year period, with the award period beginning July 2009.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Only the current CanCORS awardee institutions are eligible to submit a single joint application.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. More than one Principal Investigator (PI), or multiple Principal Investigators may be designated on the application in response to this FOA.
• Number of Applications. Eligible institutions may submit only one joint application.
• Resubmissions. Resubmission applications are not permitted in response to the FOA.
• Renewals. A single application permitted in response to the FOA will be treated as renewal application.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

Table of Contents

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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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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. Arbitration 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

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Section I. Funding Opportunity Description

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1. Research Objectives

Purpose

The purpose of this limited competition cooperative agreement (U01) funding opportunity announcement (FOA) is to continue support for the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium. The CanCORS Consortium, originally established in 2001, was designed to collect information on approximately 10,000 newly diagnosed lung and colorectal cancer patients. The Consortium has collected extensive information about medical care received by these cancer patients and the clinical and patient-reported outcomes experienced by them over the initial acute treatment phase. The next step (and the main objective of this FOA) is to obtain a detailed assessment of the quality of follow-up care and the health outcomes among longer-term survivors using the same two CanCORS cohorts of lung and colorectal cancer patients. In addition, to maximize the benefits from the investment in CanCORS, this FOA also includes the dissemination of CanCORS data and data collection instruments as a distinct objective.

To enhance CanCORS ability to address its scientific goals and the dissemination objective, this FOA also seeks to streamline the organization of CanCORS. The currently funded CanCORS Consortium consists of separate awards for a Statistical Coordinating Center (SCC) and seven Primary Data Collection and Research Sites (PDCRs). This FOA solicits a single, joint application from the current SCC and the PDCR awardee institutions that will consolidate these components under a single organizational entity.

Background

The NCI established the CanCORS Consortium (http://healthservices.cancer.gov/cancors/) in 2001 to address the growing need for targeted information about the quality of cancer care in diverse care delivery settings in the United States (U.S.). In regards to the scope of the targeted information sought, the CanCORS effort markedly exceeded the existing limited treatment and outcomes data available from either population-based cancer registries or integrated health care delivery systems.

During the initial funding period, the CanCORS Consortium collected standardized data from two large, population-based prospective cohorts consisting of approximately 10,000 newly diagnosed lung and colorectal cancer patients, approximately 5,000 each. Baseline and follow-up patient surveys were conducted at approximately 4 and 12 months, post-diagnosis, respectively. In addition, standardized data from 4,400 health care providers (including cancer specialists and primary care physicians such as internists) and 1,600 informal caregivers, as well as salient clinical data (from medical records), have been collected. Ongoing analyses of these data permit a comprehensive evaluation of: (a) the quality of cancer care delivered to the patients in the two CanCORS cohorts; (b) the links between quality of care and patient outcomes (both clinical and psychosocial); and (c) disparities in both cancer care and patient outcomes.

CanCORS represents a novel collaborative model for studying cancer care: a large, distributed, multidisciplinary team of investigators collecting shared, standardized data. The initial set of CanCORS awards was funded in 2001 as individual cooperative agreements. These original awards included six Primary Data Collection and Research Sites (PDCRs) and one Statistical Coordinating Center (SCC). In 2003, the Department of Veterans Affairs (VA) sponsored an additional PDCR consisting of more than 12 Veterans Administration Medical Centers. This structure permitted the investigators to address a much broader array of important clinical and policy questions than would typically be feasible at a single site, or via smaller, investigator-initiated grant projects. Importantly, this approach was designed to complement multi-regional, randomized clinical trials of specific treatments that are typically conducted among more selected patients and providers.

Priority areas for cancer research identified in the 2007 NCI Strategic Plan include the following items pertinent to CanCORS:

• Establish partnerships for and support community-based and health care delivery research to translate findings into policy to improve the quality of care and reduce cancer health disparities. ; and
• Support for community-based research assessing the perspectives of the patient or consumer and the healthcare provider to expand our understanding of cancer care generally and health disparities in particular.

