MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM

Release Date:  April 2, 2001

RFA:  RFA-CA-02-004

National Cancer Institute

Letter of Intent Receipt Date:  June 8, 2001
Application Receipt Date:       July 13, 2001

PURPOSE

The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), is 
continuing the established cancer control effort which involves practicing 
oncologists who serve large minority populations in the NCI clinical trials 
program.  The Community Oncology and Prevention Trials Research Group 
(COPTRG), DCP, invites domestic institutions with the capability and intent to 
serve new cancer patients largely from minority populations to apply for 
cooperative agreements in response to this Minority-Based Community Clinical 
Oncology Program (Minority-Based CCOP) Request for Applications (RFA).  
Currently funded Minority-Based CCOPs are also invited to respond to this RFA.

The NCI clinical trials program provides a network of support for clinical 
research in cancer centers, major university centers, and community programs.  
The purpose of this program is to support as a national resource those 
physicians involved in the care of minority cancer patients who are available 
for treatment and cancer prevention and control clinical trials research.  The 
linkage of minority cancer patients to the current clinical trials network 
will also facilitate the transfer of new technology in treatment and cancer 
prevention and control practices to minority communities and their physicians.

This reissuance of Minority-Based CCOP will:  1) provide support for expanding 
clinical research in minority community settings; 2) bring the advantages of 
state-of-the-art treatment and cancer prevention and control research to 
minority individuals in their own communities; 3) increase the involvement of 
primary health care providers and other specialists in cancer prevention and 
control studies; 4) establish an operational base for extending cancer 
prevention and control and reducing cancer incidence, morbidity, and mortality 
in minority populations; and 5) examine selected issues in Minority-Based CCOP 
performance (e.g., patient recruitment, accrual, eligibility).

This Minority-Based CCOP RFA seeks to strengthen the Minority-Based CCOP by: 
1) continuing the program as a vehicle for supporting community participation 
in cancer treatment and prevention and control clinical trials through 
research bases (clinical cooperative groups and cancer centers supported by 
NCI); 2) expanding and strengthening the cancer prevention and control 
research effort; 3) utilizing the Minority-Based CCOP network for conducting 
NCI-assisted cancer prevention and control research; and 4) evaluating on a 
continuing basis Minority-Based CCOP performance and its impact in the 
community.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas. This RFA, Minority-Based Community 
Clinical Oncology Program, is related to the priority area of human resource 
development.  Potential applicants may obtain a copy of "Healthy People 2010" 
at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications for cooperative agreements to continue or establish  
Minority-Based CCOPs may be submitted by domestic institutions only. 
Institutions, organizations and/or physician group applicants for the 
Minority-Based CCOP must document that at least 40 percent of their newly 
diagnosed cancer patients are from minority populations.  Other eligibility 
requirements for new applicants and currently funded programs are described 
below.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.
  
1. An applicant may be a hospital, clinic, group of practicing physicians, 
health maintenance organization (HMO), or consortium of hospitals and/or 
clinics and/or physicians and/or HMOs that agree to work together with a 
Principal Investigator and a single administrative focus.

2. A university hospital that is the major teaching institution for that 
university AND which has greater than 40 percent of its new cancer patients 
from minority populations is eligible to apply. 

3. A military treatment facility (MTF) or Veterans Administration hospital may 
be included in an application as a nondominant member of a consortium led by a 
community institution; 

4. Funded cooperative group affiliate program participants are eligible to 
apply, but should state in the application that support through this mechanism 
will be relinquished if a MB-CCOP award is received.
  
5. An unfunded non-university clinical trials cooperative group member is 
eligible to apply.
 
6. Funded Community Clinical Oncology Program (CCOP) participants are eligible 
to apply for competitive renewal, but should state in the application that the 
current CCOP support will be relinquished if a MB-CCOP award is received.

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

1. A comprehensive, consortial, or clinical cancer center holding both an NCI 
Cancer Center Support core grant and a clinical trials cooperative group U10 
award funded by the Division;
 
2. A university hospital clinical trials cooperative group member funded by 
the Division of Cancer Treatment and Diagnosis (DCTD), NCI; and

3. Foreign institutions.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U10), an "assistance" mechanism (rather than an 
"acquisition" mechanism), in which substantial NCI scientific and/or 
programmatic involvement with the awardee is anticipated during performance of 
the activity.  Under the cooperative agreement, the NCI purpose is to support 
and/or stimulate the recipient's activity by involvement in and otherwise 
working jointly with the award recipient in a partner role, but it is not to 
assume direction, prime responsibility, or a dominant role in the activity.  
Details of the responsibilities, relationships and governance of the study to 
be funded under cooperative agreement(s) are discussed later in this document 
under the section "Terms and Conditions of Award."

The total project period for applications submitted in response to this RFA 
may not exceed 3 years for new applicants, and no more than 5 years for 
applicants currently supported under this program.  Currently supported 
applicants will be funded for 3, 4, or 5 years depending upon priority 
score/percentile, review committee recommendations, and programmatic 
considerations.  The anticipated award date is June 1, 2002

NCI has determined that there is a continuing program need for community 
participation in cancer clinical research trials, both cancer treatment and 
prevention and control.  This RFA will be published in the NIH Guide for 
Grants and Contracts periodically, provided funds are available.

FUNDS AVAILABLE

It is anticipated that up to $900,000 in total costs per year for 5 years will 
be committed to specifically fund applications that are submitted in response 
to this RFA. It is anticipated that up to three (3) awards will be made.  
Because the nature and scope of the research proposed in response to this RFA 
may vary, award sizes are expected to vary also.  Levels of support also 
depend on the number of meritorious applications.  Although this program is 
provided for in the financial plans of NCI, awards pursuant to this RFA are 
contingent upon the availability of funds for this purpose. Awards for 
research bases affiliated with Minority-Based CCOPs will be made through 
Cooperative Agreements under the Community Clinical Oncology Program RFA.

