and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)
Components of Participating Organizations
National Cancer Institute (NCI) (http://cancer.gov)
Title: Community
Clinical Oncology Program (U10)
Announcement Type
This funding opportunity announcement
(FOA) is a re-issuance of RFA-CA-08-015.
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: May 4, 2009
Letters of
Intent Receipt Date: June
8, 2009
Application Receipt Date: July 8, 2009
Peer Review
Date(s): November-December
2009
Council Review Date: January 2010
Earliest
Anticipated Start Date: June 1, 2010
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: July 9 2009
Due Dates
for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The overall objective of this Funding Opportunity Announcement (FOA) 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. To accomplish this overall goal, the Division of Cancer Prevention, National Cancer Institute (NCI), established in 1983 the Community Clinical Oncology Program (CCOP), which 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 NCI Cooperative Groups and Cancer Centers that serve as their CCOP Research Bases.
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.
This RFA elicits two types of applications for the components of the CCOP Network, as follows:
1) New and renewal applications for CCOP Groups (also referred to as CCOPs); and
2) New and renewal applications for CCOP Research Bases.
A CCOP Group consists 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 CCOP Research Base designs clinical trials for use in the CCOP Network. It also conducts the trials, manages and analyses the data, and reports the results. CCOP Research Bases must either be NCI Clinical Cooperative Groups or NCI-designated Cancer Centers.
Cancer prevention/control clinical trials include clinical evaluations of: the effectiveness of chemo-preventive agents; methods for early detection of cancer and precancerous lesions; interventions to improve patients quality of life or to treat symptoms arising from cancer or cancer therapy; and ways to improve continuing, palliative, 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 2008, the CCOP Network consisted of 47 CCOP Groups, located in 28 states and comprising more than 340 hospitals and more than 2,900 physicians. The CCOPs enrolled approximately 5,535 patients to treatment trials and over 6,000 participants/patients to prevention and control trials. The Network also included 13 CCOP Research Bases, which conducted several hundred treatment/prevention/control trials.
In addition to CCOP, a related funding
initiative, the Minority-Based Community Clinical Oncology Program (Minority
Based-CCOP) has similar goals, but is distinctly focused on community
institutions and oncologists serving primarily minority populations.
Potential applicants for support as CCOP Groups who are working at community
institutions serving primarily minority populations should consider a companion
funding opportunity for Minority Based-CCOP (for details, seehttp://grants.nih.gov/grants/guide/rfa-files/RFA-CA-09-023).
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the U10 cooperative agreement award mechanism(s).
The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This
FOA uses Just-in-Time information concepts. It also uses
non-modular budget formats described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity
will use a cooperative agreement award mechanism. In
the cooperative agreement mechanism, the Project Director/Principal
Investigator (PD/PI) retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award".
NCI
has determined that there is a continuing need for community participation in
cancer clinical trials that cover both cancer prevention/control and
treatment. While this FOA is a one-time issuance, it is expected that a
CCOP FOA will be published in the NIH Guide for Grants and Contracts on an
annual basis using the U10 cooperative agreement award mechanism, provided that
funds are available.
2. Funds Available
The estimated amount of funds available for support of approximately 21 CCOP Group and/or Research Base awards as a result of this announcement is $21.2 million for fiscal year 2010. Future year amounts will depend on annual appropriations.
Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation; see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1. A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1. B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
For new and renewal CCOP Group applications, the following provisos apply:
Institutions not eligible to apply for the CCOP Group awards include:
For new and renewal Research Base applications, the following provisos apply:
Number of Applications. Applicant institution may
submit only one application in response to this FOA.
Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals: Renewal applications are permitted in response to this FOA
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711
or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form and the YES box must be checked.
The
exceptions from the PHS398 instructions and detailed information on the
application structure and components are provided in Section IV.6. Other
Submission Requirements. All applicants must follow the specific instructions
in that section.
3.
Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section IV.3.A).
Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of
Intent Receipt Date: June 8, 2009
Application Receipt Date: July
8, 2009
Peer Review Date(s): November-December
2009
Council Review Date: January 2010
Earliest Anticipated Start Date: June
1, 2010
3. A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent
should be sent to:
Lori
Minasian, M.D.