The NCI strategic plan also underscores that the patterns of care and patient outcomes can be more rigorously examined if multiple, linked data sources are used to track patient information. CanCORS provides the unique capability to integrate data from patients, medical records, physicians, caregivers, and administrative databases to address these priority areas. Moreover, CanCORS is the only NCI effort to conduct collaborative community-based cancer care delivery research across the entire spectrum of the health care delivery system including: (a) NCI comprehensive cancer centers; (b) community cancer centers; (c) cancer registries; and (d) healthcare provider organizations such as the VA. The continued support for the CanCORS Program under this limited competition FOA will take maximal advantage of the research resources already created during the initial funding period. The CanCORS Program addresses several priorities related to cancer care delivery, which would not be easily addressed in a cost-effective manner by other existing initiatives or research infrastructures.

In the long run, it is anticipated that the CanCORS-generated data and analyses will aid efforts to create practical and cost-effective systems to monitor the quality of healthcare for cancer patients in diverse healthcare delivery settings. Such systems are expected to be applicable to the initial treatment phase as well as post-treatment survivorship and end-of-life phases of care.

Specific Objectives and Requirements

As the overarching goal of this FOA is to continue support for CanCORS as a unique resource, only the current CanCORS awardees may apply to this FOA. This limited competition, however, is also an opportunity to enhance the program. Therefore, all interested current CanCORS awardees must work together and submit a joint application. This consolidated application must propose appropriate subcontractual arrangements to provide the following required components:

• One Statistical Coordinating Center (SCC); and
• Up to seven Primary Data Collection and Research Sites (PDCRs).

To allow for proper recognition of program leaders at the individual participating institutions, the applicants are encouraged to take advantage of the multiple Principal Investigators (PIs) option. If the multiple PDs/PIs option is used, it is expected that the SCC PI and one of the PDCR PDs/PIs will jointly oversee and coordinate the entire program. To reflect their roles, such individuals may be designated as lead PDs/PIs .

Applicants must describe detailed plans addressing the two primary research objectives and the dissemination objective for CanCORS as outlined below. All the participating institutions must agree to work jointly toward these goals. Beyond these mandatory aspects, applicants may also propose other elements that may additionally enhance the CanCORS program.

A. Research Objectives

1. Assessment of longer-term patient health outcomes beyond the first year of cancer diagnosis. An understanding of the longer-term health outcomes for patients enrolled in the two CanCORS cohorts, approximately 5-7 years post-diagnosis, is necessary to fully characterize the impact of initial cancer care (that was evaluated in the previous funding cycle). Applicants must address two aspects: (a) clinical outcomes (e.g., tumor status, late effects of treatment) and (b) patient-reported outcomes (e.g., symptom burden, side effects, health-related quality of life, economic burden). In addition, disparities in health outcomes and factors that are likely to mediate such disparities should also be evaluated.
2. Assessment of the quality of follow-up care delivered to patients beyond the initial acute treatment phase. The current funding cycle focused on characterizing the quality of medical care received by patients during the initial phase of treatment. Research efforts proposed for this new funding cycle should address several (if not all) of the following aspects of follow-up care:
   
   
• Assess the quality of post-treatment surveillance for disease-free survivors in the two CanCORS cohorts (e.g., use of care plans, variation in health promotion, cancer screening, utilization of new imaging tests);
• Evaluate the use of emerging new targeted therapies (e.g., Bevacizumab, Erlotinib, Cetuximab, Eloxatin) for treating patients with metastatic or recurrent disease as well as the barriers to, and facilitators of, the use of such treatments need to be assessed;
• Examine patterns of end-of-life care for patients who are terminally ill; and
• Characterize the quality of palliative care provided to all patients enrolled in the two cohorts, including patients who are disease-free, those experiencing recurrence/progression, as well as those who are terminally ill.

Both clinical and patient-centered aspects of the quality of care should be examined. Disparities in quality of care and factors that are likely to mediate such disparities, should also be evaluated. These topics have rarely been investigated systematically because of the traditionally greater emphasis of quality of care research on establishing reasons for under use of proven, curative therapies during the acute phase(s) of care.

