RFA-CA-10-011: Community Clinical Oncology Program Research Bases (U10)

Department of Health
and Human Services (HHS)

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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://www.cancer.gov/)

Title: Community Clinical Oncology Program Research Bases (U10)

Announcement Type
This funding opportunity announcement (FOA) is a re-issue of RFA-CA-09-022.

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

May 24, 2011 - This RFA has been reissued as RFA-CA-11-007.

Request For Applications (RFA) Number: RFA-CA-10-011

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

Key Dates
Release Date: July 16, 2010
Letters of Intent Receipt Date(s): August 16, 2010
Application Receipt Date: September 16, 2010
Peer Review Date: November-December 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: June 1, 2011
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 17, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This funding opportunity announcement (FOA) solicits applications from institutions/organizations that propose to serve as Research Bases for the NCI-supported Community Clinical Oncology Program (CCOP) Network. The goal for CCOP is to develop and conduct state-of-the-art cancer prevention, control, and treatment clinical trials with significant involvement of community oncologists and populations they serve. The CCOP Network consists of three components (each with its own FOA), which are: CCOP Groups (also referred to as CCOPs); Minority Based-CCOPs; and CCOP Research Bases (covered by this FOA). A CCOP Group encompasses community oncologists who accrue patients/participants to NCI-approved clinical trials. The Minority Based CCOPs are formed by oncologists in communities with a high proportion of minority patients that accrue patients/participants to NCI-approved clinical trials. These trials are designed and conducted by the CCOP Research Bases, which also manage and analyze the data, and report the results. CCOP Research Bases must be located either at an NCI-supported Clinical Cooperative Group or at an NCI-designated Cancer Center.
Mechanism of Support. This FOA will utilize the NIH U10 cooperative agreement award mechanism. Parallel FOAs (RFA-CA-10-010 and RFA-CA-10-012) solicit applications for CCOP groups and MBCCOP Groups respectively. It is imperative that CCOP Research Base applicants familiarize themselves with these parallel FOAs for Groups.
Funds Available and Anticipated Number of Awards. The NCI intends to commit up to $1.5 million in total costs in FY 2011 to fund one (1) CCOP Research Base award.
Budget and Project Period. For CCOP Research Base applications, the total project period may not exceed 5 years..
Application Research Strategy Length: The Research Strategy section may not exceed: 12 pages for Program Overview; 12 pages for Prevention and/or Control Research Program; 6 pages for Large-scale Prevention Trials (only if applicable); and 12 pages for Administrative Core, including tables, graphs, figures, diagrams, and charts (see http://grants1.nih.gov/grants/funding/funding_program.htm),
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
Number of Applications. Applicants may submit only one application in response to this FOA.
Resubmissions. Resubmission applications are not allowed except for those Research Base applications that were submitted in response to RFA-CA-09-022 and were not selected for funding. The resubmission applications must include an Introduction addressing the previous peer review critiques (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Renewals. Renewal applications are permitted in response to this FOA.
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review, and Anticipated Start Dates.
Application Materials. See Section IV.1 for application materials.
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution
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 the Community Clinical Oncology Program (CCOP) is to develop and conduct state-of-the-art cancer prevention clinical trials and control and treatment clinical trials with prominent involvement of community oncologists and the populations that they serve. The CCOP, established by the Division of Cancer Prevention, National Cancer Institute (NCI) in 1983, is a community-based clinical trials network that links community physicians, who accrue participants/patients to cancer clinical trials as part of their overall practice, with the CCOP Research Bases formed at the awardee institutions of the NCI-sponsored Clinical Trials Cooperative Groups and NCI-designated Cancer Centers.

The CCOP Network is designed to: (1) increase the involvement of community oncologists, other specialists (e.g., surgeons, family practitioners, gastroenterologists, urologists, gynecologists), and their patients in clinical trials designed by NCI Cooperative Groups and Cancer Centers; (2) involve a wider segment of the community in cancer clinical trials, including minorities, women, and other underserved (e.g., rural) populations; and (3) accelerate the transfer of knowledge gained from clinical trials to community oncology practices.

The CCOP Network consists of three types of components:

CCOP Groups (covered by RFA-CA-10-010);
Minority Based CCOPs (covered by RFA-CA-10-012); and
CCOP Research Bases (this FOA).

A CCOP Group is a consortium of community oncologists from one or more interacting community institutions that accrue patient/participants to clinical trials designed and conducted by the CCOP Research Bases. Each CCOP Group must accrue annually at least 50 patients to treatment clinical trials and at least 50 participants to prevention and control clinical trials. Equally important to accrual, CCOPs also assure the quality of the data collected and the safety of the participants/patients entered on trials.

A Minority Based CCOP Group is a consortium of oncologists from one or more interacting community institutions with at least 40% minority cancer patients that accrue patients/participants to clinical trials that are designed and conducted by the CCOP Research Bases. Each MB-CCOP must accrue annually at least 50 patients to treatment clinical trials and at least 50 participants to cancer prevention and control clinical trials. Equally important to accrual, MB-CCOPs also assure the quality of the data collected and the safety of the participants/patients entered on trials.

A CCOP Research Base designs clinical trials for use in the CCOP Network. It also conducts the clinical trials, manages and analyses the data, and reports the results. Cooperative Group CCOP Research Bases design and conduct both cancer treatment and cancer prevention and control clinical trials. Cancer Center CCOP Research Bases design and conduct only cancer prevention and control clinical trials.

This Funding Opportunity Announcement (FOA) solicits new and renewal applications for CCOP Research Bases.

Applicants for these awards must meet specific eligibility criteria defined Section III.3.

Definition: Cancer prevention/control clinical trials include clinical evaluations of: the effectiveness of interventions for the purpose of reducing the risk for developing cancer (including but not limited to chemo-preventive agents, surgical interventions, and lifestyle modification); methods for early detection of cancer and precancerous lesions; interventions to improve patients quality of life and/or to treat symptoms arising from cancer or toxicities arising from cancer therapy; and ways to improve continuing, palliative, and end-of-life care.