Division of
Cancer Prevention
National
Cancer Institute
6130
Executive Boulevard
Executive
Plaza North, Room 2017
Bethesda,
MD 20892
Telephone:
(301) 496-8541
FAX:(301)
496-8667
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Referral
Officer
Division of
Extramural Activities
National
Cancer Institute
6116
Executive Boulevard
Room 8041 , MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-U.S.P.S. delivery)
Telephone:
(301) 496-3428
FAX:(301)
402-0275
Email: [email protected]
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is
not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the cost.
NIH prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or
renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
Restrictions for CCOP Applications:
Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, clinical research associates, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., Research Base meetings, NCI-sponsored strategy sessions/workshops, local travel). For CCOP Groups that consistently accrue 250 or more patients annually to cancer treatment trials, use of grant funding to cover handling of investigational drugs will be considered. Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the PI and associate PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort, and funds requested.
Restrictions for Research Base Applications:
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
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
Research Plan Page Limitations (See Details Below)
Applicants are allowed 25 to 50 pages for the research plan portion of the application (applicants are encouraged to use the minimum number of pages necessary to clearly and succinctly describe the research plan).
In addition, a CCOP Research Base application that includes large-scale cancer prevention clinical trial(s) and/or Prevention Member(s) proposals may use up to an additional 25 pages (maximum of 75 pages total) to describe these elements of the application (see definition of Prevention Member under IV.2.B.Form and Content of Application for CCOP Research Base Award, Section 5.
Application Structure
A suggested application format is available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply. All applicants are encouraged to use the suggested format instructions for organizing the specific information concerning the FOA programmatic requirements in the PHS 398. Tables should be part of the body of the application and counted toward the page limitation if included in appropriate sections of the Research Plan. Some tables may also be included as part of the Resources, Progress Report, and/or Human Subjects Research sections, as appropriate. Do not include the tables in the appendix.
Note: A part of the standard PHS 398 Research Plan (Items 2-5 as per Revision 11/07) are substituted with Sections 1-7 with altered page limits as indicated below. Other items of the PHS 398 Research Plan remain unmodified.
A. Content and Form of Application for CCOP Group Award
For CCOP Group applications submitted in response to this FOA, the standard PHS 398 "Research Plan" (Items 2-5) is altered as follows:
Research Plan for all CCOP Group Applications must contain the following Sections:
Section 1: Progress Report
An application from a currently funded CCOP Group (a renewal application) must include a progress report. NOTE: new CCOP Group applicants should insert Not applicable in this section.
The progress report should at a minimum, consist of:
Section 2: Catchment Area.
Each application must delineate its catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. In addition, provide an estimate of the oncologists (i.e., percent) in the service that will participate in the CCOP. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. A description of the study population in the application’s catchment area, with a breakdown by percentage of the gender and minority composition, should be provided.
Section 3: Accrual Requirements.
Each application must include plans for maintaining or increasing accrual to cancer prevention/control trials and treatment trials. Plans must list estimated accrual to specified NCI-approved trials by participating physicians (current or proposed). A narrative explanation pertinent to the estimated accrual may be provided. Strategies for implementing the trials and facilitating accrual should also be described. In addition, plans for recruiting women and minority populations must be described. Applications must include evidence that the CCOP Group can meet or exceed the requirement to accrue 50 new participants/patients to cancer prevention/control trials and 50 new participants/patients to cancer treatment trials, annually (with exceptions noted below). In addition, provide statistics on the numbers of patients on treatment trials who are still being followed per protocol requirements. For renewal CCOP Groups, the best evidence is prior accrual and trends in accrual. Exceptions and additional considerations are as follows:
Each applicant must describe, in detail, two examples of NCI-approved cancer prevention and/or control clinical trials it intends to use from the CCOP Group’s affiliated Research Base(s).
