Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Agency for Health Care Research and Quality (AHRQ) (http://www.ahrq.gov)

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

Title: Cancer Research Network (U19)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-CA-02-507, which was previously released January 2002. This FOA is a limited competition Request for Applications (RFA).

Request for Applications (RFA) Number: RFA-CA-06-505

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates
Release Date: June 9, 2006
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): August 16, 2006
Peer Review Date(s): November/December 2006
Council Review Date(s): February 2007
Earliest Anticipated Start Date(s): March 2007
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: August 17, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• NCI will award one grant to continue support for the NCI Cancer Research Network across Health Care Systems initiative (CRN). The CRN is expected to continue as a cooperative agreement to provide a resource that will facilitate the conduct of NCI-sponsored research on prevention, early detection, treatment, long-term care and post diagnosis monitoring in the context of health care delivery systems. To accomplish this goal, the initiative supports the development of cancer research capabilities across multiple healthcare provider organizations using integrated data systems in the context of a multi-site population-based research laboratory.
• The amount of the award (total cost) is $30 million over 5 years, and includes $6 million in Fiscal Year 2006.
• The anticipated number of awards is one.
• The mechanism for this grant will be the NIH U19 cooperative agreement.
• This is a Limited RFA for the renewal of U19CA079689.
• More than one Principal Investigator (PI), or multiple PIs, may be designated on the application.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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

Section I. Funding Opportunity Description

Nature of the Funding Opportunity

The purpose of this Request for Applications (RFA) is to provide continued support for the Cancer Research Network Across Health Care Systems Initiative (CRN). The renewal of this program will allow the NCI to continue support for collaborative cancer research among healthcare provider organizations that: are oriented on community care; have access to large, stable, and diverse patient populations; are able to take advantage of existing integrated databases; and that can provide patient- and provider-level information relevant to research studies on cancer control and cancer-related population studies. Enhanced support also will facilitate increased research collaboration between healthcare provider organizations and researchers affiliated with cancer centers, other academic institutions, the NCI, and other federal agencies.

The ultimate purpose of the research funded by NCI is to reduce the burden on the society of morbidity and mortality of cancer. Therefore, it is appropriate that studies funded by this RFA focus on cancer sites that are responsible for substantial components of cancer morbidity and mortality. However, because of its large denominator human population, the CRN may also be well suited for proposing research on cancers sites, or sub-types of cancers, that are relatively rare.

Need for the Research

The CRN responds to several key scientific needs articulated by NCI and other scientific organizations. CRN’s work exemplifies the Delivery arm of NCI’s mission of Discovery, Development, and Delivery. The goals of the CRN RFA coincide with the priority areas of the 2007 NCI Strategic Plan for Leading the Nation to Eliminate the Suffering and Death Due to Cancer (http://strategicplan.nci.nih.gov/pdf/nci_2007_strategic_plan.pdf), which include such elements as: establish partnerships for healthcare delivery research to improve the quality of care and reduce cancer health disparities, implement state-of-the-art information systems to quickly access relevant patient health information for use in research and practice, encourage research collaborations across disciplines and care delivery systems to investigate biological mechanisms of cancer and treatment-related symptoms and impairments, and support community-based research to include the perspectives of the patient or consumer and that of the healthcare provider to expand our understanding of cancer care generally and health disparities in particular. The strategic plan also supports the need to link data sources to track patient information and provide detailed patient reported data to better examine patterns of care and patient outcomes. The 2007 NCI Plan and Budget indicates that the cancer Biomedical Informatics Grid (caBIG^TM ) will be extended to support efforts that build upon the informatics resources of the CRN. Among United States (U.S.) healthcare delivery systems, those affiliated with the CRN are in the forefront of developing clinical and health informatics systems. The existence of a cancer research network affiliated with these healthcare systems provides opportunities for the NCI to leverage these informatics resources for cancer research.