The research of applicants applying to this RFA must be focused on cancer prevention and/or control clinical trials, which in the CCOP Network is aimed at reducing cancer incidence, morbidity, and mortality through the identification, testing, and evaluation of interventions in cancer prevention and/or control clinical trials. The scope of the research supported by this RFA includes: the effectiveness of interventions to reduce the incidence of cancer; methods for early detection of cancer and precancerous lesions; interventions to improve patient’s quality of life and/or to treat symptoms arising from cancer itself or toxicities resulting from cancer therapy; and ways to improve continuing care, palliative care and end-of-life care.

Background

The CCOP Network was initiated in 1983 as a mechanism for including community oncologists and their patients in treatment clinical trials designed by NCI Cooperative Groups and Cancer Centers. In 1986, the Network’s focus expanded to include cancer prevention/control clinical trials research aimed at reducing cancer incidence, morbidity, and mortality through the evaluation of interventions in controlled clinical trials. Prevention and control research in the CCOP Network has increased steadily since funding began in 1987.

The CCOP Network is a vital resource for conducting NCI cancer prevention/control clinical trials because the Network provides access to: (1) cancer prevention trials; (2) large populations of cancer patients for symptom management, supportive care, and quality-of-life interventions; (3) large populations of former cancer patients and survivors who may benefit through participation in chemoprevention clinical trials; (4) cancer patients' family members and other classes of individuals who may be at increased risk of developing cancer and thus be candidates for cancer prevention and/or detection studies; and (5) geographic areas inhabited by diverse populations not always available in university or urban settings. Several large chemo-prevention trials have been implemented through the CCOP Network, among them the prostate cancer prevention trial with finasteride (PCPT), the study of tamoxifen and raloxifene in the prevention of breast cancer (STAR), and the selenium and vitamin E trial in the prevention of prostate cancer (SELECT).

In 2009, the CCOP Network consisted of 47 CCOP Groups, located in 28 states and comprising more than 340 hospitals and more than 3,000 physicians. The CCOPs enrolled approximately 6,680 patients to treatment trials and over 5,500 participants/patients to prevention and control trials. The Network also included 12 CCOP Research Bases, which conducted several hundred treatment/prevention/control trials. The MBCCOP Program consisted of 14 MBCCOP Groups, located in 11 states and Puerto Rico with more than 50 hospitals and 470 physicians. MBCCOP Groups enrolled over 1,275 patients to NCI-approved cancer clinical trials.

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

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

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

2. Funds Available

The estimated amount of funds available for support of one (1) Research Base award as a result of this announcement is $1.5 million for fiscal year 2011. Future year amounts will depend on annual appropriations.

For Research Base applications, project period proposed must not exceed 5 years.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1. A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education;
Private Institutions of Higher Education;
Hispanic-serving Institutions;
Historically Black Colleges and Universities (HBCUs);
Tribally Controlled Colleges and Universities (TCCUs);
Alaska Native and Native Hawaiian Serving Institutions;
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education);
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education);
For-Profit Organizations (Other than Small Businesses);
Indian/Native American Tribal Governments (Federally Recognized);
Indian/Native American Tribally Designated Organizations;
U.S. Territories or Possessions;
Eligible Agencies of the Federal Government; and
Faith-based or Community-based Organizations.

Within the eligible categories, only institutions that are NCI-funded Cancer Centers, NCI-funded Clinical Trials Cooperative Oncology Groups (Cooperative Groups), or existing (currently funded) CCOP Research Base(s) are eligible to apply for CCOP Research Base awards.

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.

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

For new and renewal Research Base applications, the following provisos apply:

New Applications: An application must be submitted by an NCI-funded Clinical Trials Cooperative Oncology Group (Cooperative Group) or an NCI-funded Cancer Center
Renewal Applications: CCOP Research Base awardees seeking renewal of their current awards may submit renewal applications regardless of whether the applicant institutions have maintained their NCI-Cancer Center status or Cooperative Group status;
Cooperative Groups applying for CCOP Research Base awards must propose to design and conduct both cancer treatment and prevention/control clinical trials; and
Cancer Centers applying for CCOP Research Base awards must propose to design and conduct only cancer prevention/control clinical trials.

NOTE: Institutions applying for CCOP Research Base are not eligible to apply for CCOP Group award (under RFA-CA-10-010) or MBCCOP Group award (under RFA-CA-10-012) if they are either: (1) a NCI-funded Cancer Center; or (2) a university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI.

Number of Applications: Applicants may submit only one application in response to this FOA.

Resubmissions: Resubmission applications are not allowed except from those that were submitted in response to RFA-CA-09-022 and were not selected for funding. These applications must include an Introduction addressing the previous peer review critiques (Summary Statement). See the new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

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: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

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

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.

Applications with Multiple PDs/PIs

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

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

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

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

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): August 16, 2010
Application Receipt Date: September 16, 2010
Peer Review Date: November-December 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: June 1, 2011

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(s), address(es), and telephone number(s) of the Principal Investigator(s);
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 NCI 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:

Lori Minasian, M.D.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2017, MSC 7340
Bethesda, MD 20892-7340 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: minasilo@mail.nih.gov

3. B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

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

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

3. C. Application Processing

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

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.

Resubmission applications are not allowed except for those CCOP Group applications that were submitted in response to RFA-CA-09-022 and were not selected for funding.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

Notes on Budget: Requests for funds should reflect costs associated with the design and development of cancer prevention/control clinical trials. The request should also reflect operations/statistical costs for quality control and data management costs for CCOP participation in clinical trials based on the expected accruals from affiliated CCOP/Minority-Based CCOP Groups and for member/affiliate accruals in cancer prevention and control. CCOP-Research Base affiliation agreements must be included. Each application should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee(s) for the Research Base), and for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops).

6. Other Submission Requirements

PHS398 Research Plan Sections

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

Introduction (required for a resubmission application) is limited to 1 page.
Specific Aims is limited to 1 page.
Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to: 12 pages for Program Overview; 12 pages for Prevention and/or Control Research Program; 6 pages for Large-scale Prevention Trials (only if applicable); and 12 pages for Administrative Core,. See Table of Page Limits.

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

For CCOP Research Base applications submitted in response to this FOA, the standard PHS 398 Research instructions are altered as follows:

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to include in Section 3 Research Strategy of the PHS 398 Research Plan the following new sub-sections A D:

A. Program Overview

B. Prevention and/or Control Research Program

C. Large-scale Prevention Trials (only if applicable)

D. Administrative Core.

Standardized table templates are available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply. Applicants are strongly encouraged to use templates for Tables 1 through 6 for inclusion as directed in RFA-CA-10-011.

RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:

Standard sub-sections of Section 3. Research Strategy of the PHS 398 Research Plan are replaced by the new sub-sections A D (see details below); and

The PHS 398 standard page limit for Research Plan is replaced by individual limits indicated below for the new sub-sections A D.

Other sections of the PHS 398 Research Plan remain unmodified and should be completed following standard instructions.

NOTE: An application from a currently funded CCOP Research Base (renewal application) must include a progress report under Section 3. Research Strategy, sub-section A Program Overview.

A. Program Overview (up to 12 pages)

Leadership Team

Describe qualifications and experience of a designated PD/PI (or multiple PDs/PIs if this option is used). The PD/PI may be the Chair of the Cooperative Group (for those applicants). In addition, describe the qualifications and experience of an individual designated to coordinate cancer prevention and control research. This individual must be qualified in the field of cancer prevention/control and have experience within the Research Base. Describe also the involvement of professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention/control clinical trials. Medical, surgical, radiation, and other oncology specialists, nurse oncologists, epidemiologists, statisticians, health educators, and/or other public health professionals and basic scientists may be included.

Define the proposed prevention and/or control committee(s) (or equivalents) and describe the committee(s) role in development of the Research Base’s scientific research agenda. In addition, a description of how the committee(s) functions, the composition of the committee(s), and the relationship to other clinical trial committee(s), if applicable, should be outlined. For the committees that are not yet formed, outline the type of expertise sought. However, do not provide names of any potential external candidates and do not contact them, in order not to compromise the selection of potential reviewers.

Background and Key Expertise (new applications). Describe group history and/or background in terms of cancer clinical trials experience. Succinctly describe the group’s history with the conduct of multicenter clinical trials and experience with community organizations. Describe the group’s history pertaining to the development of cancer prevention and control research with an emphasis on cancer prevention and control clinical trials.

Overall Progress (renewal applications). Succinctly describe the background and accomplishments as a funded CCOP Research Base. At a minimum, include the following:

a) A summary of CCOP Research Base activities and major accomplishments focusing on prevention/control trials opened during the past funding period (i.e., 5 years), with an emphasis on the scientific contributions and clinical significant of the completed trials.

b) Status and relevant publications for active, closed, and completed cancer prevention and control clinical trials conducted in the past funding period (i.e., 5 years).

c) Accrual to each NCI approved cancer prevention and control clinical trial during the past year to be broken down by CCOPs and MB-CCOPs and Member and Affiliates (see Table 2 under standardized template tables available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply);

d) Accrual to each NCI approved cancer treatment clinical trial during the past year (see Table 1 under standardized template tables available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply);

e) Include the patient accrual to prevention and/or control and treatment clinical trial (if applicable) by gender and ethnicity/race composition. (Use the Inclusion Enrollment Report tables. Include in section 5.5.4 Inclusion Enrollment Report.)

f) Renewal applications with currently funded prevention member(s) must describe how the prevention member(s) has contributed to the CCOP Research Base’s cancer prevention and control research focus.

g) Describe contributions of each funded prevention member (if applicable) including, but not limited to, preclinical studies in the development towards chemoprevention protocol(s), chemoprevention protocols, ancillary studies to prevention trials and other research activity relevant to the Research Base’s cancer prevention program. Include data on accruals to chemoprevention trials developed by the Research Base applicant, if applicable.

B. Cancer Prevention and Control Research Program (up to 12 pages)

Research Agenda

Applicants should articulate their vision of the prevention and/or control scientific agenda for the proposed Research Base (in the time frame of the project period, i.e., 5 years). The cancer prevention and control research agenda should be compatible with the scientific interests of the group and the expertise within the group.

The research plan should provide information on the prevention and/or control clinical trials proposed for the next project period that reflect the Research Bases overarching research agenda. Provide the underlying study hypothesis, study design, and implementation plan for each of the proposed studies.

Provide the long-term plans for the recruitment and retention of participants or patients to cancer clinical trials, including programs or plans for the recruitment and retention of minorities. For any specific programs, describe ongoing evaluations of the efforts to recruit patients/participants from underserved populations.

The CCOP Research Base applicants should demonstrate their ability to provide the CCOPs, Minority Based CCOPs and their member and affiliates with a selection of cancer prevention and control clinical trials of high scientific merit.

For existing CCOP Research Bases (renewal applications), describe how the clinical trials build upon previous trials and their results to further the overall goal of the cancer prevention and control research focus of the Research Base.

As a recommended format of information summary, applicants are strongly encouraged to use Tables 3, 4, and 5 available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply and provide a concise description of the prevention/control clinical trials currently under development (approved concepts, protocols under development), approved and active protocols and concepts in development.

In addition, a new CCOP Research Base application must provide at least two examples of active or proposed cancer prevention/control clinical trials and describe plans for study design, intervention(s), and statistical considerations; access to potential study patients/participants; and procedures for data management, quality control, and follow-up. The availability of the appropriate expertise to design, implement, and analyze the results of the proposed clinical trials must be documented.

Accrual Plans: Renewal applicants must demonstrate that the Research Base can enroll into clinical trials at least 50 participants annually from CCOPs, MB-CCOPs, and/or member/affiliate institutions to NCI-approved prevention/control clinical trials designed by the CCOP Research Base. An established Research Base is expected to have exceeded the stated minimal number of accruals and have a credible plan for maintaining or increasing accrual throughout the funding period. For Cooperative Group CCOP Research Bases, the applicant must demonstrate that the proposed Research Base can accrue at least 50 patients from CCOPs and MB-CCOPs annually to the NCI-approved treatment clinical trials designed by the CCOP Research Base. An established Research Base participating in treatment clinical trials is expected to achieve a higher number of accruals annually.

A new application must demonstrate that the proposed Research Base can develop a portfolio of treatment clinical trials (if applicable) and cancer prevention/control clinical trials to meet the accrual minimums by the end of the first competing project period. The applicant should use Tables 1 and 2 available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply to provide evidence of capability related to its previous history in accruing to cancer treatment and/or prevention and control trials.