These two main research objectives are also consistent with the recommendations of the Institute of Medicine’s report, From Cancer Patient to Cancer Survivor: Lost in Transition (2005). This report calls for a substantial expansion of the NCI’s commitment to survivorship studies in large ongoing cohorts, such as the CanCORS Consortium.

The comprehensive detailed data collected on quality of care and patient outcomes during both initial treatment and follow-up care, should allow for the identification of key attributes of care delivery (clinical and patient-centered), which are likely to drive short-term and/or longer-term patient health outcomes. Such analyses that take advantage of the data collected as part of the initial FOA and this re-issuance, would lay the foundation for future intervention-based studies aimed primarily at improving the quality of care delivered to, and health outcomes of, survivors of lung and colorectal cancer.

B. Dissemination Objective

This FOA also includes a dissemination objective that is geared towards maximizing the benefits from the investment in CanCORS. CanCORS as a research resource may be used to facilitate: (a) new ancillary studies that may be funded through separate, competitive grant mechanisms; and (b) studies that use existing CanCORS data to address additional important questions in care delivery and outcomes. To address these goals, applicants must plan the creation of a shared, open data resource accessible to investigators outside of CanCORS. Plans must also be described to encourage collaboration of CanCORS investigators with other non-CanCORS investigators with the goal to promote CanCORS data and related data collection instruments as a shared resource and facilitate researchers access to this resource. The long-term goal behind expanding access of the larger extramural community to the CanCORS database should be to facilitate initiation of novel projects in understudied areas that are relevant to the overarching goals of CanCORS. Some examples of pertinent areas in which CanCORS data may aid or inspire new investigator-initiated studies, include:

• Development of interventions to improve healthcare delivery and/or reduce health disparities;
• Dissemination and implementation of such interventions;
• Use of health-related information technology in clinical practice; and
• Integration of biological, health services, and behavioral research in care delivery and outcomes.

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

Section II. Award Information

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1. Mechanism of Support

This FOA will use the U01 award mechanism. The multiple Principal Investigators (MPIs) will be solely responsible 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."

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 is 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 total amount of funding that NCI expects to award through this announcement is approximately $11 million for 3 years starting FY2009; the first year budget is expected to be approximately $3.7 million (total costs). The total project period for applications submitted in response to the present FOA may not exceed 3 years. The earliest anticipated award date is July, 2009

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.

Facilities and administrative costs requested by Consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

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

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education;
• Private Institutions of Higher Education;
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education);
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education);
• Small Businesses;
• For-Profit Organizations (Other than Small Businesses);
• State Governments;
• U.S. Territories or Possessions;
• Regional Organizations; and
• Eligible Agencies of the Federal Government.

Only those organizations funded under RFA-CA-01-013 are eligible to apply, but all the eligible (and interested) institutions must jointly submit a single application.

1.B. Eligible Individuals

Eligible individuals include the current PDs/PIs of the CanCORS Consortium funded under RFA-CA-01-013 or other qualified individuals designated by the current awardee institutions. Within the framework of the existing CanCORS Consortium, any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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.

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://era.nih.gov/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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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

Renewal applications will be permitted for this FOA.

Resubmission applications are not permitted in response to this FOA.

Only one application may be submitted in response to this FOA.

Section IV. Application and Submission Information

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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) 710-0267; Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms. 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.

In this FOA, the NCI solicits a single consolidated application from all the current CanCORS awardees seeking funding continuation. The applicant must demonstrate in the application the ability to meet the scientific objectives (both research and dissemination objectives) outlined in Section I Funding Opportunity Description of the FOA and meet the investigator responsibilities described in Section VI.2 Cooperative Agreement Terms and Conditions of Award.

Applicants are strongly encouraged to take advantage of the multiple PD/PI option and designate separate PDs/PIs for the SCC and PDCRs. If this option is used, it is expected that the SCC PI and one of the PDCR PDs/PIs will assume jointly the roles of lead PDs/PIs to coordinate the entire program.