A new CCOP Group application must provide implementation plans for at least two NCI-approved cancer prevention/control clinical trials that use an intervention, such as a trial of a chemo-preventive agent or a trial to study an intervention/agent for the treatment of a cancer symptom. The application should include specifics on patient/participant recruitment, compliance and follow-up. The clinical trials selected must come from CCOP Research Bases with which the applicants propose to affiliate (see Section 5 below). In addition, a new CCOP Group must describe a plan demonstrating the likelihood of accruing the 50 new participants/patients to cancer prevention/control and 50 new participants/patients treatment trials, annually.
Section 4: Team Organization and Qualifications.
A designated PI is required. An Associate PI should be named to assure continuity in the event of resignation of the PI. The qualifications and experience of both persons must be described, specifically documenting their respective abilities to organize and manage a community oncology program that includes cancer prevention/control/ treatment clinical trials and related activities, as well as experience in accruing patients/participants to clinical trials.
Each application should propose a committed multidisciplinary professional group appropriate for its expected clinical trial participation. This team should include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, gastroenterology, pediatrics, internal medicine, family practice), as appropriate. The training and experience of participating physicians who are in the top 25 percent of the CCOP Group’s highest accruing physicians must be described.
The application should include a description of planned organizational structure and procedures for implementing the workflow necessary for choosing trials to open, accruing and following participants/patients, and data management. In addition, describe the plans for communication among physicians and component/affiliate institutions and incentives for participation in clinical trial accrual. The details of any prior experience of working together as a group, particularly in implementing cancer prevention/control/treatment clinical trials and related activities should be described. An organizational chart showing how the group will function must also be included. If the CCOP has more than one component/affiliate institution, describe the relationship of component(s)/affiliate(s) to each other and to the CCOP headquarters. Include a diagram showing the distance between these institutions (including administrative office and shared resources) and location of proposed personnel. The qualifications, experience, and proposed duties of all proposed support personnel should be described.
Section 5: Affiliations with Research Bases.
Each CCOP Group application must demonstrate access to an adequate selection of cancer prevention/control/treatment clinical trials so that the CCOP Group can meet or exceed accrual goals, and provide appropriate trials to the participants/patients in the CCOP Group’s catchment area. Trial access must be documented through formal affiliations with Research Bases. Multiple Research Base affiliations are permitted, in the following configuration:
Typically, an established CCOP Group affiliates with about four to six CCOP Research Bases, in addition to the mandatory affiliation with a multi-specialty cooperative group. Existing or planned affiliations with each specific CCOP Research Base must be justified in terms of the scope and breadth of research that the applicants anticipate undertaking. The conditions of affiliation must be provided in the CCOP Research Base affiliation agreement(s). Copies of these agreements should be included under the Resources section and referenced in the Research plan under Section 5. Initial affiliations should be maintained during the funding cycle. If applicable, the contributions of CCOP Group investigators and their key personnel to the infrastructure of the affiliated CCOP Research Bases should be described. Such contributions may involve, for example, participation/membership in CCOP Research Base committees, serving as chair(s) of cancer clinical trials, and authorship of joint publications.
Note: A list of currently eligible CCOP Research Bases may be obtained at http://prevention.cancer.gov/programs-resources/programs/ccop/rbccop or from the Community Oncology and Prevention Trials Research Group, DCP, NCI, at (301) 496-8541.
Section 6: Quality Assurance and Investigational Drug Management.
The internal quality control procedures of the CCOP Group must be described in detail. Assurance of quality is the joint responsibility of the CCOP Group and its affiliated Research Bases. Quality control procedures of the CCOP Research Base will be applied to the CCOP Groups and should be specified in the CCOP Research Base affiliation agreement. In addition, procedures for data management and investigational drug monitoring must be described in the application. For data management procedures, include details on who is responsible for data management overall; what is the source of records (e.g., hospital, office, clinic, registry); who will register patients on trials; how will the information flow (provide flow chart); who will enter data on primary patient records and study forms (e.g., nurses, physicians, data managers, secretaries); who will collect and send patient materials (e.g., pathology slides, port films, etc.) to the Research Bases if required; what records (study flow sheets, reminder slips) will be included on patient charts; how will data be transmitted (e.g. batch mode or as real-time); and are there mechanisms in place for electronic data transfer. In addition, describe data management operations within and between components/affiliates and the central CCOP office, if applicable. Describe how NCI and Food and Drug Administration requirements for investigational drug management will be handled.