Prevention Member(s) if applicable: The application (new or renewal) may designate selected Research Base member/affiliate institutions as Prevention Members, provided these institutions have already contributed, or are expected to contribute, in a significant way to the proposed Research Base s cancer prevention clinical research. The experience and pertinent contributions of the member/affiliate institution(s) designated Prevention Member should be described, including how the designee will contribute to cancer prevention research and the overall goal(s) of the proposed Research Base.

Examples of significant contributions might include:

Establishing community networks of non-oncology medical specialties that participate in Research Base cancer prevention protocols either by accruing to the Research Bases studies or actively developing clinical trials for that Research Base;

Member institutions that accrue large numbers of participants to the Research Base’s large-scale prevention trials and/or support disease-specific multidisciplinary prevention working group(s) that develop the relevant research agenda(s);

Conducting pilot and/or early phase I/II trials pertinent to chemo-preventive agent(s) development;

Research focused on the mechanism(s) of action of chemo-preventive agents;

Correlative studies addressing specific questions that emerge from the conduct of prevention trials; and/or

Research pertinent to recruitment and retention strategies that are relevant to prevention trials.

C. Large-scale Cancer Prevention Trials (only if applicable - up to 6 pages)

Succinctly describe the past experience with large-scale cancer prevention trials. The summary should include information regarding the successful conduct of ongoing or complete cancer prevention trials with an emphasis on the scientific contributions of the trial(s). If the clinical trials are completed, describe research results, the clinical significance, and the availability of resources (e.g., specimen repository) to the extramural research community. If the clinical trials are ongoing, the applicants should include a summary that outlines the major milestones during the past funding period. In addition, provide information as outlined in Table 6 available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply regarding the on-site activities associated with the trial(s).

D. Administrative Core (up to 12 pages)

Organizational Structure: The application must describe the organizational structure for the development and conduct of clinical trials. This description should be limited to the structure in place for the development of cancer prevention and control clinical trials only.

Appropriate personnel must be included to assure the timely design, development, conduct, analysis, and reporting of cancer prevention/control clinical trials. Include an organizational chart and a description of the Research Base operations showing the relationship(s) between the scientific and administrative units of Research Base organization in conducting clinical trials.

Community Engagement. Collaboration with affiliated CCOPs and/or Minority-Based CCOPs in treatment clinical trials (if applicable) and cancer prevention/control clinical trials is required. The application should describe the processes and experience it has with educating community sites on protocol specific requirements. The application must describe the ability of the organization applying for Research Base award to involve community physicians and administrators in designing cancer clinical trials that are appropriate for use in community research organizations, such as CCOP Groups. Provide details on the ways affiliated CCOPs and/or Minority-Based CCOPs will be involved in the organizational structure of the Research Base (e.g., committee memberships, clinical trial chair positions, training programs, authorship on publications, etc.). Include the Research Base affiliation agreements with CCOPs and/or Minority-Based CCOPs under 14. Letters of Support.

Operations (Data Management and Quality Assurance)

Describe the infrastructure that exists to develop the statistical parameters for clinical trials, analyze the data, and report study results. Include the relevant Standard Operating Procedures used by the Research Base to perform the activities cited above in the Resources section of the application.

Describe the process for managing the data, assuring quality control of the data, monitoring the conduct of the clinical trials, and assuring the safety of participants through the monitoring of the trials. In addition, outline how the independent data and safety monitoring for all prevention/ control clinical trials will be implemented by the Research Base.

The applicant must describe its ability to train and maintain proficiency of personnel from affiliated CCOP and/or Minority-Based CCOP Groups on research techniques required in the successful management of treatment (if applicable) and cancer prevention/control clinical trials. Training activities should include data managers/nurses and any other individuals responsible for data collection, monitoring, and/or carrying out the intervention(s).

Provide the methods used for on-site auditing or monitoring for data verification and assurance of compliance with regulations for the protection of human subjects (e.g., Institutional Review Board approval and informed consent) and investigational drug accountability. In addition, describe the applicant’s ability to conduct periodic performance review(s) of affiliated CCOP and/or Minority-Based CCOP Groups, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations. Periodic reviews of other Research Base member/affiliates institutions participating in cancer prevention/control clinical trials must be described as well.

The applicants must describe their data-sharing plan. See Section IV. 6. Other Submission Requirements. Include the procedures that will be used and a timeline for making the data available. In addition, discuss how the rights and confidentiality of participants are protected.

Budget Component

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

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information, see 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

Review Process

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

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

Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
Receive a written critique; and
Receive a second level of review by National Cancer Advisory Board.

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

Overall Impact

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

Scored Review Criteria

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, and/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, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

Review Criteria for Research Base Application(s)

Program Overview

Leadership Team. Are the qualifications and experience of the PD/PI(s) and the individual(s) directly responsible for cancer prevention/control clinical trials adequate and appropriate for their positions within the Research Base? Are there sufficient and appropriately experienced multidisciplinary health professionals and allied professionals with the skills needed to develop, conduct, and analyze prevention/control clinical trials and treatment trials (if applicable)? Are the relevant prevention/control committees represented and configured with the appropriate expertise? Are the committees well integrated with the Research Base in terms of contributing to the scientific research agenda as well as with other disease committees (if relevant)? What is the likelihood that these committees will be efficient and productive?

Background and Experience (New Applications). How adequate is the history and experience of the applicant team in terms of their capability of conducting multi-center clinical trials involving community organizations? How strong is their prior experience in developing prevention and/or control clinical trials?

Progress (Renewal Applications). How successful was the applicants Research Base in the current funding period in contributing to the advancement of cancer prevention and/or control research? How significant were their contributions? How successful was the Research Base in the current project period in terms of completing relevant clinical trials and publication of their results? How adequate is the range of developed, active clinical trials for CCOP, MBCCOP, and member institutions? To what degree has the applicants Research Base fulfilled their obligations regarding enrolling enough participants into treatment and prevention/control clinical trials? If applicable, how sufficient and how significant were the contributions of the prevention members to the activities of the Research Base?

For an application that describes a completed large-scale prevention trial(s), are the research results and/or clinical outcomes significant? What will be the impact of the trial results on prevention of cancer? If the trial(s) is still ongoing, has the study achieved expected milestones per the study design based on when the trial was activated during the past project period?