The application must contain appropriate budget pages for each participating institution under subcontractual arrangements with the institutions submitting the application. Follow PHS 398 instructions to include other required information about key personnel, their biosketches, and resources at each participating institution.

Research Plan

For the CanCORS application submitted in response to this FOA, the standard PHS398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as Sections A-D ) is altered as follows:

• The number of pages for the Research Plan is increased from 25 to 75. Applicants are encouraged to use the minimum number of pages necessary to describe the research plan clearly and succinctly. The 75 pages (or fewer, if possible) should be apportioned as desired by the applicants to cover new Sections A-E as outlined below.
• Other items of the PHS398 Research Plan remain unmodified.

New sections of the Research Plan include the following:

A. Background and Significance;

B. Progress Report/Past Performance;

C. Research Aims and Methods;

D. Project Operations and Administration; and

E. Open Data Resource.

Section A. Background and Significance: This section should briefly outline: (a) the significance of the research conducted in the previous funding cycle along with the main accomplishments to date of the CanCORS Consortium; and (b) the significance of the research proposed in the current application for the next funding period in terms of the program’s overall objectives.

Section B. Progress Report/Past Performance: This section should describe the work conducted and productivity of the CanCORS Consortium to date. Include information on activities conducted by the Consortium as a whole during the previous funding cycle, as well as specific information on the work conducted by individual CanCORS Consortium member institutions (i.e., the SCC and the seven PDCRs). Specifically address the following aspects:

a. Number of patients accrued by cancer type, total for the Consortium and by each PDCR along with associated response rates;

b. Number of physicians surveyed by specialty, total and by each PDCR along with associated response rates (similar information should also be provided for the caregiver survey that was conducted);

c. Percentage of patients for whom medical record data were abstracted by cancer type, total for the Consortium and by each PDCR along with any pertinent information on the quality of information that was abstracted.

d. Manuscripts planned, submitted, and published, including representation of different Consortium institutions (lead and co-author);

e. Research presentations made to date along with a distribution of lead presenter by Consortium institution; and

f. Efforts made, if any, to disseminate the tools developed (e.g., data collection instruments) may be presented.

g. The evolution and operations of the Consortium: describe the roles and responsibilities of the SCC and the different PDCRs in collecting, managing, and analyzing the data. Identify the key challenges encountered and how they were overcome. Describe efforts made for quality improvement and how these efforts enhance the functioning of the Consortium. Provide any additional information that could be helpful in assessing the performance of the SCC and/or the individual PDCRs.

Section C. Research Aims and Methods: This section should include details on how the research objectives identified in Section I of this FOA will be addressed by the applicants. Specifically, the following information should be provided:

a. Specific research questions and hypotheses related to quality of follow-up care, patient health outcomes, and potential links between quality of care and patient outcomes should be presented.

b. Data collection: It is expected that the research objectives of this FOA will be addressed by utilizing more than one data collection approach. The applicants should propose to conduct a comprehensive follow-up survey of patients in the two CanCORS cohorts. Patient survey data may be complemented by relevant clinical data abstracted from medical records. Medical record data may also be abstracted to provide information on the end-of-life care for patients who are no longer alive. Provider perceptions, attitudes, and beliefs about issues related to quality of follow-up care may also be assessed by conducting a focused survey of health care providers. The applicants may also propose collecting data from any additional sources within the CanCORS institutions as deemed necessary, to address the scientific objectives of this FOA. The rationale for and specific focus of all data collection modalities should be clearly stated. This FOA does not require a follow-up caregiver survey to be conducted.