NCI program staff will take into account demographic and geographic 
distributions of peer-reviewed and scored Minority-Based CCOPs in the final 
funding selection process. Multiple Minority-Based CCOP applicants who are 
proposing to use the same patient population will be considered for funding, 
but all may not be awarded unless warranted by the population density.

RESEARCH OBJECTIVES

A. BACKGROUND

The NCI clinical trials network has evolved over the past 30 years.  The major 
NCI program initiatives supporting this network are the Clinical Trials 
Cooperative Group Program, the Cancer Centers Program, and the Community 
Clinical Oncology Program (CCOP).  Treatment and cancer prevention and control 
clinical trials research funded through these programs provides patients and 
their physicians with access to state-of-the-art cancer care management 
opportunities, and provides oncologists with a source of continuing education 
on innovations in cancer prevention and control interventions, diagnostic 
techniques, and treatment applications.

One of the major efforts of NCI has been to design and implement program 
interventions to assure that patients treated in their own communities have 
access to the same quality of cancer care and the same technological advances 
that are available to patients treated in major centers.  The CCOP, which was 
first initiated in 1983, has proven to be a successful model for bringing the 
benefits of clinical research to cancer patients in their communities by 
providing support for community physicians to enter patients on treatment 
research protocols.  In addition to increasing patient accrual to treatment 
clinical trials, the CCOP stimulated many communities to organize their cancer 
activities and expedited the development of local-regional cancer programs. 

Increased numbers of physicians, hospitals, and other health care 
professionals participated in the CCOP, accruing patients and meeting the same 
quality control standards as other members and affiliates. In 1987, the CCOP 
expanded the cancer prevention and control effort to include support for 
research in prevention, health promotion, smoking cessation, chemoprevention, 
treatment applications, continuing care and rehabilitation.  With the 
development and implementation of cancer control research through the clinical 
trials network, opportunities exist for the implementation of effective 
preventive strategies for reducing cancer incidence, morbidity, and mortality.

When compared to the general population, African-Americans have an increased 
incidence of a number of malignancies and worse overall survival rates.  
Greater involvement in clinical trials research by Black, Hispanic, 
Asian-American, American Indian, and other racial/ethnic minority patients is 
needed if the advances in clinical research are to be extended to all groups, 
and the results of clinical trials are generalizable to the entire population.  
In general, there has been limited participation in clinical trials research 
by minority cancer patients.

Broader access to clinical research protocols is needed in order to develop 
and implement effective treatment and cancer prevention and control strategies 
in minority populations.  Areas of research where minority involvement is 
especially needed include:  cancer prevention and control, interventions to 
improve screening and early detection practices; methodological research on 
ways to increase the educational awareness of individuals at risk for cancer; 
and studies of barriers to prevention and treatment of cancer.  The 
Minority-Based CCOP has become an important part of these efforts.  It links 
physicians caring for large numbers of minority patients to the NCI clinical 
trials network.

The CCOP model has been an effective mechanism for facilitating the linkage of 
investigators and their institutions with the clinical trials network.  The 
Minority-Based CCOP was initially approved by the NCI, Division of Cancer 
Prevention Board of Scientific Counselors in January 1989.  Implementation 
began in the fall of 1990.  By 1992 the program was beginning to succeed in 
its goal of providing minority populations access to clinical trials.  In the 
year ending 2000, there were eight programs in seven states and Puerto Rico 
involving approximately 40 hospitals and over 420 physicians.

In the past, approximately 70 percent of Minority-Based CCOP patients entered 
on study have been minority populations.  In one study, 14.1 percent of all 
patients entered onto NCI sponsored treatment trials were from ethnic 
minorities.  These Minority-Based CCOPs contributed more than 10 percent of 
all minority accrual to NCI-sponsored cancer treatment trials.

B. OBJECTIVES AND SCOPE

The Minority-Based CCOP initiative is designed to: (1) Bring the advantages of 
state-of-the-art cancer treatment and prevention and control research to 
minority individuals in their own communities by having practicing physicians 
and their patients/participants participate in NCI-approved cancer treatment 
and prevention and control clinical trials; (2) Provide a basis for involving 
a wider segment of the community in cancer prevention and control research and 
investigate the impact of cancer therapy and control advances in community 
medical practices; (3) Increase the involvement of primary health care 
providers and other specialists (e.g., surgeons, family practitioners, 
urologists, gynecologists) with the Minority-Based CCOP investigators in 
cancer treatment and prevention and control research, providing an opportunity 
for education and exchange of information; (4) Facilitate wider community 
participation among racial/ethnic minorities, women, and other underserved 
populations in cancer treatment and prevention and control research approved 
by NCI; (5) Provide an operational base for extending cancer control and 
reducing cancer incidence, morbidity, and mortality in minority populations by 
accelerating the transfer of newly developed cancer prevention, early 
detection, treatment, patient management, rehabilitation, and continuing care 
technology to widespread community application; and (6) Examine selected 
issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, 
eligibility, patient behavioral modification) and evaluate its impact in the
community.

Participating community programs (Minority-Based CCOPs) will be required to 
enter patients/ participants onto NCI-approved cancer treatment and prevention 
and control clinical trials through the research base(s) with which each 
Minority-Based CCOP is affiliated.  Minority-Based CCOPs may contact NCI 
program staff directly for assistance and participation in selected cancer 
prevention and control protocols.  Minority-based CCOP performance will be 
evaluated on a continuing basis by the NCI program director.