Scientific Objectives

The overall goal of the CRN is to increase scientific knowledge in cancer epidemiology, risk factors, prevention, early detection, diagnosis, prognosis, treatment, and end-of-life care in the context of community-based health care delivery. Research funded by this RFA should be designed to take advantage of the large patient populations and diverse patient care settings, the integrated data systems, and the other complimentary research resources made available by the CRN to achieve research objectives that would otherwise be infeasible or prohibitively expensive.

This renewal of the CRN program will focus on supporting continued productive research by the CRN, enhancing the capacity of the CRN to provide massive health informatics resources for research purposes (via the CRN-affiliated healthcare delivery systems), and enhancing the capacity of the CRN to conduct multi-site, collaborative research projects with external as well as internal research partners.

The overarching goals of CRN Research Program are as follows:

• To understand the distribution of preventable cancer risk factors and the burden of disease in the covered population of the CRN;
• To effectively disseminate and implement in the context of health care provider systems innovative cancer prevention and control programs that are based on rigorous intervention and systems research; and
• To understand the relationship between health care delivery system organizational structure(s), patterns of cancer prevention and control service delivery, and health-related outcomes.

These research objectives will be accomplished by: developing and applying innovative methods to efficiently collect and interpret data from automated data systems, conventional medical record systems, newly emerging electronic medical records, and web-based medical communication systems; assembling large samples of patient data, including data for patients with specific cancers; documenting patient demographic and chronic disease risk characteristics; documenting longitudinal patterns of health care resource utilization and cost; collecting and integrating complex data from patients, providers, and organizations to examine issues in healthcare delivery from multiple perspectives; and conducting studies on patient and provider directed behavioral and systems-based interventions designed to improve the delivery of care in the realistic settings of community-based healthcare delivery systems

Types of Research Sought

Areas of research that are expected to be particularly enhanced by the CRN program include, but are not limited to:

1. Epidemiological Studies

• Epidemiological studies in which longitudinal medical records are particularly useful in identifying cancer risk factors, including the potential risks associated with pharmaceuticals, medical devices, and other forms of non‑cancer treatment.
• Studies of the long‑term risk of second cancers, or other late effects of cancer treatment.
• Methodological research to identify cancer recurrences using health system data resources and informatics tools.

2. Behavioral Cancer Prevention and Control

• Studies of the feasibility, cost‑effectiveness and dissemination of efficacious bio‑behavioral cancer prevention and control interventions.
• Studies of innovative behavioral cancer prevention and control interventions targeted to specific populations in different organization settings, e.g., physician practice, ancillary health, personnel, or public education.
• Studies of delivery systems for counseling and other approaches used for genetic testing, monitoring for cancer occurrence and preventive interventions.
• Methodological research on the incorporation of quality-of-life, patient satisfaction and other measures into routine clinical care.

3. Evaluation and Methodological Studies Related to Clinical Trials

• Research on the costs and benefits to patient enrollees and health care provider institutions that result from participation in NCI-sponsored trials or other trials. One purpose of this research is to identify strategies for increasing accrual to NCI trials.
• Methodological research on the incorporation of quality‑of‑life, patient satisfaction, and economic endpoints in NCI trials through direct clinical trial data collection or by other methods such as using modeling or other extrapolation methods to make it possible to use retrospective data to supplement the analysis of within‑trial data.

4. Survivorship Issues

• Studies of indirect costs, quality‑of‑life, complications, and recurrence(s) as a function of treatment approach(es), care setting(s) and referral patterns.
• Studies of interventions to prevent morbidity associated with cancer and its treatment.

5. Cancer Control Surveillance and Outcomes Research

• Studies of existing patterns of care for cancer prevention, screening, treatment, rehabilitation, and end-of-life care in relationship to existing evidence of efficacy, cost‑effectiveness, clinical recommendations, and practice guidelines.
• Studies of the effectiveness of preventive medicine and evidence‑based medical practice.
• Studies of the diffusion of state‑of‑the‑art cancer prevention, screening, treatment, rehabilitation, and end-of-life care.
• Studies of the formulation and implementation of organizational policy regarding the dissemination of innovative technology, e.g., counseling, screening for genetic predisposition to cancer, and newly approved advanced diagnostic imaging tools in clinical settings.