Cancer Prevention and Control Research Program

Research Agenda. How appropriate is the proposed research agenda for the goals of the CCOP and the role of Research Bases? How well does this agenda build on past research accomplishments? To what degree are the clinical trials proposed pertinent to the stated research agenda? What is the value to the CCOP of the proposed clinical trials in terms of study hypothesis, design, implementation plan, etc.? For Renewal Applications: How sufficient/appropriate is the portfolio of developed active cancer prevention/control clinical trials for use in CCOP Groups and member and affiliates (in terms of successful and timely participant accrual)? For New Applications: Based on the details for the two prevention/control trials (relative to design, intervention, etc.), what is the assessment of the group’s ability to successfully conduct this type of clinical trials research?
Accrual Plans. Based on the proposed clinical trial selection and overall implementation capability, what is the likelihood that the applicant team can meet the accrual requirements?
For applications with designated Prevention Members. What is the likelihood that newly proposed Prevention Members (if applicable) will enhance the productivity of cancer prevention research in the Research Base?

Large-scale Cancer Prevention Trials (if applicable)

How well is the applicant’s team positioned to conduct large-scale clinical trials?

Administrative Core

Organizational Structure. How appropriate are the structure and personnel for the development, conduct and analysis of prevention and/or control cancer clinical trials? How well are the administrative components organized and integrated with scientific aspects and goals of the proposed operation?

Community Engagement. Is there a significant involvement of the affiliated CCOP and MBCCOP Groups in terms of protocol development for use in community settings? Are these affiliated Groups sufficiently well integrated into the organizational and research structure of the Research Base?

Has the application demonstrated experience in successfully working with community oncologists and orienting their clinical research staff to the study specific requirements?

Operations (Data Management and Quality Assurance)

Will the proposed Research Base have adequate processes and procedures in place for collecting, quality controlling and analyzing the data from multi-institutional clinical trials? Is there adequate data management staff to perform the proposed scope of work? Are the monitoring and auditing plans for study conduct adequate to ensure patient safety and compliance with human subject protections regulations? Are there appropriate and adequate mechanisms for the periodic review of the elements cited above, including the procedures for the data safety and monitoring committees and on-site auditing programs?

Are there adequate plans (and qualified staff) to train CCOP and Minority-Based CCOP Groups on research techniques pertinent to successful management of cancer clinical trials? Will the proposed Research Base have a standard process for a periodic performance review of CCOP, MBCCOP and member affiliate sites? Is the planned process appropriate to ensure that the performance review is informative and constructive for the participating institutions?

Is the infrastructure for statistical support within the Research Base robust enough to develop the parameters for clinical trials, analyze the study data, and report the research results in a timely fashion?

Additional Review Criteria

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

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

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

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

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

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

Resubmission Applications. Resubmissions are not allowed for this FOA except for those Research Base applications that were submitted in response to RFA-CA-09-022 and were not selected for funding. 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.

Additional Review Considerations

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

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

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

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

Selection Process

The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

2. A. Cooperative Agreement Terms and Conditions of Award

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

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

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

Separate sub-sections below outline the Rights and Responsibilities of CCOP Awardees and Research Base awardees (Part A and Part B, respectively).

Research Base Awardees Responsibilities (including PD/PI Responsibilities)

Throughout these Terms and Conditions of Award, CCOP Research Base 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, which implement the clinical trials and agree to collaborate on research goals of the NCI Community Clinical Oncology Program and/or Minority Based Community Clinical Oncology Program. In addition, throughout these Terms of Conditions of Award, Research Base, refers to all of its member institutions no matter how the membership is defined by a particular Research Base.

The following three 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. The documents are as follows:

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).

It is the responsibility of the Research Base awardee, in accordance with its constitution, bylaws, policies, and procedures, to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, publication of results, interpretations, and conclusions of the clinical trials. The Research Base shall designate Research Base investigators to serve as Study Chairpersons for each proposed clinical trial. All clinical trials will be developed in accordance with the instructions in the INVESTIGATOR'S HANDBOOK (http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm).

Specific Responsibilities of the CCOP Research Base PD/PI

Oversees the development and conduct of the Clinical Trials by the CCOP Research Base.
Responsible for the content and direction of the CCOP Research Base’s cancer prevention and control research program.
Prioritizes the plans and clinical trials in the context of the CCOP Research Base’s overall scientific objectives.
Assures that all Human Subjects Requirements are met by all accruing physicians.
Ensures that appropriate Quality Assurance/Quality Control mechanisms are in place for complete and accurate data collection.
Submits annual Progress Report PHS 2590 to the NCI Program Official.
Attends periodic NCI strategy meetings.
Reports any findings of suspicious or suggestions of intentional misrepresentations of data to the NCI Program official.

Clinical Trials Development by a CCOP Research Base

The awarded CCOP Research Base is responsible for the development and conduct of high quality cancer prevention/ control clinical trials and treatment trials, if applicable, and for evaluation of the results of such clinical trials. The document that describes the clinical trial (referred to as a protocol) must be reviewed and approved by the Protocol Review Committee for either NCI DCP or NCI DCTD prior to implementation.

The process for submission includes:

Submission of all prevention/control trials to the NCI DCP Protocol Information Office (PIO at http://prevention.cancer.gov/clinicaltrials/management/pio;
An initial concept document is submitted for review;
If the concept is approved, the protocol document with an informed consent is submitted;
Submission of all treatment trials to CTEP Protocol Information Office (PIO), DCTD, NCI (http://ctep.cancer.gov/branches/pio/); and
Appropriate and adequate response to all concerns raised in the review of the documents.

A complete description of the submission and review process may be found at http://prevention.cancer.gov/programs-resources/programs/ccop/protodev.

Accrual Requirements for a CCOP Research Base

A CCOP Research Base must meet the following minimal requirements for accrual to clinical trials which a given Research Base has designed and developed:

For prevention/control clinical trials, at least 50 participants per year from CCOP and Minority-Based CCOP awardees, and from other member institutions; and
For treatment clinical trials, at least 50 participants/patients per year from CCOP and Minority-Based CCOP awardees.

A new application must develop a portfolio of treatment clinical trials (if applicable) and cancer prevention/control clinical trials to meet the accrual minimums, referenced above, by the end of the first competing project period.

Data Management and Analysis by CCOP Research Base

Data management includes development of: data collection forms; procedures for data transmittal, entry, editing, compilation, analysis, and quality control; and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/participants entered on clinical trials.