Information in this section should include, but may not be limited to, the following:

• For a follow-up patient survey, the application should include the number of patients expected to be eligible for follow-up stratified by the two cancer sites and individual PDCRs.
• Procedures needed to determine vital status of patients and other eligibility criteria should be discussed along with steps to be taken to maximize participation rates;
• If a physician survey is proposed, the application should include the number of specialists and non-specialists that would be sampled along with expected participation rates by PDCRs (power analyses to justify the sampling plan should be included as necessary) and methods for maximizing participation rates should be highlighted;
• For all surveys, information on monetary incentive for survey participants should be discussed;
• For the medical record abstraction, the application should discuss feasibility and utility of collecting medical record information on cancer survivors who are post initial treatment and may have received care from several health care providers since the time of the previous contact by the research team.
• The applicants may consider proposing different targeted approaches to abstracting medical record data based on the current cancer status of the patient (e.g., disease-free survivors, survivors experiencing a recurrence, patients who are no longer alive). Justification for any targeted approach to collecting medical record data should be provided along with specifics on the methods that would optimize the abstraction process.

c. Core data elements to assess the quality of follow-up care and associated patient outcomes should be proposed. A potential list of instruments that might be used to measure these data elements should also be presented. This should be done for all data collection instruments that might be used (e.g., surveys, medical record abstraction forms) to address the research questions and hypotheses outlined in the application. Procedures for selection of final core data elements and associated measures should be outlined.

d. Analytic approach: An analysis plan and statistical methods for evaluating key research hypotheses should be proposed.

e. Any additional information on the technical strengths deemed important by the applicants may also be provided.

Section D. Project Operations and Administration: This section should address recommendations to streamline CanCORS operations that were made by the evaluation committee that evaluated the performance of the Consortium in the initial phase. Include the following elements in this section:

a. Describe specific roles and responsibilities of the Statistical Coordinating Center (SCC) and the PDCRs in conducting follow-up activities identified under the research aims and methods section of the application. Include a timeline for conducting the various activities over the 3-year funding period.

b. Present a detailed break down of how the various tasks will be allocated across the participating organizations along with plans for ensuring coordination among all the Consortium members. Budget allocations for the Consortium members should be consistent with the tasks assigned to them.

c. Discuss quality control and assurance procedures for all phases of the research proposed from data collection, storage, transfer, and analysis.

d. Discuss functioning of the SCC, including plans for:

• Collection of standardized data;
• Maintaining data privacy and confidentiality and ensuring data security;
• Conducting efficient pooling and management of data collected including data formatting, documentation, and reporting; and
• Facilitation of key statistical analyses by the Consortium members.

e. Describe the administrative/governance structure of the Consortium (must be consistent with the Terms and Conditions of Award section). Provide appropriate plans (including a budget for travel expenses as needed) for participation in all required meetings of the CanCORS Consortium including the annual in-person meeting of the Consortium and regular CanCORS Steering Committee (CSC) teleconferences. Describe the process for the identification of CanCORS scientific leadership. If desired, the function of a lead scientific PI could rotate among the PDs/PIs of CanCORS sites. Describe other working groups (besides CSC) that may be necessary.

f. Outline plans for monitoring the performance of participating institutions along with a discussion of procedures that would be taken to respond to inadequate performance at individual institutions.

Section E. Open Data Resource: This section should address the dissemination objective of the FOA by providing specifics on the procedures for the development, maintenance, and dissemination of the open data resource. The applicants should present efficient methods by which non-CanCORS investigators might be engaged to conduct new ancillary studies that would build upon CanCORS capabilities and resources.

The application should include plans to develop appropriate procedures and policies regarding the access to and use of CanCORS data and related data collection instruments by outside investigators. Institutional Review Board (IRB) approvals and Health Insurance Portability and Accountability Act (HIPAA) considerations at the awardee institutions must be addressed as needed. Plans for the development and maintenance of the collaborative open-access data resource, as well as its dissemination to outside investigators, especially new investigators should be presented in sufficient detail. As part of the development and expansion of the data resource, CanCORS applicants should also outline plans for interacting with NCI’s Center for Biomedical Informatics and Information Technology (CBIIT) to ensure data compatibility with NCI’s Cancer Biomedical Informatics Grid (caBIG). The applicants must also agree to participate in any efforts by the U.S. Department of Health & Human Services to develop privacy standards, thereby protecting the confidentiality of all participants in population-based research on the quality of cancer care delivery systems.