6. Clinical Informatics Studies

• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems to identify, recruit, and track organization members for targeted cancer prevention and screening interventions.
• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems to aid patient/physician decision making for cancer prevention, screening, and treatment in clinical settings.
• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems as an aid to multi‑disciplinary management of cancer care.
• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems for provider feedback with the goal of improving the quality of care.
• Studies that develop and apply innovative standard-based informatics to bridge research and health care, including the development of methods of extracting data from electronic medical records and other clinical data sources to aid in identifying suitable patients for clinical trials and methods of ensuring continuity of care for patients when they return to community-based and other healthcare delivery systems from clinical research studies.

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

Section II. Award Information

1. Mechanism(s) of Support

The administrative and funding instrument to be used for this program will be a multi-component Research Program cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI s purpose is to support and/or stimulate the activity of recipient(s), to generate a high quality resource by involvement in and otherwise working jointly with the award recipient(s) in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. NCI staff will also be involved with the coordination of different groups, should there be more than one award recipient. Details of the responsibilities, relationships, and governance of the study to be funded under the cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses NIH just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U19 grant is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (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 PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award." It is anticipated that at the termination of this current U19 award the RFA will be reissued for continuation of this project through the U19 mechanism.

2. Funds Available

NCI expects to provide a total of $30 million, over 5 years, for this RFA. The anticipated number of awards is one. The anticipated total direct cost of the award is $27 million. The anticipated start date for this award is March 1, 2007, and the probable period of performance is March 1, 2007 February 28, 2012.

AHRQ will not provide any initial funds for this RFA, but will have the opportunity to consider contributing supplemental funding to the resultant grant during its term of award.

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 meritorious application.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The eligibility to apply in response to this Limited Opportunity RFA is limited to the current recipient of the CRN award under U19CA079689.

The CRN will be led by one or more Principal Investigators (PIs), researchers affiliated with one of the CRN member research organizations, who will coordinate activities of the CRN and/or provide scientific leadership in the areas of cancer research. Each CRN member research organization may also be represented by one or more PIs, who may also be designated as lead researchers on one or more of the specific research projects of the CRN. The organizational entity with which the CRN contact PI is affiliated will be the awardee institution for this RFA and the lead institution for the CRN. The application must name the CRN PIs, co-Investigators and the respective CRN organizational members.

Applications may be submitted by domestic for-profit and non-profit health care provider organizations (network members) acting jointly as a U.S. research network. A domestic application may not include an international component. Networks must include a sufficient number of health care provider organization members, such that total patient enrollment is at least 2 million adults (ages 18 and over). Also, network covered populations must include diverse populations with respect to gender, race/ethnicity and, to the extent that it is practical, rural/urban populations from a range of geographic locations. Applicants must demonstrate a shared commitment among all participating network members to working together on proposed research studies. Applicants must show evidence of ability to access and organize data collection from all participating network members. Applicants are encouraged to demonstrate the capability of data linkages with local centralized tumor registries, pathology and radiologic facilities, and state vital records. If these capabilities do not currently reside within one or more of the network members, the applicant may assemble a group with plans to develop the necessary expertise across all network members. Each network member must have access to a resource unit that supports research data management locally or centrally.

1.B. Eligible Individuals

The eligibility to apply in response to this Letter RFA is limited to current recipients of the CRN award under U19CA079689. Within the framework of the existing CRN, any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 PI, or multiple PIs, may be designated on the application. Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research awards can be found at http://grants.nih.gov/grants/multi_pi. All PIs must be registered in the 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 single PI or multiple PI grant is the responsibility of the applicant organization and should be determined by the scientific goals of the project. Applications for multiple PI grants will require additional information, as outlined in the instructions below, and the NIH review criteria for approach and investigator will be modified as indicated below. For example, a weak or inappropriate PI can have a negative effect on the review. If the multiple PIs grant option is elected, a contact PI must be named, as described in the instructions below. Multiple PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each 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 all required reports.

