Expired RFA-CA-07-049: Minority-Based Community Clinical Oncology Program (U10)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

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

Component of Participating Organization
National Cancer Institute (NCI) (http://cancer.gov/)

Title: Minority-Based Community Clinical Oncology Program (U10)

Announcement Type
This Funding Opportunity Announcement (FOA) is a re-issuance of RFA-CA-07-026, which was previously released on June 28, 2006.

Update: The following update relating to this announcement has been issued:

April 29, 2008 - This RFA has been reissued as (RFA-CA-08-016).

Request For Applications (RFA) Number: RFA-CA-07-049

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates
Release Date: May 25, 2007
Letters of Intent Receipt Date(s): June 18, 2007
Application Receipt Date(s): July 18, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): June 2008
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: July 19, 2007

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), announces the continuation of the established program known as Minority-Based Community Clinical Oncology Program (Minority-Based CCOP) through which practicing oncologists who serve large minority populations participate in the NCI-sponsored clinical trials. The purpose of this program is to support, as a national resource, research activities of physicians involved in the care of minorities who are eligible to participate in NCI-sponsored cancer prevention/control and treatment clinical trials. The NCI clinical trials program supports Minority-Based CCOP groups by providing access to clinical trials in cancer centers, major university centers, and community programs. The linkage of minority cancer patients/participants to the current clinical trials network facilitates the transfer of new research advancements in cancer prevention/control/treatment practices to minority communities and their physicians.
This Funding Opportunity Announcement (FOA) solicits U10 cooperative agreement applications from applicants seeking to establish a new Minority-Based CCOP group as well as from existing Minority-Based CCOP groups seeking renewal. The NCI intends to commit approximately $2.4 million in total costs in FY 2008 to fund approximately five new and/or renewal Minority-Based CCOP applications.
Eligible Institutions: For-profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals, and laboratories; Domestic Institutions; and Faith-based or community-based organizations. Foreign institutions and organizations are ineligible to apply for Minority-Based CCOP award.
Additional conditions of eligibility: This FOA is explicitly designed for Domestic institutions with the capability and intent to serve new cancer patients/clinical trial participants largely from minority populations (as defined by the Office of Management and Budget Statistical Policy Directive No. 15, Race and Ethnic Standards for Federal Statistics and Administrative Reporting at http://www.whitehouse.gov/omb/fedreg/1997standards.html). Provided these minority population requirements are met, the following categories of institutions/organizations are eligible for new and renewal Minority-Based CCOP cooperative agreements: hospitals; clinics; groups of practicing physicians; health maintenance organizations (HMOs); or consortia of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a Principal Investigator (PI) and a single administrative focus. Applicants for the Minority-Based CCOP group award must document that at least 40 percent of their newly diagnosed cancer patients are from minority populations.
Eligible Principal Investigators (PIs) with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Each applicant organization may submit only one application.
Applications must be prepared using the PHS 398 research grant application and forms. Application materials are available from the NIH Office of Extramural Research (OER) at http://grants.nih.gov/grants/oer.htm. See Section IV.1 for application materials.
Potential applicants who represent community health care institutions/organizations serving primarily non-minority populations may consider a related FOA designed for general (non-minority based) CCOP (RFA-CA-07-048).
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

1. Research Objectives

Purpose

The overall objective of this initiative is to bring state-of-the-art cancer clinical trials to minority individuals in their own communities and to involve physicians practicing in these communities in NCI-approved clinical trials in an effort to reduce health disparities in minority populations.

To pursue this goal, the NCI has established and funds the program known as Minority-Based Community Clinical Oncology Program (Minority-Based CCOP). The purpose of this program is to support, as a national resource, clinical trial research activities of physicians involved in the care of minority cancer patients who are eligible for participation in clinical trials pertinent to cancer prevention/control and treatment. The NCI clinical trials program supports Minority-Based CCOP groups (also referred to as Minority-Based CCOPs) by providing access to clinical trials in cancer centers, major university centers, and community programs. This access is realized through another, separately funded, arm of the program termed Research Bases , which comprise participating NCI Cooperative Groups and Cancer Centers. The linkage to the current clinical trials network is expected to facilitate the transfer of advances in cancer prevention/control/treatment practices to minority communities and their physicians.

Background

When compared to the general population, minority populations experience an increased incidence of a number of malignancies and worse mortality. However, the participation of minorities in clinical trials tends to be limited. Greater enrollment in clinical trials of Black, Hispanic, Asian-American, American Indian, and other racial/ethnic minority patients is needed to ensure that the advances in clinical trials research and the ensuing improvements in oncology practice are applicable to (and benefit) all groups.

Broader access to clinical trials is needed to develop and implement effective cancer prevention/control/ treatment strategies in minority populations. Areas of research where increased enrollment of minorities is especially needed include: cancer prevention/control trials; interventions to improve screening and early detection practices; methodological research on ways to increase the educational awareness of individuals at risk for cancer; and studies of barriers to prevention and treatment of cancer. The Minority-Based CCOP has become an important part of these efforts, as the program links physicians caring for large numbers of minority patients to the NCI clinical trials network. The Minority-Based CCOP has a unique opportunity to help identify and address research questions related to the more serious and more prevalent cancers and cancer-related problems which exist in racial/ethnic minorities and other underserved populations. Outcomes of such research will help facilitate the application of these findings to cancer prevention, control, treatment, and survival to these populations.

