MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM

RELEASE DATE:  May 16, 2003

RFA:  CA-04-007  (see reissuance RFA-CA-05-015)

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.399

LETTER OF INTENT RECEIPT DATE:  June 16, 2003

APPLICATION RECEIPT DATE:  July 14, 2003  

This RFA is a reissuance of RFA-CA-03-012, which was published in the NIH 
Guide on April 24, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

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.

RESEARCH OBJECTIVES

Background

The NCI clinical trials network has evolved over the past 35 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, 
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 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 
2002, there were eleven (11) programs in eight states, the District of 
Columbia and Puerto Rico involving approximately 40 hospitals and over 500 
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.

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.

MECHANISM OF SUPPORT

This RFA will use NIH U10 award mechanism.  The NIH U10 is a cooperative 
agreement award mechanism in which the Principal Investigator 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 
"Cooperative Agreement Terms and Conditions of Award"

This RFA uses just-in-time concepts. It uses the non-modular budgeting formats 
so follow the instructions for non-modular research grant applications.  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

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, 
review committee recommendations, and programmatic considerations.  The 
anticipated award date is June 1, 2004.

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.  

FUNDS AVAILABLE

The NCI intends to commit approximately $1.9 million in FY 2004 to fund four 
(4) to five (5) new and/or competitive continuation grants in response to this 
RFA. $1.9 million in total costs per year for 5 years is to specifically fund 
applications that are submitted in response to this RFA.  Approximately five 
(5) Minority-Based CCOP 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.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, hospitals, and health 
maintenance organizations
o Domestic 
o Faith-based or community organizations
 
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.
  
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.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

SPECIAL REQUIREMENTS

Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program is a 
cooperative agreement (U10), which involves anticipated assistance to awardees 
from the NCI Program Staff. 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, as described 
below.

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. TERMS AND CONDITIONS OF AWARD FOR MINORITY-BASED CCOP AWARDEES

The awardee's programmatic responsibilities for the conduct of the research 
supported by this cooperative agreement are described in the following; 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: 
http://ctep.cancer.gov/handbook/.  GUIDELINES FOR ON-SITE MONITORING OF 
CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES: 
http://ctep.cancer.gov/monitoring/guidelines.html and any subsequent 
modifications of these documents; and the Intellectual Property Option to 
Collaborator: http://ctep.cancer.gov/industry/ipo.html These documents are 
hereby incorporated by reference as terms of award and are available at the 
URLs cited above or from the program staff listed under "INQUIRES."

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. 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 
CTSU 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 tasks 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 federally funded mechanisms, 
such as investigator-initiated awards.  Collaborations between Minority-Based 
CCOPs and independent investigators may facilitate the implementation of a 
wide variety on 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 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. 

NOTE:  A list of currently eligible research bases is available at: 
http://www3.nci.nih.gov/prevention/ccop/rbccop.html 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 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 CCOP Organizational Changes are available 
at: http://cancer.gov/prevention/ccop/guidelines.html  

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 specialty 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 specialty 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 federally 
funded mechanisms, 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 is available at: 
http://www3.nci.nih.gov/prevention/ccop/rbccop.html   

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 FDA Form 1572 on file 
with the Pharmaceutical Management Branch, CTEP, DCTD, NCI. 

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) 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, a component, or a research base.  The Guidelines for Obtaining 
Approval of CCOP Organizational Changes are available at: 
http://cancer.gov/prevention/ccop/guidelines.html.

10. REPORTING REQUIREMENTS

Annual progress reports must be submitted to DCP.  A suggested format will be 
provided for this purpose.  The format is available at: 
http://cancer.gov/prevention/ccop/.  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 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.

NIH requires that Minority-Based CCOP studies meet the NIH policy requirements 
for inclusion of women and minorities in clinical research and inclusion of 
children as participants in research involving human subjects. 

The NIH expects investigators supported by NIH funding to make their research 
data available to the scientific community for subsequent analysis based on a 
data sharing plan approved as part of the award; see the NIH Data Sharing 
Policy website at http://grants.nih.gov/grants/policy/data_sharing/ and CCOP 
guidance at http://cancer.gov/prevention/ccop. This requirement on data 
sharing is an extension to NIH policy regarding sharing research resources, 
which expects that recipients of NIH support will provide prompt and effective 
access to research tools.
  
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 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, a component, or a research base.  The Guidelines for Obtaining 
Approval of CCOP Organizational Changes are available at: 
http://cancer.gov/prevention/ccop/guidelines.html.

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 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.