Minority-Based CCOP applicants must demonstrate the potential for accessing 
appropriate cancer patients/participants within their communities for 
participation in cancer treatment and prevention and control protocols 
provided by their research bases.

SPECIAL REQUIREMENTS

TERMS AND CONDITIONS OF AWARD

The administrative and funding instrument used for this program is a 
cooperative agreement (U10), and anticipated assistance to awardees from the 
NCI Program Staff will include: clarification of Minority-Based CCOP 
requirements; review of accrual to clinical trials; monitoring of community 
efforts to increase minority participation in clinical research; participation 
in protocol review; and discussions on the continuing needs of the program for 
enhancing Minority-Based CCOP performance.

Under the cooperative agreement, the NIH purpose is to support and/or 
stimulate the recipient's activity by involvement in and otherwise working 
jointly with the award recipient in a partnership role, but it is not to 
assume direction, prime responsibility, or a dominant role in the activity. 
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardee(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
the awardees and the NCI Program Staff.

The following terms and conditions pertaining to the scope and nature of the 
interaction between NCI and the investigators will be incorporated in the 
Notice of Award.  These terms will be in addition to the customary 
programmatic and financial negotiations which occur in the administration of 
grants.  The terms and conditions described in this section are in addition 
to, and not in lieu of, otherwise applicable OMB administrative guidelines; 
HHS Grant Administration Regulations at 45 CFR part 74; other HHS, PHS, and 
NIH Grant Administration
policy statements; and other NCI administrative terms of award.

A. MINORITY-BASED CCOP AWARDEES RIGHTS AND RESPONSIBILITIES

The awardee's programmatic responsibilities for the conduct of the research 
supported by this cooperative agreement are described in the following 
documents: the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical 
Trials of Investigational Agents Sponsored by the Division of Cancer Treatment 
and Diagnosis (DCTD), National Cancer Institute and available at the following 
URL: http://ctep.cancer.gov/handbook; and the NCI-CTMB 
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS 
AND CCOP RESEARCH BASES available at the URL: 
http://ctep.cancer.gov/monitoring/guidelines.html and any subsequent 
modifications of this document; and the Intellectual Property Option to 
Collaborator that can be found at the URL address: 
http://ctep.cancer.gov/industry/ipo.html.   
These documents are hereby incorporated by reference as terms of award and are 
available at the URL sites referenced above or from program staff listed under 
“INQUIRIES”.

1. Protocols

All protocols originating from and/or coordinated by the research bases for 
Minority-Based CCOPs use must be reviewed and approved by the Cancer 
Prevention and Control Protocol Review Committee (CPCPRC), Division of Cancer 
Prevention (DCP) and/or the Protocol Review Committee (PRC), Division of 
Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation.  
Protocols will be assigned credit once they are approved by the review 
committee.

Each research base protocol approved for Minority-Based CCOP use will be 
assigned a credit value.  Credits will be based on the complexity of the 
intervention, the amount of data management required, and the duration of 
follow-up.  For example, each patient accrued to an average Phase II or Phase 
III treatment protocol will count 1 credit; and an NCI-designated high-
priority treatment protocol 1.5 credits. Cancer prevention and control 
protocols will be assessed for credit using a similar approach.  For example, 
a randomized Phase III chemoprevention protocol will be assigned a value of 1 
credit per participant entered.  Cancer control protocols involving limited 
interventions will receive credit that is commensurate with the amount of data 
management effort required.  Follow-up credit for chemoprevention protocols 
may also be assigned.

To receive credit for accruals the Minority Based-CCOP must access NCI-
approved treatment and/or prevention and control protocols through the 
research bases with which it has affiliation agreements.  The research base is 
responsible for the development and implementation of high quality cancer 
treatment and prevention and control clinical trials, and for evaluation of 
the results of such studies  The Minority-Based CCOP also may access treatment 
trials from research bases with which it is not affiliated through the NCI’s 
Cancer Trials Support Unit (CTSU).  Minority-Based CCOP accruals to protocols 
will receive credits and not per case reimbursement.  The purpose of the CTSU 
is to broaden access to clinical trials and to streamline and centralize 
administrative, financial and data collection task associated with conducting 
NCI-approved treatment trials.

Minority-Based CCOPs are encouraged to participate in cancer prevention and 
control research that is supported through other federal administrative and 
funding instruments.   This activity is encouraged because the cooperative 
agreements awarded under this RFA primarily support development and conduct of 
studies evaluating an intervention.  Research supported through these other 
mechanisms might include nonintervention research in cancer control (e.g., 
epidemiology, methods development, population-based surveys, etc.).  Minority-
Based CCOP participation in these studies would advance cancer prevention and 
control research and improve public health outcomes.  This activity will be 
considered in the evaluation of the Minority-Based CCOP’s productivity.

2. Research Base Affiliation(s)

Each Minority-Based CCOP must affiliate with one national multi-specialty 
cooperative group (research base) having a spectrum of cancer treatment and 
prevention and control clinical trials.  Each Minority-Based CCOP can 
affiliate with a maximum of four additional research bases exclusive of the 
national multi-specialty cooperative groups (exceptions may be granted in 
conjunction with participation in an NCI sponsored “pilot” project).  
Affiliation with a sixth research base may be considered if it is with one of 
the cancer center CCOP research bases that participates in only cancer 
prevention and control research. 

Note:  A list of currently eligible research bases may be obtained from the 
URL: http://dcp.nci.nih.gov/corb/ or from the Community Oncology and 
Prevention Trials Research Group at (301) 496-8541..