Section 7: Facilities and Institutional Commitment.
The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided (include in the Resources section). In addition, each application must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. The description of this space may be included under the Resources section or in the Research Plan.
B. Form and Content of Application for CCOP Research Base Award
For CCOP Research Base applications submitted in response to this FOA, the standard PHS 398 Research Plan (Items 2-5) is substituted with Sections 1- 6 with altered page limits as indicated below. Other items of the PHS 398 Research Plan remain unmodified.
The prevention/control clinical trials research agenda of a CCOP Research Base should be compatible with the scientific interest(s) and the expertise of the individual Cooperative Group or Cancer Center. In addition, the portfolio of clinical trials, including completed, ongoing, and proposed trials, should reflect the breadth and scope of research focus the CCOP Research Base.
Research Plan for CCOP Research Base Applications must contain the following Sections:
Section 1: Progress Report. An application from a currently funded CCOP Research Base (a renewal application) must include a progress report. NOTE: new CCOP Research base applicants should insert Not applicable in this section. The progress report should consist, at a minimum, of the following:
Section 2: Clinical Trials Design and Implementation. The following elements must be described:
Section 3: Accrual Requirements. The following elements of patients/participants recruitment must be described (if applicable):
Section 4: Team Organization and Qualifications.
A designated PI is required and his/her qualifications and experience must be described. An individual designated to coordinate cancer prevention and control research must be qualified in the field of cancer prevention/control and have experience within the Research Base. His/her qualifications and experience within the Research Base structure must be described. Each application must also demonstrate the availability 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, health educators, and/or other public health professionals and basic scientists may be included.
Each application must have an organizational structure that involves the appropriate personnel to assure the timely development, conduct, analysis, and reporting of cancer prevention/control clinical trials. 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 must be provided.
The organization applying for Research Base award must describe the scope of its cancer prevention/control clinical trials research. A description of the prevention and/or control committee(s) (or equivalents) and their activities must be provided. In addition, their relationship to other clinical trial committees must be described.
Section 5: Membership.
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 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. Details should be provided on the ways to involve affiliated CCOPs and/or Minority-Based CCOPs in the organizational structure of the Research Base (e.g., committee memberships, clinical trial chair positions, training programs, authorship on publications, etc.). Research Base affiliation agreements with CCOPs and/or Minority-Based CCOPs must be included in the application.
Prevention Members: The application 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:
Section 6: Quality Assurance and Data Management. Each application must describe the following elements:
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/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 core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned
and appropriate to accomplish the specific aims of the project? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.
A. Review Criteria for CCOP Application
1. Progress (for renewal applications only).
Does the CCOP Group meet or exceed accrual requirements for prevention/control/treatment trials, and does the trend in accrual over the funding period provide evidence for continuing accrual at these levels during the upcoming funding period?
Are plans for the follow-up of participants enrolled on the large-scale prevention trials (e.g., STAR, SELECT) described and are the plans adequate?
Has the CCOP Group been properly evaluated by the affiliated Research Bases and how was the CCOP performance rated?
2. Catchment Area.
Does the information on the CCOP Group’s catchment area (including geography, population, location and number of components, presence of cancer care resources that are not part of the application) demonstrate access to a patient population that will provide adequate accrual to trials and that will benefit from the CCOP Group’s portfolio of trials?
Is the study population in the application’s catchment area described, along with a breakdown by gender and minority?
3. Accrual Requirements.
For all CCOP Group applications:
Does the application demonstrate the ability to successfully meet or exceed the minimum accrual goals (i.e., at least 50 accruals to treatment trials and 50 accruals to prevention/control trials)?
In addition, for new CCOP Group applications:
Does the application demonstrate a plan for opening trials and accessing appropriate participants/patients to consistently meet or exceed NCI’s minimum accrual requirements (i.e., at least 50 accruals to treatment trials and 50 accruals to prevention/control trials)?