WHERE TO SEND INQUIRIES  

Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.  Inquires may fall into three areas:  programmatic, peer review, and 
financial or grants management issues:

o Direct inquiries regarding programmatic issues to:

Worta McCaskill-Stevens, MD, MS
Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI
Executive Plaza North - Room 2017
6130 Executive Boulevard, MSC-7340
Bethesda, Maryland 20892-7340
Telephone:  (301) 496-8541
Fax: (301) 496-8667
E-mail address:  wm57h@nih.gov

o Direct inquiries regarding peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

o Direct inquiries regarding financial or grants management issues to:

Ms. Jane Paull
Grants Administration Branch
Office of the Director, NCI
Executive Plaza South - Room 243
6120 Executive Boulevard
Bethesda, Maryland 20892
Telephone:  (301) 496-2182
Fax: (301) 496-8601
E-mail: jp97x@nih.gov

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NCI staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Worta McCaskill-Stevens, MD, MS
Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI
Executive Plaza North - Room 2017
6130 Executive Boulevard, MSC-7340
Bethesda, Maryland 20892-7340
Telephone:  (301) 496-8541
Fax: (301) 496-8667
E-mail address: wm57h@nih.gov

SUBMITTING AN APPLICATION

APPLICATION PROCEDURES

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at:  
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS:

A suggested format ("Suggestions for Organizing Information for a Minority-
Based CCOP Application,") is available at the URL address: 
http://cancer.gov/prevention/ccop/.  All applicants are encouraged to obtain 
and use the suggested format instructions and tables for organizing the 
specific information concerning the RFA programmatic requirements in the PHS 
398.  If tables from the format are included, those tables should be part of 
the body of the application, and NOT included in the appendix.  These tables 
may be included in the application as part of the Resources, Progress Report 
and/or Human Subjects Research sections, as appropriate.  Also, responses to 
the instructions concerning "Human Subjects" verification must be included in 
the application at the time of submission.  Applications in response to this 
RFA may use up to 75 pages to describe the research plan, sections a through 
d.  Applicants are encouraged to use the minimum number of pages necessary to 
clearly and succinctly describe the research plan.  

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 protocols 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 found at: 
http://www3.cancer.gov/prevention/ccop/approved_protocols.html

If applicable, Minority-Based CCOPs should describe their participation in 
cancer prevention and control research studies supported through other 
federally funded mechanisms 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.  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 at: 
http://cancer.gov/prevention/ccop 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 Minority-Based CCOP must describe how its plan to share data.  The 
procedures to be used and a timeline for making the data available should be 
included in the description of the plan.  The Minority-Based CCOP also should 
discuss how the rights and confidentiality of participants are protected.

12. 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.

13. 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.

USING THE RFA LABLEL

The RFA label available in the PHS 398 (rev. 5/2001) 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 RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 

SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:
 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/
NOT-CA-02-002.html)  This change in practice is effective immediately.  
This policy is similar to and consistent with the policy for applications 
addressed to Centers for Scientific Review as published in the NIH Guide 
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 
review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 for a previous Minority-Based CCOP 
RFA, but such applications must include an Introduction addressing the 
previous critique.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by the NCI program staff.

Incomplete applications will be returned to the applicant without further 
consideration.  

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 Division of Extramural Activities (DEA) at NCI in accordance with the 
review criteria stated below.  As part of the initial merit review, all 
applications will:

o  Receive a written critique
o  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 and assigned a priority score
o  Those that receive a priority score will undergo a second level review by 
the National Cancer Advisory Board.

REVIEW CRITERIA

All applicants will be evaluated on the following 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 federally funded mechanisms 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 
the individuals' 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.  The adequacy of the data-sharing plan.

11. 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.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

ADDITIONAL CONSIDERATIONS

DATA SHARING:  The adequacy of the proposed plan to share data. 

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

OTHER REVIEW CRITERIA

For competing continuations, the review group will critically examine the 
adequacy of progress during the funding period, including ability to meet the 
accrual goals in cancer treatment and prevention and control, progress made as 
a Minority-Based CCOP, and evaluation of Minority-Base 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-Base CCOP was funded.  The research base evaluation report(s) must be 
provided in the application.  Plans for continued accrual and follow-up of 
participants on protocols will be evaluated.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:   June 16, 2003
Application Receipt Date:        July 14, 2003
Review by NCAB Advisory Board:   February 2004
Anticipated Award Date:          June 1, 2004

AWARD CRITERIA

Applications recommended by the National Cancer Advisory Board will be 
considered by NCI program staff for award based upon: 

o  Scientific and technical merit (as determined by peer review);
o  Availability of funds;
o  Programmatic priorities; and
o  Demographic and geographic distribution of applicants to assure inclusion 
of minority and underserved populations.  

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.

REQUIRED FEDERAL CITATIONS 

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

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
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).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH Guide 
Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II 
Trials" for additional information: http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-00-038.html.  Information concerning essential elements of 
data safety monitoring plans for clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

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 - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02
-001.html); a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy 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 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 is available at 
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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research is available online at:  http://cme.nci.nih.gov/

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this RFA 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.

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). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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. 
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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance No. 93.399 at http://www.cfda.gov/, and is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under 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 described at 
http://grants.nih.gov/grants/policy/policy.htm 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 Grant 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.


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