If participation in the protocols of one group competes with that of another 
group with which the Minority-Based CCOP is affiliated, the Minority-Based 
CCOP must prioritize the protocols in order to avoid bias in the allocation of 
patients to competing protocols.  Initial affiliations should be maintained 
for the duration of the funding cycle.  When circumstances require changes in 
research base affiliations, prior written approval from the DCP Program 
Director is required.    The Guidelines for Obtaining Approval of Minority-
Based CCOP Organizational Changes may be obtained from the following URL 
address: http://dcp.nci.nih.gov/corb/

3. Accrual

Patient accrual to clinical trials is expected to be reflective of the new 
cancer patient distribution of the participating physicians; that is, greater 
than 40 percent of new cancer patients from minority populations. An 
additional measure of performance is that at least 10 percent of all new 
cancer patients for whom protocols are available will be placed on clinical 
trials by Minority-Based CCOP physicians.

Each Minority-Based CCOP is required to accrue a minimum of 50 credits per 
year to treatment clinical trials that have been approved by the PRC, DCTD, 
NCI.    The 50 credit minimum to treatment requirement may be waived for: 1) 
those applicants whose speciality is pediatrics and are able to place a 
majority of their eligible patients on protocols; and 2) for those applicants 
with an outstanding record in accrual to cancer prevention and control 
protocols.

Each Minority-Based CCOP is eventually required to accrue the minimum of 50 
credits per year to cancer prevention and control clinical trials that have 
been approved by the CPCPRC, DCP.  Cancer prevention and control research 
should be intervention-oriented and may include such areas as cancer 
prevention, early detection, symptom management, rehabilitation, quality of 
life, and continuing care.  New Minority-Based CCOP Awardees are required to 
accrue a minimum of 30 cancer control credits in the first year of funding, 40 
credits in the second year, and 50 credits thereafter in cancer prevention and 
control.

Existing Minority-Based CCOPs undergoing competitive renewal are expected to 
accrue a minimum of 50 credits per year in cancer treatment and 50 credits per 
year in prevention and control.

The 50 credit minimum to cancer prevention and control requirement may be 
waived for those applicants whose speciality is pediatrics and are able to 
place a majority of their eligible patients on protocols.

The Minority-Based CCOP's ability to meet projected accrual goals to both 
cancer treatment and prevention and control clinical trials will also be 
assessed by the program directors.  The ability to incrementally accrue and 
maintain minority enrollment will be assessed and weighted toward credits 
gained.

In addition, Minority-Based CCOPs are encouraged to participate in cancer 
prevention and control research that is supported through other federal 
administrative and funding instruments, such as investigator-initiated awards.  
Collaborations between Minority-Based CCOPs and independent investigators may 
facilitate the implementation of a wide variety of nonintervention research in 
cancer control such as descriptive, qualitative, survey, methods development 
or epidemiology that will contribute to improving public health outcomes.   
Participation in such research will be considered in the evaluation of 
Minority-Based CCOP’s productivity.

4. Quality Control

In accordance with research base guidelines and NCI policies, the Minority-
Based CCOP must establish and follow procedures for the assurance of data 
quality and for the prevention and/or identification of false or otherwise 
unreliable data.  The Minority-Based CCOP must follow policies developed by 
the research bases with which they are affiliated  and approved by the NCI for 
auditing the accuracy of scientific data submitted to them by the Minority-
Based CCOP participants.  A list of the research bases can be found at the URL 
address: http://dcp.nci.nih.gov/corb/.

5. Data Management

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

6. Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected, 
in cooperation with NCI, to comply with all FDA monitoring and reporting 
requirements for investigational agents.  Specifically, all Minority-Based 
CCOP investigators accruing patients must have an active NCI investigator 
number. 

7. Monitoring

Each Minority-Based CCOP must agree to periodic on-site audits by 
representatives of its research base(s), NCI, or an NCI-designee. Such on-site 
audits may include review of the following: use of investigational drugs; 
compliance with regulations for institutional review board (IRB) approval and 
informed consent (compliance with 45 CFR 46); compliance with protocol 
specifications; quality control and accuracy of data recording; and 
completeness of reporting adverse drug reactions.

Research Base evaluation reports of such on-site audits will be reviewed by 
the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation 
Program (CTEP), DCTD, and by the DCP Program Director.  In addition, NCI 
program and grants management staff will review protocol accrual, fiscal, and 
administrative procedures.

All institutions participating or collaborating in the Minority-Based CCOPs on 
NCI-supported multi-institutional clinical trials must be in compliance with 
the monitoring standards established by the research base.  They should 
include the following standards: (1) Medical records submitted in support of 
NCI multi-institutional trials must conform to usual standards for the 
maintenance of clear, accurate, and unambiguous medical records.  White-outs 
on medical records are unacceptable; (2) If it is the usual and customary 
practice of a department, laboratory, clinic or office to prepare or issue 
official reports, then only that department, laboratory, clinic or office can 
change the report, and alterations of the medical record must be initialed and 
dated by the person making such alterations.  For clinical progress notes, the 
change must be dated and initialed by the person making the change.  Only one 
line should be placed through the initial entry, so that both the original 
entry and the change are legible; (3) The improper modification of important 
patient records will result in additional investigations by the NCI Clinical 
Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and 
funding.

8. 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 protocols requiring radiation therapy, as required by the 
affiliated research base(s).