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 (Section 14 in the PHS 398 Table of Content).

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new 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
Application Receipt Date: December 16, 2008
Peer Review Date: February/March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009

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 (for 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: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date) described above Their previous application would have had to be funded(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.

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 or renewal 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 or renewal 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 and Information

Applicants must plan for and budget appropriate travel funds for the participation in the annual CanCORS meetings. From each CanCORS site, at least two investigators, including the site PI, (but no more than four investigators) must attend these meetings. See additional information on annual meetings in the section on Terms and Conditions of Award .

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. 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 of the Research Plan component. 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 must 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: Regardless of the amount requested, investigators 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 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/.

Section V. Application Review Information

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1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

It is anticipated that only one application will be submitted in response to this limited competition (U01) FOA. An application that is 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, the application will:

• be discussed and assigned a priority score;
• Receive a written critique; and
• Receive a second level of review by National Cancer Advisory Board.

The following will be considered in making funding decisions:

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the Consortium will be able to meet the responsibilities described in Section VI.2A.1 and will be successful in meeting NCI’s goal of supporting a group of experienced investigators from highly capable institutions to conduct follow-up of the CanCORS cohort.

Review Criteria:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific to this FOA:

• Do the applicants propose research questions and/or hypotheses that would facilitate an improved understanding of the quality of follow-up care provided to and health outcomes experienced by survivors of lung and colorectal cancer?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PD/PIs?

In addition, specific to this FOA:

• Have the applicants proposed a reasonable set of core data elements for each data collection instrument that would facilitate evaluation of the quality of follow-up care, patient health outcomes, and the association between the two?
• Does the overall approach to data collection proposed in the application build upon the lessons learned in the first phase of CanCORS?
• Are plans for quality control and assurance for the different stages of the study from planning, collecting, transferring, and analyzing the data adequately presented? Are plans for monitoring the quality of performance of individual sites outlined and procedures for responding to inadequate performance discussed?
• How appropriate are the plans for the SCC to ensure: (a) collection of standardized data in a manner that maintains data privacy, confidentiality and ,security; (b) efficient management of pooled data,(including data formatting, documentation, and reporting); and (c) facilitated statistical analyses of the collected data?
• Are the dissemination plans adequate? Will these plans ensure maximal utilization of CanCORS data by making them accessible to non-CanCORS investigators?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

In addition, specific to this FOA:

• Do the applicants propose novel methods to serve CanCORS scientific goals and the dissemination objective?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do the PD/PIs and the investigative team bring complementary and integrated expertise to the project (if applicable)?

In addition, specific to this FOA:

• Are the qualifications, experience and commitment of the PD/PIs at all the proposed CanCORS sites appropriate for providing adequate scientific leadership for developing and implementing the next phase of CanCORS?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In addition, specific to this FOA:

• Are the roles assigned to the participating institutions appropriate for their respective strengths?

Additional Review Criterion Specific to This FOA:

Past Performance/Progress: Have the applicants achieved the goals for the current funding period of CanCORS? How well did the individual CanCORS awardees perform, particularly in terms of coordinating and participating in a large data collection effort and conducting pooled data analysis? Is the performance of the CanCORS investigators in the current funding cycle sufficient to ensure the likelihood of success in the next phase?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities, and Children in Research: The adequacy of plans to include subjects of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. All the PD/PIs and other key personnel at all the proposed CanCORS sites are expected to devote sufficient amount of time (effort) to accomplish the research and dissemination goals of the FOA. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

• Data Sharing Plan. [http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm]
• Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
• Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information

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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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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.

Throughout these Terms and Conditions of Award, the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium refers to all individual CanCORS components including Statistical Coordinating Center (SCC) and Primary Data Collection and Research Sites (PDCRs). All the awardee institutions, principal investigators (PI/PDs) and other key personnel must agree to collaborate on the goals of the CanCORS Consortium.