The awarded CCOP Research Base shall establish and implement mechanisms for data management and analysis that ensure:

Adequate procedures for quality control and analysis; and
Sufficient simplicity to encourage maximum participation of physicians entering participants/patients and to avoid unnecessary expense.

Data generated are the property of the awardee; however, the CCOP Research Base must provide DCP/DCTD with access to all data generated under this award. In addition, the Research Bases must have a data-sharing plan as required by the extension of NIH policy regarding sharing research resources (see NIH Grants Policy, Part II Subpart A, Availability of Research Results). See also Applying to Become a CCOP, MBCCOP, or Research Base, for guidance on the application of this policy to Research Base cooperative agreements at http://prevention.cancer.gov/programs-resources/programs/ccop/apply.

Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents.

Quality Control by CCOP Research Base

Each awarded CCOP Research Base must follow all the policies and procedures for quality control established by NCI.

The CCOP Research Base is responsible for monitoring the progress of each clinical trial following good clinical practices through:

Tracking and reporting of participant/patient accrual and adherence to defined accrual goals;
Conducting ongoing assessment of case eligibility and evaluability;
Timely medical review and assessment of participant/patient data;
Assuring that medical records used in support of NCI multi-institutional trials conform to usual standard for the maintenance of clear, accurate, and unambiguous medical records,
Reporting of all adverse events that are intervention-related and communicating this information to all parties;
Rapid reporting of all serious adverse events in compliance with NCI DCP and DCTD policies;
Interim evaluation and consideration of measures of outcome as consistent with participant/patient safety and good clinical trials practice;
Timely communication of results of clinical trials supported under this award; and
An on-site monitoring program.

The CCOP Research Base is responsible for ensuring that all performance sites have routine audits that are reported to the NCI in accordance with the NCI/CTMB 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. In the event that the NCI determines that the awardee failed to comply with these guidelines, the accrual of new patients/participants to the Research Base's clinical trials at the affected performance site shall be suspended immediately upon notice from the NCI. The suspension will remain in effect until the awardee conducts the required audit and the audit report is accepted by the NCI.

The CCOP Research Base will be responsible for notifying any affected performance site of the suspension. During the suspension period, no funds from this award may be provided to the performance site for new accruals, and no changes to the award for new accruals will be permitted. The NCI will also notify an institution that is the direct recipient of a cooperative agreement from the NCI if it is necessary to suspend accrual at that institution.

Quality Assurance of Data Guidelines for CCOP Research Base

The CCOP Research Base must develop and follow procedures for the assurance of data quality in accordance with Research Base guidelines and NCI policies. The CCOP Research Base must follow NCI-approved procedures for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected. The CCOP Research Base must develop and implement NCI-approved policies for auditing the accuracy of scientific data submitted to them.

Any data irregularities identified through quality control procedures or through the audit program that raise any suspicion of intentional misrepresentation of data must be immediately reported to CTMB/CTEP/NCI. The CTMB must be notified immediately by telephone [301-496-0510] of any findings suspicious and/or suggestive of intentional misrepresentation of data and or disregard for regulatory safeguards for any of the three (regulatory, pharmacy, and patient care) components of an audit. Similarly, any data irregularities identified through other quality control procedures suspicious and/or suggestive of intentional misrepresentation of data must be immediately reported to CTMB. It is the responsibility of the CCOP Research Base to immediately notify CTMB when they learn of any significant irregularities or allegations related to scientific misconduct by a staff member or institution participating in their research program. It should be emphasized that the irregularity/misrepresentation does not need to be proven, a reasonable level of suspicion suffices for CTMB/CTEP notification. It is also essential that involved individual(s) and/or institutions follow their own institutional misconduct procedures in these matters.

In the event that there is a finding through the quality assurance and/or quality control programs of any indication of a pattern of non-compliance with protocol or regulatory requirements or a finding of possible alteration of data, these findings must be reported in accordance with the NCI-CTMB 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

Monitoring Plan and Data Safety and Monitoring Boards for CCOP Research Base

NIH policy requires that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (see the NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

The CCOP Research Base must establish and maintain Data and Safety Monitoring Committees (DSMCs) for all Phase III clinical trials in accordance with the NCI’s policy for Data Safety and Monitoring of Clinical Trials at http://grants.nih.gov/grants/policy/hs/data_safety.htm. The CCOP Research Base must comply with the approved policies and procedures of the DSMB. Further, the CCOP Research Base must establish data safety and monitoring plans for all phase I and II clinical trials in accordance with NIH policies at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. A CCOP Research Base may develop standard monitoring plans for Phase I and II trials; however, these plans should be evaluated for appropriateness to each particular clinical trial. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://cancer.gov/clinical_trials. These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

Clinical Trial Closure by CCOP Research Base

The CCOP Research Base shall establish a mechanism for interim monitoring of progress and results of the clinical trials. If the CCOP Research Base wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI staff for review and concurrence prior to closure. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the clinical trial document in order to facilitate these decisions. In the event that the DSMC has recommended early closure, DSMC procedures regarding notification of DCP must be followed.

Performance Review by CCOP Research Base

The CCOP Research Base shall establish policies and procedures for credentialing participating CCOP awardees and Minority Based-CCOP awardees and conducting periodic review of the performance and membership status of each performance site conducting prevention/control clinical trials. This review should examine scientific contributions, participant/patient accrual, data accuracy and timeliness, protocol compliance, and audit results.

In addition, procedures for selecting institutions as Prevention Members of the CCOP Research Base should be established, if applicable, as well as evaluation criteria for these members progress.

Access to CCOP Research Base Data Files by NCI

Upon the request of the Grants Management Officer, NCI, copies of data files and supporting documentation for all NCI-supported protocols that have a major impact on patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner.

Investigational Drug Management by CCOP Research Base

Investigators performing trials under cooperative agreements will be expected, in cooperation with DCP/DCTD, to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents.

Network Participation of CCOP Research Bases

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

Federally Mandated Requirements as Pertinent to CCOP Research Base

Each Research Base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCP/DCTD-sponsored investigational agents and DHHS/PHS regulations for the protection of human subjects. These regulations include, but are not limited to, Title 21 CFR 50, 56 and 312 and Title 45 CFR 46.