9. Organizational Changes

Certain Minority-Based CCOP organizational changes must have the prior written 
approval of the DCP Program Director.  These include the addition/deletion of 
a participating physician, a health care professional other than a physician 
(who actively enters patients to cancer prevention and control trials), an 
affiliate, component, or research base.    The Guidelines for Obtaining 
Approval of Minority-Based CCOP Organizational Changes may be obtained from 
the URL address: http://dcp.nci.nih.gov/corb/

10. Reporting Requirements

Annual progress reports must be submitted to DCP.  A suggested format will be 
provided for this purpose.  The format may be found at the URL address: 
http://dcp.nci.nih.gov/corb/.  The inability of a Minority-Based CCOP to meet 
the performance requirements set forth in the Terms and Conditions of Award in 
the RFA, or significant changes in the level of performance, may result in an 
adjustment of funding, withholding of support, suspension, or termination of 
the award.

11. Network Participation

Minority-Based CCOPs are part of a national network for conducting cancer 
treatment and prevention and control clinical trials.  As such, each 
Minority-Based CCOP may be asked to participate in strategy sessions or 
workshops and in the continuing evaluation of the program and its impact in 
the community.  Minority-Based CCOPs may also be asked to share their process 
and outcome methods for recruiting and maintaining minority enrollment.

12. Patient/Participant Log

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

13. Federally Mandated Regulatory Requirements

Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS 
regulations for the protection of human subjects.  At a minimum, these 
include:  (1) methods for assuring that each facility at which CCOP 
investigators are conducting clinical trials has a current, approved assurance 
on file with the Office of Human Research Protections (OHRP); that each 
protocol is reviewed by the responsible IRB prior to patient entry; and that 
each protocol is reviewed annually by the IRB so long as the protocol is 
active; (2) methods for assuring or documenting that each patient (or 
patient's parent/legal guardian) gives fully informed written consent to 
participation in a research protocol prior to the initiation of the 
experimental intervention; (3) a system for assuring timely reporting of all 
serious and unexpected toxicities to the Investigational Drug Branch, CTEP, 
DCTD, according to DCTD guidelines and/or to DCP according to DCP guidelines; 
(4) implementation of DCP/DCTD requirements for storage and accounting for 
investigational agents provided under DCP/DCTD sponsorship; and (5) education 
on the protection of human research participants for all investigators 
involved in the design or conduct of research involving human subjects.

14. Publications

Timely publication of major findings is encouraged.  Publication or oral 
presentation of work done under this agreement requires acknowledgment of NCI 
support.

B. NCI STAFF INVOLVEMENT

1. Protocol Review

To be eligible for credit assignment protocols must be reviewed and approved 
by the CPCPRC, DCP , and/or the PRC, DCTD, NCI, prior to implementation.  
Credit will be assigned after the protocol is approved..  

NCI will not provide investigational drugs, permit expenditure of NCI funds, 
or allow accrual credit for a protocol that has not been approved or that has 
been closed (except for patients already on study).

2. Monitoring

There will be periodic on-site audits of each Minority-Based CCOP by 
representatives of its research base(s), NCI, or an NCI-designee, such as 
DCTD's current Clinical Trials Monitoring Service contractor.

The DCP and CTMB/CTEP will review and provide advice regarding mechanisms 
established for study monitoring, including the on-site auditing program.  
DCP/CTEP and/or its contractor staff may attend the on-site audits conducted 
by the research base or its NCI designee as observers.

3. Data Management

The DCP Program Director will have access to all data generated under this 
award and will periodically review the data management procedures of the 
Minority-Based CCOPs.  Data must also be available for external monitoring if 
required by NCI's agreement with other Federal agencies, such as the Food and 
Drug Administration (FDA).

4. Investigational Drug Management

The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB), 
CTEP, DCTD and the Chemopreventive Agent Development Research Group, DCP will 
advise investigators of specific requirements and changes in requirements 
about investigational drug management that the FDA and NCI may mandate.

5. Organizational Changes

The DCP Program Director will review requests for certain organizational 
changes and provide written approval.  These changes include the 
addition/deletion of a participating physician or other health professional 
entering patients/participants in cancer prevention and control research in 
the Minority-Based CCOP, an affiliate, component, or research base.  The 
Guidelines for Obtaining Approval of CCOP Organizational Changes may be 
obtained from the URL address: http://dcp.nci.nih.gov/corb/

6. Program Review

The DCP Program Director will review the annual progress report submitted by 
each Minority-Based CCOP.  A suggested format will be developed by the DCP 
Program Director for this purpose.  The DCP Program Director will review the 
progress of each Minority-Based CCOP through consideration of the 
Minority-Based CCOP annual report, program site visits, and reports from 
affiliated research bases.  This review may include, but not be limited to, 
overall accrual credits, percent of available patients/participants placed on 
study, eligibility and evaluability of individuals entered on study, and 
timeliness and quality of data reporting.  The inability of a Minority-Based 
CCOP to meet the performance requirements set forth in the Terms and 
Conditions of Award, or significant changes in the level of performance, may 
result in an adjustment of funding, withholding of support, suspension or 
termination of the award.

7. Strategy Sessions

The DCP Program Director or designee will sponsor strategy sessions when 
indicated, attended by principal investigators from the Minority-Based CCOPs 
and appropriate DCP/DCTD staff.  At these meetings, information relevant to 
the Minority-Based CCOPs will be reviewed and discussed, including such issues 
as overall Minority-Based CCOP performance and the science of current or 
proposed clinical trials.  Data will be analyzed and the outstanding research 
questions established and prioritized into national research goals by 
Minority-Based CCOP investigators and the DCP/DCTD attendees.  The principal 
investigators will have the primary responsibility for analyzing and 
prioritizing the research questions to be developed into clinical trials.  The 
DCP Program Director will also assist the Minority-Based investigators in 
exploring mutual interests in cancer prevention and control research.