The major NCI program initiatives supporting clinical trials network are: the Clinical Trials Cooperative Group Program (http://ctep.info.nih.gov/resources/ctcgp.html); the Cancer Centers Program (http://www.cancer.gov/cancercenters); and the Community Clinical Oncology Program (CCOP) (http://www.nci.nih.gov/prevention/ccop). Cancer prevention/control/treatment clinical trials funded through these programs provide patients and their physicians with access to state-of-the-art cancer care management opportunities, and provide oncologists with a source of continuing education on innovations in cancer prevention/control interventions, diagnostic techniques, and treatment applications.

The CCOP model has been an effective mechanism for increasing access to the clinical trials network to oncologists and their institutions. The Minority-Based CCOP was approved in January 1989. In 2006, there were 13 Minority-Based CCOPs in 10 states, the District of Columbia, and Puerto Rico. Approximately 50 hospitals and over 520 physicians, including over 100 minority investigators, participated in the activities of these Minority-Based CCOPs. Over the last decade, more than 5,500 minorities have enrolled in treatment and prevention clinical trials sponsored by NCI through the Minority-Based network. In 2005, an analysis of the successes in enhancing minority participation in clinical trials by the Minority-Based CCOP was published in the Journal of Clinical Oncology (J Clin Oncol. 2005;23:5247-5254).

The Minority-Based CCOP is designed to:

(1) Provide access to state-of-the-art cancer prevention/control and/treatment clinical trials to practicing physicians for the enrollment of minority individuals (as defined by the Office of Management and Budget Statistical Policy Directive No. 15, Race and Ethnic Standards for Federal Statistics and Administrative Reporting at http://www.whitehouse.gov/omb/fedreg/1997standards.html);

(2) Serve as a basis for (a) involving communities in diverse geographic regions of the United States (U.S.) in cancer prevention/control/treatment clinical trials and (b) investigating the impact of cancer therapy and control advances in community medical practices;

(3) Increase the involvement of primary health care providers and other specialists (e.g., surgeons, urologists, gynecologists) with the Minority-Based CCOP investigators in cancer prevention/control /treatment clinical trials, providing an opportunity for education and exchange of information;

(4) Increase overall enrollment of minorities to NCI-approved cancer prevention/control/treatment clinical trials;

(5) Provide an operational base for extending cancer control and reducing cancer incidence, morbidity, and mortality in minority populations by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, and continuing care technology to widespread community application; and

(6) Contribute to reducing disparities in cancer prevention, detection, control, and treatment by the recruitment, enrollment, and retention of minorities and to provide access to these populations to facilitate collection of data from other relevant research disciplines.

Minority-Based CCOP applications must describe their experience and demonstrate the potential for accessing appropriate participants/patients within their communities for participation in cancer prevention /control /treatment clinical trials provided by their CCOP Research Bases. In particular, applications must contain documentation regarding access of the participating investigators to a population in which 40 percent or more of new cancer patients are from minority groups. Other requirements and detailed instructions on the content and organization of the application are provided in Section IV. Application and Submission Information.

Potential applicants who represent community health care institutions/organizations serving primarily non-minority populations may consider a related FOA designed for general (non-minority based) CCOP (RFA-CA-07-048, http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-07-048).

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH U10 cooperative agreement award mechanism.

This funding opportunity uses the just-in-time 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 U10 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."

NCI has determined that there is a continuing program need for community participation in cancer clinical trials, both cancer prevention/control and treatment. While this RFA is a one-time issuance, it is expected that a Minority-Based CCOP RFA will be published in the NIH Guide to Grants and Contracts on an annual basis, provided that funds are available.

2. Funds Available

The NCI intends to commit approximately $2.4 million dollars in FY 2008 to fund approximately five new and/or renewal Minority-Based CCOP grants in response to this RFA. An applicant may request a project period of up to 3 years for new applications and up to 5 years for renewal applications and a budget for direct costs that is commensurate with the scope of work proposed. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The anticipated project start date for the application(s) selected for funding is June 2008.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics (with the additional restrictions outlined below):

For-profit organizations;
Non-profit organizations;
Public or private institutions, such as universities, colleges, hospitals, and laboratories;
Domestic Institutions; and
Faith-based or community-based organizations.

Additional conditions of eligibility:

Institutions, organizations, and/or physician group applying for the Minority-Based CCOP award must document that at least 40 percent of their newly diagnosed cancer patients are from minority populations. Other eligibility requirements for new applications and currently funded Minority-Based CCOPs are described below.

