MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM
Release Date: April 24, 2002 (see reissuance RFA-CA-04-007)
RFA: CA-03-012
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
LETTER OF INTENT RECEIPT DATE: June 24, 2002
APPLICATION RECEIPT DATE: July 22, 2002
This RFA is a reissuance of RFA-CA-02-004, which was published in the NIH
Guide on 04/2001
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 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
2001, there were ten (10) programs in eight states, the District of Columbia
and Puerto Rico involving approximately 40 hospitals and over 470 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"
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, 2003
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 $2.2 million 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.
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 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. 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.
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.
The NIH expects investigators supported by NIH funding to make their research
data available to the scientific community for subsequent analysis.
Consequently, applicants must address their plans for data sharing in the
grant application (e.g., in sections related to significance, budget, and the
end of the research plan). 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. Investigators should refer to the NIH Guide: NIH Announces Draft
Statement on Sharing Research Data https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-035.html and https://grants.nih.gov/grants/policy/data_sharing/
for guidance on addressing this application requirement. For additional
guidance on the application of this policy to Minority-Based CCOP cooperative
agreements see "Suggestions for Organizing Information for a MBCCOP
Application at: http://cancer.gov/prevention/ccop.
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 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.
NOTE: A list of currently eligible research bases is available at:
http://cancer.gov/prevention/ccop/grantees.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 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 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 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 is available at:
http://cancer.gov/prevention/ccop/grantees.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) 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 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 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.
In addition, the Minority-Based CCOP must have a data-sharing plan as required
by the extension of NIH policy regarding sharing research resources (See NIH
Grants Policy, Part II Subpart A, Availability of Research Results). Also,
see the Suggestions for Organizing Information for a Minority-Based CCOP
Application for guidance in the application of this policy to Minority-Based
CCOP cooperative agreements at: http://cancer.gov/prevention/ccop.
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://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 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.
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.
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
Direct inquiries regarding 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: ncidearefof@mail.nih.gov
Direct inquiries regarding fiscal matters 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) 496-7800
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
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:
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS:
A suggested format is available at the URL address:
http://cancer.gov/prevention/ccop/. 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 Minority-Based
CCOP Application" 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
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. 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:
https://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.) (https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by 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.
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, 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. And, if the application is not responsive to the RFA, CSR
staff may contact the applicant to determine whether to return the application
to the applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
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 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
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, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: 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 included in the
section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 24, 2002
Application Receipt Date: July 22, 2002
Review by NCAB Advisory Board: February 2003
Anticipated Award Date: June 1, 2003
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
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:
https://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: https://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 AMENDMENT "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 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at
https://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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research in now 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
https://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.
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, 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 https://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
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.