2. A.1. Awardees and Principal Investigator Rights and Responsibilities

The PD/PI(s) has (have) primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the CanCORS research in accordance with these terms and conditions of the award.

1. Responsibilities of the lead PD/PIs will include:

Lead PDs/PIs responsible for the SCC and PDCRs will have, as appropriate, the following responsibilities:

• Lead the activities of the CanCORS Steering Committee (CSC);
• Oversee the overall performance of the SCC and the individual PDCRs;
• Coordinate the Consortium’s interactions with the NCI staff members;
• Oversee the reporting on the progress of the CanCORS Consortium; and
• Administer the sub-contractual arrangements with other Consortium member institutions (pertains to the PI of the institution submitting the application). Any modifications to the sub-contractual arrangements will require approval of the CSC and the NCI.

2. Responsibilities of all Consortium PD/PIs (including the lead PDs/PIs) will include:

• Oversee and direct their respective research projects;
• Participate in the efforts of the entire Consortium to maximize the scientific rigor and efficiency of data collection procedures (including the development of the common protocols to be used by all CanCORS sites to collect data);
• Fully cooperate with other PD/PIs of the Consortium and NCI staff members in the planning and implementation of the research and dissemination objectives;
• Participate in the activities of the CSC and adhere to the policies and procedures established by the CSC related to both scientific and administrative aspects of the project (see more information on the CSC under Collaborative Responsibilities);
• Participate as required on any committees or working groups that may be established by the CSC during the course of the project; and
• Attend annual meetings that will be held to discuss and review scientific and technical aspects of project implementation as well as analysis of data and presentation of key findings. At least two investigators (including the PI), but no more than four investigators, from each Consortium site must attend these meetings. The first meeting will be convened by NCI staff and will be held shortly after initiation of the award. The NCI will also host the final meeting at the end of the 3-year funding period. Two additional meetings at the start of year 2 and 3 respectively will be hosted by the Consortium member institutions (SCC and PDCRs). Budget for attending these four meetings should be included in the application.

3. Responsibilities specific to the Statistical Coordinating Center (SCC).

SCC and its PI(s) will be responsible for the following activities:

• Facilitate collection of follow-up data via the various data collection modalities proposed in the application.
• Establish procedures to ensure efficiency of data collection processes across the various PDCRs.
• Serve as the central repository for pooled data by maintaining confidential and secure mechanisms for transmitting electronic files for core data elements from the PDCRs as needed to the SCC.
• Provide centralized training as needed to survey staff and medical record abstraction personnel.
• Examine and report on the quality of data for the purpose of pooled data analysis.
• Provide data files in ready-to-analyze format (for example, in formats recognized by common statistical packages such as SAS) to the PDCR site investigator(s) responsible for the specific pooled study.
• Provide research expertise and collaboration to PDCR site investigators on complex statistical issues for analysis of pooled data.
• Facilitate the development and maintenance of the open data resource. Establish protocols to maintain data confidentiality and security while making CanCORS data available to non-CanCORS investigators.
• Assume leadership and coordination of regular conference calls of the CSC.
• Maintain the CanCORS website and related e-mail lists needed to facilitate coordination among all the members of the Consortium.

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

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 described below. The NCI Project Scientist may invite, as needed, additional NCI scientific staff members with relevant expertise to have substantial involvement in the conduct of the Consortium’s scientific activities. All NCI staff members who may be involved in the scientific activities of the Consortium, including the Project Scientist, will not attend peer review meetings of renewal (competing continuation) 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.

Additionally, 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. The Program Official may occasionally serve as a second or substitute Project Scientist. If this is the case, this individual will not participate in the peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, this individual will seek NCI waiver according to the NCI procedures for management of conflict of interest.