An application may be submitted by a community institution defined as a hospital, clinic, group of practicing physicians, health maintenance organization (HMO), or consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a PI and a single administrative focus.
A university hospital that is the major teaching institution for that university AND which has greater than 40 percent of its new cancer patients from minority populations is eligible to apply.
A military treatment facility (MTF) or Veterans Administration (VA) hospital may be included in an application as a non-dominant member of a consortium led by a community institution.
Funded cooperative group affiliate program participants are eligible to apply, but should state in the application that support through this mechanism will be relinquished if a Minority-Based CCOP award is received.
An unfunded non-university clinical trials cooperative group member is eligible to apply.
Funded Community Clinical Oncology Program (CCOP) participants are eligible to apply for renewal, but should state in the application that the current CCOP support will be relinquished if a Minority-Based CCOP award is received.

Institutions and organizations not eligible to apply as a Minority-Based CCOP include:

An NCI Cancer Center holding an NCI Cancer Center Support core grant and a clinical trials cooperative group U10 award funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI;
A university hospital clinical trials cooperative group member funded by a U10 cooperative agreement award through the Division of Cancer Treatment and Diagnosis (DCTD), NCI.

1.B. Eligible Individuals

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.

2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo -- Telephone: (301) 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 most 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 on line 2 of the face page of the application form and the YES box must be checked.

A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

A suggested format ( Suggestions for Organizing Information for a Minority-Based CCOP Application ) is available at http://cancer.gov/prevention/ccop/. All applications are encouraged to use the suggested format instructions and tables for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. Tables should be part of the body of the application (and counted toward the page limit if included in appropriate sections of the Research Plan). Some tables may also be included as part of the Resources, Progress Report and/or Human Subjects Research sections, as appropriate. Do not include the tables in the appendix.

Note: A part of the standard PHS 398 Research Plan (Sections A-D) is substituted with new Sections 1-8 with altered page limits as indicated below. Other sections of the PHS 398 Research Plan (Sections E-L) remain unmodified.

Form and Content of Application

For Minority-Based CCOP applications submitted in response to this RFA, the standard PHS 398 Research Plan (Sections A-D) is altered as follows:

The number of pages has been increased from 25 to 50 pages (applicants are encouraged to use the minimum number of pages necessary to clearly and succinctly describe the research plan); and
The 50 pages (or fewer if possible) should be apportioned as desired by the applicant to cover new Sections 1- 8, as outlined below.

Research Plan for Minority-Based CCOP Applications must contain the following Sections:

Section 1: Progress Report. An application from a currently funded Minority-Based CCOP group (a renewal application) must include a progress report (NOTE: new Minority-Based CCOP group applicants should insert Not applicable in this section), which, at a minimum, consists of:

A summary of Minority-Based CCOP group activities and accomplishments, including annual accrual data over the funding period;
An evaluation of Minority-Based CCOP group performance by affiliated CCOP Research Base(s); and
A complete description of how the applicant group has met the special cooperative agreement terms and conditions of the award (see 2.A. Cooperative Agreement Terms and Conditions of Award).

Section 2: Access to Minority Populations. Applicants must describe their experience with serving minority populations and demonstrate access to a population in which 40 percent or more of new cancer patients are from minority groups. The application must include plans for recruiting and maintaining women and minority participants to clinical trials. The dominant pattern of care of minorities in the community must be described as well as plans to facilitate the recruitment to cancer prevention/control and treatment clinical trials. The application must describe the existing (and potentially available for enrollment) pools of individuals at high risk of developing cancer. Data from hospital registries (analytic cases), admission, discharge, clinic, and billing records may be used to document the new minority cancer patient population available to the applicant organization AND its physician participants. In describing the study population, a breakdown, by percentage of the gender and minority composition, must be provided.

Section 3: Catchment Area. Each application must delineate its catchment area. A map of the service area should be provided, designating counties or zip codes from which approximately 80 percent of the patients/participants will be drawn. A description of other cancer-care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. The application should describe the minority population’s experience with clinical trial exposure (e.g., cardiovascular trials, screening trials, other). The application should provide a plan to address the needs and/or gaps of the population’s knowledge of cancer prevention/control clinical trials to facilitate implementation of CCOP Research Base trials.

Section 4: Accrual Requirements. Each application must include plans and supporting evidence that the applicant group can meet or exceed the minimum accrual requirements to cancer prevention/control trials. Strategy for implementing the trials and facilitating accrual should also be described. Plans must list estimated accrual to specified NCI-approved trials.

The following quotas and conditions apply for renewal and new application requirements:

Renewal applications - the MB-CCOP group must accrue at least 50 participants/patients to cancer prevention/control annually. Plans must be described how the MB-CCOP will continue to accrue 50 new participants/patients to cancer prevention/control annually (with exceptions noted below), including plans for follow-up of participants from the large prevention trials.
New applications must demonstrate the potential of the proposed Minority-Based CCOP group to accrue 30 patients/participants in the first year, 40 patients/participants in the second year and 50 patients/participants in the third year.
The quotas of newly accrued participants may be, in part, fulfilled by listing active follow-up of participants previously accrued to multi-year chemoprevention trials. For purposes of meeting accrual targets; however, ten participants in active follow-up are needed to substitute for three participants enrolled in cancer prevention/control trials.
The accrual quotas may be waived for applicants whose specialty is pediatrics and who are able to enroll a majority of their eligible patients on cancer prevention/control clinical trials.