8. Federally Mandated Regulatory Requirements

The DCP Program Director or designee and DCTD staff will review mechanisms 
established by each Minority-Based CCOP to meet the Department of Health and 
Human Service (DHHS) / Public Health Service (PHS) regulations for the 
protection of human subjects and FDA requirements for the conduct of research 
using investigational agents.

C. ARBITRATION PROCESS

NCI will establish an arbitration process when a mutually acceptable agreement 
cannot be obtained between the awardee and the involved NCI Program Staff 
related to program performance and programmatic decisions on scientific 
technical matters.  An arbitration panel (with appropriate expertise) composed 
of one member of the recipient group, one NCI nominee, and a third member 
chosen by the other two will be formed to review the NCI decision and 
recommend a course of action to the Director, DCP.  These special arbitration 
procedures in no way affect the awardee's right to appeal an adverse action in 
accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulations 
at 45 CFR Part 16.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete 
copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

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” that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

Note:  Applicants for National Cancer Institute funding who propose clinical 
research for adults with cancer may use language similar to the following for 
the “Participation of Children” section of their application:

This Minority-Based CCOP project does not include children because the number 
of children with cancer is limited and because the majority are already 
accessed by a nationwide pediatric cancer research network.  This exemption is 
based on Exclusion 4b of the NIH Policy and Guidelines on the Inclusion of 
Children as Participants in Research Involving Human Subjects.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants and Contracts, June 5, 
2000 (Revised August 25, 2000), available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 8, 2001, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title 
of the RFA in response to which the application is being submitted.  Although 
a letter of intent is not required, is not binding, and does not enter into 
the review of subsequent applications, the information allows NCI staff to 
estimate the potential review workload and to plan the review.

The letter of intent should be sent to Dr. Worta McCaskill-Stevens listed 
under INQUIRIES.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

A. Preparation of Applications

The research grant application form PHS-398 (Rev. 4/98) is to be used in 
applying for cooperative agreements.  Application kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Research and Information Resources, National Institutes 
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, Maryland 20892-7910, 
Telephone: 301/435-0714; e-mail: grantsinfo@nih.gov.  For those applicants 
with internet access, the 398 kit may be found at 
http://grants.nih.gov/grants/forms.htm.

A suggested format will be available at the URL address: 
http://dcp.nci.nih.gov/corb/.  All applicants are encouraged to obtain and use 
the suggested format instructions for organizing the specific information 
concerning the RFA programmatic requirements in the PHS 398.  If tables from 
the "Suggestions for Organizing Information for a MBCCOP Application" are 
included, those tables should be part of the body of the application, and NOT 
included in the appendix.  Also, responses to the instructions concerning 
"Human Subjects" verification must be provided when the application is 
initially submitted.

Because the Terms and Conditions of Award (discussed in the SPECIAL 
REQUIREMENTS Section above) will be included in all awards issued as a result 
of this RFA, it is critical that each applicant include specific plans for 
responding to these terms.  Plans must describe how the applicant will comply 
with NCI staff involvement as well as how all the responsibilities of awardees 
will be fulfilled.

An application from a currently funded program will be a competitive renewal 
and must include a progress report that, at a minimum, consists of the 
following: (1) A summary of prior Minority-Based CCOP 
activities/accomplishments, including: a clear presentation of yearly accrual 
over the funding period (i.e. accrual tables from previous annual progress 
reports), a summary of accrual to all cancer treatment and a summary of 
accrual to all cancer prevention and control protocols by gender and 
ethnicity; and progress in meeting DCP's established accrual goals.  (2) A 
plan for continuing to meet prevention and control accrual requirements, 
including plans for follow-up of participants from the large prevention trials 
as well as plans for implementation of additional cancer control protocols.  
(3) Tables of the current budget and FTEs with a justification for any request 
for additional resources.  (4) An evaluation of Minority-Based CCOP 
performance by affiliated research base(s).  (5) A complete description of how 
the applicant has met the special cooperative agreement terms and conditions 
of the award including staffing patterns that may have significantly 
contributed to minority involvement in clinical trials.

Both new and currently funded applicants should address the following:

1. Each applicant must demonstrate access to a population in which at least  
40 percent of new cancer patients are from minority groups and must include 
plans for recruiting and maintaining women and minority participants.  Data 
from hospital registries (analytic cases), admission, discharge, clinic, and 
billing records may be used to document the new minority cancer patient 
population available to the applicant organization AND its physician 
participants. In describing the study population, a breakdown, by percentage 
of the gender and minority composition of the study population, should be 
provided.  This information may be based on the institutional records and/or 
prior experience.

2. Each applicant must delineate its catchment area.  A map of the service 
area should be provided, designating counties or zip codes from which 
approximately 80 percent of the patients will be drawn.  A description of 
other cancer care resources in the catchment area (i.e., hospitals, clinics, 
physicians, cancer centers) that are not part of the application should be 
included.

3. Each applicant must demonstrate the potential and stated commitment to 
accrue a minimum of 50 credits per year to treatment clinical trials (except 
if waived for applicants whose specialty is pediatrics and are able to place a 
majority of their eligible patients on protocols or those applicants with an 
outstanding record in cancer prevention and control accrual).  Documentation 
must include any prior participation in treatment research clinical trials 
with a clear presentation of the number of patients and credits accrued to 
NCI-approved treatment clinical trials.  A list of the NCI-approved treatment 
protocols in which the applicant expects to participate and the projected 
accrual to each must be provided.