The main NCI responsibilities pertinent to CanCORS include the following activities:

• NCI Project Scientist will be a voting member of the CanCORS Steering Committee (CSC).
• Other NCI staff members, including Program Official, may also participate in the CSC meetings as non-voting members.
• The NCI Project Scientist and the Program Official will convene the first of the annual meetings for the CanCORS Consortium. Throughout the term of the project, the NCI Project Scientist and the Program Official will continue to facilitate and coordinate interactions among the CanCORS investigators to ensure standardized collection of all core data elements selected by the CSC and to facilitate data analyses and publication.
• The NCI Project Scientist will have access to all data generated under this award consistent with current HHS, PHS, and NIH policies. Periodically, the NCI Project Scientist or designee will review data management and analysis procedures.
• The NCI Project Scientist along with other NCI scientific staff members (as deemed necessary by the Project Scientist) will provide advice on specific scientific and technical issues as needed to the Consortium.
• The NCI Project Scientist and other NCI scientific staff who contribute scientifically to the process of data collection will have opportunities to participate in data analyses and publication efforts of the Consortium.
• The NCI Project Scientist along with other NCI staff (as appropriate) will perform at least two site visits with the SCC site during the project period.
• The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those CanCORS 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.

2.A.3. Collaborative Responsibilities

The main governing body of the CanCORS Consortium will be the CanCORS Steering Committee (CSC).

The CSC will have the following organization and functions:

• Voting Membership of the CSC will consist of the PDs/PIs from each of the PDCRs, the PI of the SCC, and the NCI Project Scientist. Each of these individuals will have a single vote. The NCI Program Official and other NCI representatives will participate in the CSC meeting as a non-voting member.
• It is expected that the CSC will be co-chaired by both lead PDs/PIs (i.e., a lead PI responsible for the SCC and a scientific lead PI designated to oversee all the PDCRs and serve as the scientific leader of the Consortium). The CSC chairperson(s) may not be an NCI employee or representative. The CSC may decide to rotate the scientific leadership on a time-limited basis.
• The CSC may establish sub-committees, as it deems appropriate. The NCI Project Scientist will serve on sub-committees, as s/he deems appropriate. Other NCI representatives may serve on committees as deemed appropriate by the Project Scientist. The CSC may also decide to invite additional individuals as non-voting members of the CSC as needed. Examples of such groups include: a publications committee, a data standards committee, a participation monitoring committee, a program manager’s committee, working groups in charge of the various data collection modalities such as the provider survey working group. The functions, goals, and membership of such groups if established will be decided mutually by members of the CSC.
• CSC will establish administrative procedures (i.e., meeting dates, guidelines for reporting, etc.) and methods by which all research and dissemination requirements of the FOA will be met.
• CSC will establish or approve collaborative study protocols, core data elements, and instruments to collect core data within a timeframe to be established at the first CanCORS meeting.
• CSC will define (or refine as needed) policies and procedures regarding publication or presentation of project findings.
• CSC will meet separately during the course of the annual CanCORS meetings as needed. The CSC will also meet regularly by conference call at the minimum once a month or at a more frequent interval if desired by the CSC members.
• CSC will establish guidelines for monitoring the quality of performance of the Consortium as a whole as well as the individual member institutions and identify procedures for correcting performance that is deemed inadequate.
• CSC will facilitate the evaluation of the work of the Consortium by an external panel of evaluators. Members of the evaluation committee will be chosen by the NCI Project Scientist and Program Official.
• CSC will evaluate any major budgetary changes to the sub-contractual arrangements of the Consortium member institutions.
• All the participating institutions must abide by the decisions of CSC.

The inability of an awardee to meet the performance requirements set forth in these Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award.

2.A.4. Arbitration 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 arbitration. An Arbitration 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 arbitration procedure in no way affects 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

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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:

Neeraj K. Arora, Ph.D.
Program Director
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4092, MSC 7344
Bethesda, MD 20892 (for US Postal Service Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-594-6653
Email: [email protected]

Anita Ambs, M.P.H.
Program Director
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4106, MSC 7344
Bethesda, MD 20892 (for US Postal Service Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-451-6051
Email: [email protected]

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: [email protected]

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
Fax: 301-496-8601
Email: [email protected]

Section VIII. Other Information

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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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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-02-005.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. Applications that do not provide this information will be returned without review.

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.