At a minimum, the CCOP Research Base must be able to:

Demonstrate that each performance site has a current approved Federal Wide Assurance (FWA) on file with the Office of Human Research Protections (OHRP);
Demonstrate that each clinical trial and informed consent is approved by the responsible Institutional Review Board (IRB) prior to participant/patient entry;
Demonstrate that each investigator has a current FDA Form 1572 and curriculum vitae on file with the Pharmaceutical Management Branch (PMB), CTEP, DCTD;
Demonstrate that each participant/patient (or legal representative) gives written informed consent prior to entry on study;
Implement the CTEP requirement for storage and accounting for investigational agents provided under DCP/DCTD sponsorship;
Establish an on-site audit program for periodic data verification and review of regulatory responsibilities at each affiliated CCOP awardee, cooperative group member, cooperative group affiliate program, and cancer center affiliate institution;
Provide a method, upon DCP/DCTD request, of summarizing efficacy and toxicity data to be included in DCP/DCTD annual reports to the FDA for each investigational agent;
Establish a method for the timely reporting of all serious and unexpected toxicities;
Verify completion of education on the protection of human research participants for all investigators involved in the design or conduct of research involving human subjects;
Institute data and safety monitoring plans for all phase I and II clinical trials and establish and maintain Data and Safety Monitoring Committee (DSMC) for all Phase III clinical trials in accordance with the NCI’s policy for Data Safety and Monitoring of Clinical Trials (see also Section VIII. Other Information - Required Federal Citations).

Affiliations of CCOP Research Bases with CCOP and/or Minority-Based CCOP awardees

CCOP Research Bases must establish guidelines for CCOP and MBCCOP awardees to affiliate (i.e., become members). The awarded CCOP Research Bases must fulfill their promises to affiliate with proposed CCOPs/Minority-Based CCOPs when these groups are actually funded.

Publications by CCOP Research Base

Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires proper acknowledgment of NCI support. See the NIH Access Policy for specific requirements.

Procedures in the Event of Scientific Misconduct

If a duly authorized governmental or institutional body issues a final determination that scientific misconduct has occurred or if the awardee determines that other events have occurred which have significantly affected the quality or integrity of the Group data or participant/patient safety, the awardee is responsible for notifying the Group Data and Safety Monitoring Committee (DSMC), the CTMB, the collaborating investigators, the appropriate Institutional Review Boards (IRBs), and other sponsors of the affected work.

The awardee is also responsible, if the events described above have occurred, for ensuring that submitted but unpublished abstracts and manuscripts are corrected, if possible. If publication deadlines have passed or if abstracts and/or manuscripts containing the affected data have already been published, the awardee is responsible, within 90 days after learning of the event(s) significantly affecting the quality of the Group data or participant/patient safety, for submitting to NCI a re-analysis of the results deleting the false or otherwise unreliable data, and disclosing within the text the reason(s) for the re-analysis. The awardee must submit the re-analysis for publication. The NCI may disseminate information about the re-analysis as broadly as it deems necessary.

The awardee must use its best efforts to notify all scientists, research laboratories, and other organizations to which the awardee has sent research materials affected by false or otherwise unreliable data.

True copies of data files and other supporting documentation from studies affected by scientific misconduct or other findings affecting the quality or integrity of data or participant/patient safety shall be made available to the NCI in a timely manner upon the request of the Grants Management Officer, NCI. The NCI reserves the right to re-analyze, to publish, or to distribute its analyses of these data when it is in the interest of public health. Prior to release, publication or distribution of such analyses, the NCI will provide such analyses to the awardee.

Notification of Participants/patients by the Awardee during Participants/patient’s Lifetime

In order for there to be an appropriate response in the event the NCI determines, either while a clinical trial is active or (if relevant) during the lifetime of the participants following the trial’s closure, that a medically important toxicity or side effect is associated with the study intervention or that the medical care of one or more participants may have been compromised by scientific misconduct or other finding affecting the integrity of the data or patient safety at the awardee institution or at a third-party institution, funded or unfunded, the awardee shall assure that the institution(s) responsible for these participant(s') accrual, whether funded or unfunded, will have procedures in place to: (1) contact each participant individually at his or her last known address on file with the institution and give each participant contacted appropriate information and the right to communicate with an appropriate institutional representative and, in the event of misconduct, to meet with a physician not connected with the clinical trial or study in which the participant has participated; and (2) encourage participants to notify the institution of any changes of address. The procedure must provide for informing the participants fully of the consequences of the toxicity or misconduct for their care and well-being, if any, and the availability of follow-up; and their opportunity to examine any portion of their medical records relevant to the potential effect of the toxicity or side effect upon them or that may be affected by scientific misconduct or other findings affecting the quality or integrity of the data or participant/patient safety.

It is understood that under regulations at 45 CFR Section 74.53, NCI has a right of access to research records pertinent to the NCI funding. In exceptional circumstances, such as a public health emergency, the institutions will be required to provide participant names and treatments to the NCI in a format that allows direct notification of the participant/patient by the NCI.

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 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 CCOP may claim credit.

Monitoring, Investigational Drug and Data Management

NCI or an NCI-designated entity will conduct periodic on-site audits.
DCP and/or CTMB/CTEP will review and advise on mechanisms for monitoring, including the on-site auditing program.
DCP/CTEP representatives (or a designee) may attend the on-site audits conducted by the Research Base.
The DCP Project Scientist(s) and Project Coordinator(s) will have access to all data generated under this award and will periodically review the data management procedures of the 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.

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

Program Review and Federally Mandated Requirements

The NCI Program staff members will provide a suggested format for the annual progress report (PHS 2590).
The review of each CCOP awardee by the DCP/NCI Program staff members will include the following:
- An analysis of the CCOP awardee annual report, follow up of problems noted, and recommendations for improvement;
- Periodic site visits;
- Review of CCOP Research Base evaluations;
- 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 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 DCP and DCTD staff members review mechanisms established by each 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.

The main NCI responsibilities pertinent to CCOP Research Base awards include the following activities.

Scientific Resource

NCI DCP Project Scientist(s) and/or Project Coordinator(s) will:

Set priorities for prevention/control clinical trials research based on state of the science, CCOP Research Base resources and availability of funds;
Act as a resource for scientific information on cancer prevention/control clinical trials, study regimens, and clinical trial design(s);
Assist in developing information required for specific trials;
Advise the Research Base of the nature and results of relevant trials being carried out nationally or internationally;
Sponsor strategy sessions, when indicated, to discuss specific research initiatives; and
Provide updated information on the efficacy, toxicity and availability of all Investigational New Drugs (IND) supplied by NCI to the Research Base.