4. Each new applicant must demonstrate the potential and plans for accrual of 
a minimum of 30 credits in the first year of funding, 40 credits in the second 
year, and 50 credits in the third year to cancer prevention and control 
protocols.  Documentation must include any prior participation in cancer 
prevention and control research clinical trials with a clear presentation of 
the total number of patients and credits accrued to NCI-approved cancer 
prevention and control clinical trials.  A list of the NCI-approved prevention 
and control protocols in which the applicant expects to participate and the 
projected accrual to each must be provided. A complete listing of NCI-approved 
cancer prevention and control clinical trials can be requested from the NCI 
program staff listed under “INQUIRIES”.

If applicable, Minority-Based CCOPs should describe their participation in 
cancer prevention and control research studies supported through other federal 
administrative and funding instruments such as research project grants (R01s) 
and contracts.  Participation in such research will be considered in the 
evaluation of Minority-Based CCOP productivity.

5. NEW applicants must provide an implementation plan for at least two 
examples of NCI-approved intervention cancer prevention and control protocols 
appropriate for Minority-Based CCOP participation.  For these two protocols, 
the applicant should describe their implementation, including specifics on 
patient/participant recruitment, compliance, and follow-up.  These studies 
must come from research bases with which they propose to affiliate.

The Minority-Based CCOP applicant must document the ability to access the 
appropriate physicians and patient/participant populations and adequate 
facilities to participate in the proposed clinical trials.

6. A designated Principal Investigator is required.  An associate Principal 
Investigator should also be named to assure continuity in the event of 
resignation of the Principal Investigator.  The qualifications and experience 
of both  must be described in terms of ability to organize and manage a 
community oncology program which includes cancer treatment and prevention and 
control research and related activities as well as experience in accruing 
patients/participants to treatment and cancer prevention and control clinical 
trials must be described.

7. Each applicant is expected to have a committed multi disciplinary 
professional group appropriate for its expected protocol participation.  This 
team may include medical oncologists, surgeons, radiation oncologists, 
pathologists, oncology nurses, data managers, health educators, and other 
disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family 
practice) as appropriate.  Where appropriate, each applicant should include 
plans to utilize minority professionals to assure accrual success.  The 
training and experience of participating physicians must be provided, along 
with a description of working relationships. Any experience working together 
as a group, particularly in implementing clinical cancer treatment and 
prevention and control research and related activities, should be included.  
An organizational chart showing how the group will function must also be 
included.

Special personnel resources needed to support the recruitment and retention of 
eligible minority patients on clinical trials may be requested.

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

9. Through formal affiliations with only one multi-specialty cooperative group 
(exceptions may be granted in conjunction with participation in an NCI 
sponsored “pilot” project) and up to four additional research bases, each 
applicant must demonstrate access to both cancer treatment and prevention and 
control research protocols.  Evidence must be provided that an affiliation has 
been established with at least one NCI- funded research base that has the 
capacity to provide both clinical cancer treatment and prevention and control 
protocols.  In addition, affiliations with research bases offering only cancer 
prevention and control protocols are appropriate.  Affiliation with a sixth 
research base may be considered if it is with one of the cancer center CCOP 
research bases that participates in only cancer prevention and control 
research.  The conditions of affiliation must be provided in the 
Minority-Based CCOP-research base affiliation agreement(s).  Initial 
affiliations should be maintained during the funding cycle.

Multiple research base affiliations are permitted provided they are not 
conflicting.  The affiliation agreements must state specifically how the 
problem of competing protocols will be resolved.

Note:  A list of currently eligible research bases may be obtained from the 
following URL: http://dcp.nci.nih.gov/CORB/ or from the Community Oncology and 
Prevention Trials Research Group at (301) 496-8541

10. Quality control procedures must be described in detail.  Assurance of 
quality is the joint responsibility of the Minority-Based CCOP and its 
research base(s).  Quality control procedures of the research base will be 
applied to the Minority-Based CCOPs and should be specified in the affiliation 
agreement between the Minority-Based CCOP and the research base.  Procedures 
for investigational drug monitoring and data management must also be 
described.

11. 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.  Evidence of 
involvement with community-based voluntary organizations may be submitted. In 
addition, each applicant must have a defined space for administrative 
activities and administrative personnel which will serve as a focus for data 
management, quality control, and communication.

12. 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, 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).  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 Principal Investigator (PI) and Co-PI, specifically for time spent on 
Minority-Based CCOP organizational/ administrative tasks.  Justification must 
be provided for personnel time, effort, and funds requested.

B. Method of Applying

The RFA label available in the PHS-398 (Rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  

In addition, the RFA title and number must be typed on line 2 of the face page 
of the application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three (3) signed, photocopies, in one package to:

Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040-MSC 7710
Bethesda, Maryland  20892-7710
(20817 for courier service)

Photocopies must be clear and single-sided.  At the time of submission, two 
(2) additional copies of the application must also be sent to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC-8239
Rockville, Maryland 20852 (for courier service)
Bethesda, Maryland  20892-8239

It is important to send these copies at the same time that the original and 
three (3) copies are sent to CSR; otherwise, the NCI cannot guarantee that the 
applications will be reviewed in competition with other applications received 
on or before the designated receipt date.

Applications must be received by July 13, 2001.  If an application is received 
after that date, it will be returned to the applicant without review.  The 
Center for Scientific Review (CSR) will not accept any application in response 
to this announcement that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such an application must 
follow the guidance in the PHS Form 398 application instructions for the 
preparation of revised applications, including an introduction addressing the 
previous critique.

REVIEW METHODS

A. REVIEW PROCEDURES

Upon receipt, applications will be reviewed for completeness by CSR staff and 
for responsiveness by NCI staff.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

Those applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer review 
group convened by the NCI in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the applications under 
review, will be discussed, assigned a priority score, and receive a second 
level review by the appropriate National Cancer Advisory Board.