Each application must include plans for meeting or increasing accrual requirements to cancer treatment trials. This requirement may be waived for those applications whose specialty is pediatrics and are able to enroll a majority of their eligible patients/participants on prevention/control clinical trials or applications that have an outstanding record of accrual to prevention/control clinical trials. Plans should include a list of estimated accrual to specified NCI-approved trials together with a strategy for implementing the trials and facilitating accrual. Applications should include evidence that the Minority-Based CCOP can meet or exceed the requirement that it accrue 50 new patients to cancer treatment annually. Plans for recruiting women and minority populations must be described.

A new Minority-Based CCOP application must provide implementation plans for at least two NCI-approved cancer prevention/control clinical trials that use an intervention, such as a trial of a chemopreventive agent or a trial to study an intervention/agent for the treatment of a cancer symptom. The application should include specifics on patient/participant recruitment, compliance and follow-up. The clinical trials selected must come from Research Bases with which the applicant propose to affiliate (see Section 6 below).

Section 5: Team Organization and Qualifications. A designated Principal Investigator (PI) is required. An Associate PI should be named to assure continuity in the event of resignation of the PI. The qualifications and experience of both must be described, specifically documenting their ability to organize and manage a community oncology program that includes cancer prevention/control/treatment clinical trials and related activities, as well as experience in accruing patients/participants to clinical trials.

Each application should propose a committed multi-disciplinary professional group appropriate for its expected clinical trial participation. This team should include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. Where appropriate, each applicant should include plans to utilize minority health professionals to assure accrual success. The training and experience of participating physicians who are in the top 25 percent of the Minority-Based CCOP group’s highest accruing physicians must be described.

The application should include a description of planned organizational structure and procedures for implementing workflow in the Minority-Based CCOP. Details should be provided on any prior experience working together as a group, particularly in implementing cancer prevention/control/ treatment clinical trials and related activities. An organizational chart showing how the group will function must be included.

Institutional support for recruiting minorities to clinical trials should be described and appropriate documentation of such support should be included in the application [e.g. letters of support from the chair(s) of the institution’s medical specialties and/or clinics (include under the Resources section)]. Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials should be described.

Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position.

Section 6: Affiliations with CCOP Research Bases. Each Minority-Based CCOP application must demonstrate access to cancer prevention/control/treatment clinical trials.

Such access must be documented through formal affiliations with CCOP Research Bases. Multiple Research Base affiliations are permitted, in the following configuration:

only one NCI-approved multi-specialty cooperative group (except for Minority-Based CCOPs participating in NCI pilot project); and
as many other Research Bases (excluding the multi-specialty groups) as the Minority-Based CCOP group deems appropriate.

Typically, an established Minority-Based CCOP affiliates with approximately four to six Research Bases in addition to its multi-specialty cooperative group so that the Minority-Based CCOP has access to an adequate selection of clinical trials to meet and exceed accrual goals.

Existing or planned affiliations with each specific CCOP Research Base must be justified in terms of the scope and breadth of research that the applicants anticipate undertaking. The conditions of affiliation must be provided in the CCOP-Research Base affiliation agreement(s). Copies of these agreements should be included with the Minority-Based CCOP application (include in Resources section). If applicable, the contributions of investigators from a Minority-Based CCOP group and their key personnel to the infrastructure of the affiliated CCOP Research Bases may be described. Such contributions may involve, for example, participation/membership in CCOP Research Base committees, serving as chair(s) of cancer clinical trials, and authorship of joint publications.

Note: A list of currently eligible CCOP Research Bases may be obtained at http://cancer.gov/prevention/ccop or from the Community Oncology and Prevention Trials Research Group, DCP, NCI, at (301) 496-8541.

Section 7: Quality Assurance and Investigational Drug Management

Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the Minority-Based CCOP and its Research Base(s). Quality control procedures of the CCOP Research Base will be applied to the awarded Minority-Based CCOP groups and should be specified in the affiliation agreement. In addition, procedures for investigational drug monitoring and data management must also be described.

Section 8: Facilities and Institutional Commitment

The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. The level of commitment should be discussed in the Research Plan and the documentation provided in the Resources section. In addition, each applicant must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. The description of this space may be provided in the Resources section.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

For details on what items are generally allowed as Appendix materials, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

At the end of the entire application, include a List of Appendix Materials. However, do not attach Appendix materials to the application. These materials must be submitted in pdf format, see Section IV. 3.B. Sending an Application to the NIH).

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): June 18, 2007
Application Receipt Date(s): July 18, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): June 2008

3.A.1. Letter of Intent

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

Descriptive title of proposed research;
Name, address, and telephone number of the PI;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Worta McCaskill-Stevens, M.D., M.S.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2017, MSC 7340
Bethesda, MD 20892-7340 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 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 paper copies of the application and one copy of the appendix material in paper or in pdf format (pdf format encouraged) 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 express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

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 for 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

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 the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Restrictions for Minority-Based CCOP Applications

Allowable budget items include: requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials will be considered. Funding is not allowed for clinical care provided to patients (e.g., for patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, and dosimetrist). Physician compensation is only an allowable cost for the PI (PI) and Associate PI, specifically for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested.