Multiple PIs may request budget apportionment between the PIs (see supplementary instructions below). For multiple organizations, a subcontract or consortial arrangement must be agreed on by the participating organizations, as described in special instructions below.

2. Cost Sharing or Matching

There is no cost sharing requirement for this RFA.

The most current NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An applicant may submit only one application under this announcement.

Section IV. Application and Submission Information

The application format is to be that of the PHS 398 as customized for the NIH multi-component cooperative agreement U19 mechanism. Each component is to be an individual unit (including budget) and may consist of projects or core. A complete application must be received by the NIH Center for Scientific Review (CSR) no later than August 16, 2006. If an application is received after that date, it will be returned to the applicant without review. CSR will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. CSR will not accept any application that is essentially the same as one already reviewed. This rule does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an introduction addressing the previous critique.

The PI(s) is (are) the individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating institution, for the proper conduct of the project or program, including submission of all required reports.

When multiple PIs are proposed, use Face Page (Continued) page to provide items 3a-3h for all PIs. NIH requires one PI be designated as the Contact PI for all communications between the PIs and the agency. The Contact PI must meet the eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The Contact PI may be changed during the project period. The Contact PI should be listed in block 3 of Form Page 1 (the Face Page), with additional PIs listed on the Face Page (Continued). All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Format Page 2. Key Personnel

When multiple PIs are proposed, list the Contact PI first, then all additional PIs in alphabetical order. Then, list all Key Personnel, giving name and organization.

The Research Plan in application must be organized in the following sections:
A. Background and Significance
B. Overall Aims
C. Progress Report
D. Administrative Structure
E. Multiple PI Leadership Plan (if appropriate)
F. Individual Research Projects
G. Research Infrastructure
H. Consortium/Contractual Arrangements
I. Supplementary Documentation

Sections A-E must not exceed 100-page limit. Section F is limited to 30 pages per project. Section G must not exceed 75-page limit.

A. Background and Significance. This section should briefly describe the purpose and history of the CRN, the researchers that it serves, and the types of studies that it conducts.

B. Overall Aims. The overall, broad, long-term objectives of CRN as well as what the CRN intends to accomplish in this funding period should be described in this section. The renewal application must describe how the structure of the CRN and its individual research projects and cores will further the overall goals of the CRN program. These plans must address recommendations of an external evaluation report of the CRN and discuss the following key areas:

(a) increasing the role of clinical and managerial personnel of healthcare delivery organizations affiliated with CRN in the formulation of CRN research and in the dissemination of CRN research results.
(b) enhancing the capacity of CRN to engage non-CRN investigators in collaborative research projects;
(c) enhancing the capacity of CRN to engage in collaborative health informatics research projects with NCI, especially with the Cancer Bio-Informatics Grid project (caBIG^TM);
(d) increasing communication and collaboration with a wide scope of healthcare delivery system-based research networks, national quality improvement organizations, and cancer advocacy groups;
(e) increasing the number and diversity of CRN member organizations;
(f) forming formal or informal research alliances with cancer centers or other academic centers;
(g) intensifiying interaction(s) with other healthcare delivery system-based research networks, such as those sponsored by AHRQ,
(h) enhancing collaboration(s) with NCI units involved in research and dissemination of national quality standards;
(i) improving quality of data on race and ethnicity of healthplan members at the individual level;
(j) increasing research collaborations and professional development involving young investigators, both from within CRN and through collaborations with external research organizations;
(k) increasing informatics development, including data systems and web-based communication systems to provide standardized information for research purposes, including such person-level characteristics as family history, body-mass index, dietary patterns, health related quality of life, and patient-report treatment outcomes and satisfaction; and
(l) improving multi-site institutional review board (IRB) review process and the sharing of research data under the constraints of Health Insurance Portability and Accountability Act (HIPAA) regulations.