B. REVIEW CRITERIA

1. Ability to access through participating Minority-Based CCOP physicians a 
population in which at least 40 percent of new cancer patients are from 
minority groups. In describing the study population, it is required that a 
description of the gender and minority population served be provided, 
including an outreach plan and utilization of minority personnel.  This 
information may be based on institutional records and/or prior experience.

2. For new applicants, ability to accrue a minimum of 50 credits per year to 
treatment clinical trials and a minimum of 30 credits per year to cancer 
prevention and control clinical trials in the first year, increasing to 50 
credits per year in the third year.  Established Minority-Based CCOPs may be 
funded at a yearly accrual goal higher than 50 credits for treatment clinical 
trials and 50 credits for cancer prevention and control clinical trials.  
These established Minority-Based CCOPs will be evaluated for their past 
performance in meeting these accrual goals.  The minimum accrual to treatment 
requirements may be waived for: 1) applicants whose specialty is pediatrics 
and are able to place a majority of their eligible patients on protocol; and 
2)  for applicants with an outstanding record in accrual to prevention and 
control protocols.  Each applicant's ability to access the appropriate 
populations, professional disciplines, and facilities to participate with 
affiliated research bases in NCI-approved cancer prevention and control 
intervention protocols will be appraised.  Any prior participation in cancer 
treatment and prevention and control research will be considered.

Minority-Based CCOPs participation in cancer prevention and control research 
studies supported through other federal administrative and funding instruments 
such as research project grants (R01s) and contracts will be considered in the 
evaluation of the Minority-Based CCOP’s productivity

 3. Qualifications, experience and track record of the Principal 
Investigator/associate Principal Investigator, in terms of ability to organize 
and manage a community oncology program that includes both cancer treatment 
and prevention and control research and related activities.

4. Training, experience, and commitment of participating physicians for 
accruing individuals to protocols in which the applicant has agreed to 
participate.  The experience of proposed investigators in the entry and 
treatment of cancer patients on research trials (gained from residency, 
fellowships, postdoctoral training and/or subsequent practice) will be 
appraised.  For multi disciplinary studies, evidence of the availability of 
appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, 
gynecology, urology, pathology, internal medicine, family practice, nursing, 
and nutrition) will be required.  Experience or special skills in cancer 
prevention and control research and related activities will be considered, 
together with availability of other community resources and personnel for such 
clinical trials.

5. Stability of the functional unit or group applying to become a 
Minority-Based CCOP.  Preexisting organizational affiliations of at least a 
core of the group applying and evidence of stable working relationships will 
be appraised.  Examples of established consortium arrangements and committee 
structure which demonstrate the participation of appropriate physicians and 
administrators may be submitted.  Evidence of previous success as a group in 
implementing clinical cancer treatment and prevention and control research and 
related activities will be considered.

6. Qualifications and experience of all proposed support personnel relative to 
their position descriptions.  The relevant credentials and expected 
contributions to the program of personnel not fiscally supported by the award 
will be considered.

7. Adequacy of quality assurance mechanisms for both cancer treatment and 
prevention and control interventions, and adequacy of procedures for 
investigational drug monitoring and data management identification of false or 
otherwise unreliable data.

8. Adequacy of available facilities, including laboratories, in-patient and 
outpatient resources, cancer registries, etc., and adequacy of space for 
administrative activities and personnel.

9. Appropriateness of research base affiliations and of the cancer treatment 
and prevention and control research protocols chosen.  Affiliation agreements 
must be provided in the application.

10. For competitive renewals, adequacy of progress during the funding period, 
including ability to meet the minimum accrual credits in cancer treatment and 
prevention and control, progress made as a Minority-Based CCOP, and evaluation 
of Minority-Based CCOP performance by affiliated research bases(s).  
Consideration will be given to previous accrual and the ability to meet the 
previous accrual projections for which the Minority-Based CCOP was funded.  
Minority-Based CCOP evaluation by affiliated research bases must be provided.  
Plans for continued accrual and follow-up of participants on protocols will be 
evaluated.

The review group will critically examine the submitted budget and will 
recommend an appropriate budget and period of support for each favorably 
recommended application.

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

The initial review group will also examine: the appropriateness of the 
proposed project budget and duration; the adequacy of plans to include both 
genders and minorities and their subgroups and plans for the recruitment and 
retention of subjects; the provisions for the protection of human and animal 
subjects; and the safety of the research environment.

AWARD CRITERIA

The anticipated date of award is June 1, 2002.  Applications recommended by 
the National Cancer Advisory Board will be considered by NCI program staff for 
award based upon (a) scientific and technical merit; (b) demographic and 
geographic distribution of applicants to assure inclusion of minority and 
underserved populations; and (c) availability of funds.  Multiple 
Minority-Based CCOP respondents who are competing for the same patient 
population will be considered, but all may not be awarded unless warranted by 
the population density.

SCHEDULE

Letter of Intent Receipt Date:  June 8, 2001
Application Receipt Date:       July 13, 2001
Review by NCAB Advisory Board:  February 2002
Anticipated Award Date:         June 1, 2002

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.

Direct inquiries regarding programmatic issues to:

Worta McCaskill-Stevens, MD
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 305-D, MSC-7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
FAX:  (301) 496-8667
Email:  wm57h@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8239
Bethesda, MD  20892-8239
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 496-0275
Email:  tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800
FAX:  (301) 496-8601
Email: crystal.wolfrey@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.399, Cancer Control.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92. This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the nonuse 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.


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