Does the application already demonstrate a level of accrual to NCI-approved treatment and prevention/control clinical trials that provides evidence that it will meet or exceed minimal accrual goals?
Do the plans for implementing at least two NCI approved cancer prevention/control trials demonstrate the CCOP Group’s ability to participate successfully to Research Base trials, as indicated by the proposed operations for identifying and accruing participants/patients in the CCOP components, and managing the data?
In addition, for renewal CCOP applications:
Does the application demonstrate a successful past history of accrual to NCI-approved treatment and prevention/control clinical trials, as demonstrated by exceeding the minimum (i.e., at least 50 accruals to treatment trials and 50 accruals to prevention/control trials)?
If the application describes participation in only pediatric oncology clinical trials, does the application show accrual of a majority of the eligible patients even if the minimum accrual requirements are not met?
Does the application demonstrate outstanding accrual to cancer prevention/control clinical trials even without meeting the minimum accrual goals for cancer treatment trials?
4. Team Organization and Qualifications
Are the qualifications, training, and experience of the PI/associate PI appropriate for organizing and managing a community oncology clinical research program that includes accrual to NCI approved treatment and prevention/control clinical trials as well as related activities?
Do the applicants document availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, gastroenterology, pathology, internal medicine, family practice, nursing, and nutrition) for multidisciplinary clinical trials?
Is the overall structure of the organization stable? Does it demonstrate institutional support for ongoing accrual? Is there evidence of previous success in collaborating as a group?
Does the proposed organizational structure demonstrate previous success in implementing cancer treatment and prevention/control clinical research and related activities?
5. Affiliations with CCOP Research Bases
Has the applicant demonstrated affiliation of the CCOP Group with CCOP Research Bases to ensure access to an adequate selection of clinical trials needed to meet or exceed the accrual requirements and provide an appropriate menu of trials to the participants/patients in their catchment area?
Are the proper affiliation agreements and appropriate Research Base evaluations included in the application?
Has the CCOP Group demonstrated contributions by its team to the overall structure of one or more of its affiliated CCOP Research Bases, by committee participation, serving as committee chairs and/or chairs of cancer clinical trials, and by authorship in joint publications?
6. Quality Assurance and Investigational Drug Management
Has the application demonstrated appropriate and adequate mechanisms for quality assurance for both cancer treatment and prevention/control clinical trials?
Does the application demonstrate, through audit reports and otherwise [e.g., by providing CCOP Research Base evaluation(s)], appropriate and adequate procedures for investigational drug monitoring and data management and identification of false or otherwise unreliable data?
If data irregularities have occurred, has the application demonstrated appropriate and adequate resolutions of the issues and put appropriate corrective action in place?
7. Facilities and Institutional Commitment
Are the available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., adequate to support the research activities?
Is there adequate and appropriate space for administrative activities and personnel?
B. Review Criteria for CCOP Research Base Applications
1. Progress Report (for renewal applications only).
Has the Research Base developed a portfolio of active cancer prevention/control clinical trials that are appropriate for use in CCOP Groups and member and affiliates, as demonstrated by successful and timely accrual?
Is the portfolio of cancer prevention/control trials open in the Research Base large enough to make a significant contribution to the prevention/control needs of the CCOP Groups, as measured by the ability of the Research Base to meet or exceed accrual goals?
Has the Research Base demonstrated that it will maintain accrual and continue to open new prevention/control trials by having an adequate number of studies in various stages of development that are both scientifically meritorious and feasible for timely accrual in CCOP Groups and members and affiliates?
Are the prior activities adequately summarized, including a clear presentation of annual accrual data, completion of prevention/control trials, interim data analyses, publication of findings or other form of dissemination of trial findings throughout the Research Base, and other milestones in successfully meeting the requirements for a Research Base?
2. Clinical Trials Design and Implementation
Has the Research Base demonstrated the ability to successfully design, develop, conduct and complete multi-institutional NCI-approved clinical trials in cancer prevention and control (i.e., those with interventions affecting quality of life, cancer and treatment-related symptoms, and early detection)?