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.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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 expects that grant 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.

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

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

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

Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are 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, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score;
Receive a written critique; and
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.

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, well reasoned, 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, 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 principal investigator 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 studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In additional to the standard NIH review criteria identified above, reviewers will be asked to comment on the following criteria in order to judge the likelihood that the proposed research program will be successful in 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 deserve a high priority score.

Applicants will be evaluated on the following criteria:

1. Progress Report (for renewal applications only).

Does the Minority-Based CCOP group meet or exceed accrual requirements for prevention/control and treatment trials, and does the trend in accrual over the funding period provide evidence for continuing accrual at these levels during the upcoming funding period?

Are plans for the follow-up of participants enrolled on the large-scale prevention trials (e.g., STAR, SELECT) described and are the plans adequate?

Does the progress report include the performance evaluations of the Minority-Based CCOP group by the affiliated Research Bases?

2. Access to Minority Populations

Is a breakdown by gender and minority of the proposed study population clearly presented in the application?

Have the applicants demonstrated access to a population in which 40 percent or more of the new cancer patients are from minority populations?

Are the plans for recruiting women and minorities to cancer clinical trials appropriate and described adequately?

Has the application assessed existing pools of individuals at high risk of cancer in the proposed catchment area?

3. Catchment Area

Does the application adequately describe the catchment area and the study population in this area? Is a map of the service area provided?

Are other cancer care resources in the service area, that are not a part of the application, described?

Is the exposure/involvement in clinical trials of the minority population in the catchment area adequately described?

Does the application describe a plan to address needs and/or gaps in knowledge relative to the participation of the minority population in prevention/control clinical trials?

4. Accrual Requirements

For all CCOP group applications:

Does the application demonstrate the ability to successfully meet or exceed the minimum accrual goals (i.e., at least 50 accruals to treatment trials and 50 accruals to prevention/control trials)?

In addition, for new CCOP group applications:

Does the application demonstrate a plan for opening trials and accessing appropriate participants/patients to consistently meet or exceed the annual minimum accrual goal to NCI-approved treatment clinical trials (i.e., 50 patients) and prevention/control clinical trials (i.e., 30, 40, and 50 participants in year-1, year-2, and year-3, respectively)?

Does the application already demonstrate a level of accrual to NCI-approved treatment and prevention/control clinical trials that provides evidence that it will meet or exceed minimal accrual goals?

Do the plans for implementing at least two NCI approved cancer prevention/control trials demonstrate the Minority-Based CCOP group s ability to participate successfully to Research Base trials, as indicated by the proposed operations for identifying and accruing participants/patients in the Minoroty-Based CCOP components, and managing the data?

In addition, for renewal CCOP applications:

Does the application demonstrate a successful past history of accrual to NCI-approved treatment and prevention/control clinical trials, as demonstrated by exceeding the minimum (i.e., at least 50 accruals to treatment trials and 50 accruals to prevention/control trials)?

If the application describes participation in only pediatric oncology clinical trials, does the application show accrual of a majority of the eligible patients even if the minimum accrual requirements are not met?

Does the application demonstrate outstanding accrual to cancer prevention/control clinical trials even without meeting the minimum accrual goals for cancer treatment trials?

5. Team Organization and Qualifications

Are the qualifications, training, and experience of the PI/associate PI appropriate for organizing and managing a community oncology clinical research program that includes accrual to NCI approved treatment and prevention/control clinical trials as well as related activities?

Does the applicant document availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, gastroenterology, pathology, internal medicine, family practice, nursing, and nutrition) for multidisciplinary clinical trials?

Is the overall structure of the applicant organization stable? Does the application demonstrate institutional support for ongoing accrual to cancer clinical trials, including explicitly, support for recruitment of minority individuals?

Is there evidence of previous success in collaborating as a group?

Does the proposed organizational structure demonstrate previous success in implementing cancer treatment and prevention/control clinical research and related activities?

6. Affiliations with CCOP Research Bases

Has the applicant demonstrated affiliation of the Minority-Based CCOP group with CCOP Research Bases to ensure access to an adequate selection of clinical trials needed to meet or exceed the accrual requirements and provide an appropriate menu of trials to the participants/patients in their catchment area?

Are the proper affiliation agreements and appropriate Research Base evaluations provided in the application?

Has the Minority-Based CCOP group demonstrated contributions by its team to the overall structure of one or more of its affiliated CCOP Research Bases, by committee participation, serving as committee chairs and/or chairs of cancer clinical trials, and by authorship in joint publications?

7. Quality Assurance and Investigational Drug Management

Has the application demonstrated appropriate and adequate mechanisms for quality assurance for both cancer treatment and prevention/control clinical trials?