C. Progress Report section should document the development and progress of the CRN, including a description of the interactions that occurred among institutions and among the researchers involved in developing the CRN. Application should contain a description of efforts that have been made toward development of the infrastructure for documenting and facilitating the use of HMO-based data resources, increasing standardization of HMO-based data resources, data abstraction and survey instruments, facilitating the communication and collaboration between CRN and non-CRN researchers; and facilitating the rapid and efficient design and implementation of CRN-based studies as well as the development of health informatics resources and tools. Internal evaluation and quality improvement activities and external evaluation activities and the results of these efforts should be described. Results and products of the specific research projects that were previously funded must be described, including research publications, other reports, survey and data abstraction instruments, data warehouse development, informatics capacity and tools, and effects of CRN research on policies, practices, and procedures of the healthcare delivery systems affiliated with CRN or other healthcare delivery systems. If applicable, progress pertinent to specific aspects listed as items a-j under the Overall Aims should also be reported.

D. Administrative Structure. This section should describe the proposed administrative structure of the project, e.g, PI(s), co-investigators, the Steering Committee, other functional committees and special interest groups, other research support resources, and how these units function to support and maintain the core and research projects of the CRN, and to maintain communication and collaboration between core and research projects and across participating CRN member research organizations, participating Federal agencies (i.e., NCI/NIH and AHRQ), and other research collaborators. Costs should be budgeted for attendance at Steering Committee meetings, site visits, and other key administrative functions. Appropriate structures that would oversee quality control of the research (e.g., internal or external advisory committees) should be described.

E. Multiple PI Leadership Plan. For applications designating multiple PIs, a new section titled Leadership Plan should be included. The governance and organizational structure of the overall research project (ICMIC) should be described, including communication plans, publications, intellectual property issues, and procedures for resolving conflicts. The roles and shared administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs, including responsibilities for human subjects and animal studies as appropriate. For competing continuation applications, the application should contain a description of how the research will be enhanced by employing a multiple PI approach. This section should also address the governance and organizational structure for Research Components that have designated more than one PI.

F. Individual Research Projects. This section should provide details on how the CRN resources will continue to be used to support a portfolio of at least three research projects organized under a well defined research agenda that is responsive to specific research priorities of NCI as defined in Plans and Priorities for Cancer Research 2007 (http://plan.cancer.gov/) and The NCI Strategic Plan (http://strategicplan.nci.nih.gov/). A narrative should be provided for each proposed research project (not to exceed 25 pages). The narrative should provide information on: (1) scientific background and the significance of the research project; (2) preliminary results, including methodological investigations and pilot research data from the previous CRN grants that form the basis for follow-up research; (3) research design and methodology; (4) data sources and data collection instrumentation; and (5) analytical methods. In addition, information on the performance sites, budget, key personnel, resources and environment for each research project should be provided.

G. Research Infrastructure. Research Cores should be described in detail, including their specific roles in supporting and integrating the research projects of the CRN. Each research core should provide support for at least two research projects. In addition, information on the performance sites, budget, key personnel, resources, and environment for each research core should be provided. Procedures should be described for the evaluation of core functioning (e.g., by an advisory board) and for implementing recommendations resulting from such evaluations. This section should also outline plans for anticipated interactions with non-CRN researchers or research organizations, including interactions needed to ensure data compatibility with the NCI caBIG^TM requirements. The narrative description for the entire Section F (including all cores) should not exceed 75 pages.

H. Consortium/Contractual Arrangements: If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.

I. Supplementary Documentation: Statements of Institutional Commitment, Letters of Support, letters of collaborations, and other similar documents, if appropriate, should be included in this section.