Are there adequate procedures in place to collect, monitor, and analyze the data and assure the safety of patients/participants?
Are there appropriate long-term plans for the recruitment and retention of participants/patients?
Is the evaluation process for the Research Base’s programs to recruit and retain of minorities adequate?
In addition, for new applications:
Has the application demonstrated the potential of the team to successfully design, develop, conduct and complete multi-center clinical trials?
Is a detailed plan with adequate procedures to collect, monitor, and analyze the data and assure the safety of patients/participants provided?
Has the application demonstrated the potential to develop a selection of cancer prevention/control clinical trial as needed to meet its minimum criteria of 50 participant accruals from affiliated CCOP/ MB-CCOP Groups and member/affiliate institutions?
Are detailed descriptions of at least two actual or planned cancer prevention/control clinical trials provided?
3. Accrual Requirements
For renewal applications:
Has the Research Base generated 50 accruals from treatment trials (if applicable) from CCOP/MBCCOP Groups and 50 accruals from prevention/control trials from CCOP/MBCCOP Groups and/or member/affiliate institutions?
Has the Research Base exceeded these minimum accrual requirements?
For new applications:
Does the application demonstrate the potential of the group to accrue to appropriate clinical trials the required minimum of 50 participants from affiliated CCOP/ MB-CCOP Groups and member/affiliate institutions?
4. Team Organization and Qualifications
Are the qualifications and experience of the PI and the individual directly responsible for the cancer prevention/control clinical trial activity adequate and appropriate for the individuals holding these 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 (if applicable)?
Is the organizational structure staffed with sufficient and appropriately trained personnel to assure the timely development, conduct, analysis and reporting of clinical trial data? Does the application have an organizational focus for cancer prevention/control research, as demonstrated by the composition and activities of the cancer prevention/control committee(s), and its relationship to other clinical trial committees and activities?
5. Membership
Does the application demonstrate the contribution of investigators from the affiliated CCOP Group(s) in the organizational structure of the CCOP Research Base? For example, do the CCOP members (accruing physicians, nurses, and clinical research associates) participate in the full spectrum of CCOP Research Base committees or in the design and development of the clinical trials?
For new applications:
Are there sufficient numbers of affiliated CCOP and/or MB-CCOP Groups through which the CCOP Research Base can meet the minimum accrual goals?
Does the application provide the required CCOP Research Base affiliation agreements?
Has the application demonstrated experience in successfully working with community oncologists and orienting their clinical research staff to the study specific requirements?
For applications with designated Prevention Members :
Does the application demonstrate relevant accomplishments of each previously designated Prevention Member (e.g., protocol development, conduct of pilot or laboratory studies, and/or accrual) that have enhanced the productivity of the cancer prevention research for the Research Base?
Does the application provide evidence that the newly proposed Prevention Member (if applicable) will enhance the productivity of cancer prevention research in the Research Base?
6. Quality Assurance and Data Management
Does the application adequately describe appropriate quality control, quality assurance and data management procedures? Are there appropriate and adequate mechanisms for the periodic review of quality control, quality assurance, data management procedures, and safety monitoring (including the procedures for the data safety and monitoring committees and on-site auditing programs)?
Does the application
adequately demonstrate experience in the collection, management, and analysis
of multi-institutional clinical trials? Is there adequate data management
staff to perform the proposed scope of work?
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
3. Anticipated Announcement and Award
Dates
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A.
Cooperative Agreement Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
2.
A.1. 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).
2. A.1. Part A. CCOP Awardee Responsibilities (including PI Responsibilities)
Throughout these Terms and Conditions of Award, CCOP awardee refers to the organizational structure which is composed of the key personnel (including the designated accruing physicians) and the institutions/organizations of the performance sites, including those designated as affiliates and CCOP components, all of whom agree to collaborate on research goals of the NCI Community Clinical Oncology Program.