Does the application demonstrate, through audit reports and otherwise [e.g., by providing CCOP Research Base evaluation(s)], appropriate and adequate procedures for investigational drug monitoring and data management and identification of false or otherwise unreliable data?

If data irregularities have occurred, has the application demonstrated appropriate and adequate resolutions of the issues and put an appropriate corrective action in place?

8. Facilities and Institutional Commitment

Are the available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., adequate to support the research activities?

Is there adequate and appropriate space for administrative activities and personnel?

2.A. Additional Review Criteria:

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 NCI Program staff through an administrative review of the plan. 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 (http://grants.nih.gov/grants/policy/data_sharing).

2.D. Sharing Research Resources

NIH policy expects that grant 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

Applicants will be notified about the disposition of their applications once the National Cancer Advisory Board completes its second level of review of the applications. Applicants can expect notification in March of 2008.

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 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 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 (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Minority-Based CCOP Awardee Responsibilities (including PI Responsibilities)

Throughout these Terms and Conditions of Award, Minority-Based CCOP awardee refers to the organizational structure which is composed of the key personnel (including the designated accruing physicians) and the institutions/organizations of the performance sites, including those designated as affiliates and CCOP components, all of whom agree to collaborate on research goals of the NCI Minority-Based Community Clinical Oncology Program.

The following documents (and any subsequent modification to them) are hereby incorporated by reference as terms of award. These documents describe the programmatic responsibilities for the conduct of the research supported by this cooperative agreement.

INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment and Diagnosis, (DCTD), National Cancer Institute (http://ctep.cancer.gov/handbook/);

GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES and THE CANCER TRIALS SUPPORT UNIT (CTSU) (http://cancer.gov/monitoring/guidelines.html);

Intellectual Property Option to Collaborator (http://cancer.gov/industry/ipo.html).

Specific Responsibilities of the Minority-Based CCOP PI

Oversees the implementation of the Clinical Trials across the Minority-Based CCOP awardee.
Assures that all Human Subjects Requirements are met by all accruing physicians.
Ensures appropriate Quality Assurance/Quality Control is in place for complete and accurate data collection.
Submits quarterly accrual reports in a standard format as described at http://www.cancer.gov/prevention/ccop/resources.html
Submits annual Progress Report PHS 2590 to the NCI Program Official.
Attends periodic NCI strategy meetings and meetings of affiliated CCOP Research Bases.
Reports any findings of suspicious or suggestions of intentional misrepresentations of data to the NCI Program official and the Research Base PI.

Clinical Trials Appropriate to Meet the Accrual Requirements

To receive credit for accruals the Minority-Based CCOP awardee must access NCI-approved treatment and prevention/control clinical trials through the CCOP Research Bases with which it has affiliation agreements. The Minority-Based CCOP awardee also may access treatment trials from CCOP Research Bases with which it is not affiliated through the NCI s Cancer Trials Support Unit (CTSU). For accruals to CTSU clinical trials, Minority-Based CCOP awardee will receive credits (towards the required accrual quotas) and not per case reimbursement.

All clinical trials originating at the CCOP Research Bases must be reviewed and approved by the Protocol Review Committee of the Division of Cancer Prevention (DCP) or the Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation.

Affiliations of Minority Based CCOP Awardees with Research Bases

Each Minority-Based CCOP awardee must affiliate with one national multi-specialty cooperative group having a spectrum of cancer treatment and prevention/control clinical trials. As an exception, CCOP awardees may be granted permission to affiliate with more than one multi-specialty group, if the CCOP awardee participates in NCI-sponsored pilot projects. In addition, each Minority-Based CCOP may affiliate with as many other Research Bases, exclusive of the multi-specialty groups, as the Minority-Based CCOP deems appropriate.

Typically, an established Minority-Based CCOP is expected to affiliate with approximately four to six CCOP Research Bases, in addition to its multi-specialty cooperative group. Through these affiliations the Minority-Based CCCOP awardee must ensure access to an adequate selection of clinical trials for its patient population and to meet or exceed the minimum accrual requirements.

If participation in the clinical trials of one CCOP Research Base competes with that of another CCOP Research Base with which the Minority-Based CCOP is affiliated, the Minority-Based CCOP must prioritize the clinical trials to avoid bias in the allocation of participants/patients to competing clinical trials.

Note: A list of eligible Research Bases may be obtained from http://cancer.gov/prevention/ccop/rbccop.html or by contacting the Community Oncology and Prevention Trials Research Group (COPTRG), DCP, NCI, at (301) 496-8541.

When circumstances require changes in Research Base affiliations, prior written approval from the DCP Program Director is required. The Guidelines for Obtaining Approval of CCOP Organizational Changes is available at http://cancer.gov/prevention/ccop/guidelines.html.

Accrual Requirements

Each Minority-Based CCOP awardee must accrue a minimum of 50 participants/patients per year to cancer prevention/control clinical trials (except for Type 1 funded applications which must meet the incremental requirements of 30, 40 and 50 during the initial 3 years). The quotas of newly accrued participants may be, in part, fulfilled by listing active follow-up of participants previously accrued to multi-year chemoprevention trials. For purposes of meeting accrual targets; however, ten participants in active follow-up are needed to substitute for three participants enrolled on cancer prevention/control trials. The minimum for cancer prevention/control accruals may be waived for applicants whose specialty is pediatrics and who are able to enroll a majority of their eligible participants/patients on cancer prevention/control trials.