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(s): August 16, 2006
Peer Review Date(s): November/December 2006
Council Review Date(s): February 2007
Earliest Anticipated Start Date: March 2007

3.A.1. Letter of Intent

Not applicable

3.B. Sending an Application to the NIH

Applications must be prepared using 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 (but no appendix materials) in one package to:

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

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 a pdf version of the appendix materials must be sent to:

Martin L. Brown, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-5716
Fax: (301) 435-3710
E-mail: mb53o@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCI. Incomplete and 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

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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 NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

This RFA will provide enhanced support so that the rapidly developing health informatics tools and resources of the participating healthcare provider organizations can be utilized for purposes of cancer research and integrated with the activities of the NCI Cancer Biomedical Informatics Grid (caBIG) initiative (http://cabig.nci.nih.gov).

CRN expertise will be brought into diverse components of the caBIG^TM including but not limited to: discussions related to standards and support systems for data sharing, policies related to intellectual capital, clinical trials management systems, tissue banks and pathology tools, architecture, vocabularies and common data elements, and in vivo Imaging. This interaction will facilitate a collaborative process for identification of opportunities to develop informatics tools that will improve cancer prevention and cancer care. Software systems supported through this RFA will be analyzed for current caBIG^TM compatibility and interoperability. Following this analysis, CRN will undertake the necessary steps to modify these systems to reach caBIG^TM silver level, and for elements where appropriate, gold level, according to caBIG^TM Compatibility Guidelines https://cabig.nci.nih.gov/guidelines_documentation/caBIGCompatGuideRev2_final.pdf.

After evaluating caBIG^TM and the NCI Center for Bioinformatics technology, the CRN will aid in developing patient accrual tools that are standard-based and intended to permit characterization and identification of a pool potentially eligible patients. These tools shall be caBIG-compatible at the Silver or Gold level and utilize information from multiple sources so that patients in this pool can be compared with the pool of available clinical trials, in order to facilitate accrual to NCI sponsored clinical trials. CRN will participate in a collaborative caBIG process for identifying the appropriate eligibility criteria for such tools. Processes to enable patient and provider knowledge, interest and understanding of such trials will be explored.

Clinical Terms of Awards

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

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

2. Review and Selection Process

It is anticipated that only one application will be submitted in response to this Letter RFA. An a pplication that is complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI in accordance with the review criteria stated below.

As part of the initial merit review, the application will receive a written critique.

The application will receive a second level of review by the National Cancer Advisory Board.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them 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 high 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.

Peer review emphasizes a synthesis of two major aspects of the U19 application: review of the merit of each of the individual research projects and core components compared to a standard of quality in a related, broad, scientific discipline, and review of the program as an integrated research effort focused on a central theme. In arriving at an overall merit priority score for the U19, members of the review committee also will consider the likelihood that the proposed research program will have a substantial impact on the scientific field.

The review criteria for both the overall program and the individual projects are the standard NIH review criteria of Significance, Approach, Innovation, Investigators, and Environment. The sections below give more detail about how these five criteria are applied to the overall program and the individual projects.

A. Review Criteria for the Overall Program

• Significance: The potential of the overall program to advance knowledge in one or more broad scientific areas or fields.
• Approach: The overall adequacy and quality of the experimental approaches proposed in the projects, the adequacy of services provided by the cores, and the overall design of theU19. For applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs? Are the administrative plans for the management of the research appropriate, including plans to resolving conflicts?
• Innovation: The degree to which the overall program applies novel concepts and innovative approaches.
• Investigators: The qualifications of the PIs and other senior scientists to lead the U19 scientifically and coordinate all P01 activities, including:
  • The demonstrated ability of the PIs to provide effective scientific and administrative leadership, as demonstrated by selection of individual projects for scientific excellence and thematic relatedness and by promotion of effective interactions and collaborations. Although the scientific merit of the U19 is based on the overall quality of scored and rated projects and cores, any components Not Recommended for Further Consideration (NRFC) are considered in the peer review evaluation of the PIs leadership and program administration skills.
  • The adequacy of the commitment (percent effort) of the PIs to the U19. There should be a specific commitment to both the scientific and administrative aspects of the U19. Though a common practice, it is not mandatory that the PIs be a project leader of an individual research project.
• Environment: Scientific, organizational, and administrative environment.
• Integration: Scientific and administrative integration of the U19, including:
  • Evidence of coordination, interrelationships, and synergy between meritorious research projects and core components as related to the common theme of the U19.
  • The advantages or value added that could be realized by conducting the proposed research as a U19 rather than through separate research efforts.
  • The presence and quality of mechanisms for regular communication and coordination among investigators.
  • The mechanisms for quality control of the research (e.g., internal or external advisory committees).
  • For competing renewal applications, evidence of productive collaborations, such as joint publications, resulting from the U19 award.
• For Competing Renewal Applications: Progress during the current funding period.