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:
Specific Responsibilities of the CCOP PI
Clinical Trials Appropriate to Meet the CCOP Accrual Requirements
To receive credit for accruals the CCOP awardee must access NCI-approved treatment and prevention/control clinical trials through the CCOP Research Bases with which CCOP awardee has affiliation agreements. The CCOP awardee also may access treatment trials from Research Bases with which it is not affiliated through the NCI’s Cancer Trials Support Unit (CTSU). Accruals by CCOP awardees to CTSU protocols will receive credits (towards the required accrual quotas) and not per case reimbursement.
All clinical trials originating at the CCOP Research Bases must be reviewed and approved by the Protocol Review Committee of the Division of Cancer Prevention (DCP) or the Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation.
Required Affiliations of CCOP Awardees with Research Bases
Each CCOP awardee must affiliate with one national multi-specialty cooperative group having a spectrum of cancer treatment and prevention/control clinical trials. As an exception, CCOP awardees may be granted permission to affiliate with more than one multi-specialty group, if the CCOP awardee participates in NCI-sponsored pilot projects. In addition, each CCOP awardee may affiliate with as many other Research Bases (exclusive of the multi-specialty groups) as the CCOP deems appropriate.
Typically, an established CCOP Group is expected to affiliate with approximately four to six CCOP Research Bases (in addition to its affiliation with multi-specialty cooperative group). Through these affiliations, the CCOP awardee must ensure an access to an adequate selection of clinical trials for its patient population and to meet/or exceed the minimum accrual requirements.
If participation of the CCOP awardee in the clinical trials of one CCOP Research Base competes with that of another CCOP Research Base with which the CCOP awardee is affiliated, the CCOP must prioritize the protocols to avoid bias in the allocation of participants/patients to competing protocols.
Note: A list of eligible Research Bases may be obtained from the CCOP Web pages at http://prevention.cancer.gov/programs-resources/programs/ccop/rbccop or by contacting the Community Oncology and Prevention Trials Research Group (COPTRG), DCP, NCI, at (301) 496-8541.
When circumstances require changes in Research Base affiliations, prior written approval from the DCP Program Director is required. The Guidelines for Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource
Accrual Requirements for CCOP Awardees
Each CCOP awardee must accrue a minimum of 50 participants/patients per year to cancer prevention/control clinical trials.
Each CCOP awardee must accrue a minimum of 50 participants/patients per year to treatment clinical trials. The minimum of 50 treatment participants/patients may be waived in case of:
Quality Control Guidelines for CCOP Awardees
In accordance with CCOP Research Base guidelines and NCI policies, the CCOP awardee must establish and follow procedures for the assurance of data quality and for the prevention and/or identification of false or otherwise unreliable data. The CCOP awardee must follow policies developed by the CCOP Research Bases with which they are affiliated. Any data irregularities identified through quality control procedures or through the audit program that raise the suspicion of intentional misrepresentation of data must be reported to the NCI DCP Program Director within 24 hours. COPTRG must be notified by telephone (301-496-8541) of any findings suspicious or suggestive of intentional misrepresentation of data and/or disregard of regulatory safeguards for any of the three components (regulatory, pharmacy, and patient care) within an audit. It should be emphasized that a reasonable level of suspicion is sufficient to warrant notification to NCI of irregularity and/or misrepresentation.
Data Management by CCOP Awardees
The CCOP awardee must provide the NCI DCP Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data.
Investigational Drug Management by CCOP Awardees
Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. Specifically, all CCOP investigators accruing participants/patients must have an active FDA Form 1572 on file with the Pharmaceutical Management Branch, Clinical Trials Evaluation Program (CTEP), DCTD, NCI.
Monitoring of the Activities of CCOP Awardees
Each CCOP awardee must agree to periodic on-site audits by representatives of its CCOP Research Base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following:
The performance sites designated as affiliates and CCOP components and the individual accruing investigators participating or collaborating with the CCOP awardee must be in compliance with the monitoring standards established by the CCOP Research Base(s) and stated in the NCI GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, and THE CANCER TRIALS SUPPORT UNIT (CTSU) (http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm).
Sites found not to be in compliance with the NCI monitoring guidelines may be suspended from participating in Research Base trials until compliance can be confirmed by NCI/CTMB.