Each Minority-Based CCOP awardee must accrue a minimum of 50 participants/patients per year to treatment clinical trials. The minimum of 50 treatment participants/patients may be waived in case of:

Minority-Based CCOP awardees participating only in pediatric cancer clinical trials and able to enroll a majority of their eligible participants/patients on trial;
and/or
Minority-Based CCOP awardees with an outstanding record in accrual to cancer prevention/control trials.

Quality Control

In accordance with CCOP Research Base guidelines and NCI policies, the Minority-Based CCOP must establish and follow procedures for the assurance of data quality and for the prevention and/or identification of false or otherwise unreliable data. The Minority-Based CCOP must follow policies developed by the CCOP Research Bases with which they are affiliated. Any data irregularities identified through quality control procedures or through the audit program that raise the suspicion of intentional misrepresentation of data must be reported to the DCP/NCI Program Director within 24 hours. COPTRG must be notified by telephone (301-496-8541) of any findings suspicious or suggestive of intentional misrepresentation of data and/or disregard of regulatory safeguards for any of the three components (regulatory, pharmacy, and patient care) within an audit. It should be emphasized that a reasonable level of suspicion is sufficient to warrant notification to NCI of irregularity and/or misrepresentation.

Data Management

The Minority-Based CCOP awardee must provide the DCP Program Director with access to all data generated under this award for periodic review of data management procedures of the Minority-Based CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data.

Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. Specifically, all Minority-Based CCOP investigators accruing participants/patients must have an active FDA Form 1572 on file with the Pharmaceutical Management Branch, CTEP, DCTD, NCI.

Monitoring

Each Minority-Based CCOP must agree to periodic on-site audits by representatives of its CCOP Research Base(s), NCI, or an NCI-designee. Such on-site audits may include reviews of the following:

use of investigational drugs;
compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46);
compliance with clinical trial specifications;
quality control and accuracy of data recording; and/or
completeness of reporting adverse drug reactions.

The performance sites designated as affiliates or components and the individual accruing investigators participating or collaborating with the Minority-Based CCOP awardee must be in compliance with the monitoring standards established by the CCOP Research Base(s) and stated in the NCI GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, and THE CANCER TRIALS SUPPORT UNIT (CTSU) (http://cancer.gov/monitoring/guidelines.html). Sites found not to be in compliance with the NCI monitoring guidelines may be suspended from participating in Research Base trials until compliance can be confirmed by NCI/CTMB.

Specifically, the sites should include the following standards:

Medical records submitted in support of NCI multi-institutional trials must conform to usual standards for the maintenance of clear, accurate, and unambiguous medical records. White-out corrections on medical records are unacceptable;
If it is the usual and customary practice of a department, laboratory, clinic, or office to prepare or issue official reports, then only that department, laboratory, clinic, or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations (for clinical progress notes, the change must be dated and initialed by the person making the change, and only one line should be placed through the initial entry, so that both the original entry and the change are legible);
Improper modification of important participant/patient records will result in additional investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding.

Radiotherapy Equipment

Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in clinical trials requiring radiation therapy, as required by the affiliated Research Base(s).

Organizational Changes

Certain organizational changes in the structure of a Minority-Based CCOP awardee must have the prior written approval of the DCP Program Director. These changes include the addition/deletion of a participating physician, a health professional other than a physician (who is active in enrolling participants/patients to cancer prevention and control trials), an affiliate, a component, or a Research Base affiliation. The Guidelines for Obtaining Approval of CCOP Organizational Changes is available at the URL address: http://cancer.gov/prevention/ccop/guidelines.html.

Network Participation

Minority-Based CCOP groups are part of a national network for conducting cancer prevention/control and treatment clinical trials. As such, each Minority-Based CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community.

Logging Patients/Participants

Each Minority-Based CCOP may be asked to maintain a new patient/participant log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/participant pool seen by the Minority-Based CCOP investigators.

Federally Mandated Requirements

Each Minority-Based CCOP awardee must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. Appropriate documentation must be available for review. At a minimum, these requirements include:

Current and approved Federal Wide Assurance (FWA) is on file with the Office of Human Research Protection (OHRP) for each facility in which CCOP investigators are conducting clinical trials;
Each and every clinical trial is reviewed by the responsible IRB prior to participant/patient entry;
Each and every clinical trial is reviewed annually by the IRB as long as the protocol is active;
Every participant/patient (or participant s/patient's parent/legal guardian) gives fully informed written consent to participation in a clinical trial prior to the initiation of the experimental intervention;
Timely reporting of all serious and unexpected toxicities to the appropriate sponsor to include Investigational Drug Branch, CTEP, DCTD, according to DCTD guidelines and/or to DCP according to DCP guidelines;
Implementation of DCP/DCTD requirements for storage and accounting for investigational agents provided under DCP/DCTD sponsorship; and
Education on the protection of human research participants for all investigators involved in the design or conduct of research involving human subjects.