Clinical Trial Development, Review, and Closure

DCP/NCI Project Scientist(s) and/or Project Coordinator(s) will:

Communicate, as appropriate, with the Research Base during all stages of clinical trial development;
Assist the Research Base in clinical trial design to develop a mutually acceptable protocol compatible with the research interests, capabilities, and needs of the Research Base, its affiliates, and NCI;
Assist in trial design, as appropriate, by providing information and/or comment on:
Scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of the proposed study;
Feasibility and appropriateness of the research for use by the CCOP and/or in a community setting;
The existence and nature of concurrent clinical trials in the area of research;
Relevant pharmacokinetic and pharmaco-dynamic data on investigational agents;
Availability of investigational agents, including biologic response modifiers; and
Research in other NCI-funded programs that may be ready for clinical trials.
DCP/DCTD review and approve all clinical trials designed by CCOP Research Bases for use by CCOP and/or Research Base member/affiliate institutions with the major considerations being:
- Strength of the scientific rationale supporting the study;
- Importance of the question being proposed;
- Avoidance of undesirable duplication with ongoing clinical trials;
- Appropriateness and feasibility of study design;
- Appropriateness of patient/participant selection, evaluation, assessment of toxicity, response to intervention, and follow-up;
- Patient/participant safety;
- Compliance with NIH and the federal regulatory requirements;
- Satisfactory projected accrual rate and follow-up period;
- Adequacy of data management; and
- A consensus review that describes recommended modifications and other suggestions as appropriate will be communicated to the Research Base PD/PI.
NCI Project Scientist(s) and/or Project Coordinator(s) will review Research Base mechanisms for interim monitoring of results and will monitor clinical trial progress.
NCI may request that a clinical trial be closed for reasons including:
- Insufficient accrual rate;
- Accrual goal met;
- Poor protocol performance;
- Patient/participant safety;
- Already conclusive study results; and
- Emergence of new information which diminishes the scientific importance of the study question.

Data Management and Analysis

DCP/DCTD will have access to all data generated under this award.
DCP/DCTD representative may review data management and analysis procedures of the Research Base.
DCP/DCTD Data may request data be made available for external monitoring.

Quality Control, Data Monitoring, and Investigational Drug Management

NCI Project Scientist(s) and/or Project Coordinator(s) may review quality control and monitoring procedures of the Research Base including the on-site auditing program.
NCI Project Scientist(s) and/or Project Coordinator(s) (DCP and DCTD) will serve as non-voting members on each DSMC.
NCI staff members will assess the Research Base compliance with NCI-established policies on Data and Safety Monitoring Plans for Phase I and II trials and Data and Safety Monitoring Committees for Phase III trials.
NCI staff members may attend on-site audits conducted by the Research Base or its NCI designee.
NCI Project Scientist(s) and/or Project Coordinator(s) (working as needed with other NCI program staff members) will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the FDA may mandate.

Program Review, Strategy Sessions and Federally Mandated Requirements

The NCI will provide a suggested format for the CCOP Research Base annual progress report (PHS 2590) and other reports as needed.
The DCP/NCI will review the progress of each CCOP Research Base based on:
- Annual reports;
- Periodic site visits;
- A progress in designing, developing, implementing and completing cancer prevention/control clinical trials;
- Quarterly accrual reports by clinical trial; and
- Adjust funding annually based on planned scope of work and availability of funds.
The NCI Program may adjust funding, withhold support, suspend or terminate the award, if the Research Base fails to meet the performance requirements set forth in the Terms and Conditions of Award in the FOA, and/or the level of performance changes dramatically.
NCI Project Scientist(s) and/or Project Coordinator(s) or designee will sponsor strategy sessions when indicated.
NCI Project Scientist(s) and/or Project Coordinator(s) and DCTD staff will review mechanisms established by each 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 PDs/PIs of the CCOP Groups and CCOP Research Bases, the DCP Project 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 disagreement(s) that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

Additional Reporting Requirements for Research Base awardees

A suggested format for Research Base specific information relative to the progress summary section of the Form PHS 2590 will be provided. The format is available at https://ccop.nci.nih.gov/. An update on clinical trials, in development, and clinical trials that were approved, activated, closed and/or completed during the relevant budget period should be discussed in the progress summary. Plans pertaining to clinical trial activities for the next budget period should be addressed as well. An annual performance report on each affiliated CCOP must be included. The performance report will include, at a minimum, information on: overall case accrual; cancer prevention/control clinical trials research, existing or planned; eligibility and evaluability of patients/participants entered on study; timeliness and quality of data reporting; and results of quality control review and audits if performed during that year.

A Research Base must submit a list of the participating sites as defined by the NCI DCTD CTEP Clinical Trials Monitoring Branch along with the audit schedule of these sites in the annual progress report.

Clinical Trials Reporting Requirements

Reporting requirements will be in agreement with FDA regulations and NCI procedures. Interim reports of each activated and ongoing clinical trial shall appear in the minutes of each Research Base meeting and shall include specific data on patient/participant accrual as well as, when appropriate, detailed reports of treatment-associated morbidity. Quarterly accrual reports must be provided as appropriate to CTEP for all active trials through the NCI’s Clinical Data Update System (CDUS). Instructions and Guidelines for CDUS are at http://cancer.gov/reporting/cdus.html.

Adverse Event Reporting Procedures

To comply with FDA regulations, all recipients of NCI support for clinical trials, including Research Bases responsible for coordinating and monitoring such trials, must promptly report adverse events (including adverse drug reactions) to the NCI and any other trial sponsor(s) according to NCI Guidelines. For treatment trials utilizing CTEP investigational agents, guidelines are listed at http://ctep.cancer.gov/reporting/adeers.html. For cancer prevention and control trials utilizing DCP investigational agents, guidelines are listed at http://prevention.cancer.gov/clinicaltrials/management/pio.

The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/investigators' responsibility to report adverse events as specified in the protocol.

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

2. Peer Review Contacts:

3. Financial or Grants Management Contacts:

Sean Hine
Office of Grants Administration
National Cancer Institute, NIH
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-2182
FAX: (301) 496-8601
(email) hines@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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