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Part I Overview Information

Department of Health and Human Services

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

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

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

Announcement Type
This funding opportunity announcement (FOA) is a re-issue of RFA-CA-08-016.

Request For Applications (RFA) Number: RFA-CA-09-023

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates
Release Date: May 1, 2009
Letters of Intent Receipt Date: June 8, 2009
Application Receipt Date: July 8, 2009
Peer Review Date(s): November-December 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: June 1, 2010
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: July 9, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

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 overall mortality. However, minorities are underrepresented in NCI sponsored clinical trials. 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://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group);the Cancer Centers Program (http://cancercenters.cancer.gov); and the Community Clinical Oncology Program (CCOP)(http://prevention.cancer.gov/programs-resources/programs/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 first approved in January 1989. In 2008, there were 13 Minority-Based CCOPs in 10 states and Puerto Rico. Approximately 55 hospitals and over 475 physicians, including over 100 minority investigators, participated in the activities of these Minority-Based CCOPs in 2008. Over the last decade, more than 6,850 minorities have enrolled in treatment and prevention clinical trials sponsored by NCI through the Minority-Based network. Several years ago, 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-09-022, http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-09-022).

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 U10 cooperative agreement award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

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

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

NCI has determined that there is a continuing need for community participation in cancer clinical trials that cover both cancer prevention/control and treatment. While this FOA is a one-time issuance, it is expected that a Minority-Based CCOP RFA will be published in the NIH Guide for Grants and Contracts on an annual basis using the U10 cooperative agreement award mechanism, provided that funds are available.

2. Funds Available

The estimated amount of funds available for support of approximately 7 projects awarded as a result of this announcement is $4.3 million for fiscal year 2010. Future year amounts will depend on annual appropriations.

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

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

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

Section III. Eligibility Information

1. Eligible Applicants

1. A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1. B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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.

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

Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals: Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

The exceptions from the PHS398 instructions and detailed information on the application structure and components are provided in Section IV.6. Other Submission Requirements. All applicants must follow the specific instructions in that section.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: June 8, 2009
Application Receipt Date: July 8, 2009
Peer Review Date(s): November-December 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: June 1, 2010

3. A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Worta McCaskill-Stevens, MD, MS
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 2017
Bethesda, MD 20892
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 forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard
Room 8041 , MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-U.S.P.S. delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

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). For MBCCOP Groups that consistently accrue 250 or more patients annually to cancer treatment trials, use of grant funding to cover handling of investigational drugs will be considered. 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 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

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Research Plan Page Limitations (See details below)

Applicants are allowed 25 to 50 pages for the research plan portion of the application (applicants are encouraged to use the minimum number of pages necessary to clearly and succinctly describe the research plan).

Application Structure

A suggested application format is available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply. All applicants 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 (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Content) is substituted with Sections 1-8 with altered page limits as indicated below. Other items of the PHS 398 Research Plan remain unmodified.

Content and Form of MBCCOP Application

For Minority-Based CCOP applications submitted in response to this FOA, the standard PHS 398 Research Plan (Items 2-5) is altered as follows:

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.

The progress report should, at a minimum, consists of:

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. In addition, provide an estimate of the oncologists (i.e., percent) in the service that will participate in the Minority-Based CCOP. 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 by participating physicians (current or proposed). A narrative explanation pertinent to the estimated accrual may be provided.

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

Each applicant must describe, in detail, two examples of NCI-approved cancer prevention and/or control clinical trials it intends to use from the CCOP Group’s affiliated Research Base(s).

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 by participating physicians (current or proposed). A narrative explanation pertinent to the estimated accrual may be provided including 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. In addition, provide statistics on the numbers of patients on treatment trials who are still being followed per protocol requirements. 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 chemo-preventive 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 proposes 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. In addition, describe the plans for communication among physicians and component/affiliate institutions and incentives for participation in clinical trial accrual. 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. If the CCOP has more than one component/affiliate institution, describe the relationship of component(s)/affiliate(s) to each other and to the CCOP headquarters. Include a diagram showing the distance between these institutions (including administrative office and shared resources) and location of proposed personnel. 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

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.

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:

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 should 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://prevention.cancer.gov/programs-resources/programs/ccop/rbccop or from the Community Oncology and Prevention Trials Research Group, DCP, NCI, at (301) 496-8541.

Section 7: Quality Assurance and Investigational Drug Management

The internal quality control procedures of the MBCCOP 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 data management and investigational drug monitoring must be described in the application. For data management procedures, include details on who is responsibility for data management overall; what is the source of records (e.g., hospital, office, clinic, registry); who will register patients on trials; how will the information flow (provide flow chart); who will enter data on primary patient records and study forms (e.g., nurses, physicians, data managers, secretaries); who will collect and send patient materials (e.g., pathology slides, port films, etc.) to the Research Bases if required; what records (study flow sheets, reminder slips) will be included on patient charts; how will data be transmitted (e.g. batch mode or as real-time); and are there mechanisms in place for electronic data transfer. In addition, describe data management operations within and between components/affiliates and the central CCOP office, if applicable. Describe how NCI and Food and Drug Administration requirements for investigational drug management will be handled.

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

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

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

Resource Sharing Plan(s)

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

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

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

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

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

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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

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

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the 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?

Has the Minority-Based CCOP Group been properly evaluated by the affiliated Research Bases and how well was its performance rated?

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 Minority-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?

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

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

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

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

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

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

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

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2. A. Cooperative Agreement Terms and Conditions of Award

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

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

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/investigatorResources/investigators_handbook.htm);

GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, and THE CANCER TRIALS SUPPORT UNIT (CTSU) (http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm); and

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

Specific Responsibilities of the Minority-Based CCOP 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://prevention.cancer.gov/programs-resources/programs/ccop/rbccop

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 Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource

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:

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:

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://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm). 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:

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 Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource.

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:

For other Federally mandated requirements see the following Federal citations:

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. See the NIH Public Access Policy for specific requirements.

NOTE: The responsibilities of Research Base Awardees and PIs are defined under the parallel FOA Community Clinical Oncology Program (U10) (RFA-CA-09-022,) that solicits Research Base applications.

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

2. A.2. NIH Responsibilities

A National Cancer Institute (NCI) Division of Cancer Prevention (DCP) Program staff member(s) acting as a Project Scientist(s) or Project Coordinator(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (e.g., in the role of Project Coordinators). The NCI Project Scientist(s)/Coordinator(s) will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

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

The main NCI responsibilities pertinent to the Minority-Based CCOP awards include the following activities.

Review of Clinical Trials in CCOP Network

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

Monitoring, Investigational Drug and Data Management

Approval of Organizational Changes

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

Program Review and Federally Mandated Requirements


2. A.3. Collaborative Responsibilities (optional)

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

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's rights in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Reporting by Minority-Based CCOP group awardees

CCOP group awardees will report their cumulative accrual to NCI-approved clinical trials at 6 months, 9 months (included in the annual progress report), and 12 months for each budget period.

A suggested format for CCOP specific information relative to the progress summary section of the PHS Form 2590 will be provided. The format is available at https://ccop.nci.nih.gov/.

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

Clinical Trials Reporting Requirements

Reporting requirements (via Research Bases) will be in agreement with FDA regulations and NCI procedures. Clinical trial data entered into the NCI system will then be transferred also to the centralized registry of all clinical trials at clinicaltrial.gov.

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
Executive Plaza North, Room 2017
Bethesda, MD 20892
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 non-U.S.P.S. delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

3. Financial or Grants Management Contacts:

Sean Hine
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, Suite 300
Rockville, MD 20852
Telephone: (301) 846-1005
FAX: (301) 846-5720
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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