For other federally mandated requirements see the following Federal citations:

Human Subjects Protection (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm);
Data and Safety Monitoring Plan (http://grants.nih.gov/grants/guide/notice-files/not98-084.html);
Sharing Research Data (http://grants.nih.gov/grants/policy/data_sharing);
Access to Research Data through the Freedom of Information Act (http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm;
Inclusion of Women And Minorities in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html) and http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm;
Inclusion of Children as Participants in Clinical Research (http://grants.nih.gov/grants/funding/children/children.htm). ;
Required Education on the Protection of Human Subject Participants http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html);
NIH Public Access Policy (http://www.nihms.nih.gov, http://publicaccess.nih.gov/ and http://publicaccess.nih.gov/publicaccess_Manual.htm);
Standards for Privacy of Individually Identifiable Health Information (http://www.hhs.gov/ocr/ and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html
Healthy People 2010 (http://www.health.gov/healthypeople);
Authority and Regulations (http://www.cfda.gov/ and http://grants.nih.gov/grants/policy/policy.htm).

Publications

Timely publication of major findings is encouraged. Publications or oral presentations of work conducted under this cooperative agreement require proper acknowledgment of NCI support.

NOTE: The responsibilities of Research Base Awardees and PIs are defined under the parallel FOA Community Clinical Oncology Program (U10) (RFA-CA-07-048, http://grants.nih.gov/guide/rfa-files/RFA-CA-07-048.html) that solicits Research Base applications.

2.A.2. NIH Responsibilities

A National Cancer Institute (NCI)/Division of Cancer Prevention (DCP) Program Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Additionally, an NCI Program Director/Program Official will also be assigned for each award and named in the award notice, and will be responsible for the normal scientific and programmatic stewardship for the award. The Program Director/Program Official may serve as the designated Program Scientist.

The Program Scientist or Program Director will designate other NCI staff that will have substantial involvement as described below.

Review of Clinical Trials in CCOP Network

DCP and/or DCTD Program officials must review and approve any clinical trial for which a Minority-Based CCOP may claim credit.

Monitoring, Investigational Drug and Data Management

NCI, or an NCI-designee will conduct periodic on-site audits
A DCP and/or CTMB/CTEP official will review and advise on mechanisms for monitoring, including the on-site auditing program.
DCP/CTEP or its designee may attend the on-site audits conducted by the Research Base
The DCP Program Scientist will have access to all data generated under this award and will periodically review the data management procedures of the Minority-Based CCOP.
RAB/PMB/CTEP/DCTD and COPTRG/CADRG/DCP, will advise investigators of specific requirements and updates in requirements about investigational drug management that the FDA and NCI may mandate.

Organizational Changes

The NCI Program Director will review organizational change request and provide a written response. Organizational changes requiring NCI approval are outlined in The Guidelines for Obtaining Approval of CCOP Organizational Changes, available at: http://cancer.gov/prevention/ccop.

Program Review and Federally Mandated Requirements

The NCI Program Director will provide a suggested format for the Minority-Based CCOP’s initial and renewal application as well as the annual report (PHS 2590)
The review of each CCOP awardee by the DCP/NCI Program Director will include the following:
A review of the Minority-Based CCOP annual report with follow up of problems noted and recommendations for improvement;
Periodic site visits;
Review of the evaluations of the Minority-Based CCOP by affiliated CCOP Research Bases;
Adjust funding annually based on planned scope of work and availability of funding;
The NCI Program may adjust funding, withhold support, suspend or terminate the award, if the Minority-Based CCOP fails to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, the level of performance changes dramatically; and
NCI Program Director and DCTD staff members review mechanisms established by each Minority-Based CCOP to meet the Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents.

2.A.3. Collaborative Responsibilities

Execution of this program will require collaboration among the PIs of the Minority-Based CCOP awardee and the DCP Program Scientists(s) and staff as well as CTEP/DCTD/NCI Program officials and staff, and/or its designees/contractors as described above.

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. The panel will be composed of one member of the recipient group, one NCI 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.

Minority-Based CCOP awardees will report their cumulative accrual to NCI-approved clinical trials at 6 months, 9 months (included in the non-competing grant progress report, see below), and 12 months for each budget period.

A suggested format for Minority-Based CCOP specific information relative to the progress summary section of the PHS Form 2590 will be provided. The format is available at http://cancer.gov/prevention/ccop/.

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:

Worta McCaskill-Stevens, M.D., M.S.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2017, MSC 7340
B ethesda, MD 20892-7340 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8541
FAX: (301) 496-8667
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 express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

3. Financial or Grants Management Contacts:

Kathryn Dunn
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 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: 301-846-6829
Fax: 301-846-5720
Email: [email protected]

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 PA 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 clinical trials 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. 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 RFA 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 No. 93.399 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 two years to the research. For further information, please see: http://www.lrp.nih.gov.