B. Review Criteria for Projects

• 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?
• Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
• 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 or methodologies, tools, or technologies for this area?
• 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 project leader and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
• Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Projects may be Not Recommended for Further Consideration (NRFC) based on seriously flawed research approach or on inclusion of research hazardous to human subjects.

NOTE: Synergy and thematic relatedness between the projects and cores, and their significance for the program as a whole, are not discussed when rating individual projects. These characteristics are discussed and rated under the Integration review criterion when evaluating the Overall Program.

C. Review Criteria For Core(s)

• The utility of the core to the U19. Each core must provide essential facilities or services for two or more projects judged to have substantial merit.
• The quality of the facilities or services provided by this core (including procedures, techniques, and criteria for prioritization).
• The qualifications, experience, and commitment of the personnel involved in this core.
• The appropriateness of the budget and accountability for distribution of costs to projects. A realistic budget reflects the core director's understanding of the scope of the work.
• When appropriate, adequacy of the proposed plan to augment and/or complement an existing shared resource supported by an NCI Cancer Center Support Grant (P30).
• For an administrative core: The quality of administrative resources, the decision-making process for the allocation of resources and funds, and the plans for the evaluation of progress.
• The adequacy of procedures for using recommendations resulting from the meetings.

Cores may be Not Recommended for Further Consideration (NRFC) based on seriously flawed research approach or on inclusion of research hazardous to human subjects or if they do not serve two or more projects or lack sufficient evidence of technical expertise and experienced leadership.

D. Additional Criteria for Competing Renewal Applications

• The progress and achievements specific to this U19 since the previous competitive review. Both continuing and discontinued projects and cores should be assessed.
• Evidence that scientific synergy has occurred as indicated by joint publications and new collaborative aims and/or projects.
• Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions.
• The previous performance and cost-effectiveness of the core(s).
• The justification for adding new projects or cores or deleting previous components.
  

E. Additional Criterion for Amended Applications

Amended applications should be assessed based on the overall merit of the application as now presented. An amended application may be improved, the same as, or worse than the previous application.

2.A. Additional Review Criteria:

In addition to the above review criteria, this application will be reviewed for progress and plans to further the overall objectives of the CRN program and responsiveness to the recommendations of an external evaluation report of the CRN, including specific aspects listed in Section IV.2 (items a-k, under instructions to Section B of the Research Plan).

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

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 E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from 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 E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 e-mail 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 PI 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 U 19, 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

The PI(s) will have the primary responsibility for the CRN effort as a whole, including research design and the actual performance of the CRN effort, preparation of publications, as well as collaboration with other awardees, with assistance from the NCI Scientific Coordinator. The PI(s) is (are) expected to make any necessary adjustments in the overall research strategies to accommodate the changing environment resulting from improved technologies during the course of the project period. While joint research projects are strongly encouraged under this RFA, research projects conducted at individual CRN member research organizations under the supervision of a member PI, that otherwise contribute to meeting the goals and objectives of this RFA, are allowed. PIs of such single member institution studies will have equivalent status with all other PIs in regard to participation on the CRN Steering committees and other CRN committees.

Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. All awardees and NCI will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions involved in CRN research projects. No identifying information of individual patients or providers should be available through pooled CRN research databases. Encrypted study identification numbers will be used for all pooled CRN studies. Awardees will collaborate with the NCI caBIG^TM project and engage in efforts to reach appropriate levels of caBIG^TM compatibility for CRN research data where feasible.

The PI(s) will attend all annual CRN meetings and will annually document progress in written reports to the NCI Program Director and will provide periodic supplementary reports upon request. The NCI Program Director will make copies of these reports available for review by the AHRQ Program Director.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2.A.2. NIH and AHRQ Responsibilities

NIH/NCI will assign one staff member and AHRQ will assign another staff member to serve as the coordinators of the project (Project Scientists). The Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Substantial involvement in coordinating the activities of the awardee with the non-CRN researchers and other NCI-sponsored research networks, as necessary.
• Participation in the Steering Committee and any subcommittee meetings that may be called.
• Serving as a resource with respect to other ongoing NCI/NIH activities that may be relevant to this effort and providing expert advice to the awardee on specific scientific and/or analytic issues.
• Assisting, with the agreement of the PI(s), in the design, development, and coordination of the CRN studies.
• Reviewing study design and protocols, data abstraction and survey instruments to insure that they are within the scope of this effort and within the scope of peer review.

NCI intramural researchers may also be involved in the development of new CRN projects through scientific collaboration with CRN investigators and will have similar rights and responsibilities as other CRN investigators. Any such NIH staff involvement is independent of the role of the NCI Project Scientist.

Additionally, an NCI program official (a Program Director) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will be responsible for managing collaboration between the CRN and caBIG^TM. The NCI designated Program Director may act as the Project Scientist as well.

The NCI reserves the right to terminate or curtail the study (or an individual component of the award) in the event of inadequate progress, data reporting, or insufficient use of this resource.

The NCI Program Director will interact with the PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PI and his staff, periodic site visits for discussion with the awardee research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.

The NCI Program Director will also identify other NCI extramural staff who have appropriate experience and expertise to collaborate with CRN in the development of research ideas, review of study designs and methods, participation in study analyses, and review of scientific reports and articles.

2.A.3. Collaborative Responsibilities

During the course of the award period, the awardee(s) will be invited to meet with the NCI, other PIs, and/or other uninvolved experts in Bethesda, MD, to review scientific progress.

The CRN Steering Committee will be the main oversight body for this cooperative agreement. The Steering Committee will coordinate the overall governance of the CRN and establish and administer specific CRN-wide policies. Membership of the Steering Committee will consist of CRN PI(s), PIs from each CRN member research organization, project leaders for each CRN research project, and Project Scientists from the Issuing Organization (i.e., NCI) and Participating Organization (-s) (at present AHRQ). The lead PI of the CRN will serve as the chair of the steering committee. All members of the steering committee will have one vote, which includes only one vote each for the NCI and AHRQ Project Scientists.

The purpose of the Steering Committee will be to periodically review the research agenda and specific research projects, conducted evaluations of the overall operations of the CRN, determine directions for future development and improvement, and to share experiences with implementation of this network. It is expected that decisions made or actions taken by the Steering Committee will be by consensus and all awardees will be expected to implement them. The Steering Committee will meet twice each year. Financial support for these meetings should be anticipated in the CRN application budget.

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 PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

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:

Martin L. Brown, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-5716
Fax: (301) 435-3710
E-mail: mb53o@nih.gov

William F. Lawrence, M.D., M.S.
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 2000
Rockville, MD 20850
Telephone: (301) 427-1517
Fax: (301) 427-1520
E-mail: wlawrenc@AHRQ.GOV

2. Peer Review Contacts:

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

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 Express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8634
Fax: 301-496-8601
E-mail: crystal.wolfrey@nih.gov

Section VIII. Other Information

Required Federal Citations

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); and 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 institutional review board (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.

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.

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 U.S. 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 PA 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 or Health Systems Agency review. 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 2 years to the research. For further information, please see http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices

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