Specifically, the institutions/organizations representing performance sites must adhere to the following standards:
CCOP Radiotherapy Equipment
Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in clinical trials requiring radiation therapy, as required by the affiliated Research Base(s).
Organizational Changes in a CCOP
Certain organizational changes in the structure of a CCOP awardee must have the prior written approval of the DCP Program Director. These changes include the addition/deletion of a participating physician, a health professional other than a physician (who is active in enrolling participants/patients to cancer treatment, prevention and control trials), an affiliate, a component, or a Research Base affiliation. The Guidelines for Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource
CCOP Network Participation
CCOPs are part of a national network for conducting cancer prevention/control and treatment clinical trials. As such, each CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community.
Logging Patients/Participants by CCOP Awardees
Each CCOP awardee may be asked to maintain a new patient/participant log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/participant pool seen by the CCOP investigators.
Federally Mandated Requirements as Pertinent to CCOP Awardees
Each CCOP awardee must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. Appropriate documentation must be available for review. At a minimum, these requirements include the following:
For other Federally mandated requirements see the following Federal citations:
Publications by CCOP awardees
Timely publication of major findings is encouraged. Publications or oral presentations of work conducted under this cooperative agreement require proper acknowledgment of NCI support. See the NIH Public Access Policy for specific requirements.
2. A.1. Part B. Research Base Awardees Responsibilities (including 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. In addition, throughout these Terms of Conditions of Award, Research Base, refers to all of its members 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:
It is the responsibility of the Research Base 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, and publication of results, interpretations and conclusions of the 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.
Specific Responsibilities of the CCOP Research Base PI
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:
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:
Data Management and Analysis by CCOP Research Base
The awarded CCOP Research Base shall establish and implement mechanisms for data management and analysis that ensure:
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:
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 (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 (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:
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: (a) 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 (b) 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
Monitoring, Investigational Drug and Data Management
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 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:
Clinical Trial Development, Review and Closure
DCP/NCI Project Scientist(s) and/or Project Coordinator(s) will:
Data Management and Analysis
Quality Control, Data Monitoring and Investigational Drug Management
Program Review, Strategy Sessions and Federally Mandated Requirements
2. A. 3. Collaborative Responsibilities
Execution of this program will
require collaboration among the 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 disagreements
that may arise in scientific or programmatic matters (within the scope of the
award) between award recipients and the NIH may be brought to arbitration. A
Dispute Resolution Panel composed of three members will be convened. It will
have three members: a designee of the Steering Committee chosen without NIH
staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special dispute resolution procedure does not alter the awardee's rights in
accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations
45 CFR Part 16.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
Reporting by CCOP Group awardees
CCOP group awardees will report their cumulative accrual to NCI-approved clinical trials at 6 months, 9 months (included in the annual progress report), and 12 months for each budget period.
A suggested format for CCOP-specific information relative to the progress summary section of the PHS Form 2590 will be provided. The format is available at https://ccop.nci.nih.gov/.
Reporting by 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 be in compliance 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.
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:
Lori
Minasian, M.D.
Division of
Cancer Prevention
National
Cancer Institute
Executive
Plaza North, Room 2017
6130
Executive Boulevard
Bethesda,
MD 20892
Telephone:
(301) 496-8541
FAX: (301)
496-8667
Email: [email protected]
2. Peer Review Contacts:
Referral
Officer
Division of
Extramural Activities
National
Cancer Institute
6116
Executive Boulevard, Room 8041 , MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-U.S.P.S. delivery)
Telephone:
(301) 496-3428
FAX: (301)
402-0275
Email: [email protected]
3. Financial or Grants Management Contacts:
Sean
Hine
Office of Grants Administration
National
Cancer Institute
6120
Executive Boulevard, Suite 243
Rockville, MD 20852
Telephone:
(301) 846-1005
FAX: (301)
846-5720
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided guidance
at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and compelling
justification is provided indicating that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human
Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008, investigators
must include the PubMed Central reference number when citing an article in NIH
applications, proposals, and progress reports that fall under the policy, and
was authored or co-authored by the investigator or arose from the
investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||